A traditional Chinese medicine composition for treating uric acid nephropathy, a traditional Chinese medicine preparation, a preparation method and application thereof

Abstract

This invention provides a traditional Chinese medicine composition, preparation method, and application for treating uric acid nephropathy, specifically belonging to the field of traditional Chinese medicine preparation technology. The traditional Chinese medicine composition of this invention comprises the following components in parts by weight: Aconitum carmichaelii 3-7 parts, Cinnamomum cassia 1-7 parts, Morinda officinalis 3-10 parts, Sinapis alba 3-9 parts, Fritillaria thunbergii 5-10 parts, Atractylodes lancea 3-9 parts, Coix lacryma-jobi 10-30 parts, Phellodendron chinense 3-12 parts, Pyrrosia lingua 6-15 parts, Dioscorea hypoglauca 9-15 parts, Smilax glabra 15-60 parts, and Prunus persica 5-10 parts. The traditional Chinese medicine composition of this invention can treat uric acid nephropathy, specifically including uric acid nephropathy of kidney yang deficiency type. It has a mild medicinal property, warms the kidney and invigorates the spleen, clears turbidity and detoxifies, and has no toxic side effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition, preparation method and application for treating uric acid nephropathy. Background Technology

[0002] Uric acid nephropathy is kidney damage caused by hyperuricemia resulting from excessive uric acid production or reduced excretion. Uric acid crystals and high concentrations of amorphous uric acid directly damage the kidneys, especially the renal tubular epithelial cells, leading to deterioration of kidney function and progression to end-stage renal disease. This requires blood purification treatment, causing significant psychological and physical harm to patients and placing a heavy burden on families and society. Modern medical treatment for this disease only focuses on controlling blood uric acid levels and cannot reverse the damage it causes to other organs, such as reducing gout attacks and kidney damage. Specifically, Western medicine advocates that controlling blood uric acid is the treatment of uric acid nephropathy, often using febuxostat tablets with fewer side effects. While febuxostat has proven effective in controlling blood uric acid, it is less effective in protecting kidney function and can trigger gout attacks. Therefore, Western medicine faces many challenges in treating this disease, especially in controlling recurrent gout attacks and protecting kidney function. Currently, there is still a lack of drugs that can lower uric acid, treat uric acid nephropathy, and reduce adverse reactions. Summary of the Invention

[0003] The purpose of this invention is to provide a traditional Chinese medicine composition, preparation, preparation method, and application for treating uric acid nephropathy. The traditional Chinese medicine composition of this invention can treat uric acid nephropathy, specifically including uric acid nephropathy of kidney yang deficiency type. It has a mild medicinal property, warms the kidney and invigorates the spleen, eliminates turbidity and detoxifies, and has no toxic side effects.

[0004] This invention provides a traditional Chinese medicine composition comprising the following components in parts by weight: Aconitum carmichaelii 3-7 parts, Cinnamomum cassia 1-7 parts, Morinda officinalis 3-10 parts, Sinapis alba 3-9 parts, Fritillaria thunbergii 5-10 parts, Atractylodes lancea 3-9 parts, Coix lacryma-jobi 10-30 parts, Phellodendron chinense 3-12 parts, Pyrrosia lingua 6-15 parts, Dioscorea hypoglauca 9-15 parts, Smilax glabra 15-60 parts, and Prunus persica 5-10 parts.

[0005] Preferably, the ingredients include the following components in parts by weight: 3-6 parts Aconitum carmichaelii, 3-5 parts Cinnamomum cassia, 6-10 parts Morinda officinalis, 5-6 parts Sinapis alba, 8-9 parts Fritillaria thunbergii, 5-6 parts Atractylodes lancea, 18-20 parts Coix lacryma-jobi, 9-10 parts Phellodendron chinense, 9-12 parts Pyrrosia lingua, 10-12 parts Dioscorea hypoglauca, 28-30 parts Smilax glabra, and 5-6 parts Prunus persica.

[0006] The present invention also provides a method for preparing the traditional Chinese medicine composition described in the above technical solution, comprising the following steps: mixing each traditional Chinese medicine component with water, decocting 2 to 3 times, filtering the decoction, combining the filtrates, and obtaining the traditional Chinese medicine composition.

[0007] The present invention also provides the use of the traditional Chinese medicine composition described in the above technical solution or the traditional Chinese medicine composition prepared by the preparation method described in the above technical solution in the preparation of a drug for treating any one or more of the following diseases: uric acid nephropathy, primary gout, and primary gouty arthritis.

[0008] The present invention also provides the application of the traditional Chinese medicine composition described in the above technical solution or the traditional Chinese medicine composition prepared by the preparation method described in the above technical solution in the preparation of a drug for treating uric acid nephropathy of the kidney yang deficiency syndrome.

[0009] The present invention also provides the application of the traditional Chinese medicine composition described in the above technical solution or the traditional Chinese medicine composition prepared by the preparation method described in the above technical solution in the preparation of a drug for treating uric acid nephropathy of the type of dampness and blood stasis obstructing collaterals and kidney yang deficiency.

[0010] The present invention also provides a traditional Chinese medicine preparation for treating uric acid nephropathy, comprising the traditional Chinese medicine composition described in the above technical solution or the traditional Chinese medicine composition prepared by the preparation method described in the above technical solution and pharmaceutically acceptable excipients.

[0011] Preferably, the dosage form of the traditional Chinese medicine preparation includes decoction, granules, capsules or tablets.

[0012] The present invention also provides a method for preparing the traditional Chinese medicine preparation described in the above technical solution, comprising the following steps: mixing each traditional Chinese medicine component with water, decocting 2-3 times, filtering the decoction, combining the filtrates, concentrating, and obtaining the traditional Chinese medicine preparation.

[0013] Preferably, when the dosage form of the traditional Chinese medicine preparation is granules, capsules or tablets, the preparation method further includes, after concentration: drying and pulverizing to obtain traditional Chinese medicine powder, mixing the traditional Chinese medicine powder with pharmaceutically acceptable excipients to prepare granules, capsules or tablets.

[0014] This invention provides a traditional Chinese medicine composition for treating uric acid nephropathy. The composition effectively lowers uric acid and reduces adverse drug reactions. It is mild in nature, neither too hot nor too cold, and regular use benefits the kidneys and warms yang, strengthens the spleen and stomach, replenishes essence and nourishes deficiency, and eliminates turbidity and detoxifies. It can be used to treat uric acid nephropathy (such as uric acid nephropathy due to kidney yang deficiency and dampness-stasis obstructing the collaterals). Guided by traditional Chinese medicine theory, based on solid clinical practice, and utilizing modern scientific research methods, this invention provides a traditional Chinese medicine composition for treating uric acid nephropathy, with the principles of warming the kidneys and invigorating the spleen, and eliminating turbidity and detoxifying. Compared with similar drugs, this invention's composition is mild in nature, rigorously and exquisitely formulated, and exhibits significant clinical efficacy, achieving good results in a relatively short period. Detailed Implementation

[0015] This invention provides a traditional Chinese medicine composition comprising the following components in parts by weight: 3-7 parts Aconitum carmichaelii, 1-7 parts Cinnamomum cassia, 3-10 parts Morinda officinalis, 3-9 parts Sinapis alba, 5-10 parts Fritillaria thunbergii, 3-9 parts Atractylodes lancea, 10-30 parts Coix lacryma-jobi, 3-12 parts Phellodendron chinense, 6-15 parts Pyrrosia lingua, 9-15 parts Dioscorea hypoglauca, 15-60 parts Smilax glabra, and 5-10 parts Prunus persica. This invention discovers that kidney yang deficiency is the root cause of uric acid nephropathy. When kidney yang fails to warm and nourish the essence, yin and cold stagnate, forming turbid toxins that deposit in the joints and kidneys. Therefore, the internal accumulation of turbid toxins is the key to the pathogenesis. The medicine of this invention focuses on warming and tonifying kidney yang while simultaneously strengthening the spleen and detoxifying. The traditional Chinese medicine composition described in this invention is referred to as the Kidney-Warming and Detoxifying Formula.

[0016] The traditional Chinese medicine composition of this invention comprises 3-7 parts of Aconitum carmichaelii, specifically 3, 5, or 6 parts. In this invention, Aconitum carmichaelii plays the role of warming and tonifying the kidney's vital energy (Mingmen fire) and dispelling deep-seated cold. This invention does not have a specific limitation on the source of Aconitum carmichaelii; commercially available Aconitum carmichaelii is sufficient.

[0017] The traditional Chinese medicine composition of this invention comprises 1 to 7 parts of cinnamon, specifically 3 to 5 parts, or more specifically 3, 4, or 5 parts. In this invention, the role of cinnamon in the traditional Chinese medicine composition is to tonify fire and assist yang, guiding fire back to its source. This invention does not have a specific limitation on the source of the cinnamon; commercially available cinnamon is sufficient.

[0018] The traditional Chinese medicine composition of this invention comprises 3-10 parts of Morinda officinalis, specifically 6, 8, or 10 parts. In this invention, Morinda officinalis plays the role of tonifying kidney yang, strengthening tendons and bones, and also dispelling wind-dampness and relieving pain. This invention does not have a specific limitation on the source of the Morinda officinalis; commercially available Morinda officinalis is sufficient.

[0019] The traditional Chinese medicine composition of this invention comprises 3-9 parts of white mustard seed, specifically 5-6 parts. In this invention, the function of white mustard seed in the traditional Chinese medicine composition is to promote qi circulation, disperse stagnation, unblock meridians, and relieve pain. This invention does not have a specific limitation on the source of the white mustard seed; commercially available white mustard seed is sufficient.

[0020] The traditional Chinese medicine composition of this invention comprises 5-10 parts of Fritillaria thunbergii, specifically 8-9 parts. In this invention, Fritillaria thunbergii plays the role of clearing heat and resolving phlegm, relieving stagnation and dissipating nodules in the traditional Chinese medicine composition. This invention does not have a specific limitation on the source of Fritillaria thunbergii; commercially available Fritillaria thunbergii is sufficient.

[0021] The traditional Chinese medicine composition of this invention comprises 3-9 parts of Atractylodes lancea, specifically 5-6 parts. In this invention, Atractylodes lancea in the traditional Chinese medicine composition functions as pungent, aromatic, bitter, and warm in nature, drying dampness and strengthening the spleen, and also dispelling wind and cold. This invention does not have a specific limitation on the source of Atractylodes lancea; commercially available Atractylodes lancea is sufficient.

[0022] The traditional Chinese medicine composition of this invention comprises 10-30 parts of raw Job's tears, specifically 18-20 parts, 18 parts, 19 parts, or 20 parts. In this invention, the raw Job's tears in the traditional Chinese medicine composition function as being sweet, bland, and slightly cold in nature, promoting diuresis and dampness elimination, and strengthening the spleen and relaxing muscles. This invention does not have a specific limitation on the source of the raw Job's tears; commercially available raw Job's tears are sufficient.

[0023] The traditional Chinese medicine composition of this invention comprises 3-12 parts of Phellodendron bark, specifically 9-10 parts. In this invention, the function of Phellodendron bark in the traditional Chinese medicine composition is to clear damp-heat in the lower burner. This invention does not have a specific limitation on the source of the Phellodendron bark; commercially available Phellodendron bark is sufficient.

[0024] The traditional Chinese medicine composition of this invention comprises 6-15 parts of Pyrrosia lingua, specifically 9-12 parts, including 9, 10, 11, or 12 parts. In this invention, Pyrrosia lingua in the traditional Chinese medicine composition has the functions of being bitter, sweet, and slightly cold in nature, and promoting diuresis and relieving strangury. This invention does not have a specific limitation on the source of the Pyrrosia lingua; commercially available Pyrrosia lingua is sufficient.

[0025] The traditional Chinese medicine composition of this invention comprises 9-15 parts of Dioscorea hypoglauca, specifically 10, 11, or 12 parts. In this invention, Dioscorea hypoglauca functions to promote diuresis, eliminate turbidity, dispel wind, and relieve numbness. This invention does not specifically limit the source of the Dioscorea hypoglauca; commercially available Dioscorea hypoglauca is sufficient.

[0026] The traditional Chinese medicine composition of this invention includes 15-60 parts of Smilax glabra, specifically 28-30 parts, or more specifically 28, 29, or 30 parts. In this invention, Smilax glabra plays the role of detoxification, dampness removal, and joint mobility promotion in the traditional Chinese medicine composition. This invention does not have a specific limitation on the source of the Smilax glabra; commercially available Smilax glabra is sufficient.

[0027] The traditional Chinese medicine composition of this invention comprises 5-10 parts, specifically 5-6 parts, of peach kernel. In this invention, the peach kernel functions to invigorate blood circulation, remove blood stasis, and promote bowel movement. This invention does not have a specific limitation on the source of the peach kernel; commercially available peach kernels are sufficient.

