Traditional Chinese medicine composition for treating gout in non-acute phase and its application

Abstract

The invention discloses a Chinese medicine composition for the treatment of gout in the non-acute phase, and the raw materials include the following components by weight: 40-60 parts of cherry juice, 20-40 parts of smilax glabra, 10-20 parts of papaya, 10-20 parts of honeysuckle, and 10-20 parts of lotus leaf; the treatment method of invigorating qi and strengthening spleen, clearing heat and removing dampness, and promoting joints is adopted to improve the spleen deficiency and damp-heat syndrome of patients, reduce the onset of gout, and is safe, effective and has no toxic and side effects. The Chinese medicine composition of the present invention, with cherry as the monarch medicine, invigorates qi, invigorates spleen and stomach, dispels wind and overcomes dampness; smilax glabra clears heat and removes dampness, promotes joints, papaya removes dampness, relaxes muscles and activates collaterals, promotes joints, and both are ministerial medicines; honeysuckle clears heat and detoxicates, and lotus leaf clears heat and removes dampness, and is adjuvant. All medicines are used together, and the whole recipe invigorates qi and invigorates spleen, clears heat and removes dampness, promotes meridians, and promotes joints.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating gout in a non-acute phase and application thereof. Background Art

[0002] Gout is a crystal-related disease caused by the deposition of monosodium urate. It is directly related to hyperuricemia caused by purine metabolism disorders and (or) reduced uric acid excretion, and belongs to the category of metabolic rheumatic diseases. When gout attacks, patients will experience severe pain, which is called the "king of pain". With the changes in people's lifestyles and dietary structures, the incidence of gout is increasing year by year. As an important biochemical basis of gout, hyperuricemia, when the urate concentration exceeds its saturated solubility, urate crystals will be deposited in joints, cartilage and other tissues, causing acute inflammation of joints and tissues, leading to gout. According to the process of gout occurrence and development and the clinical manifestations of different stages, it can be divided into asymptomatic hyperuricemia stage, acute attack stage, inter-attack period, and chronic gouty stage. In the asymptomatic hyperuricemia stage, patients only have elevated uric acid, and have not yet experienced gout attacks. This stage is mainly to control the uric acid level to avoid the deposition of urate after the uric acid concentration is too high, thereby causing gout attacks. The acute attack stage is the rapid onset of joint redness, swelling, heat and pain. The interictal period refers to the occasional pain or soreness of the joints after the acute gouty arthritis is relieved. If there is no good treatment at this stage, the frequency of gout attacks will increase, and repeated attacks will lead to a gradual increase in the number of affected joints, prolonged attacks, and shortened interictal periods, gradually reaching the chronic gout stage. Therefore, the treatment of gout is not only to control the joint symptoms in the acute phase, but also to reduce the onset of gout in the interictal period, that is, the non-acute period, which is of great significance for the prognosis of gout patients. Acute gout is generally manifested as redness, swelling and pain in the joints. Non-acute gout can simply manifest as dull pain in the joints without obvious redness and swelling. Joint pain worsens on rainy days or when the climate changes, especially after eating foods high in purine, which may induce acute gout. Gouty arthritis is the most common in gout patients. More and more evidence shows that long-term hyperuricemia can cause or aggravate multiple organ damage, and is also an independent risk factor for hypertension, metabolic syndrome, chronic kidney disease and cardiovascular disease. Therefore, lowering blood uric acid levels is the key to treating gout. Currently, uric acid-lowering drugs used in the clinic to treat hyperuricemia and gout can be divided into two categories: xanthine oxidase (XOD) inhibitors that inhibit uric acid production (such as allopurinol and febuxostat) and uricosuric drugs (such as benzbromarone). Allopurinol can cause skin allergic reactions, liver and kidney damage, and in severe cases, hypersensitivity reactions, such as fatal exfoliative dermatitis; while febuxostat may cause side effects including elevated liver enzymes, gastrointestinal symptoms, cardiovascular events, etc.; benzbromarone's adverse reactions include diarrhea, stomach discomfort, nausea and other digestive system symptoms, skin allergies, abnormal liver function, etc. Although these drugs can effectively lower blood uric acid levels, Western medicine has many side effects, and rapid uric acid reduction can easily induce gout attacks again. Uric acid levels rise rapidly after drug withdrawal, and patient compliance is poor. Traditional Chinese medicine believes that the causes of gout are divided into internal and external causes. Internal causes include congenital deficiencies, such as spleen deficiency and kidney deficiency; external causes include improper diet, wind, cold, dampness and heat invading the human body.Under the interaction of internal and external factors, the occurrence of this disease is caused. In the "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine", it is proposed that gout is caused by dampness and turbidity, stagnation of joint meridians, and poor circulation of qi and blood. The main clinical manifestations are redness, swelling, pain, or fever in the joints of toes and fingers. Gout is summarized into four main symptoms, namely, damp-heat accumulation, stasis and heat obstruction, phlegm obstruction, and liver and kidney yin deficiency. In the prior art, both traditional Chinese medicine and Western medicine are mainly symptomatic treatments for the acute stage of gout, while there are fewer studies on the non-acute stage of gout (inter-attack period), and there is no therapeutic drug to reduce the recurrence of gout clinically. Summary of the invention

