Traditional Chinese medicine composition for treating chronic kidney diseases and application

Abstract

The invention discloses a preparation method and application of a traditional Chinese medicine composition for treating chronic kidney diseases, and belongs to the technical field of traditional Chinese medicine preparation, and the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of astragalus membranaceus, 10-20 parts of salvia miltiorrhiza, 10-30 parts of euonymus alatus, 15-30 parts of rhizoma smilacis glabrae, 10-20 parts of yam rhizome, 10-15 parts of semen cuscutae and 5-20 parts of centella asiatica. The traditional Chinese medicine composition provided by the invention has an exact curative effect on patients suffering from chronic kidney diseases (spleen and kidney qi deficiency and damp turbid syndromes) at the stage 2-4.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating chronic kidney disease and its application. Background Art

[0002] Chronic kidney disease (CKD) refers to a type of disease in which kidney structure or function abnormalities caused by various reasons last for more than 3 months or more and have an impact on health. Renal damage includes proteinuria, abnormal urine sediment, electrolyte and other abnormalities caused by tubular dysfunction, abnormal kidney histology or imaging examinations, and a history of kidney transplantation. With economic development, people's lifestyles and dietary structures have changed, and the prevalence of chronic kidney disease has increased year by year. The global prevalence has reached 14.3%, and the prevalence of CKD in people over 18 years old in my country is about 10.8%. A large number of clinical studies have preliminarily confirmed that traditional Chinese medicine has certain efficacy and advantages in delaying the progression of chronic kidney disease. In recent years, although many companies at home and abroad have conducted drug research and development for the indication of chronic kidney disease, only a small number of drugs have been approved for this indication, and there is still a lack of safe and effective drugs to delay the progression of chronic kidney disease in clinical practice.

[0003] A large number of studies have shown that traditional Chinese medicine has multiple advantages in treating chronic renal insufficiency, such as improving renal function, reducing complications, and improving the quality of life. CKD patients have complex conditions and weak gastrointestinal function. Commonly used Chinese patent medicines include Urea Clearing Granules, Shenshuai Ning Capsules, Shenwu Yishen Tablets, etc. Although these drugs can achieve certain therapeutic effects in clinical applications, long-term clinical practice has found that they will have poor efficacy, gastrointestinal reactions, liver damage and other manifestations. Therefore, for patients with chronic kidney disease, especially those with chronic renal failure, existing drugs still cannot meet the clinical treatment of CKD. The Chinese medicine composition in this study is an empirical prescription summarized clinically under the academic thinking of famous old Chinese medicine experts. Supported by a number of major projects, it has been proven through systematic clinical observation that it can effectively relieve the clinical symptoms of CKD patients and improve renal function. Our previous study was based on network pharmacology and molecular docking technology verification, and found that the Chinese medicine composition contains 113 active compounds, 269 compound predicted target genes, and 70 compounds and disease-related common targets. Among them, the key genes for the treatment of CKD are Akt1, IL-6, TNF, IL-1β, and TP53. Enrichment analysis suggests that the Chinese medicine composition treats CKD through multiple pathways and multiple targets, including AGE / RAGE, HIF-1, PI3K / Akt, JAK / STAT and other signaling pathways. Molecular docking validation results show that the active ingredients in the Chinese medicine composition have a high binding ability with the key targets of AKT1, IL-6, TNF, IL1B and TP53. Network pharmacology studies have confirmed that the Chinese medicine composition treats CKD based on the pharmacodynamic characteristics of multiple Chinese medicine active ingredients, multiple targets and multiple pathways. CKD is both deficient and full of evil. Compared with the previous technology, the Chinese medicine preparation of the present invention has the effect of tonifying the spleen and kidney, and at the same time has a certain improvement effect on the state of CKD turbid toxin accumulation, treating both the symptoms and the root causes, and can comprehensively coordinate the functions of the internal organs. It can not only improve the renal filtration function, but also reduce the impact of toxin metabolic waste. The therapeutic effect in delaying the decline of glomerular filtration rate in CKD patients, delaying the progression of kidney disease, and improving the quality of life of patients is worth referring to.