[0028] In the herbal composition described in this invention, Aconitum carmichaelii, Cinnamomum cassia, and Morinda officinalis greatly tonify the primordial yang, warm the body's yang, and promote the dissolution and excretion of uric acid crystals; Atractylodes lancea, Coix lacryma-jobi, and Phellodendron chinense invigorate the spleen and eliminate dampness; Sinapis alba warms and transforms cold phlegm, preventing the regeneration of uric acid crystals; Phellodendron chinense, Smilax glabra, Pyrrosia lingua, and Dioscorea hypoglauca detoxify and purge turbidity, promoting uric acid excretion; Prunus persica invigorates blood and removes blood stasis, improving local stagnation and helping to dissipate and expel turbid toxins, achieving the effect of free flow and pain relief; Fritillaria thunbergii clears heat and resolves phlegm, relieving stagnation and dispersing nodules. The combined effects of these herbs warm the kidneys and invigorate the spleen, purge turbidity and detoxify, effectively lowering uric acid and reducing adverse drug reactions; the herbs are mild in nature, neither cold nor hot, and regular use benefits the kidneys and warms the yang, strengthens the spleen and stomach, replenishes essence and tonifies deficiency, and purges turbidity and detoxifies, making it suitable for the treatment of uric acid nephropathy (such as uric acid nephropathy of the kidney yang deficiency and dampness-stasis obstruction syndrome types). The herbal composition of this invention is exquisitely formulated and has significant clinical efficacy.

[0029] The present invention also provides a method for preparing the traditional Chinese medicine composition described in the above technical solution, comprising the following steps: mixing each traditional Chinese medicine component with water, decocting 2 to 3 times, filtering the decoction, combining the filtrates, and obtaining the traditional Chinese medicine composition.

[0030] This invention involves mixing various Chinese herbal medicine components with water. In a specific embodiment, the total mass ratio of the Chinese herbal medicine components to the water is 1:(6~8), specifically 1:6, 1:7, or 1:8. The decoction process described in this invention is carried out under natural pressure. After mixing the Chinese herbal medicine components with water, the mixture is decocted. In a specific embodiment, the decoction time for each batch can be 1.5~2.5 hours, specifically 2 hours.

[0031] The present invention also provides the use of the traditional Chinese medicine composition described in the above technical solution or the traditional Chinese medicine composition prepared by the preparation method described in the above technical solution in the preparation of a drug for treating any one or more of the following diseases: uric acid nephropathy, primary gout, and primary gouty arthritis.

[0032] The present invention also provides the application of the traditional Chinese medicine composition described in the above technical solution or the traditional Chinese medicine composition prepared by the preparation method described in the above technical solution in the preparation of a drug for treating uric acid nephropathy of the kidney yang deficiency syndrome.

[0033] The present invention also provides the application of the traditional Chinese medicine composition described in the above technical solution or the traditional Chinese medicine composition prepared by the preparation method described in the above technical solution in the preparation of a drug for treating uric acid nephropathy of the type of dampness and blood stasis obstructing collaterals and kidney yang deficiency.

[0034] This invention also provides a traditional Chinese medicine preparation for treating uric acid nephropathy, comprising the traditional Chinese medicine composition described in the above-described technical solution or the traditional Chinese medicine composition prepared by the preparation method described in the above-described technical solution, and pharmaceutically acceptable excipients. In specific embodiments, the dosage form of the traditional Chinese medicine preparation includes decoction, granules, capsules, or tablets. In specific embodiments, the dosage and administration of the traditional Chinese medicine preparation can be as follows: decoction, 1 dose per day, twice daily; granules, 10-15g each time; tablets, 3-4 tablets each time; capsules, 6-8 capsules each time, orally three times daily. One course of treatment is 30 days.

[0035] This invention also provides a method for preparing the traditional Chinese medicine preparation described in the above technical solution, comprising the following steps: mixing each traditional Chinese medicine component with water, decocting 2-3 times, filtering the decoction, combining the filtrates, and concentrating to obtain the traditional Chinese medicine preparation. In a specific embodiment, the concentration can be to concentrate to an extract with a relative density of 1.20-1.25 (80℃). In a specific embodiment, when the dosage form of the traditional Chinese medicine preparation is granules, capsules, or tablets, the preparation method further includes, after concentration: drying and pulverizing to obtain traditional Chinese medicine powder, mixing the traditional Chinese medicine powder with pharmaceutically acceptable excipients to prepare granules, capsules, or tablets. In a specific embodiment, the drying can be vacuum drying. This invention does not specifically limit the excipients; commonly used excipients for granules, capsules, or tablets known to those skilled in the art can be used. This invention does not specifically limit the preparation methods for granules, capsules, and tablets; conventional preparation methods can be used.

[0036] To further illustrate the present invention, the following detailed description, in conjunction with embodiments, provides a traditional Chinese medicine composition, preparation method, and application for treating uric acid nephropathy provided by the present invention, but these descriptions should not be construed as limiting the scope of protection of the present invention.

[0037] Example 1 Weigh out 6g of Aconitum carmichaelii, 3g of Cinnamomum cassia, 9g of Morinda officinalis, 6g of Sinapis alba, 9g of Fritillaria thunbergii, 6g of Atractylodes lancea, 20g of Coix lacryma-jobi, 9g of Phellodendron chinense, 9g of Pyrrosia lingua, 12g of Dioscorea hypoglauca, 30g of Smilax glabra, and 6g of Prunus persica. Add 8 times the amount of water, and decoct three times under natural pressure, 2 hours each time. Filter the decoction, combine the filtrates, and obtain the traditional Chinese medicine decoction.

[0038] Example 2 diagnosis 1. Disease diagnosis (1) Diagnostic criteria for hyperuricemia: According to the Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout (2019), the diagnostic criteria for hyperuricemia are: under normal purine diet conditions, regardless of male or female, if the fasting blood uric acid level exceeds 420 μmol / L on two separate days, it is called hyperuricemia.

[0039] (2) Diagnostic criteria for uric acid nephropathy: The diagnostic criteria were formulated with reference to the diagnostic criteria in Wang Haiyan's "Nephrology" (3rd edition): A history of gout or hyperuricemia, or one of the following types of kidney damage: a. Decreased renal function indicators (serum creatinine, blood urea nitrogen, glomerular filtration rate); b. Persistent abnormal urinalysis results (including proteinuria, hematuria, crystalloids, etc.); c. Urinary tract stones (tested to be composed of urate crystals); d. There are lesions in the renal interstitium, accompanied by crystal (urate) formation.

[0040] It also excludes other causes of abnormal urine tests and kidney function, such as various primary kidney diseases, diabetes, hepatitis B, autoimmune diseases, malignant tumors, and nephrotoxic drugs.

[0041] 2. Traditional Chinese Medicine (TCM) Syndrome Diagnosis Criteria: These criteria are formulated with reference to the diagnostic standards in the People's Republic of China's TCM Industry Standard "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine" and the "Trial Scheme for Diagnosis, Syndrome Differentiation, and Efficacy Evaluation of Uric Acid Nephropathy" developed by the Nephrology Branch of the China Association of Traditional Chinese Medicine. Main symptoms: pale (or dark) complexion, edema, aversion to cold and cold limbs, soreness or cold pain in the lower back and knee joints, and heel pain.

[0042] Secondary symptoms: lethargy, poor appetite or loose stools (early morning diarrhea), sexual dysfunction (nocturnal emission, impotence, premature ejaculation) or menstrual disorders, frequent and clear urination at night.

[0043] Tongue and pulse: The tongue is tender, pale, and swollen with teeth marks, and the pulse is deep, thready, or deep, slow, and weak.

[0044] 3. Western medicine efficacy evaluation criteria (referring to the "Diagnosis, Syndrome Differentiation and Efficacy Evaluation of Uric Acid Nephropathy" (Trial Scheme) formulated by the Nephrology Branch of the China Association of Traditional Chinese Medicine in 2008, see Table 1 for details) Table 1. Criteria for Judging the Efficacy of Western Medicine

[0045] Research Methods 1. Inclusion criteria (1) Meets the above-mentioned TCM and Western medicine diagnoses of kidney yang deficiency and dampness obstructing the collaterals; (2) Age between 18 and 75 years old; (3) Glomerular filtration rate ≥30 ml / min·1.73 m 2 those; (4) Be aware of this experiment and sign an informed consent form.

[0046] 2. Exclusion criteria (1) Secondary uric acid nephropathy; (2) Patients with underlying primary diseases, tumors, or mental disorders; (3) Individuals who are known to be allergic to any of the components of the investigational drug, or who have an allergic constitution; (4) Pregnant women and breastfeeding mothers; (5) When the clinical researcher believes that the subjects participating in the clinical study cannot cooperate with the observation.

[0047] 3. Research Methods A total of 180 patients with uric acid nephropathy meeting the inclusion and excretion criteria were collected and divided into a cohort study group and a control group, with 90 patients in each group. Both groups received basic treatment: ① a bland, low-purine diet; ② regular rest, reasonable exercise, and abstinence from smoking and alcohol. The control group received basic treatment plus oral febuxostat tablets 20mg once daily. The traditional Chinese medicine group received the same treatment as the control group, plus oral administration of the traditional Chinese medicine prepared in Example 1 of this invention (hereinafter referred to as Wen Shen Jie Du Fang). The treatment course was 3 months. Statistical analysis was performed after the trial to verify the clinical efficacy and safety of Wen Shen Jie Du Fang in treating uric acid nephropathy.

[0048] Treatment criteria 1. Traditional Chinese Medicine (TCM) syndrome differentiation and efficacy criteria: Refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs (Trial Implementation)" formulated and promulgated in 2002. The calculation formula adopts the nimodipine method.

[0049] Calculation formula: [(Pre-treatment score - Post-treatment score) ÷ Pre-treatment score] × 100%; ① Clinically cured: Symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥95%; ②Significant effect: Symptoms and signs are significantly improved, and the syndrome score is reduced by ≥70%; ③ Effective: Symptoms and signs improved, and the syndrome score decreased by ≥30%; ④ Ineffective: Symptoms and signs show no significant improvement, or even worsen, and the syndrome score decreases by <30%.

[0050] (1) Therapeutic indicators: ① Observe the TCM syndrome scores of the two groups of patients before treatment and at weeks 2, 4, 8, and 12 of treatment. ② Compare the interval between drug withdrawal and the frequency of uric acid recurrence to 420 μmol / L between the two groups. ③ Compare the number of gout attacks and the severity of pain during the medication period between the two groups. ④ Observe the serum creatinine, uric acid, blood urea nitrogen, urinary protein, and urinary NAG enzyme levels of the patients at weeks 0, 4, 8, and 12. See Table 2 for detailed TCM diagnostic information.

[0051] Table 2 Quantitative Scoring Table for Traditional Chinese Medicine Symptoms

[0052] (2) Other observation indicators: ① Demographic information: gender, age, long-term living region, diet, personal history, history of uric acid nephropathy, etc.

[0053] ② Physical examination information: height, weight, blood pressure, etc.

[0054] Safety indicators: Observe blood routine, liver function, electrocardiogram, etc. before and after treatment.

[0055] The experimental results and analysis are shown in Tables 3 to 6: Table 3 Comparison of efficacy and overall effective rate between the two groups of patients with uric acid nephropathy

[0056] Note: Compared with the control group, # P <0.01.

[0057] As shown in Table 2, compared with the control group, the total effective rate of the traditional Chinese medicine group was significantly higher, which was statistically significant (P<0.01).

[0058] Table 4 Comparison of symptom quantification scores between the two groups of patients with uric acid nephropathy ( ±s)

[0059] Note: Compared with the control group, #P<0.01.

[0060] As shown in Table 3, the scores of both primary and secondary symptoms decreased after treatment in both groups. Compared with the control group, the scores of primary and secondary symptoms in the traditional Chinese medicine group decreased significantly after treatment, which was statistically significant (P<0.05).

[0061] Table 5 Comparison of uric acid recurrence in the two groups of patients with uric acid nephropathy ( ±s)

[0062] As shown in Table 4, after treatment, compared with the control group, the uric acid recurrence rate in the traditional Chinese medicine group was significantly lower, which was statistically significant.

[0063] Table 6 Comparison of physical and chemical indicators between the two groups of IgA nephropathy patients ( ±s)

[0064] As shown in Table 5, compared with before treatment, serum creatinine, uric acid, blood urea nitrogen, and urinary NAG enzyme levels in both the control group and the traditional Chinese medicine group were significantly improved after treatment, with statistical significance (P<0.05).

[0065] In the treatment of uric acid nephropathy, the core of Western medicine combined with basic treatment is to precisely control indicators, such as rapidly lowering uric acid and delaying the decline of kidney function. However, it has limited effect on the fundamental pathogenesis of "deficiency of kidney yang and obstruction of the collaterals by dampness and blood stasis". Patients often face the dilemma that the indicators improve but symptoms such as aversion to cold, cold back, and joint pain still exist.

[0066] This invention, the "Kidney-Warming and Detoxifying Formula," combined with basic treatment, addresses the root cause of the disease. It restores the body's Qi transformation by warming and tonifying kidney Yang, and combines this with methods to strengthen the spleen, eliminate dampness, invigorate blood, and detoxify. This not only synergistically improves kidney function and uric acid levels but also significantly alleviates systemic symptoms caused by kidney Yang deficiency and dampness stagnation. Its core advantage lies in the integration of Western medicine's indicator control with Traditional Chinese Medicine's symptom regulation. Through multi-target holistic regulation, it enhances efficacy while reducing toxicity, aiming to improve the patient's constitution and quality of life. This provides a more holistic and individualized TCM solution for the long-term management of this chronic disease.