[0003] In view of this, the object of the present invention is to provide a Chinese medicine composition for the treatment of gout in the non-acute phase and its application, which can reduce the onset of gout during the intermittent period of gout, i.e. the non-acute phase, and is safe, effective and has no toxic side effects.

[0004] The Chinese medicine composition for treating gout in the non-acute stage of the present invention comprises the following components by weight: 40-60 parts of cherry juice, 20-40 parts of smilax glabra, 10-20 parts of papaya, 10-20 parts of honeysuckle, and 10-20 parts of lotus leaves;

[0005] Furthermore, the raw materials include the following components by weight: 50 parts of cherry juice, 30 parts of smilax glabra, 15 parts of papaya, 15 parts of honeysuckle, and 15 parts of lotus leaves;

[0006] Furthermore, the Chinese medicine composition can be added with a carrier acceptable in medicine, food science or health care products science to prepare a preparation;

[0007] Furthermore, when the Chinese medicine composition is used, one or more Chinese medicines for improving or treating concurrent symptoms may be added.

[0008] The Chinese medicine composition for treating gout in the non-acute stage of the present invention is used in preparing medicines for preventing and treating gout in the non-acute stage, health products for preventing and treating gout in the non-acute stage, and foods for preventing and treating gout in the non-acute stage.

[0009] Beneficial effects of the present invention: The Chinese medicine composition for the treatment of gout in the non-acute phase of the present invention adopts the treatment method of invigorating qi and strengthening spleen, clearing heat and removing dampness, and unblocking joints to improve the patient's spleen deficiency and damp-heat syndrome, reduce the onset of gout, and is safe, effective and has no toxic side effects. The Chinese medicine composition of the present invention uses cherry as the main medicine, invigorating qi, strengthening spleen and stomach, and dispelling wind and dampness; Smilax glabra clears heat and removes dampness, unblocks joints, and papaya removes dampness and relaxes muscles and activates collaterals, and both are ministerial medicines; honeysuckle clears heat and detoxifies, and lotus leaves clear heat and remove dampness, which are adjuvants. All the medicines are used together, and the whole prescription invigorates qi and strengthens spleen, clears heat and removes dampness, unblocks meridians, and benefits joints. DETAILED DESCRIPTION

[0010] For a better understanding of the present invention, the following examples are provided to further illustrate the present invention, but the present invention is not limited to the following examples.

[0011] In the examples, the experimental methods used are conventional methods unless otherwise specified, and the materials, reagents, etc. used are all commercially available unless otherwise specified.

[0012] The Chinese medicine composition for the treatment of gout in the non-acute phase of the present embodiment, the raw materials include the following components by weight: 40-60 parts of cherry juice, 20-40 parts of rhizoma smilax, 10-20 parts of papaya, 10-20 parts of honeysuckle, and 10-20 parts of lotus leaves; the cause of gout is diet and dampness and heat, and the pathogenesis is that the spleen loses its healthy transportation and feels dampness and heat exogenous pathogens, and the disease position is spleen and stomach. Due to the patient's long-term uncontrolled diet, spicy stimulation, fat and sweet taste, the spleen and stomach are damaged for a long time, resulting in dysfunction of spleen and stomach transportation and transformation, water and dampness are not transported, and spleen deficiency is easy to produce phlegm and dampness, stagnates in joint meridians, and causes joint swelling and pain; under the influence of external environment climate, it is in a damp and hot place for a long time, and the body is invaded by damp and hot exogenous pathogens, blocking joint meridians, and aggravating joint swelling and pain. Therefore, the treatment method adopted should focus on invigorating qi and strengthening the spleen, clearing away heat and dampness, and promoting joint function, improving the spleen deficiency and dampness and heat syndrome of patients, which is of great significance for alleviating gout symptoms and related prognosis.