[0004] The relevant experimental data are as follows:

[0005] The chemical components of the Chinese medicine composition were retrieved through the TCMSP database using the keywords "Astragalus", "Cuscuta", "Danshen", "Guijianyu", "Tusmilax", "Dioscorea", and "Centella asiatica". The target information of each component was obtained from the "Targetsinformation" in TCMSP. The screening criteria for active ingredients met the oral bioavailability (OB) ≥ 30% and drug-likeness (DL) ≥ 0.18. The target protein information obtained was used to query the gene name corresponding to the human target protein with the help of the UniProt database. Using "Chronic Kidney Disease" as the keyword, CKD-related genes were searched and screened in the TTD, GeneCards, DrugBank, and OMIM databases. The genes obtained in each database were merged and the duplicate data were removed, and finally the CKD-related target genes were obtained. The Venny2.1 website was used to obtain the common target genes of the target group of the Chinese medicine composition and CKD. The screened active ingredients and corresponding targets were imported into CytosCape3.7.1 to construct a drug-active ingredient-target interaction network, and the "Analysis Network" in the software was used for analysis to screen out the key ingredients of the Chinese medicine composition for the treatment of CKD based on the node degree. Figure 1 .Network diagram of active ingredients and target actions of traditional Chinese medicine compositions.

[0006] The shared targets were imported into the STRING network platform, and the species was set to "Home sapiens" with a confidence level of >0.9 for target protein interaction analysis. The results were then imported into the CytosCape3.7.1 software for PPI network visualization. The core target genes were screened using the "CytoHubba" plug-in and the "Analysis Network" tool in the software. The shared target genes were imported into the DAVID database for GO enrichment analysis and KEGG signaling analysis. The enrichment analysis results were imported into Excel 2019, and the results with PValue <0.01 were screened as the biological enrichment analysis of the traditional Chinese medicine composition for the treatment of CKD. The analysis results were imported into the Microbiological Information Platform for visualization. The top 20 KEGG signaling pathway information were screened, and the corresponding drug components and target genes were reversely searched. The "active drug ingredient-target-signaling pathway" network was constructed using CytosCape3.7.1. See Figure 2 .Drug active ingredient-corresponding target-signal pathway network diagram.

[0007] In addition, the top eight key active ingredients in the Chinese medicine composition (quercetin, kaempferol, β-sitosterol, isorhamnetin, luteolin, 7-O-methylisononanol, tanshinone IIa, tanshinone) were selected for molecular docking with the top five core targets in the PPI network (AKT, TNF, IL-6, IL1B, TP53). Some docking results with low binding energy were selected for visualization, so as to further verify the scientific feasibility of the present invention's formula for treating CKD. Figure 3 .Molecular docking diagram of key components and compounds of traditional Chinese medicine composition for the treatment of CKD. Summary of the invention

[0008] The first object of the present invention is to provide a Chinese medicine composition for treating chronic kidney disease. The second object of the present invention is to provide clinical application of the Chinese medicine composition.

[0009] According to the first aspect of the present invention, a traditional Chinese medicine composition for treating chronic kidney disease is provided, wherein the main active ingredients include, by weight: 10-20 parts of Astragalus, 10-20 parts of Salvia miltiorrhiza, 10-30 parts of Psoralea corylifolia, 15-30 parts of Smilax glabra, 10-20 parts of Radix Dioscoreae, 10-15 parts of Cuscuta australis, and 5-20 parts of Centella asiatica.

[0010] The present invention believes that Chinese medicine classifies CKD into the categories of "drowning poison", "closed block", "deficiency and fatigue", etc., and its internal organs are based on spleen and kidney, and are related to heart, liver, lung, and triple energizer. The pathogenesis is complex, the symptoms are numerous, and the condition is difficult to cure repeatedly. Its fundamental pathogenesis is the syndrome of deficiency and excess, with spleen and kidney deficiency as the basis, and dampness, damp heat, and blood stasis as the symptoms. The development of CKD is the product of the interaction of internal and external factors. External factors are conditions, and internal factors are fundamental. Among them, spleen deficiency is the key step of onset and evolution, and kidney deficiency is the inevitable trend of progress and outcome. Spleen and kidney qi deficiency runs through the development of the disease. The viewpoint of "kidney failure is the first injury of spleen and stomach" believes that spleen and kidney failure runs through the whole process of the pathological evolution of chronic kidney disease. Spleen and kidney qi deficiency is common in the early stage, and the disease lasts for a long time, and qi and yin are gradually consumed, which eventually leads to deficiency of yin and yang in the body. Most previous literature studies have found that the distribution of Chinese medicine syndrome types in CKD2-4 stages is mainly spleen and kidney qi deficiency, and the symptoms are mostly dampness and turbidity. Therefore, we realize that it is of great significance to carry out clinical and basic research on the treatment of CKD stage 2-4 with spleen and kidney qi deficiency and dampness turbidity syndrome using traditional Chinese medicine.