[0067] Example 3 Typical Case 1: Mr. Gao, male, 57 years old, first visit on November 10, 2024.

[0068] Chief complaint: Fatigue accompanied by elevated blood uric acid for more than 2 years.

[0069] Present Illness: Two years ago, the patient developed fatigue without any obvious cause and sought medical attention at Jilin Provincial People's Hospital. A urinalysis showed proteinuria (+), negative occult blood, urine NAG enzyme 56 U / L, and serum creatinine 139 μmol / L. Current Symptoms: Fatigue, lower back pain, frequent urination (5 times per night), cold hands and feet, occasional joint pain, good appetite, good sleep, and normal bowel movements. Dark tongue with a thin white coating, and a deep, slippery pulse.

[0070] Physical examination: Gouty tophi were found in the joints of both hands and feet.

[0071] Auxiliary examinations: serum creatinine 139 μmol / L, uric acid 527 μmol / L, blood urea nitrogen 10.1 mmol / L, urine protein +, occult blood negative, urine NAG enzyme 56 U / L. History of gout for over 10 years.

[0072] Traditional Chinese Medicine diagnosis: Asthenia, Kidney Yang Deficiency, Dampness and Blood Stasis Obstructing the Collaterals; Western Medicine diagnosis: Uric acid nephropathy.

[0073] Treatment principle: warm the kidneys and invigorate the spleen, purge turbidity and detoxify.

[0074] Prescription: Kidney-warming and detoxifying formula (a traditional Chinese medicine decoction prepared in Example 1). Usage: Decocted in water to obtain 450 ml of juice, 150 ml each time, orally twice a day.

[0075] Second visit: Fatigue and cold intolerance significantly improved; urinary frequency slightly improved, 3 times per night. Physical examination: Gouty tophi were present in the joints of both hands and feet. Auxiliary examinations: Serum creatinine 125 μmol / L, uric acid 475 μmol / L, blood urea nitrogen 9.1 mmol / L, urine protein +, occult blood negative, urine NAG enzyme 45 U / L. Continue the original prescription for 10 more doses. Dosage: Decoction in water to obtain 450 ml of liquid; take 150 ml each time, twice daily.

[0076] The third visit revealed significant improvement in fatigue, lower back pain, and cold intolerance; urinary frequency also improved; and there were no gout attacks. Physical examination revealed gouty tophi in the joints of both hands and feet. Auxiliary examinations showed: serum creatinine 119 μmol / L, uric acid 445 μmol / L, blood urea nitrogen 7.1 mmol / L, urine protein (±), occult blood negative, and urine NAG enzyme 26 U / L. The previous treatment plan was continued.

[0077] Six months later, a follow-up examination showed serum creatinine of 110 μmol / L, uric acid of 410 μmol / L, blood urea nitrogen of 7.2 mmol / L, urine protein (+-), negative occult blood, and urine NAG enzyme of 22 U / L.

[0078] This invention, the "Kidney-Warming and Detoxifying Formula," demonstrates a clear therapeutic effect on uric acid nephropathy and its syndrome of "Kidney Yang Deficiency and Dampness-Blood Stasis Obstructing the Collaterals." After treatment, patients experienced significant improvement in systemic symptoms such as fatigue, lower back pain, and cold hands and feet. Simultaneously, key laboratory indicators continued to improve: serum creatinine decreased from 139 μmol / L to 110 μmol / L, and uric acid decreased from 527 μmol / L to 410 μmol / L, indicating that kidney function was protected and uric acid excretion was enhanced; urinary NAG enzyme decreased from 56 U / L to 22 U / L, more directly reflecting the effective repair of renal tubular damage.

[0079] The success of this treatment lies in the high degree of consistency between the prescription and the pathogenesis. This prescription addresses the root cause by warming and tonifying kidney yang, rapidly improving the symptoms of deficiency and cold; at the same time, it addresses the symptoms by promoting diuresis, eliminating turbidity, invigorating blood, and detoxifying. Thus, while improving symptoms, it also promotes a simultaneous decrease in objective indicators reflecting kidney damage and uric acid levels, demonstrating the integrated advantages of traditional Chinese medicine's "syndrome differentiation and treatment, addressing both the root cause and the symptoms" in treating this disease.

[0080] Typical Case 2: Initial diagnosis Name: Zhang; Gender: Male; Age: 56; Ethnicity: Han; Marital Status: Married; Occupation: Retired worker; Date of Consultation: 9:30 AM, January 7, 2025.

[0081] Chief complaint: Recurrent lower limb joint pain for 3 years, weakness and edema for 1 month, worsening with increased nocturia for 3 days.

[0082] Present Illness: Three years ago, the patient developed bilateral metatarsophalangeal joint pain without any obvious cause. The pain worsened with cold and was slightly relieved by warmth. A local hospital examination revealed elevated uric acid levels (specific value unknown), and the patient was diagnosed with gout. Allopurinol was intermittently taken orally (specific dosage unknown), with symptoms fluctuating in severity. One month ago, the patient experienced general weakness after exertion, which worsened with activity. Mild pitting edema of both lower extremities and morning eyelid swelling were also observed, accompanied by loss of appetite and abdominal distension. No systematic treatment was sought. Three days ago, the above symptoms worsened, with edema spreading to the knees. Nocturia increased to 3-4 times per night, with thin, clear urine. The patient also experienced cold limbs, lower back and knee weakness, but no fever, cough, urinary frequency, urgency, dysuria, or gross hematuria. The patient sought systematic treatment at our hospital. Since the onset of the illness, the patient has been lethargic, has poor sleep, poor appetite, loose stools (1-2 times daily), and has lost approximately 2 kg in the past month.

[0083] Past medical history: 5-year history of hypertension, with a highest blood pressure of 150 / 95 mmHg. Intermittently taking "nifedipine sustained-release tablets" to control blood pressure (specific dosage unknown), but blood pressure control is poor; denies history of chronic diseases such as diabetes and coronary heart disease; denies history of infectious diseases such as hepatitis and tuberculosis; denies history of surgery or trauma.

[0084] Allergy history: Denies any history of drug or food allergies.

[0085] Personal history: Long-term resident of the local area, with a 30-year smoking history, approximately 10 cigarettes per day; a 25-year drinking history, consuming approximately 2 liang (100ml) of baijiu (Chinese liquor) daily; enjoys foods high in purines, such as animal offal and seafood; denies any history of exposure to dust or toxins, and denies any history of prostitution.

[0086] Traditional Chinese Medicine Four Diagnostic Methods: Fatigue and weakness, listlessness, pale complexion, aversion to cold and cold limbs, soreness and weakness of the lower back and knees, pitting edema of both lower limbs, abdominal distension, poor appetite, increased urination at night, and loose stools. The tongue is pale and swollen with teeth marks on the edges, a white and greasy coating, and the pulse is deep, slow, and weak.

[0087] Auxiliary examinations: Urinalysis: proteinuria (++), glucoseuria (-), hematuria (+), white blood cells (-), red blood cells 3-5 / HP, casts 1-2 / LP; Renal function: serum creatinine 186 μmol / L (reference range: 57~111 μmol / L), blood urea nitrogen 9.8 mmol / L (reference range: 3.2~7.1 mmol / L), uric acid 682 μmol / L (reference range: 208~428 μmol / L); Electrolytes: potassium 4.2 mmol / L, sodium 138 mmol / L, chloride 102 mmol / L; Blood pressure: 145 / 90 mmHg.

[0088] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins).

[0089] Western medical diagnosis: 1. Uric acid nephropathy; 2. Primary gout; 3. Primary hypertension, grade 1.

[0090] Treatment: 1. Traditional Chinese Medicine Treatment: Warming the kidneys and strengthening the spleen, clearing away turbidity and detoxifying. Administer the herbal decoction described in Example 1. 7 doses, one dose daily, taken warm twice a day, morning and evening. 2. Western Medicine Treatment: Low-purine diet, quitting smoking and limiting alcohol consumption, drinking 2000-3000ml of water daily; oral benzbromarone 50mg once daily (to promote uric acid excretion); nifedipine sustained-release tablets 20mg twice daily (to control blood pressure); regular monitoring of blood uric acid, kidney function, and blood pressure. 3. Nursing Care: Keep warm, avoid fatigue, avoid getting cold and damp, engage in appropriate light exercise (such as walking), and avoid strenuous exercise.

[0091] Follow-up visit Consultation time: 9:36 AM, January 15, 2025 Changes in condition: After taking the above medication for 7 doses, the patient's symptoms of aversion to cold, cold limbs, and weakness in the lower back and knees were significantly relieved. The edema in both lower limbs was reduced compared to before (only mild edema in the ankles). The frequency of urination at night decreased to 1-2 times / night. Appetite improved compared to before, abdominal distension was reduced, bowel movements became formed once a day, and mental state improved. Mild fatigue still exists, which is slightly more pronounced after activity. There is no obvious soreness in the metatarsophalangeal joints of both lower limbs.

[0092] Traditional Chinese Medicine diagnosis: The patient's fatigue and weakness have improved; complexion is rosier; aversion to cold and cold limbs have lessened; lower back and knee pain has eased; mild pitting edema is present in the ankles of both lower limbs; appetite has improved; abdominal distension has lessened; nocturia has decreased; and stools are formed. The tongue is pale with teeth marks on the edges; the coating is white and slightly greasy; and the pulse is deep and slow.

[0093] Auxiliary examinations: Urinalysis: proteinuria (+), occult blood in urine (±), red blood cells 1~2 / HP, casts 0~1 / LP; Renal function: serum creatinine 162μmol / L, blood urea nitrogen 8.5mmol / L, uric acid 546μmol / L; Blood pressure: 135 / 85mmHg.

[0094] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins, and residual toxins not yet cleared).

[0095] Western medicine diagnosis: 1. Uric acid nephropathy (condition improving); 2. Primary gout (remission period); 3. Primary hypertension grade 1 (well controlled).

[0096] Treatment: 1. Traditional Chinese Medicine Treatment: The herbal decoction described in Example 1. 14 doses, one dose daily, taken warm twice a day, morning and evening. 2. Western Medicine Treatment: Continue taking benzbromarone 50mg once daily; nifedipine sustained-release tablets 20mg twice daily; maintain a low-purine diet, continue to ensure adequate daily water intake, quit smoking and limit alcohol consumption. 3. Nursing Care: Continue to keep warm, avoid fatigue, and appropriately increase exercise intensity (such as brisk walking). Regularly check blood uric acid, kidney function, urinalysis, and blood pressure (after 2 weeks).

[0097] According to the follow-up treatment results, after taking 7 doses of the medication, the patient's typical symptoms of kidney yang deficiency and internal retention of dampness, such as aversion to cold and cold limbs, soreness and weakness of the lower back and knees, edema, and frequent urination at night, were significantly relieved. Objectively, serum creatinine, reflecting kidney function, decreased from 186 μmol / L to 162 μmol / L, and urinary protein decreased; serum uric acid decreased significantly from 682 μmol / L to 546 μmol / L. This indicates that while this formula works synergistically with Western medicine to lower uric acid, it focuses more on warming and tonifying kidney yang to enhance qi transformation and eliminating dampness and turbidity to clear the water passages. This achieves multiple therapeutic goals—improving kidney filtration function from the root cause, protecting nephrons, and alleviating clinical symptoms—highlighting the holistic regulatory advantages of traditional Chinese medicine's syndrome differentiation and treatment for this type of disease.

[0098] Note: The treatment outcomes of typical cases 2 to 11 after follow-up treatment follow the same trend as typical case 1. These cases only provide information from the initial consultation to the follow-up consultation (second consultation) to illustrate the treatment effect.

[0099] Typical Case 3: Initial diagnosis Name: Li; Gender: Male; Age: 62; Ethnicity: Han; Marital Status: Married; Occupation: Self-employed (Seafood Business); Date of Consultation: February 8, 2025, 2:10 PM.

[0100] Chief complaint: Intermittent redness, swelling, heat and pain in the first metatarsophalangeal joint of the right foot for 5 years, soreness and weakness in the lower back and knees and edema of the limbs for 2 months, which has worsened and been accompanied by cloudy urine for 1 week.

[0101] Present Illness: Five years ago, the patient developed redness, swelling, heat, and pain in the first metatarsophalangeal joint of his right foot after drinking alcohol. The pain was so severe that he could not walk. A local hospital test showed a blood uric acid level of 720 μmol / L, and he was diagnosed with gouty arthritis. He was prescribed colchicine, which relieved his symptoms. Since then, attacks have occurred 3-4 times a year, triggered by alcohol consumption or seafood intake, with intermittent use of febuxostat (irregular dosage). Two months ago, the patient developed lower back and knee weakness without any obvious cause, which worsened with activity. He also experienced mild pitting edema in both lower limbs, accompanied by dizziness, tinnitus, and chills, which he did not pay much attention to. One week ago, these symptoms worsened, with the edema spreading to the calves. His urine became cloudy like rice water, and he experienced increased nocturia (4-5 times per night), accompanied by loss of appetite and nausea, but no vomiting, fever, or gross hematuria. He came to our hospital seeking traditional Chinese medicine treatment. Since the onset of the illness, he has experienced lethargy, poor sleep, poor appetite, loose stools (twice daily), and a weight loss of 3 kg in the past two months.