[0013] Cherry has the effects of invigorating Qi, strengthening the spleen, harmonizing the stomach, and removing rheumatism. It is mainly used to treat physical weakness, fatigue, poor appetite, dry throat and thirst, rheumatic pain in the waist and legs, numbness of the limbs, and poor flexion and extension of joints. It is rich in nutrients such as iron, vitamin C, phosphorus, potassium, calcium, and carotene, and has a strong antioxidant effect.

[0014] Smilax glabra detoxifies, removes dampness, and clears the joints. It is used to treat muscle and bone pain. The water extract of Smilax glabra rhizomes is rich in flavonoids. The total flavonoids of Smilax glabra have anti-inflammatory effects on mice with acute gouty arthritis and can effectively reduce joint swelling. It reduces the inflammatory response of gouty arthritis by inhibiting the activation of the NLRP3 inflammasome axis and reducing the expression of downstream inflammatory factors IL-1β, IL-6, TNF-α, as well as the expression of NLRP3, ASC, and Caspase-1.

[0015] Papaya has the function of relaxing muscles and tendons, and is used to treat dampness, arthritis, cramps, soreness and pain in the waist and knee joints, and cramps. The triterpenes, phenylpropanoids, flavonoids and other chemical components in papaya have anti-inflammatory and analgesic effects.

[0016] Honeysuckle is mainly used to clear away heat and detoxify, and to dispel wind-heat. It is used for carbuncle, furuncle, erysipelas, and heat toxins. Honeysuckle extract can inhibit the release of TNF-α and IL-6. Honeysuckle contains ingredients that can inhibit xanthine oxidase (3,4-dicaffeoylquinic acid methyl ester, quercetin, and luteolin), which can reduce the production of uric acid by inhibiting XOD activity.

[0017] Lotus leaf functions mainly include clearing away heat and dampness, promoting the clear yang, cooling blood and stopping bleeding. It is used for thirst due to summer heat, diarrhea due to summer dampness, diarrhea due to spleen deficiency, and vomiting and bleeding due to blood heat. Both the crude extract of lotus leaves and the total alkaloid fraction of lotus leaves can significantly reduce the uric acid concentration in the serum and liver of hyperuricemia. Lotus leaves inhibit the production of uric acid in hyperuricemia by reducing the mRNA and protein expression of liver XOD. At the same time, lotus leaves inhibit the reabsorption of uric acid in the kidney by downregulating renal GLUT9 and URAT1, and activate the secretion of uric acid by upregulating renal OAT1 / 3. The inhibition of XOD activity and the regulation of urate transporters by lotus leaves promote the excretion of uric acid.

[0018] Preferably, the raw materials include the following components by weight: 50 parts of cherry juice, 30 parts of smilax glabra, 15 parts of papaya, 15 parts of honeysuckle, and 15 parts of lotus leaves.

[0019] In this embodiment, the Chinese medicine composition can be added with a carrier acceptable in medicine, food science or health care products science to prepare a preparation; the composition can be prepared into preparations such as aqueous solution and granules.

[0020] In this embodiment, one or more Chinese medicines for improving or treating concurrent symptoms may be added to the Chinese medicine composition when used.

[0021] The Chinese medicine composition for treating gout in the non-acute stage of the present invention is used in preparing medicines for preventing and treating gout in the non-acute stage, health products for preventing and treating gout in the non-acute stage, and foods for preventing and treating gout in the non-acute stage.

[0022] Embodiment 1

[0023] The Chinese medicine composition for the treatment of non-acute gout in this embodiment comprises the following components by weight: 40 parts of cherry juice, 20 parts of Smilax glabra, 10 parts of papaya, 10 parts of honeysuckle, and 10 parts of lotus leaves.

[0024] Embodiment 2

[0025] The Chinese medicine composition for the treatment of non-acute gout in this embodiment comprises the following components by weight: 60 parts of cherry juice, 40 parts of Smilax glabra, 20 parts of papaya, 20 parts of honeysuckle, and 20 parts of lotus leaves.

[0026] Embodiment 3

[0027] The Chinese medicine composition for the treatment of non-acute gout in this embodiment comprises the following components by weight: 40 parts of cherry juice, 40 parts of Smilax glabra, 10 parts of papaya, 20 parts of honeysuckle, and 10 parts of lotus leaves.