[0011] The present invention uses strengthening the kidney and spleen, invigorating the essence and activating blood circulation, and removing turbidity and detoxification as the treatment method. The Chinese medicine composition for treating chronic kidney disease of the present invention is composed of seven herbs, namely, astragalus, salvia miltiorrhiza, euphorbia pulex, smilax glabra, radix polygoni multiflori, dodder seed, and centella asiatica. It is mainly suitable for patients with chronic kidney disease with spleen and kidney qi deficiency and dampness turbidity syndrome. In the prescription, astragalus invigorates qi and consolidates defense, and can invigorate the spleen and promote diuresis; dodder seed warms the kidney and assists yang, consolidates essence and calms the spleen; the two are used together to consolidate the foundation and nourish the essence, which is the main medicine. Smilax glabra detoxifies and removes dampness, raises the clear and lowers the turbid; radix polygoni multiflori removes dampness and removes arthralgia, separates the clear and secretes the turbid; centella asiatica removes dampness and reduces swelling, clears away heat and detoxifies; the three are used together to rise and fall in a suitable manner to enhance the power of lowering adverse, removing turbidity and removing dampness, and are collectively the minister medicines. Salvia miltiorrhiza nourishes blood and promotes menstruation, promotes blood circulation and removes blood stasis, and plays the role of nourishing essence and nourishing blood together with the main medicine; Herba Astragali removes blood stasis and disperses nodules, promotes blood circulation and dredges the collaterals; Salvia miltiorrhiza and Herba Astragali are used together as adjuvants to help reach the kidney collaterals and remove turbid and stagnant evil. Looking at the whole prescription, it treats both the symptoms and the root cause, uses both cold and warm, and uses both tonifying and purging, playing the role of strengthening the kidney and strengthening the spleen, nourishing essence and promoting blood circulation, and removing turbid and detoxifying. The present invention is suitable for chronic kidney disease 2-4 stages, with symptoms of fatigue, poor appetite, soreness of waist and knees, heavy head and body, sticky mouth, sticky stool, nausea and vomiting, pale tongue with tooth marks, white or thick and greasy fur, deep and thin or slippery pulse, and TCM syndrome differentiation belongs to spleen and kidney qi deficiency and dampness and turbidity internal obstruction.

[0012] The sources of raw materials for this recipe are as follows:

[0013] Astragalus: Dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the Leguminosae family. Enters the lung and spleen meridians. Sweet, warm.

[0014] Cuscuta chinensis Lam.: Dried mature seeds of Cuscuta chinensis Lam., a plant of the Convolvulaceae family. It enters the liver, kidney, and spleen meridians. It is sweet and warm.

[0015] Danshen: The dried root and rhizome of Salvia miltiorrhiza Bunge., a plant of the Labiatae family. It enters the heart and liver meridians. It tastes bitter and slightly cold.

[0016] Ghost arrow feather: the wing-like part of the dried stem of Euonymus alatus (Thunb.) Sieb. of the Celastraceae family. Enters the liver and spleen meridians. Bitter, cold.

[0017] Smilax glabra: The dried rhizome of Smilax glabra Roxb., a plant of the Liliaceae family. It enters the liver and stomach meridians. It is sweet, light, and neutral.

[0018] Dioscorea spongiosa: the dried rhizome of Dioscorea spongiosa JQXi, M.Mizuno et WLZhao or Dioscorea futschauensis Uline ex R.Kunth, Dioscoreaceae. Enters the kidney and stomach meridians. Bitter, neutral.

[0019] Centella asiatica: The dried whole herb of Centella asiatica (L.) Urb. of the Umbelliferae family. It enters the liver, spleen, and kidney meridians. It tastes bitter, pungent, and cold.