[0102] Past medical history: 8-year history of type 2 diabetes, long-term oral administration of "metformin extended-release tablets 0.5g, twice daily", with relatively good blood glucose control (fasting blood glucose 6.5~7.5mmol / L); denies history of hypertension, coronary heart disease; denies history of hepatitis, tuberculosis, or other infectious diseases; denies history of surgery or trauma.

[0103] Allergy history: Denies any history of drug or food allergies.

[0104] Personal history: Long-term resident of the local area, engaged in the seafood business for 15 years, with daily contact with seafood, and enjoys eating seafood and animal offal; 35-year smoking history, 15 cigarettes per day; 30-year drinking history, 500ml of beer or 3 liang of liquor per day; denies any history of exposure to dust or toxins.

[0105] Traditional Chinese Medicine (TCM) diagnosis: The patient presents with lethargy, pale complexion, aversion to cold, lower back and knee weakness, pitting edema of both lower limbs (calves), dizziness and tinnitus, cloudy urine resembling rice water, increased nocturia, poor appetite and nausea, and loose stools. The tongue is pale and swollen with teeth marks on the edges, the coating is white, greasy, and slightly yellow, and the pulse is deep, slow, and slippery.

[0106] Auxiliary examinations: Urinalysis: proteinuria (+++), glucoseuria (+), hematuria (++), white blood cells (-), red blood cells 5~8 / HP, casts 2~3 / LP; Renal function: serum creatinine 210μmol / L (reference range: 57~111μmol / L), blood urea nitrogen 11.2mmol / L (reference range: 3.2~7.1mmol / L), uric acid 756μmol / L (reference range: 208~428μmol / L); Blood glucose: fasting 7.2mmol / L, 2 hours postprandial 11.5mmol / L; Blood pressure: 130 / 80mmHg; Electrolytes: potassium 4.5mmol / L, sodium 136mmol / L, chloride 101mmol / L.

[0107] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins, and concurrent damp-heat).

[0108] Western medical diagnoses: 1. Uric acid nephropathy; 2. Primary gouty arthritis (chronic phase); 3. Type 2 diabetes mellitus; Treatment: 1. Traditional Chinese Medicine Treatment: Warming the kidneys and strengthening the spleen, purging turbidity and detoxifying, and clearing damp heat. Administer the herbal decoction described in Example 1. 7 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Strictly adhere to a low-purine, diabetic diet, abstain from smoking and alcohol, drink 2500-3000ml of water daily; continue oral metformin extended-release tablets 0.5g twice daily, monitor blood glucose; oral febuxostat 40mg once daily (to inhibit uric acid production); regularly monitor blood uric acid, kidney function, blood glucose, and urinalysis. 3. Nursing Care: Keep warm, avoid fatigue, suspend contact with seafood, avoid spicy and irritating foods, rest in bed appropriately, and avoid prolonged standing.

[0109] Follow-up visit Consultation time: February 16, 2025, 2:17 PM.

[0110] Changes in the patient's condition: After taking 7 doses of the above medication, the patient's aversion to cold, lower back and knee weakness were significantly reduced, the edema in both lower limbs subsided to the ankles, the turbidity of urine decreased, the frequency of nocturia decreased to 2-3 times per night, the nausea disappeared, appetite improved, bowel movements became formed once a day, and the patient's mental state improved. Mild dizziness and tinnitus persisted, along with fatigue after activity.

[0111] Traditional Chinese Medicine diagnosis: The patient's mental state has improved, complexion is rosier than before, aversion to cold has lessened, soreness in the lower back and knees has eased, mild edema in the ankles of both lower limbs has decreased, dizziness and tinnitus have lessened, urine is clear and thin with occasional cloudiness, nocturia has decreased, appetite has improved, and bowel movements are formed. The tongue is pale with teeth marks on the edges, the coating is white and greasy, and the pulse is deep and slow.

[0112] Auxiliary examinations: Urinalysis: proteinuria (++), glucoseuria (±), occult blood in urine (+), red blood cells 2~4 / HP, casts 1~2 / LP; Renal function: serum creatinine 185μmol / L, blood urea nitrogen 9.6mmol / L, uric acid 632μmol / L; fasting blood glucose 6.8mmol / L; blood pressure: 128 / 78mmHg.

[0113] Traditional Chinese Medicine Diagnosis: Bi syndrome (Kidney Yang deficiency, internal accumulation of turbid toxins, and gradual clearing of damp heat) Western medicine diagnosis: 1. Uric acid nephropathy (condition improving); 2. Primary gouty arthritis (remission period); 3. Type 2 diabetes (well controlled).

[0114] Treatment: 1. Traditional Chinese Medicine Treatment: The herbal decoction described in Example 1. 14 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Continue febuxostat 40mg once daily and metformin extended-release tablets 0.5g twice daily; maintain a low-purine, diabetic diet, ensure adequate daily fluid intake; regularly (after 2 weeks) check blood uric acid, renal function, blood glucose, and urinalysis. 3. Nursing Care: Appropriate indoor activities are allowed, avoid getting cold, monitor weight changes, and avoid emotional fluctuations.

[0115] According to the results of the follow-up visit, in terms of symptom improvement: the patient's symptoms of kidney yang deficiency, such as aversion to cold, weakness in the lower back and knees, were significantly reduced; edema in both lower limbs subsided; nocturia decreased; and gastrointestinal symptoms such as nausea and poor appetite improved, resulting in an overall improvement in condition. In terms of objective indicator improvement: the key renal function indicator, serum creatinine, decreased from 210 μmol / L to 185 μmol / L, with a simultaneous decrease in blood urea nitrogen; serum uric acid significantly decreased from 756 μmol / L to 632 μmol / L; and urine tests showed a reduction in both proteinuria and hematuria.

[0116] This case demonstrates that the formula addresses the root cause by warming and tonifying kidney yang, thus improving the body's fundamental vitality; simultaneously, it addresses the symptoms by eliminating dampness and turbidity, and clearing damp-heat, promoting uric acid excretion and reducing kidney inflammation and damage. For this type of complex uric acid nephropathy characterized by deficiency of the root and excess of the branch, this formula demonstrates its therapeutic advantage of simultaneously improving symptoms and indicators and providing overall regulation.

[0117] Typical Case 4: Initial diagnosis Name: Wang; Gender: Male; Age: 48; Ethnicity: Han; Marital Status: Married; Occupation: Truck Driver; Date of Consultation: 11:00 AM, January 9, 2025.

[0118] Chief complaint: Recurrent left metatarsophalangeal joint pain for 4 years, lower back pain and weakness in the lower limbs for 3 months, which worsened and was accompanied by eyelid edema for 5 days.

[0119] Present Illness: Four years ago, the patient developed pain in the left metatarsophalangeal joint after a long-distance drive. The pain was described as a stabbing sensation, worsening at night. A local hospital's blood uric acid test showed a level of 650 μmol / L, and the patient was diagnosed with gout. Ibuprofen relieved the pain. Since then, attacks have occurred 2-3 times per year, triggered by staying up late, fatigue, or eating spicy or oily foods. The patient did not regularly take uric acid-lowering medication. Three months ago, after continuous long-distance driving, the patient experienced lower back pain and weakness in the lower limbs, which worsened with activity, accompanied by cold extremities and cold hands and feet. No treatment was sought. Five days ago, the above symptoms worsened, with morning eyelid edema, mild edema in both lower limbs, increased nocturia to 3 times per night, pale urine, no urinary frequency, urgency, dysuria, or gross hematuria. The patient came to our hospital seeking systematic treatment. Since the onset of the illness, the patient has experienced fatigue, light sleep with frequent awakenings, fair appetite, normal bowel movements (once a day), and no significant weight change.

[0120] Past medical history: Denies history of chronic diseases such as hypertension, diabetes, and coronary heart disease; denies history of infectious diseases such as hepatitis and tuberculosis; denies history of surgery or trauma.

[0121] Allergy history: Denies any history of drug or food allergies.

[0122] Personal history: 15 years of long-term truck driving experience, often staying up late, sitting for long periods, and having irregular drinking habits; 25-year smoking history, 20 cigarettes per day; 20-year drinking history, 2-3 liang (100-150ml) of baijiu (Chinese liquor) per day; enjoys barbecue, hot pot, and animal offal; denies any history of exposure to dust or toxins.

[0123] Traditional Chinese Medicine (TCM) diagnosis: The patient presents with mental fatigue, pale complexion, aversion to cold, cold limbs, cold hands and feet, lower back pain and coldness, eyelid edema upon waking, mild pitting edema in both lower limbs, weakness in the lower limbs, increased urination at night, and pale urine. The tongue is pale and swollen with teeth marks on the edges, a white and slippery coating, and a deep, slow, and weak pulse.

[0124] Auxiliary examinations: Urinalysis: proteinuria (++), glucoseuria (-), hematuria (+), white blood cells (-), red blood cells 2-4 / HP, casts 1-2 / LP; Renal function: serum creatinine 178 μmol / L (reference range: 57-111 μmol / L), blood urea nitrogen 8.9 mmol / L (reference range: 3.2-7.1 mmol / L), uric acid 698 μmol / L (reference range: 208-428 μmol / L); Electrolytes: potassium 4.1 mmol / L, sodium 139 mmol / L, chloride 103 mmol / L; Blood pressure: 135 / 85 mmHg.

[0125] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins, and internal retention of dampness).

[0126] Western medical diagnosis: 1. Uric acid nephropathy; Treatment: 1. Traditional Chinese Medicine Treatment: Warming the kidneys and strengthening the spleen, clearing away turbidity and detoxifying, promoting diuresis and reducing swelling. Administer the herbal decoction described in Example 1. 7 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Low-purine diet, quitting smoking and limiting alcohol consumption, drinking 2000-3000ml of water daily, regularly; oral benzbromarone 50mg once daily; regular monitoring of blood uric acid, kidney function, urinalysis, and blood pressure. 3. Nursing Care: Keep warm, avoid staying up late, overexertion, prolonged sitting, rest for 10 minutes every 2 hours of driving, appropriate lumbar massage, and avoid exposure to cold.

[0127] Follow-up visit Consultation time: 10:22 AM on January 17, 2025.

[0128] Changes in condition: After taking the above medication for 7 doses, the patient's aversion to cold, cold limbs, and lower back pain were significantly relieved; hands and feet became warmer; edema in the eyelids and lower limbs subsided; nocturia decreased to 1-2 times per night; mental state improved; fatigue lessened; and sleep improved. There was no pain in the metatarsophalangeal joint of the left foot.

[0129] Traditional Chinese Medicine diagnosis: The patient's mental state has improved, complexion is rosier than before, aversion to cold and cold limbs have eased, lower back pain and coldness have lessened, there is no edema, weakness in the lower limbs has improved, nocturia is normal, and urine is clear. The tongue is pale with teeth marks on the edges, the coating is white and slightly greasy, and the pulse is deep and slow.

[0130] Auxiliary examinations: Urinalysis: proteinuria (+), occult blood in urine (±), red blood cells 1~2 / HP, casts 0~1 / LP; Renal function: serum creatinine 156μmol / L, blood urea nitrogen 7.8mmol / L, uric acid 586μmol / L; Blood pressure: 130 / 80mmHg.

[0131] Traditional Chinese Medicine Diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins, and lingering pathogenic factors) Western medicine diagnosis: 1. Uric acid nephropathy (condition improving); Treatment: 1. Traditional Chinese Medicine Treatment: The herbal decoction described in Example 1. 14 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Continue taking benzbromarone 50mg once daily; maintain a low-purine diet, quit smoking and limit alcohol consumption, drink water regularly; regularly (every 2 weeks later) check blood uric acid, kidney function, and urinalysis. 3. Nursing Care: Maintain a regular sleep schedule, avoid staying up late, engage in appropriate outdoor exercise (such as jogging, Tai Chi) to strengthen the body, and avoid eating high-purine foods.

[0132] According to the follow-up treatment results, after 7 days of medication, the patient's symptoms of kidney yang deficiency, such as aversion to cold, cold limbs, and lower back pain, as well as signs of internal dampness retention, such as eyelid and lower limb edema, were significantly relieved. Laboratory indicators, reflecting kidney function, showed a decrease in serum creatinine from 178 μmol / L to 156 μmol / L, and a reduction in proteinuria; serum uric acid decreased from 698 μmol / L to 586 μmol / L. This demonstrates that this formula closely addresses the pathogenesis, improving the body's fundamental functions by warming and tonifying kidney yang, while simultaneously promoting the excretion of metabolic waste through dampness elimination, blood circulation, and detoxification. Thus, it achieves simultaneous improvement in both alleviating clinical symptoms and protecting the kidneys and lowering uric acid, making it an effective formula for treating this type of uric acid nephropathy.

[0133] Typical Case 5: Initial diagnosis Name: Zhao; Gender: Male; Age: 59; Ethnicity: Han; Marital Status: Married; Occupation: Government Official; Date of Consultation: 8:40 AM, April 10, 2025.