[0028] Embodiment 4

[0029] The Chinese medicine composition for the treatment of non-acute gout in this embodiment comprises the following components by weight: 60 parts of cherry juice, 20 parts of smilax glabra, 20 parts of papaya, 10 parts of honeysuckle, and 20 parts of lotus leaves.

[0030] Embodiment 5

[0031] The Chinese medicine composition for the treatment of non-acute gout in this embodiment comprises the following components by weight: 42 parts of cherry juice, 38 parts of Rhizoma Smilacis Glabrae, 15 parts of papaya, 17 parts of honeysuckle, and 13 parts of lotus leaves.

[0032] Embodiment 6

[0033] The Chinese medicine composition for the treatment of non-acute gout in this embodiment comprises the following components by weight: 50 parts of cherry juice, 30 parts of Smilax glabra, 15 parts of papaya, 15 parts of honeysuckle, and 15 parts of lotus leaves.

[0034] In the above embodiments, the formulation effects of embodiments 2-6 are significantly better than those of embodiment 1, among which the formulation effect of embodiment 6 is the best.

[0035] The Chinese medicine composition of Example 1 was used in clinical trials:

[0036] 1 Clinical Data

[0037] 1.1 Case source

[0038] The study cases were 60 patients in the non-acute stage of gout who were diagnosed with gout and had blood uric acid ≥420μmol / L at the outpatient clinic of the Rheumatology and Immunology Department of Chongqing Hospital of Traditional Chinese Medicine from July 2021 to October 2022. They were randomly divided into a control group and an observation group with 30 cases in each group.

[0039] 1.2 Diagnostic criteria

[0040] 1.2.1 Western medicine diagnostic criteria

[0041] (1) Meet the 2015 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) gout classification and staging standards.

[0042] (2) Patients with gouty arthritis and frequent gout attacks require uric acid-lowering treatment when blood uric acid level is ≥420 μmol / L.

[0043] 1.2.2 TCM syndrome diagnostic criteria

[0044] In the TCM Internal Medicine Disease Diagnosis and Efficacy Criteria (XVII), it can be found that the TCM gout diagnosis criteria are met. Combined with non-acute gout patients, the specific criteria for spleen deficiency with damp-heat syndrome are as follows:

[0045] Main symptoms: asymptomatic period, or occasional joint pain and discomfort;

[0046] Secondary symptoms: fever, thirst, restlessness, yellow urine;

[0047] Tongue and pulse: pale red or red tongue, thin yellow or greasy yellow fur, thin and rapid or slippery and rapid pulse.

[0048] 1.3 Patient selection

[0049] 1.3.1 Inclusion criteria

[0050] ① Voluntary participation and signing of informed consent;

[0051] ②Meet the diagnostic criteria of Western medicine;

[0052] ③Conform to the diagnostic criteria of TCM diseases and syndromes;

[0053] ④Age 18-70 years old;

[0054] ⑤ Patients with a history of typical gout attacks and in the non-acute stage of gout whose last gout attack was more than 2 weeks before the observation were included.

[0055] ⑥ No uric acid-lowering drugs were taken within 2 weeks before the observation.

[0056] 1.3.2 Exclusion criteria

[0057] ① Patients who were in the acute stage of gout at the time of enrollment;

[0058] ② Patients with secondary hyperuricemia caused by other reasons;

[0059] ③ Patients with serious primary diseases such as cardiovascular, liver, kidney and blood system diseases;

[0060] ④ Pregnant or lactating women, or people with allergies;

[0061] ⑤ Those who are unable to cooperate, such as patients with neurosis;

[0062] ⑥ Patients who need to take hormone painkillers for a long time;

[0063] ⑦ Patients with tophi already formed.

[0064] 1.3.3 Standards for rejection and falling off:

[0065] ① Exclusion: Subjects who should not be included in the group but have been included should be excluded, including: mistaken inclusion; misdiagnosis; failure to take the medicine once; and no test records.

[0066] ② Patients who have been enrolled but have not completed the clinical plan should be considered as dropouts in the following circumstances: patients withdraw on their own initiative; lost to follow-up; poor compliance; or physicians order them to withdraw due to complications.

[0067] 2 Treatment options

[0068] Basic treatment: low-purine and low-fat diet, quit smoking and drinking, exercise moderately, and drink more than 2000mL of water per day.