[0020] In some embodiments, the main active ingredients include, by weight: 15 parts of Astragalus, 20 parts of Salvia miltiorrhiza, 30 parts of Psoralea corylifolia, 30 parts of Smilax glabra, 20 parts of Radix Dioscoreae, 15 parts of Cuscuta australis, and 5 parts of Centella asiatica.

[0021] In some embodiments, the astragalus is raw, which has the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting fluid and nourishing blood, and relieving stagnation and relieving arthritis. The main effect of roasted astragalus is to tonify the middle and replenish qi. In clinical treatment of chronic kidney disease patients, raw astragalus is better than roasted astragalus.

[0022] In some embodiments, medically acceptable adjuvants are also included. Specifically, the adjuvants used are carriers or excipients commonly used in the art, including but not limited to starch, glucose, lactose, sodium carboxymethyl cellulose, methyl cellulose, ethyl cellulose, malt, gelatin, polyols (such as propylene glycol, glycerol, mannitol), compressed tablets, etc., to help improve the stability or activity of the drug, or add an acceptable taste or smell in the case of oral administration.

[0023] In some embodiments, the dosage form of the Chinese medicine composition is decoction, oral liquid, granule, paste, capsule, tablet, powder or pill, so as to facilitate clinical administration.

[0024] According to a second aspect of the present invention, there is provided a clinical application of the above-mentioned traditional Chinese medicine composition for treating chronic kidney disease in the preparation of a medicine for treating chronic kidney disease.

[0025] In some embodiments, the chronic kidney disease is stage 2-4 chronic kidney disease.

[0026] According to the third aspect of the present invention, there is provided the use of the above-mentioned traditional Chinese medicine composition for treating chronic kidney disease in the preparation of a drug for delaying the progression of chronic kidney disease and / or delaying the decline in glomerular filtration rate and / or improving the survival rate of patients with chronic kidney disease.

[0027] In some embodiments, the chronic kidney disease is stage 2-4 chronic kidney disease.

[0028] When the Chinese medicine composition for treating chronic kidney disease of the present invention is a decoction, the dosage of one dose is about 150 mL. One dose refers to the amount of filtrate obtained by boiling each raw material of the Chinese medicine composition for treating chronic kidney disease (such as 15 parts of Astragalus, 20 parts of Salvia miltiorrhiza, 30 parts of Radix Angelicae Pubescentis, 30 parts of Smilax glabra, 20 parts of Radix Dioscoreae, 15 parts of Cuscuta, 5 parts of Centella asiatica) with water.

[0029] Compared with the prior art, the beneficial effects of the present invention include:

[0030] Prospective randomized clinical controlled studies have shown that the Chinese medicine composition for treating chronic kidney disease of the present invention can significantly improve the survival rate of patients with chronic kidney disease, delay the decline of glomerular filtration rate, effectively reduce the risk of kidney disease progression, and has good safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 This is a network diagram of the active ingredients and targets of the Chinese medicine composition, where blue diamonds represent gene targets; grass-green squares represent the names of the Chinese medicines Astragalus, Cuscuta, Salvia miltiorrhiza, Dianthus, Centella asiatica, Smilax glabra, and Psoralea corylifolia respectively; red, purple, yellow, orange, and cyan hexagons represent the common ingredients of the drugs; pink, lavender, yellow, orange, cyan, and green circles represent active ingredients.

[0032] Figure 2 It is a network diagram of drug active ingredients-corresponding targets-signal pathways, in which the blue triangles represent drug active ingredients, the red hexagons represent signal pathways, and the yellow circles represent relevant gene targets of the traditional Chinese medicine composition for the treatment of CKD.

[0033] Figure 3 This is a molecular docking diagram of the key components and compounds of the traditional Chinese medicine composition for the treatment of CKD. DETAILED DESCRIPTION

[0034] The present invention is further described in detail below in conjunction with specific embodiments. Unless otherwise specified, the raw materials used in the present invention are all purchased from the market.

[0035] Example

[0036] The Chinese herbal decoction for treating CKD in this embodiment is prepared from the following components: 15 g of Astragalus, 20 g of Salvia miltiorrhiza, 30 g of Psoralea corylifolia, 30 g of Smilax glabra, 20 g of Radix Dioscoreae, 15 g of Cuscuta australis, and 5 g of Centella asiatica.