[0134] Chief complaint: Recurrent pain in multiple joints for 6 years, weakness and soreness in the lower back and knees for 4 months, worsening with abdominal distension and difficulty urinating for 10 days.

[0135] Present Illness: Six years ago, the patient developed pain in the right wrist and bilateral metatarsophalangeal joints without any obvious cause, accompanied by mild swelling. A local hospital's blood uric acid test showed 680 μmol / L, and the patient was diagnosed with gout. Symptoms were relieved after oral administration of colchicine and allopurinol. Subsequently, the joint pain recurred, affecting the fingers and ankles. The patient intermittently took allopurinol 100mg twice daily for a long period, with relatively good symptom control. Four months ago, the patient experienced general weakness, lower back and knee pain, which worsened with activity, accompanied by cold intolerance and memory loss, which were not taken seriously. Ten days ago, the above symptoms worsened, with abdominal distension, dysuria (decreased urine output, approximately 800ml per day), moderate pitting edema in both lower extremities, and increased nocturia to 3-4 times per night. There was no fever, cough, nausea, or vomiting. The patient came to our hospital seeking traditional Chinese medicine treatment. Since the onset of the illness, the patient has experienced lethargy, poor sleep, poor appetite, loose stools (twice daily), and a weight loss of 4 kg over the past four months.

[0136] Past medical history: 6-year history of hypertension, long-term oral administration of "valsartan capsules 80mg once daily", blood pressure is well controlled (130~140 / 80~90mmHg); denies history of diabetes, coronary heart disease; denies history of hepatitis, tuberculosis, or other infectious diseases; denies history of surgery or trauma.

[0137] Allergy history: Denies any history of drug or food allergies.

[0138] Personal history: Long-term local residence, sedentary office lifestyle, lack of exercise; 30-year smoking history, 10 cigarettes per day; 25-year drinking history, 2 liang (100ml) of baijiu (Chinese liquor) per day; enjoys rich, fatty, and sweet foods, as well as animal offal; denies any history of exposure to dust or toxins.

[0139] Traditional Chinese Medicine (TCM) diagnosis: The patient presents with lethargy, pale complexion, aversion to cold, lower back and knee weakness, general fatigue, abdominal distension, difficulty urinating, moderate pitting edema in both lower limbs, increased nocturia, poor appetite, and loose stools. The tongue is pale and swollen with teeth marks on the edges, a white and greasy coating, and a deep, slow, and weak pulse.

[0140] Auxiliary examinations: Urinalysis: proteinuria (+++), glucoseuria (-), hematuria (+), white blood cells (-), red blood cells 4-6 / HP, casts 2-3 / LP; Renal function: serum creatinine 225 μmol / L (reference range: 57-111 μmol / L), blood urea nitrogen 12.5 mmol / L (reference range: 3.2-7.1 mmol / L), uric acid 732 μmol / L (reference range: 208-428 μmol / L); Electrolytes: potassium 4.6 mmol / L, sodium 135 mmol / L, chloride 100 mmol / L; Blood pressure: 138 / 86 mmHg; Abdominal ultrasound: small amount of ascites, slightly reduced kidney volume, and increased cortical echogenicity.

[0141] Traditional Chinese Medicine Diagnosis: Bi syndrome (Kidney Yang deficiency, internal accumulation of turbid toxins) Western medical diagnoses: 1. Uric acid nephropathy (stage 3 chronic kidney disease); 2. Primary gouty arthritis (chronic phase); 3. Grade 1 essential hypertension; 4. Ascites. Treatment: 1. Traditional Chinese Medicine Treatment: Warming the kidneys and strengthening the spleen, clearing away turbidity and detoxifying. Administer the herbal decoction described in Example 1. 7 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Low-purine diet, quitting smoking and limiting alcohol, drinking 2000ml of water daily (to avoid excessive burden on the kidneys); continue oral valsartan capsules 80mg once daily; oral febuxostat 40mg once daily; regularly monitor blood uric acid, kidney function, electrolytes, blood pressure, and abdominal ultrasound. 3. Nursing Care: Keep warm, rest in bed, avoid fatigue, avoid getting cold, eat a light diet, eat small, frequent meals, and avoid overeating.

[0142] Follow-up visit Consultation time: 8:31 AM, April 18, 2025 Changes in condition: After taking the above medicine for 7 doses, the patient's fear of cold, soreness in the lower back and knees were significantly reduced, general weakness improved, abdominal distension was relieved, urine output increased (about 1500ml per day), edema in both lower limbs was reduced to mild, nocturia decreased to 2 times per night, appetite improved, stools became formed once a day, and mental state improved.

[0143] Traditional Chinese Medicine diagnosis: The patient's mental state has improved, complexion is rosier than before, aversion to cold has lessened, lower back and knee pain has eased, fatigue has improved, there is no abdominal distension, urination is smooth, there is mild edema in both lower limbs, appetite has improved, and stools are formed. The tongue is pale with teeth marks on the edges, the coating is white and slightly greasy, and the pulse is deep and slow.

[0144] Auxiliary examinations: Urinalysis: proteinuria (++), occult blood in urine (±), red blood cells 2~3 / HP, casts 1~2 / LP; Renal function: serum creatinine 198μmol / L, blood urea nitrogen 10.2mmol / L, uric acid 628μmol / L; Electrolytes: potassium 4.3mmol / L, sodium 137mmol / L, chloride 102mmol / L; Blood pressure: 132 / 82mmHg.

[0145] Traditional Chinese Medicine Diagnosis: Bi syndrome (Kidney Yang deficiency, internal accumulation of turbid toxins) Western medical diagnoses: 1. Uric acid nephropathy (stage 3 chronic kidney disease, condition improving); 2. Primary gouty arthritis (in remission); 3. Grade 1 essential hypertension (well controlled). Treatment: 1. Traditional Chinese Medicine Treatment: The herbal decoction described in Example 1. 14 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Continue taking valsartan capsules 80mg once daily and febuxostat 40mg once daily; maintain a low-purine diet, quit smoking and limit alcohol consumption, and ensure adequate daily fluid intake; regularly (after 2 weeks) check blood uric acid, renal function, electrolytes, and urinalysis. 3. Nursing Care: Appropriate ambulation (such as slow walking) is allowed, avoid fatigue, maintain a cheerful mood, avoid emotional fluctuations, and maintain a regular schedule.

[0146] According to the treatment results of the follow-up visit, the Kidney-Warming and Detoxifying Formula of this invention demonstrates a clear and stable therapeutic effect on the syndrome of kidney yang deficiency and dampness-stasis obstructing the collaterals in uric acid nephropathy. Its efficacy is mainly reflected in two aspects: in terms of symptom improvement, it can significantly alleviate core symptoms of kidney yang deficiency such as aversion to cold, cold limbs, soreness and weakness of the lower back and knees, edema, and frequent urination at night; in terms of objective indicators, it can synergistically reduce blood uric acid, serum creatinine, and urinary protein, protecting kidney function. This verifies that this formula can intervene in the disease from the source of its pathogenesis, achieving simultaneous improvement in symptoms and laboratory indicators, reflecting the overall regulatory advantages of traditional Chinese medicine's syndrome differentiation and treatment for this type of chronic disease.

[0147] Typical Case Six: Initial diagnosis Name: Sun; Gender: Male; Age: 53; Ethnicity: Han; Marital Status: Married; Occupation: Construction Worker; Date of Consultation: March 11, 2025, 3:30 PM.

[0148] Chief complaint: Recurrent pain in both foot joints for 5 years, cold pain in the lower back and spine, and heaviness in the lower limbs for 3 months, which has worsened and is accompanied by edema and cloudy urine for 1 week.

[0149] Present Illness: Five years ago, the patient developed pain and swelling in the metatarsophalangeal joints of both feet after exertion, which worsened with exposure to cold. A local hospital diagnosed gout with a blood uric acid level of 660 μmol / L, and the symptoms were relieved after oral ibuprofen. Since then, attacks have occurred 2-3 times per year after exertion or exposure to cold, without regular use of uric acid-lowering medication. Three months ago, the patient developed lower back pain, heaviness and weakness in the lower limbs after prolonged outdoor work and exposure to cold, which worsened with activity, accompanied by cold limbs and aversion to cold. No treatment was sought. One week ago, the above symptoms worsened, with the development of moderate pitting edema in both lower limbs, cloudy urine, and increased nocturia to 3 times per night. There was no fever, cough, urinary frequency, urgency, or dysuria. The patient came to our hospital seeking treatment. Since the onset of the illness, the patient has experienced fatigue, poor sleep, fair appetite, loose stools (1-2 times daily), and a weight loss of 2 kg over the past 3 months.

[0150] Past medical history: Denies history of chronic diseases such as hypertension, diabetes, and coronary heart disease; denies history of infectious diseases such as hepatitis and tuberculosis; has a history of "lumbar disc herniation" for 3 years; denies history of surgery or trauma.

[0151] Allergy history: Denies any history of drug or food allergies.

[0152] Personal history: 18 years of long-term construction work, often working outdoors, frequently exposed to cold and dampness; 28-year smoking history, 15 cigarettes per day; 23-year drinking history, drinking 2-3 liang of baijiu (Chinese liquor) per day, enjoys barbecue and animal offal; denies history of exposure to dust or toxic substances.

[0153] Traditional Chinese Medicine diagnosis: The patient presents with fatigue, pale complexion, aversion to cold, cold limbs, lower back pain, heaviness and weakness in the lower limbs, moderate pitting edema in both lower limbs, cloudy urine, increased nocturia, fair appetite, and loose stools. The tongue is pale and swollen with teeth marks on the edges, a white and greasy coating, and a deep, slow, and weak pulse.

[0154] Auxiliary examinations: Urinalysis: proteinuria (++), glucoseuria (-), hematuria (+), white blood cells (-), red blood cells 3-5 / HP, casts 1-2 / LP; Renal function: serum creatinine 182 μmol / L (reference range: 57-111 μmol / L), blood urea nitrogen 9.5 mmol / L (reference range: 3.2-7.1 mmol / L), uric acid 705 μmol / L (reference range: 208-428 μmol / L); Electrolytes: potassium 4.2 mmol / L, sodium 138 mmol / L, chloride 101 mmol / L; Blood pressure: 130 / 80 mmHg; Lumbar spine CT: L4-L5 disc herniation.

[0155] Traditional Chinese Medicine Diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins, and cold-dampness obstructing the meridians) Western medical diagnoses: 1. Uric acid nephropathy; 2. Primary gout; 3. Lumbar disc herniation. Treatment: 1. Traditional Chinese Medicine Treatment: Warming the kidneys and strengthening the spleen, clearing away turbidity and detoxifying, dispelling cold and dampness. Administer the herbal decoction described in Example 1. 7 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Low-purine diet, quitting smoking and limiting alcohol consumption, drinking 2000-3000ml of water daily; oral benzbromarone 50mg once daily; regular monitoring of blood uric acid, kidney function, urinalysis, and blood pressure. 3. Nursing Care: Keep warm, avoid exposure to cold and dampness, suspend outdoor work, wear a lumbar support belt to protect the lower back, avoid bending over and lifting heavy objects, and apply appropriate heat to the lower back.

[0156] Follow-up visit Consultation time: March 19, 2025, 9:01 AM.

[0157] Changes in condition: After taking the above medicine for 7 doses, the patient's aversion to cold, cold limbs, and cold pain in the lower back were significantly relieved, the heaviness and weakness in the lower limbs improved, the edema in both lower limbs was reduced to mild, the turbidity of urine was reduced, the frequency of urination at night was reduced to 1-2 times / night, the mental state improved, and the stool became formed.

[0158] Traditional Chinese Medicine diagnosis: Improved mental state, rosier complexion, reduced aversion to cold, relief of lower back pain, improved weakness in the lower limbs, mild edema in both lower limbs, clear and occasionally cloudy urine, reduced nocturia, and formed stools. Pale tongue with teeth marks on the edges, white and slightly greasy coating, and deep and slow pulse.

[0159] Auxiliary examinations: Urinalysis: proteinuria (+), occult blood in urine (±), red blood cells 1~2 / HP, casts 0~1 / LP; Renal function: serum creatinine 160μmol / L, blood urea nitrogen 8.2mmol / L, uric acid 598μmol / L; Blood pressure: 128 / 78mmHg.

[0160] Traditional Chinese Medicine Diagnosis: Bi syndrome (Kidney Yang deficiency, internal accumulation of turbid toxins, gradual elimination of cold and dampness) Western medical diagnoses: 1. Uric acid nephropathy (condition improving); 2. Primary gout (remission phase); 3. Lumbar disc herniation. Treatment: 1. Traditional Chinese Medicine Treatment: The herbal decoction described in Example 1. 14 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Continue taking benzbromarone 50mg once daily; maintain a low-purine diet, quit smoking and limit alcohol consumption, drink water regularly; regularly (every 2 weeks later) check blood uric acid, kidney function, and urinalysis. 3. Nursing Care: Appropriate lumbar function exercises (such as the "Little Swallow" exercise) can be performed, avoid fatigue, avoid prolonged sitting or standing, and pay attention to keeping the lower back warm.