[0069] Control group: basic treatment + oral western medicine febuxostat (Jiangsu Wanbang Biochemical Pharmaceutical Co., Ltd., national medicine standard H20130058, specification 40 mg / tablet), initial dose 20 mg, once a day, adjust the dose according to the re-examination of uric acid situation, maintain the blood uric acid level at about 360 μmol / L, 8 weeks as a course of treatment.

[0070] Observation group: basic treatment + oral western medicine febuxostat + the Chinese medicine composition of the present invention for the treatment of non-acute gout, febuxostat (Jiangsu Wanbang Biochemical Pharmaceutical Co., Ltd., national medicine standard H20130058, specification 40 mg / tablet), initial dose 20 mg, once a day, adjust the dose according to the reexamination situation, maintain the blood uric acid level at about 360 μmol / L; Chinese medicine composition, 1 dose per day, about 1000 ml of hot water, can be taken multiple times, 8 weeks as a course of treatment.

[0071] ※ If the patient has an acute attack of gout during treatment, it is recommended that the patient rest and raise the affected limb. External medication can be used for treatment; etoricoxib 120 mg once a day is given and discontinued after pain relief. For patients with unbearable pain and no symptom relief after taking etoricoxib, clinical observation will be withdrawn.

[0072] 3 Observation indicators

[0073] 3.1 Safety Observation Indicators

[0074] ① General information: body temperature, pulse, respiration, blood pressure.

[0075] ②Safety indicators: routine blood and urine tests, liver and kidney function.

[0076] ③Possible adverse reactions, such as diarrhea, rash, etc.

[0077] 3.2 Efficacy observation

[0078] ① Continue to follow up during the treatment period (0-8 weeks) and the follow-up period (within 3 months of drug discontinuation, i.e. 8-20 weeks).

[0079] Record gout attacks;

[0080] ② TCM syndrome score: compare the changes in TCM syndrome score of patients before and after treatment;

[0081] ③ Blood uric acid level: Compare the changes in blood uric acid levels of patients at 0, 4, and 8 weeks.

[0082] 4. Efficacy evaluation

[0083] After the treatment, the efficacy evaluation was carried out in accordance with the "Guidelines for Clinical Research of New Traditional Chinese Medicines" issued by the Ministry of Health.

[0084] Markedly effective: The reduction rate of TCM syndrome scores was ≥70%.

[0085] Effective: 30% ≤ TCM syndrome score reduction rate < 70%.

[0086] Ineffective: The reduction rate of TCM syndrome score is less than 30%.

[0087] The calculation formula was formulated with reference to the nimodipine method: syndrome score reduction rate (therapeutic index) = (total score before treatment - total score after treatment) / total score before treatment × 100%.

[0088] 5. Statistical analysis methods

[0089] SPSS 25.0 software was used for statistical analysis. If the data conformed to normal distribution, the measurement data were expressed as mean standard deviation. The comparison between the two groups was performed by t test, and the comparison within the same group was performed by paired t test; if it did not conform to the normal distribution, the median and interquartile range M (P25-P75) were used to represent it, and the rank sum test was used for comparison between the two groups, and the paired rank sum test was used for comparison within the same group. The chi-square test was used for count data, and the rank sum test was used for rank data.

[0090] Result analysis:

[0091] 1 Analysis of case enrollment

[0092] A total of 60 patients with non-acute gout (spleen deficiency with damp-heat syndrome) were included in this study. According to the principle of random grouping, 30 cases were included in the control group, 1 case dropped out, and 29 cases were completed; 30 cases were included in the observation group, 1 case dropped out, and 29 cases were completed. A total of 58 cases were finally completed in both groups, of which 1 case was lost to follow-up and 1 case dropped out due to work reasons.

[0093] 2 General Data Analysis

[0094] 2.1 Comparison of age distribution between the two groups

[0095] The ages of the two groups of patients were in accordance with normal distribution. An independent sample t-test was performed, and the result was P=0.827 (P>0.05), indicating that there was no significant difference in the ages of the two groups of patients and they were comparable (see Table 1).

[0096] Table 1. Age distribution of patients in the two groups

[0097]

[0098] 2.2 Comparison of gender between the two groups

[0099] There were 58 patients in the two groups, including 56 males and 2 females. There were 29 males and 0 females in the control group; there were 27 males and 2 females in the observation group. The chi-square test showed that P = 0.472 (P > 0.05), with no statistical difference and comparability. See Table 2.