[0037] Comparative Example 1

[0038] The Chinese medicine preparation (Shenshuaining Capsule) recommended by the guidelines for the treatment of CKD in this comparative example is produced by Yunnan Leiyunshang Ideal Pharmaceutical Co., Ltd., with the national medicine standard Z53021547.

[0039] Next, to illustrate the therapeutic effect of the Chinese medicine composition for treating chronic kidney disease of the present invention on CKD, a prospective randomized controlled clinical study was conducted. This study was approved by the Ethics Committee of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, with the ethics approval number TYLL2024[Z]057.

[0040] 1. Relevant standards

[0041] 1. Western medicine diagnosis

[0042] Definition of chronic kidney disease (CKD): chronic kidney structural and functional disorders caused by various reasons (history of kidney damage for more than 3 months), including pathological damage, abnormal blood or urine components, abnormal imaging examinations, or unexplained GFR decline for more than 3 months. Refer to the "2024 Clinical Practice Guidelines for the Assessment and Management of Chronic Kidney Disease" issued by the Kidney Disease Improving Global Outcomes Organization (KDIGO) for diagnosis and staging (Table 1, Table 2).

[0043] Table 1 Diagnostic criteria for chronic kidney disease

[0044]

[0045] Table 2 Chronic kidney disease stages

[0046]

[0047]

[0048] 2. TCM syndrome differentiation criteria: spleen and kidney qi deficiency with dampness and turbidity syndrome

[0049] Diagnostic criteria for TCM syndromes: With reference to the TCM diagnosis and treatment plans for chronic renal failure promulgated by the Medical Administration Department of the State Administration of Traditional Chinese Medicine in 2010, including the TCM diagnosis and treatment plans for 95 diseases in 22 specialties, and the relevant chapters of the Guidelines for the Diagnosis and Treatment of Chronic Renal Failure with Integrated Traditional Chinese and Western Medicine, combined with the clinical manifestations of CKD stages 2-4, quantitative criteria for the symptoms and signs of the TCM syndrome types studied in this project were formulated.

[0050] This syndrome is spleen and kidney qi deficiency syndrome: main symptoms: fatigue, poor appetite, sore waist and knees; secondary symptoms: abdominal distension, loose stools, bland mouth without thirst. Pale tongue with teeth marks, white or thick and greasy tongue coating, deep and thin pulse.

[0051] The concurrent symptoms are dampness and turbidity: heavy head and body, sticky mouth, sticky stool, nausea and vomiting. The tongue is fat, the tongue coating is greasy, and the pulse is thin or slippery.

[0052] The diagnosis requires at least two main symptoms, at least one secondary symptom, and at least one concomitant symptom, and the tongue and pulse must all be consistent.

[0053] 3. Inclusion criteria

[0054] (1) Aged 18 to 80 years old;

[0055] (2) Meet the Western medical diagnostic criteria for CKD and the CKD stage 2-4 staging criteria;

[0056] (3) TCM syndrome differentiation is consistent with spleen and kidney qi deficiency and dampness turbidity syndrome;

[0057] (4) The informed consent process complies with regulations and the informed consent form is signed;

[0058] 4. Exclusion criteria

[0059] (1) Secondary kidney disease caused by diabetes, rheumatic autoimmune diseases, hepatitis B virus, etc.;

[0060] (2) Accompanied by impaired consciousness, acute infection, severe cardiac, liver, lung and gastrointestinal dysfunction, severe malnutrition, etc.;

[0061] (3) Malignant tumors, primary bone metabolic diseases, and primary parathyroid diseases;

[0062] (4) Acute kidney injury caused by various reasons;

[0063] (5) receiving parathyroid surgery or kidney transplantation;

[0064] (6) Those who are mentally ill and unable to cooperate, or are breastfeeding or pregnant;

[0065] (7) Patients currently taking hormones or immunosuppressants;

[0066] (8) Those who are allergic to the experimental drugs and their excipients;

[0067] (9) Participated in other clinical trials within 30 days before screening;

[0068] (10) Those who are judged by the researchers to be unsuitable for inclusion in this trial.

[0069] 2. Source of cases:

[0070] This study prospectively collected 100 patients with chronic kidney disease (CKD stage 2-4) who met the inclusion criteria in the outpatient department of Nephrology, the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine from June 2024 to December 2024.