[0161] Based on the follow-up treatment results, the present invention's Kidney-Warming and Detoxifying Formula showed good efficacy in treating uric acid nephropathy. After taking seven doses, the patient's symptoms of kidney yang deficiency, such as aversion to cold, cold limbs, and lower back pain, as well as symptoms of dampness and turbidity, such as lower limb edema and cloudy urine, were significantly relieved. Objectively, serum creatinine, reflecting kidney function, decreased from 182 μmol / L to 160 μmol / L, and urinary protein decreased; serum uric acid decreased from 705 μmol / L to 598 μmol / L. The TCM diagnosis for this case was kidney yang deficiency with internal accumulation of turbid toxins. This formula addresses the root cause by warming and tonifying kidney yang, and treats the symptoms by dispelling cold, dampness, and turbidity, effectively improving the clinical symptoms and laboratory indicators of this type of patient.

[0162] Typical Case 7: Initial diagnosis Name: Zhou; Gender: Male; Age: 65; Ethnicity: Han; Marital Status: Married; Occupation: Farmer; Date of Consultation: May 12, 2025, 11:00 AM.

[0163] Chief complaint: Recurrent joint pain for 7 years, fatigue and aversion to cold for 4 months, which worsened and were accompanied by edema and poor appetite for 15 days.

[0164] Present Illness: Seven years ago, the patient developed pain and swelling in the first metatarsophalangeal joint of his right foot without any obvious cause. A local hospital test showed a blood uric acid level of 710 μmol / L, and he was diagnosed with gout. His symptoms were relieved after oral colchicine. Since then, the joint pain has recurred, affecting the ankle and knee joints. He has intermittently taken allopurinol for a long period, with symptoms fluctuating in severity. Four months ago, the patient experienced general weakness, chills, lower back and knee pain, and dizziness, which he did not pay much attention to. Fifteen days ago, these symptoms worsened, with severe pitting edema in both lower extremities, extremely poor appetite, abdominal distension, nausea, increased nocturia (4-5 times / night), decreased urine output, no fever, cough, or vomiting. He came to our hospital for treatment. Since the onset of the illness, he has been lethargic, has poor sleep, poor appetite, loose stools (2-3 times daily), and has lost 5 kg in the past four months.

[0165] Past medical history: 7-year history of hypertension, long-term oral administration of "nifedipine tablets 10mg 3 times daily", blood pressure poorly controlled (140~150 / 90~100mmHg); denies history of diabetes, coronary heart disease; denies history of hepatitis, tuberculosis, or other infectious diseases; denies history of surgery or trauma.

[0166] Allergy history: Denies any history of drug or food allergies.

[0167] Personal history: Long-term rural residence, engaged in agricultural labor for 20 years, often exposed to wind and sun; 35-year smoking history, 10 cigarettes per day; 30-year drinking history, drinking 2 liang (100ml) of baijiu (Chinese liquor) per day; enjoys eating animal offal and bean products; denies any history of exposure to dust or toxins.

[0168] Traditional Chinese Medicine (TCM) diagnosis: The patient presents with lethargy, pale complexion, aversion to cold, lower back and knee weakness, general fatigue, dizziness, severe pitting edema in both lower limbs, abdominal distension, nausea, poor appetite, increased urination at night, scanty urine, and loose stools. The tongue is pale and swollen with teeth marks on the edges, a white and greasy coating, and a deep, slow, thready, and weak pulse.

[0169] Auxiliary examinations: Urinalysis: proteinuria (+++), glucoseuria (-), hematuria (++), white blood cells (-), red blood cells 6-8 / HP, casts 3-4 / LP; Renal function: serum creatinine 245 μmol / L (reference range: 57-111 μmol / L), blood urea nitrogen 13.8 mmol / L (reference range: 3.2-7.1 mmol / L), uric acid 768 μmol / L (reference range: 208-428 μmol / L); Electrolytes: potassium 4.8 mmol / L, sodium 134 mmol / L, chloride 99 mmol / L; Blood pressure: 148 / 95 mmHg; Bilateral renal ultrasound: increased echogenicity of renal parenchyma, unclear corticomedullary boundary.

[0170] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins).

[0171] Western medical diagnosis: 1. Uric acid nephropathy (stage 3 chronic kidney disease); 2. Primary gouty arthritis (chronic stage); 3. Primary hypertension, grade 2.

[0172] Treatment: 1. Traditional Chinese Medicine Treatment: Warming the kidneys and strengthening the spleen, clearing away turbidity and detoxifying. Administer the herbal decoction described in Example 1. 7 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Low-purine diet, quitting smoking and limiting alcohol, drinking 2000ml of water daily; adjusting antihypertensive medication to nifedipine sustained-release tablets 20mg twice daily; oral febuxostat 40mg once daily; regular monitoring of blood uric acid, renal function, electrolytes, and blood pressure. 3. Nursing Care: Bed rest, avoiding fatigue, keeping warm, avoiding cold exposure, a light and easily digestible diet, small frequent meals, and avoiding emotional excitement.

[0173] Follow-up visit Consultation time: 9:07 AM on May 20, 2025.

[0174] Changes in condition: After taking the above medicine for 7 doses, the patient's fear of cold and soreness in the lower back and knees were significantly reduced, general weakness improved, dizziness and blurred vision were relieved, edema in both lower limbs was reduced to moderate, abdominal distension and nausea were relieved, appetite improved slightly, the frequency of urination at night decreased to 3 times / night, the amount of urine increased, the loose stools were reduced to 1-2 times per day, and the mental state improved.

[0175] Traditional Chinese Medicine diagnosis: Improved mental state, rosier complexion, reduced aversion to cold, relief from lower back and knee pain, improved fatigue, reduced dizziness, moderate edema in both lower limbs, slightly increased appetite, reduced abdominal distension, decreased nocturia, and less loose stools. Pale tongue with teeth marks on the edges, white and slightly greasy coating, and deep and slow pulse.

[0176] Auxiliary examinations: Urinalysis: proteinuria (++), occult blood in urine (+), red blood cells 3-5 / HP, casts 2-3 / LP; Renal function: serum creatinine 218μmol / L, blood urea nitrogen 11.6mmol / L, uric acid 658μmol / L; Electrolytes: potassium 4.5mmol / L, sodium 136mmol / L, chloride 101mmol / L; Blood pressure: 135 / 85mmHg.

[0177] Traditional Chinese Medicine Diagnosis: Bi syndrome (Kidney Yang deficiency, internal accumulation of turbid toxins) Western medical diagnoses: 1. Uric acid nephropathy (stage 3 chronic kidney disease, condition improving); 2. Primary gouty arthritis (in remission); 3. Grade 2 essential hypertension (well controlled). Treatment: 1. Traditional Chinese Medicine Treatment: The herbal decoction described in Example 1. 14 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Continue taking nifedipine sustained-release tablets 20mg twice daily and febuxostat 40mg once daily; maintain a low-purine diet, quit smoking and limit alcohol consumption, and ensure adequate daily fluid intake; regularly (after 2 weeks) check blood uric acid, renal function, electrolytes, urinalysis, and blood pressure. 3. Nursing Care: Appropriate ambulation is possible, avoid fatigue, maintain a cheerful mood, regular sleep schedule, and pay attention to dietary adjustments.

[0178] According to the treatment results of the follow-up visit, the Kidney-Warming and Detoxifying Formula of this invention showed a clear therapeutic effect on stage 3 chronic kidney disease with severe uric acid nephropathy. After taking 7 doses, the patient's symptoms of kidney yang deficiency, such as aversion to cold, weakness in the lower back and knees, as well as symptoms of dampness and turbidity obstruction and spleen dysfunction, such as severe edema, abdominal distension, and poor appetite, were significantly improved. Objectively, serum creatinine, reflecting kidney function, decreased from 245 μmol / L to 218 μmol / L, and urinary protein decreased; serum uric acid decreased significantly from 768 μmol / L to 658 μmol / L. This formula, by warming and tonifying kidney yang to strengthen the foundation, clearing turbidity and detoxifying to eliminate pathogens, and simultaneously replenishing qi and blood, can effectively improve the clinical symptoms and key laboratory indicators of this type of severe patient.

[0179] Typical Case 8: Initial diagnosis Name: Wu; Gender: Male; Age: 50; Ethnicity: Han; Marital Status: Married; Occupation: Chef; Date of Consultation: June 13, 2025, 4:10 PM.

[0180] Chief complaint: Recurrent pain in both foot joints for 4 years, soreness and weakness in the lower back and knees and heaviness in the limbs for 2 months, which has worsened and is accompanied by yellow and cloudy urine and dry mouth without thirst for 3 days.

[0181] Present Illness: Four years ago, the patient developed pain and mild swelling in the metatarsophalangeal joints of both feet after a long-term diet high in purines. A local hospital's blood uric acid level was 670 μmol / L, and the patient was diagnosed with gout. Symptoms were relieved after oral ibuprofen. Since then, attacks have occurred twice a year, triggered by dietary indiscretions (eating seafood and animal organs), and the patient has not regularly taken uric acid-lowering medication. Two months ago, the patient experienced lower back and knee weakness, heaviness in the limbs, accompanied by cold extremities and abdominal distension, which were not treated. Three days ago, the above symptoms worsened, with the patient experiencing yellow and cloudy urine, dry mouth but no thirst, mild pitting edema in both lower extremities, and increased nocturia to 3 times per night. There was no fever, cough, urinary frequency, urgency, or dysuria. The patient came to our hospital seeking treatment. Since the onset of the illness, the patient has experienced fatigue, poor sleep, fair appetite, loose stools (once a day), and a weight loss of 2 kg in the past two months.

[0182] Past medical history: Denies history of chronic diseases such as hypertension, diabetes, and coronary heart disease; denies history of infectious diseases such as hepatitis and tuberculosis; denies history of surgery or trauma.

[0183] Allergy history: Denies any history of drug or food allergies.

[0184] Personal history: Worked as a chef for 15 years, frequently exposed to high-purine foods, with irregular eating habits, and a preference for rich, fatty, seafood, and animal offal; smoked for 25 years, 15 cigarettes per day; drank alcohol for 20 years, 2 liang (100ml) of baijiu (Chinese liquor) per day; denies any history of exposure to dust or toxins.

[0185] Traditional Chinese Medicine (TCM) diagnosis: The patient presents with mental fatigue, pale complexion, aversion to cold, cold limbs, soreness and weakness in the lower back and knees, heaviness in the limbs, mild pitting edema in both lower limbs, yellow and cloudy urine, dry mouth without thirst, abdominal distension, increased urination at night, and loose stools. The tongue is pale and swollen with teeth marks on the edges, and the coating is yellow-white and greasy. The pulse is deep, slow, and slippery.

[0186] Auxiliary examinations: Urinalysis: proteinuria (++), glucoseuria (-), hematuria (+), white blood cells (-), red blood cells 3-4 / HP, casts 1-2 / LP; Renal function: serum creatinine 175 μmol / L (reference range: 57-111 μmol / L), blood urea nitrogen 8.8 mmol / L (reference range: 3.2-7.1 mmol / L), uric acid 712 μmol / L (reference range: 208-428 μmol / L); Electrolytes: potassium 4.1 mmol / L, sodium 139 mmol / L, chloride 102 mmol / L; Blood pressure: 128 / 80 mmHg.

[0187] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins, and damp-heat).

[0188] Western medical diagnosis: 1. Uric acid nephropathy; 2. Primary gout.

[0189] Treatment: 1. Traditional Chinese Medicine Treatment: Warming the kidneys and strengthening the spleen, purging turbidity and detoxifying, clearing heat and promoting diuresis. Administer the herbal decoction described in Example 1. 7 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Low-purine diet, quitting smoking and limiting alcohol, drinking 2500-3000ml of water daily; oral benzbromarone 50mg once daily; regular monitoring of blood uric acid, kidney function, urinalysis, and blood pressure. 3. Nursing Care: Pay attention to dietary regulation, avoid high-purine, fatty, and rich foods, maintain regular eating habits, keep warm, avoid fatigue, and get adequate rest.

[0190] Follow-up visit Consultation time: June 21, 2025, 8:46 AM.

[0191] Changes in condition: After taking the above medicine for 7 doses, the patient's aversion to cold, cold limbs, soreness and weakness in the waist and knees were significantly reduced, the heaviness in the limbs was improved, the edema in both lower limbs subsided, the yellow and cloudy urine was relieved (urine color turned clear), the symptoms of dry mouth and lack of thirst disappeared, abdominal distension was reduced, the frequency of urination at night decreased to 1-2 times / night, the mental state improved, and the stool became formed.

[0192] Traditional Chinese Medicine diagnosis: The patient's mental state has improved, complexion is rosier than before, aversion to cold has lessened, soreness and weakness in the lower back and knees have eased, heaviness in the limbs has improved, there is no edema, urine is clear, appetite is fair, abdominal distension has lessened, nocturia is normal, and stool is formed. The tongue is pale with teeth marks on the edges, the coating is white and slightly greasy, and the pulse is deep and slow.