[0071] 3. Grouping:

[0072] Patients were grouped according to the Chinese medicine prescriptions they took: patients who were treated with conventional Western medicine combined with the Chinese medicine decoction for treating chronic kidney disease in Example 1 were included in the Gushen Xiezhuo prescription group (referred to as the Gushen Xiezhuo prescription group), and patients who were treated with conventional Western medicine combined with the Chinese medicine preparation for treating chronic kidney disease in Comparative Example 1 were included in the Shenshuaining capsule group. Shenshuaining capsule group: Shenshuaining capsule, oral, 3 times a day, 4-6 capsules each time. Gushen Xiezhuo prescription group: Gushen Xiezhuo prescription decoction, oral, 1 dose per day, decocted to obtain 300 mL of juice, 150 mL each time, twice a day.

[0073] IV. Data Collection

[0074] 1. Demographic information: gender, age, height, weight, ethnicity, etc.

[0075] 2. Medical history information: past medical history, current medical history, concurrent diseases and medication, etc.

[0076] 3. Evaluation indicators and observation time points

[0077] The main efficacy indicators include serum creatinine, urea nitrogen, blood uric acid, estimated glomerular filtration rate eGFR, plasma albumin, and TCM syndrome score; secondary efficacy indicators include blood β2 microglobulin, serum cystatin C, etc. Monitor the changes of serum creatinine, urea nitrogen, blood uric acid, estimated glomerular filtration rate eGFR, blood β2 microglobulin, serum cystatin C, TCM syndrome efficacy score compared with baseline, and evaluate after the 12th week of treatment. The quantitative standard of TCM syndrome grading is shown in Table 3.

[0078] Table 3 Quantitative standards for TCM syndrome classification

[0079]

[0080]

[0081] 5. Statistical methods

[0082] ① Changes in serum creatinine, urea nitrogen, serum uric acid, estimated glomerular filtration rate eGFR, plasma albumin, blood β2 microglobulin, serum cystatin C (cyc), and TCM syndrome efficacy scores compared with baseline. Statistical description of changes in each index after medication. Inter-group comparisons were performed using variance analysis. Considering the influence of other factors, covariance analysis was used, and the least square mean of the difference between the two groups and its 95% CI were calculated. ② TCM syndrome efficacy was compared between groups using the Kruskal-Wallis rank sum test; the proportion of patients entering medium and high risk was tested using the c2 test. The above tests were all bilateral tests, and P < 0.05 was considered statistically significant.

[0083] Efficacy evaluation criteria

[0084] VI. Criteria for determining efficacy:

[0085] (1) Significant effect: eGFR increased by ≥10%.

[0086] (2) Effective: eGFR increased by ≥5%.

[0087] (3) Stable: eGFR is maintained at the baseline value (fluctuation ≤ 5%).

[0088] (4) Ineffective: decreased eGFR.

[0089] Total effective rate = (number of markedly effective + effective) cases / total number of cases × 100%.

[0090] 6. Results

[0091] 1. General Information

[0092] From June 2024 to December 2024, 100 CKD patients in our hospital were randomly divided into an observation group and a control group, 50 cases in each group. During the study, 2 cases dropped out of each group. There were 34 males and 14 females in the observation group (Gushen Xiezhuo prescription group); the age was 30-79 years old, with an average age of (53.59±8.86) years old. There were 37 males and 11 females in the control group (Shenshuai Ning capsule group); the age was 28-80 years old, with an average age of (50.15±7.46) years old. There was no statistical difference in the general data between the two groups (P>0.05), and they were comparable.

[0093] 2. Clinical efficacy

[0094] The total effective rate of the observation group was 81.25%, which was higher than that of the control group (41.67%) (P<0.05). See Table 4.

[0095] Table 4 Comparison of clinical efficacy between the two groups (n, %)

[0096]

[0097]

[0098] 2.1 Comparison of renal function indicators between the two groups of patients

[0099] After treatment, the levels of Scr, UA and eGFR in both groups were improved compared with those before treatment; the levels of BUN, Scr and eGFR in the observation group were better than those in the control group (P < 0.05), and there was no significant difference in UA between the two groups (P > 0.05), as shown in Table 5.