[0193] Auxiliary examinations: Urinalysis: proteinuria (+), occult blood in urine (±), red blood cells 1~2 / HP, casts 0~1 / LP; Renal function: serum creatinine 152μmol / L, blood urea nitrogen 7.6mmol / L, uric acid 582μmol / L; Blood pressure: 125 / 78mmHg.

[0194] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins, damp heat has been cleared).

[0195] Western medicine diagnosis: 1. Uric acid nephropathy (condition improving); 2. Primary gout (remission period).

[0196] Treatment: 1. Traditional Chinese Medicine Treatment: The herbal decoction described in Example 1. 14 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Continue taking benzbromarone 50mg once daily; maintain a low-purine diet, quit smoking and limit alcohol consumption, drink water regularly; regularly (every 2 weeks later) check blood uric acid, kidney function, and urinalysis. 3. Nursing Care: Maintain regular sleep patterns, avoid fatigue, engage in appropriate outdoor exercise (such as walking or jogging), strengthen physical fitness, and avoid dietary indiscretions.

[0197] According to the follow-up treatment results, after taking 7 doses of medication, the patient's symptoms of kidney yang deficiency, such as aversion to cold and cold limbs, and soreness and weakness in the lower back and knees, as well as symptoms of dampness and heat, such as yellow and cloudy urine, dry mouth without thirst, and heaviness in the limbs, were significantly relieved. Objectively, serum creatinine, reflecting kidney function, decreased from 175 μmol / L to 152 μmol / L, and proteinuria decreased; serum uric acid significantly decreased from 712 μmol / L to 582 μmol / L. This case demonstrated accurate diagnosis, and by addressing the root cause by warming and tonifying kidney yang, it effectively improved the clinical symptoms and key laboratory indicators of this complex syndrome patient.

[0198] Typical Case Nine: Initial diagnosis Name: Zheng; Gender: Male; Age: 61; Ethnicity: Han; Marital Status: Married; Occupation: Retired Teacher; Date of Consultation: 9:10 AM, July 14, 2025.

[0199] Chief complaint: Recurrent joint pain for 8 years, weakness and soreness in the lower back and knees for 5 months, worsening with edema and frequent urination at night for 1 week. Present Illness: Eight years ago, the patient developed pain in the first metatarsophalangeal joint of the right foot without any obvious cause, accompanied by redness, swelling, heat, and pain. A local hospital's blood uric acid test showed 730 μmol / L, and the patient was diagnosed with "gouty arthritis." Symptoms were relieved after oral administration of colchicine and allopurinol. Since then, the joint pain has recurred, affecting the fingers, wrist, and ankle joints. Long-term oral administration of allopurinol 100mg twice daily has provided relatively good symptom control. Five months ago, the patient experienced general weakness, lower back and knee pain, accompanied by chills, dizziness, tinnitus, and memory loss, which were not taken seriously. One week ago, these symptoms worsened, with mild pitting edema in both lower extremities, frequent urination at night (4-5 times / night), clear and thin urine, no fever, cough, nausea, or vomiting. The patient came to our hospital seeking traditional Chinese medicine treatment. Since the onset of the illness, the patient has experienced lethargy, poor sleep, poor appetite, loose stools (twice daily), and a weight loss of 4 kg over the past five months.

[0200] Past medical history: 10-year history of type 2 diabetes, long-term oral administration of "gliclazide extended-release tablets 30mg once daily", poor blood glucose control (fasting blood glucose 7.5~8.5mmol / L); 5-year history of hypertension, oral administration of "amlodipine tablets 5mg once daily", blood pressure control is good (135~145 / 85~90mmHg); denies history of coronary heart disease; denies history of hepatitis, tuberculosis, or other infectious diseases; denies history of surgery or trauma.

[0201] Allergy history: Denies any history of drug or food allergies.

[0202] Personal history: Long-term local resident, sedentary office work before retirement, lack of exercise; 32-year smoking history, 10 cigarettes per day; 28-year drinking history, 1-2 liang of baijiu per day, enjoys eating animal offal and nuts; denies history of exposure to dust or toxins.

[0203] Traditional Chinese Medicine (TCM) diagnosis: The patient presents with lethargy, pale complexion, aversion to cold, lower back and knee weakness, general fatigue, dizziness and tinnitus, mild pitting edema in both lower limbs, frequent urination at night, clear and thin urine, poor appetite, and loose stools. The tongue is pale and swollen with teeth marks on the edges, a white and greasy coating, and a deep, slow, thready, and weak pulse.

[0204] Auxiliary examinations: Urinalysis: proteinuria (+++), glucoseuria (++), hematuria (+), white blood cells (-), red blood cells 4~6 / HP, casts 2~3 / LP; Renal function: serum creatinine 230μmol / L (reference range: 57~111μmol / L), blood urea nitrogen 12.8mmol / L (reference range: 3.2~7.1mmol / L), uric acid 745μmol / L (reference range: 208~428μmol / L); Blood glucose: fasting 8.2mmol / L, 2-hour postprandial 13.6mmol / L; Blood pressure: 140 / 88mmHg; Bilateral renal ultrasound: increased echogenicity of bilateral renal cortex.

[0205] Traditional Chinese Medicine Diagnosis: Bi syndrome (Kidney Yang deficiency, internal accumulation of turbid toxins) Western medical diagnoses: 1. Uric acid nephropathy (stage 3 chronic kidney disease); 2. Primary gouty arthritis (chronic phase); 3. Type 2 diabetes mellitus; 4. Grade 1 essential hypertension. Treatment: 1. Traditional Chinese Medicine Treatment: Warming the kidneys and strengthening the spleen, clearing away turbidity and detoxifying. Administer the herbal decoction described in Example 1. 7 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Low-purine, diabetic diet, quitting smoking and limiting alcohol, drinking 2000-2500ml of water daily; adjust hypoglycemic medication to gliclazide sustained-release tablets 30mg twice daily, monitoring blood glucose; continue taking amlodipine tablets 5mg once daily; oral febuxostat 40mg once daily; regularly monitor blood uric acid, renal function, blood glucose, blood pressure, and urinalysis. 3. Nursing Care: Keep warm, avoid fatigue, maintain regular sleep patterns, avoid emotional fluctuations, engage in appropriate light indoor activities, and eat a light diet.

[0206] Follow-up visit Consultation time: 8:17 AM on July 22, 2025.

[0207] Changes in condition: After taking the above medication for 7 doses, the patient's aversion to cold, lower back and knee pain significantly decreased, dizziness and tinnitus were relieved, edema in both lower limbs subsided, nocturia decreased to 2 times / night, appetite improved, bowel movements became formed once a day, and mental state improved. Fasting blood glucose dropped to 7.3 mmol / L.

[0208] Traditional Chinese Medicine diagnosis: The patient's mental state has improved, complexion is rosier than before, aversion to cold has lessened, lower back and knee pain has eased, there is no edema, nocturia has decreased, appetite has improved, and bowel movements are formed. The tongue is pale with teeth marks on the edges, the coating is white and slightly greasy, and the pulse is deep and slow.

[0209] Auxiliary examinations: Urinalysis: proteinuria (++), glucoseuria (+), occult blood in urine (±), red blood cells 2~3 / HP, casts 1~2 / LP; Renal function: serum creatinine 205μmol / L, blood urea nitrogen 10.5mmol / L, uric acid 638μmol / L; fasting blood glucose 7.3mmol / L; blood pressure: 135 / 85mmHg.

[0210] Traditional Chinese Medicine Diagnosis: Bi syndrome (Kidney Yang deficiency, internal accumulation of turbid toxins) Western medical diagnoses: 1. Uric acid nephropathy (stage 3 chronic kidney disease, condition improving); 2. Primary gouty arthritis (in remission); 3. Type 2 diabetes (well controlled); 4. Grade 1 essential hypertension (well controlled). Treatment: 1. Traditional Chinese Medicine Treatment: The herbal decoction described in Example 1. 14 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Continue taking gliclazide sustained-release tablets 30mg twice daily, amlodipine tablets 5mg once daily, and febuxostat 40mg once daily; maintain a low-purine, diabetic diet, and ensure adequate daily fluid intake; regularly (after 2 weeks) check blood uric acid, renal function, blood glucose, urinalysis, and blood pressure. 3. Nursing Care: Appropriately increase outdoor activities (such as slow walking), avoid fatigue, monitor weight changes, and regularly monitor blood glucose.

[0211] According to the follow-up treatment results, after taking 7 doses of the medication, the patient's core symptoms of kidney yang deficiency, such as aversion to cold, weakness in the lower back and knees, as well as signs of water retention such as edema and frequent urination at night, were significantly improved. Regarding key indicators, serum creatinine, reflecting kidney function, decreased from 230 μmol / L to 205 μmol / L, and proteinuria decreased; serum uric acid significantly decreased from 745 μmol / L to 638 μmol / L. This formula treats the root cause by warming and tonifying kidney yang, and addresses the symptoms by clearing away turbidity and detoxifying. With flexible adjustments based on the specific symptoms, it can effectively improve the clinical symptoms and objective indicators of patients with this type of underlying deficiency and superficial excess, and multiple intertwined diseases.

[0212] Typical Case 10: Name: Qian; Gender: Male; Age: 55; Ethnicity: Han; Marital Status: Married; Occupation: Logistics porter; Date of Consultation: August 15, 2025, 1:30 PM.

[0213] Chief complaint: Recurrent metatarsophalangeal joint pain in both feet for 5 years, lower back pain and lower limb edema for 3 months, worsening with urinary difficulty for 5 days.

[0214] Present Illness: Five years ago, the patient developed pain and mild swelling in the metatarsophalangeal joints of both feet after lifting heavy objects. The pain worsened with exposure to cold. A local hospital's blood uric acid test showed a level of 690 μmol / L, and the patient was diagnosed with gout. Symptoms were relieved after oral administration of diclofenac sodium. Since then, attacks have occurred 3-4 times per year after overexertion or exposure to cold, and the patient has not regularly taken uric acid-lowering medication. Three months ago, the patient developed lower back pain, mild pitting edema in both lower extremities, accompanied by cold limbs, weakness in the lower extremities, and did not receive treatment. Five days ago, the above symptoms worsened, with edema spreading to the calves, difficulty urinating (urine output approximately 900 ml per day), increased nocturia to 3-4 times per night, abdominal distension, and poor appetite. There was no fever, cough, or gross hematuria. The patient came to our hospital seeking treatment. Since the onset of the illness, the patient has experienced fatigue, poor sleep, poor appetite, loose stools (1-2 times per day), and a weight loss of 3 kg in the past 3 months.

[0215] Past medical history: Denies history of chronic diseases such as hypertension, diabetes, and coronary heart disease; denies history of infectious diseases such as hepatitis and tuberculosis; has a history of "lumbar muscle strain" for 4 years; denies history of surgery or trauma.

[0216] Allergy history: Denies any history of drug or food allergies.

[0217] Personal history: 20 years of experience in logistics and handling work, long hours of heavy labor, and frequent exposure to cold; 27 years of smoking history, 15 cigarettes per day; 22 years of drinking history, 2-3 liang (100-150ml) of baijiu (Chinese liquor) per day; enjoys barbecue and animal offal; denies any history of exposure to dust or toxic substances.

[0218] Traditional Chinese Medicine (TCM) diagnosis: The patient presents with mental fatigue, pale complexion, aversion to cold, cold limbs, lower back pain, moderate pitting edema in both lower limbs, weakness in the lower limbs, abdominal distension, poor appetite, difficulty urinating, increased nocturia, and loose stools. The tongue is pale and swollen with teeth marks on the edges, a white and greasy coating, and a deep, slow, and weak pulse.

[0219] Auxiliary examinations: Urinalysis: proteinuria (++), glucoseuria (-), hematuria (+), white blood cells (-), red blood cells 3-5 / HP, casts 1-2 / LP; Renal function: serum creatinine 195 μmol / L (reference range: 57-111 μmol / L), blood urea nitrogen 10.2 mmol / L (reference range: 3.2-7.1 mmol / L), uric acid 726 μmol / L (reference range: 208-428 μmol / L); Electrolytes: potassium 4.3 mmol / L, sodium 137 mmol / L, chloride 101 mmol / L; Blood pressure: 132 / 82 mmHg; Lumbar spine X-ray: degenerative changes in the lumbar spine.

[0220] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins).

[0221] Western medical diagnosis: 1. Uric acid nephropathy; 2. Primary gout; 3. Lumbar muscle strain; 4. Degenerative changes in the lumbar spine.

[0222] Treatment: 1. Traditional Chinese Medicine Treatment: Warming the kidneys and strengthening the spleen, clearing away turbidity and detoxifying. Administer the herbal decoction described in Example 1. 7 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Low-purine diet, quitting smoking and limiting alcohol consumption, drinking 2000-3000ml of water daily; oral benzbromarone 50mg once daily; regular monitoring of blood uric acid, kidney function, urinalysis, and blood pressure. 3. Nursing Care: Keep warm, avoid getting cold and damp, suspend heavy physical labor, wear a lumbar support belt to protect the lower back, avoid bending over and carrying heavy loads, and apply appropriate heat to the lower back.

[0223] Follow-up visit Consultation time: 8:38 AM on August 23, 2025.