[0100] Table 5 Comparison of renal function indicators between the two groups of patients

[0101]

[0102] Compared with the group before treatment, *P<0.05; compared with the control group after treatment,# P<0.05.

[0103] 2.2 Comparison of plasma albumin ALB between the two groups

[0104] After treatment, there was no significant difference in ALB data between the two groups (P>0.05), see Table 6.

[0105] Table 6 Comparison of plasma albumin indexes between the two groups

[0106]

[0107] Compared with the group before treatment, *P<0.05; compared with the control group after treatment, # P<0.05.

[0108] 2.3 Comparison of blood β2-microglobulin and serum cystatin C between the two groups

[0109] After treatment, there was no significant difference in the level of blood β2-microglobulin between the two groups (P>0.05), and the decrease in serum cystatin C level in the observation group was better than that in the control group (P<0.05), as shown in Table 7.

[0110] Table 7 Comparison of blood β2 microglobulin and serum cystatin C between the two groups

[0111]

[0112] Compared with the group before treatment, *P<0.05; compared with the control group after treatment, # P<0.05.

[0113] 2.4 Comparison of TCM syndrome scores between the two groups of patients

[0114] After treatment, the observation group was superior to the control group in improving TCM symptoms such as fatigue, soreness of waist and knees, poor appetite, abdominal distension, loose stools, heaviness of head and body, sticky mouth, nausea and vomiting (P < 0.05), as shown in Table 8.

[0115] Table 8 Comparison of TCM syndrome scores between the two groups

[0116]

[0117] Compared with the group before treatment, *P<0.05; compared with the control group after treatment, # P<0.05.

[0118] 2.5 Comparison of adverse reactions between the two groups

[0119] During the treatment, the incidence of adverse reactions such as nausea and vomiting, abdominal distension and diarrhea, dizziness and fatigue in the observation group was lower than that in the control group (P < 0.05), see Table 9.

[0120] Table 9 Comparison of adverse reactions between the two groups of patients (n, %)

[0121]

[0122] 3. Conclusion

[0123] The solidifying kidney and eliminating turbidity prescription of the present invention has significant efficacy in treating patients with CKD stage 2-4 with spleen and kidney qi deficiency and dampness turbidity syndrome, can significantly alleviate the clinical symptoms of patients, improve renal function, and delay the progression of renal failure. It has high safety and definite clinical efficacy, and is worthy of popularization and application.

Claims

1. A Chinese medicine composition for treating chronic kidney disease, characterized in that: The main active ingredients include, by weight, 10-20 parts of astragalus, 10-20 parts of salvia miltiorrhiza, 10-30 parts of euphorbia pulex, 15-30 parts of smilax glabra, 10-20 parts of radix polygoni multiflori, 10-15 parts of dodder seeds and 5-20 parts of centella asiatica.

2. The Chinese medicine composition for treating chronic kidney disease according to claim 1, characterized in that: The main active ingredients thereof include, by weight, 15 parts of astragalus, 20 parts of salvia miltiorrhiza, 30 parts of herba smilax glabrae, 30 parts of rhizoma smilax, 20 parts of herba schizonepetae, 15 parts of herba dodder seeds and 5 parts of centella asiatica.

3. The Chinese medicine composition for treating chronic kidney disease according to claim 1 or 2, characterized in that: The astragalus is raw astragalus.

4. The Chinese medicine composition for treating chronic kidney disease according to claim 1 or 2, characterized in that: Medically acceptable excipients are also included.

5. The Chinese medicine composition for treating chronic kidney disease according to claim 1 or 2, characterized in that: The dosage form of the Chinese medicine composition is decoction, oral liquid, granules, tablets, paste, capsules, pills or powders.

6. Use of the traditional Chinese medicine composition for treating chronic kidney disease according to any one of claims 1 to 5 in the preparation of a medicine for treating chronic kidney disease.

7. The use according to claim 6, characterized in that: The chronic kidney disease is stage 2-4 chronic kidney disease.

8. Use of the Chinese medicinal composition for treating chronic kidney disease according to any one of claims 1 to 5 in the preparation of a drug for delaying the progression of chronic kidney disease and / or delaying the decline of glomerular filtration rate and / or improving the survival rate of patients with chronic kidney disease.

9. The use according to claim 8, characterized in that: The chronic kidney disease is stage 2-4 chronic kidney disease.

Images