[0224] Changes in condition: After taking the above medicine for 7 doses, the patient's aversion to cold, cold limbs, and soreness in the lower back were significantly relieved. The edema in both lower limbs was reduced to the ankles. The urine output increased (about 1500ml per day). The frequency of urination at night decreased to 2 times per night. Abdominal distension and poor appetite were relieved. Stools were formed once a day. The patient's mental state improved.

[0225] Traditional Chinese Medicine diagnosis: The patient's mental state has improved, complexion is rosier than before, aversion to cold has lessened, lower back pain has eased, mild edema in both ankles has subsided, appetite has improved, urination is smooth, nocturia has decreased, and stools are formed. The tongue is pale with teeth marks on the edges, the coating is white and slightly greasy, and the pulse is deep and slow.

[0226] Auxiliary examinations: Urinalysis: proteinuria (+), occult blood in urine (±), red blood cells 1~2 / HP, casts 0~1 / LP; Renal function: serum creatinine 170μmol / L, blood urea nitrogen 8.6mmol / L, uric acid 612μmol / L; Blood pressure: 130 / 80mmHg.

[0227] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins).

[0228] Western medical diagnosis: 1. Uric acid nephropathy (condition improving); 2. Primary gout (remission period); 3. Lumbar muscle strain; 4. Degenerative changes in the lumbar spine.

[0229] Treatment: 1. Traditional Chinese Medicine Treatment: The herbal decoction described in Example 1. 14 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Continue taking benzbromarone 50mg once daily; maintain a low-purine diet, quit smoking and limit alcohol consumption, drink water regularly; regularly (every 2 weeks later) check blood uric acid, kidney function, and urinalysis. 3. Nursing Care: Appropriate lumbar function exercises (such as five-point support) can be performed, avoid fatigue, avoid prolonged sitting or standing, and pay attention to keeping the lower back warm.

[0230] Based on the treatment results of the follow-up visit, the "Kidney-Warming and Detoxifying Formula" of this invention has a clear therapeutic effect on uric acid nephropathy. After taking 7 doses of the medicine, the patient's main symptoms, such as aversion to cold, cold limbs, lower back pain, and lower limb edema, were significantly relieved. Urination became easier, and accompanying symptoms such as abdominal distension and poor appetite also improved. The efficacy was evident in key laboratory indicators: serum creatinine, reflecting renal function, decreased from 195 μmol / L to 170 μmol / L, and urinary protein decreased; simultaneously, serum uric acid decreased significantly from 726 μmol / L to 612 μmol / L. The treatment results show that the drug of this invention can effectively improve the clinical symptoms of patients with this syndrome and exhibits good effects in reducing uric acid and protecting renal function.

[0231] Typical Case Eleven: Initial diagnosis Name: Feng; Gender: Male; Age: 63; Ethnicity: Han; Marital Status: Married; Occupation: Retired Fisherman; Date of Consultation: 10:30 AM, October 8, 2025.

[0232] Chief complaint: Recurrent joint pain for 6 years, fatigue and aversion to cold for 4 months, which worsened and were accompanied by bilateral lower extremity edema and cloudy urine for 1 week.

[0233] Present Illness: Six years ago, the patient developed pain and swelling in the first metatarsophalangeal joint of his right foot after long-term fishing at sea. A local hospital diagnosed him with gout, finding his uric acid level to be 715 μmol / L, and prescribed colchicine, which relieved his symptoms. Since then, attacks have occurred 2-3 times a year, triggered by seafood consumption or exposure to cold, with intermittent oral administration of allopurinol (irregular dosage). Four months ago, after retiring, the patient experienced general weakness, chills, lower back and knee pain, and dizziness, which he did not pay much attention to. One week ago, these symptoms worsened, with the development of moderate pitting edema in both lower extremities, cloudy urine resembling rice water, increased nocturia to 4 times per night, abdominal distension, nausea, but no vomiting or fever. He came to our hospital seeking traditional Chinese medicine treatment. Since the onset of the illness, he has experienced lethargy, poor sleep, poor appetite, loose stools (twice daily), and a weight loss of 4 kg over the past four months.

[0234] Past medical history: 8-year history of hypertension, long-term oral administration of "nifedipine sustained-release tablets 20mg once daily", with poor blood pressure control (145~155 / 90~100mmHg); denies history of diabetes, coronary heart disease; denies history of hepatitis, tuberculosis, or other infectious diseases; denies history of surgery or trauma.

[0235] Allergy history: Denies any history of drug or food allergies.

[0236] Personal history: He worked as a fisherman for 35 years, often exposed to wind, rain, cold and dampness; he smoked for 38 years, smoking 12 cigarettes a day; he drank alcohol for 33 years, drinking 2 liang (100ml) of baijiu (Chinese liquor) a day; he liked to eat seafood and animal offal; he denied any history of exposure to dust or toxins.

[0237] Traditional Chinese Medicine (TCM) diagnosis: The patient presents with lethargy, pale complexion, aversion to cold, lower back and knee weakness, general fatigue, dizziness, moderate pitting edema in both lower limbs, cloudy urine resembling rice water, increased nocturia, abdominal distension and nausea, poor appetite, and loose stools. The tongue is pale and swollen with teeth marks on the edges, and the coating is white, greasy, and slightly slippery. The pulse is deep, slow, thready, and weak.

[0238] Auxiliary examinations: Urinalysis: proteinuria (+++), glucoseuria (-), hematuria (++), white blood cells (-), red blood cells 5~7 / HP, casts 2~3 / LP; Renal function: serum creatinine 240μmol / L (reference range: 57~111μmol / L), blood urea nitrogen 13.5mmol / L (reference range: 3.2~7.1mmol / L), uric acid 762μmol / L (reference range: 208~428μmol / L); Electrolytes: potassium 4.7mmol / L, sodium 135mmol / L, chloride 99mmol / L; Blood pressure: 150 / 95mmHg; Bilateral renal ultrasound: increased echogenicity of renal parenchyma, unclear corticomedullary boundary.

[0239] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins, and excessive water retention).

[0240] Western medical diagnosis: 1. Uric acid nephropathy (stage 3 chronic kidney disease); 2. Primary gouty arthritis (chronic stage); 3. Primary hypertension, grade 2.

[0241] Treatment: 1. Traditional Chinese Medicine Treatment: Warming the kidneys and strengthening the spleen, clearing away turbidity and detoxifying, promoting diuresis and reducing swelling. Administer the herbal decoction described in Example 1. 7 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Low-purine diet, quitting smoking and limiting alcohol, drinking 2000ml of water daily; adjusting antihypertensive medication to nifedipine sustained-release tablets 20mg twice daily; oral febuxostat 40mg once daily; regular monitoring of blood uric acid, renal function, electrolytes, and blood pressure. 3. Nursing Care: Bed rest, avoiding fatigue, keeping warm, avoiding cold and dampness, a light and easily digestible diet, small frequent meals, and avoiding emotional excitement.

[0242] Follow-up visit Consultation time: October 16, 2025, 9:37 AM.

[0243] Changes in the patient's condition: After taking the above medication for 7 doses, the patient's aversion to cold, lower back and knee pain significantly decreased, general weakness improved, dizziness and blurred vision were relieved, lower limb edema decreased to mild, urine turbidity decreased, nocturia decreased to 3 times / night, abdominal distension and nausea were relieved, appetite slightly improved, loose stools decreased to 1-2 times daily, and mental state improved. Blood pressure dropped to 138 / 88 mmHg.

[0244] Traditional Chinese Medicine diagnosis: Improved mental state, rosier complexion, reduced aversion to cold, relief from lower back and knee pain, improved fatigue, reduced dizziness, mild edema in both lower limbs, slightly increased appetite, reduced abdominal distension, decreased nocturia, and less loose stools. Pale tongue with teeth marks on the edges, white and slightly greasy coating, and deep and slow pulse.

[0245] Auxiliary examinations: Urinalysis: proteinuria (++), occult blood in urine (+), red blood cells 3-4 / HP, casts 1-2 / LP; Renal function: serum creatinine 215μmol / L, blood urea nitrogen 11.2mmol / L, uric acid 650μmol / L; Electrolytes: potassium 4.4mmol / L, sodium 136mmol / L, chloride 101mmol / L; Blood pressure: 138 / 88mmHg.

[0246] Traditional Chinese Medicine diagnosis: Bi syndrome (kidney yang deficiency, internal accumulation of turbid toxins, and gradual reduction of dampness).

[0247] Western medicine diagnosis: 1. Uric acid nephropathy (stage 3 chronic kidney disease, condition improving); 2. Primary gouty arthritis (remission period); 3. Grade 2 primary hypertension (well controlled).

[0248] Treatment: 1. Traditional Chinese Medicine Treatment: The herbal decoction described in Example 1. 14 doses, one dose daily, taken warm in the morning and evening. 2. Western Medicine Treatment: Continue taking nifedipine sustained-release tablets 20mg twice daily and febuxostat 40mg once daily; maintain a low-purine diet, quit smoking and limit alcohol consumption, and ensure adequate daily water intake; regularly (after 2 weeks) check blood uric acid, renal function, electrolytes, urinalysis, and blood pressure. 3. Nursing Care: Appropriate ambulation (such as slow walking) is allowed, avoid fatigue, maintain a cheerful mood, regular rest, and pay attention to dietary regulation.

[0249] According to the treatment results of the follow-up visit, the drug of this invention has a clear effect on uric acid nephropathy. After taking 7 doses, the patient's symptoms of kidney yang deficiency, such as aversion to cold, weakness in the lower back and knees, as well as symptoms of water retention such as cloudy urine and edema, were significantly relieved. Accompanying symptoms such as abdominal distension and nausea also improved. The efficacy was equally evident in key indicators: serum creatinine, reflecting kidney function, decreased from 240 μmol / L to 215 μmol / L, and urinary protein decreased; simultaneously, serum uric acid decreased significantly from 762 μmol / L to 650 μmol / L. The results show that the drug of this invention can effectively improve the clinical symptoms of patients with this syndrome and exhibits good effects in reducing uric acid and protecting kidney function.

[0250] Although the above embodiments have provided a detailed description of the present invention, they are only some embodiments of the present invention, and not all embodiments. People can obtain other embodiments based on these embodiments without creative effort, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The formula includes the following components by weight: Aconitum carmichaelii 3-7 parts, Cinnamomum cassia 1-7 parts, Morinda officinalis 3-10 parts, Sinapis alba 3-9 parts, Fritillaria thunbergii 5-10 parts, Atractylodes lancea 3-9 parts, Coix lacryma-jobi 10-30 parts, Phellodendron chinense 3-12 parts, Pyrrosia lingua 6-15 parts, Dioscorea hypoglauca 9-15 parts, Smilax glabra 15-60 parts, and Prunus persica 5-10 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The formula includes the following components by weight: Aconitum carmichaelii 3-6 parts, Cinnamomum cassia 3-5 parts, Morinda officinalis 6-10 parts, Sinapis alba 5-6 parts, Fritillaria thunbergii 8-9 parts, Atractylodes lancea 5-6 parts, Coix lacryma-jobi 18-20 parts, Phellodendron chinense 9-10 parts, Pyrrosia lingua 9-12 parts, Dioscorea hypoglauca 10-12 parts, Smilax glabra 28-30 parts, and Prunus persica 5-6 parts.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: Mix each herbal component with water, decoct 2-3 times, filter the decoction, combine the filtrates, and obtain the herbal composition.

4. The use of the traditional Chinese medicine composition according to claim 1 or 2 or the traditional Chinese medicine composition prepared by the preparation method according to claim 3 in the preparation of a medicament for treating any one or more of the following diseases: uric acid nephropathy, primary gout, and primary gouty arthritis.

5. The use of the traditional Chinese medicine composition according to claim 1 or 2 or the traditional Chinese medicine composition prepared by the preparation method according to claim 3 in the preparation of a drug for treating uric acid nephropathy of the kidney yang deficiency syndrome.

6. The use of the traditional Chinese medicine composition according to claim 1 or 2 or the traditional Chinese medicine composition prepared by the preparation method according to claim 3 in the preparation of a drug for treating uric acid nephropathy of the type of dampness and blood stasis obstructing collaterals and kidney yang deficiency.

7. A traditional Chinese medicine preparation for treating uric acid nephropathy, characterized in that, It includes the traditional Chinese medicine composition according to claim 1 or 2 or the traditional Chinese medicine composition prepared by the preparation method according to claim 3 and pharmaceutically acceptable excipients.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The dosage forms of the traditional Chinese medicine preparations include decoctions, granules, capsules, or tablets.

9. The method for preparing the traditional Chinese medicine preparation according to claim 7 or 8, characterized in that, Includes the following steps: Mix the various Chinese herbal components with water, decoct 2-3 times, filter the decoction, combine the filtrates, concentrate, and obtain the Chinese herbal preparation.

10. The preparation method according to claim 9, characterized in that, When the dosage form of the traditional Chinese medicine preparation is granules, capsules or tablets, the preparation method further includes, after concentration: drying and pulverizing to obtain traditional Chinese medicine powder, mixing the traditional Chinese medicine powder with pharmaceutically acceptable excipients to prepare granules, capsules or tablets.

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