[0100] Table 2. Comparison of gender between the two groups of patients

[0101]

[0102] 3. Comparison of baseline before treatment

[0103] 3.1 Comparison of gout attacks between the two groups in the first 3 months

[0104] Within 3 months before enrollment, 14 people in the control group had a history of gout attacks, and 11 people in the observation group had a history of gout attacks. The chi-square test showed that the two groups had no statistical difference, P = 0.426 (P > 0.05), and were comparable, as shown in Table 3.

[0105] Table 3. Comparison of gout attacks between the two groups in the first three months of enrollment

[0106]

[0107] 3.2 Comparison of serum uric acid levels between the two groups before treatment

[0108] Before treatment, the serum uric acid levels of the two groups of patients were in accordance with normal distribution. An independent t-test was performed, and the result was P=0.064 (P>0.05). There was no statistical difference. The serum uric acid levels of the two groups of patients before treatment were comparable, as shown in Table 4.

[0109] Table 4. Comparison of blood uric acid levels between the two groups before treatment

[0110]

[0111] 3.3 Comparison of TCM syndrome scores between the two groups before treatment

[0112] The TCM syndrome scores of the two groups of patients before treatment were compared by rank sum test, P=0.387 (P>0.05), with no statistical difference, indicating that the TCM syndrome scores of the two groups of patients before treatment were comparable, see Table 5.

[0113] Table 5. Comparison of TCM syndrome scores between the two groups before treatment

[0114]

[0115] 4 Analysis of efficacy indicators

[0116] 4.1 Analysis of acute gout attacks in the two groups of patients during treatment and follow-up

[0117] 4.1.1 Acute gout attacks during treatment (0-8 weeks)

[0118] The total frequency of acute gout attacks in the observation group during the treatment period (0-8 weeks) was lower than that in the control group. The chi-square test showed that P=0.036 (P<0.05), and the difference was statistically significant, as shown in Table 6.

[0119] Table 6. Comparison of the number of acute gout attacks between the two groups during treatment

[0120]

[0121] 4.1.2 Acute gout attacks during follow-up (8-20 weeks)

[0122] The total frequency of acute gout attacks in the observation group during the follow-up period (8-20 weeks) was lower than that in the control group. The chi-square test showed that P=0.023 (P<0.05), and the difference was statistically significant, as shown in Table 7.

[0123] Table 7. Comparison of the number of acute gout attacks between the two groups during the follow-up period

[0124]

[0125] 4.2 TCM Syndrome Score Analysis

[0126] Non-normal distribution was expressed by median and interquartile range M (P25-P75). The rank sum test was used for comparison between the two groups, and paired rank sum test was performed before and after treatment.

[0127] Intra-group comparison, the TCM syndrome scores of the control group before and after treatment were compared, P < 0.05, and the difference was statistically significant; the syndrome scores of the observation group before and after treatment were compared, P < 0.05, and the difference was statistically significant. This shows that both groups have a certain effect on improving the TCM syndrome of spleen deficiency with damp-heat syndrome.

[0128] Comparison between the two groups, the TCM syndrome scores of the control group and the observation group after treatment were compared, P < 0.05, the difference was statistically significant, indicating that the observation group has an advantage in improving TCM syndromes compared with the control group. See Table 8.

[0129] Table 8. Comparison of TCM syndrome scores

[0130]

[0131] 4.3 Analysis of TCM syndrome efficacy in two groups of patients

[0132] The efficacy of TCM syndromes in the two groups of patients after treatment was compared by chi-square test, P=0.009 (P<0.05), indicating that the efficacy of TCM syndromes in the two groups after treatment was statistically significant. The total effective rate of the observation group was higher than that of the control group, indicating that the observation group was better than the control group in improving TCM syndromes of spleen deficiency and damp-heat syndrome by using Western medicine alone, as shown in Table 9.

[0133] Table 9. Comparison of TCM syndrome efficacy between the two groups

[0134]

[0135] 4.4 Comparison of the scores of various TCM syndrome elements before and after treatment

[0136] The rank sum test was used for comparison between the two groups. Before treatment, the scores of the two groups were P>0.05, with no statistical difference and comparability. After treatment, the observation group showed an advantage over the control group in the scores of fever, thirst, restlessness, and yellow urine, with P<0.05, and there was a statistical difference. However, the scores of joint soreness and swelling were P>0.05, with no statistical difference.

[0137] The paired rank sum test was used for intra-group comparison. The scores of each item before and after treatment between the two groups were P < 0.05, indicating statistically significant differences. See Table 10.

[0138] Table 10. Comparison of the scores of various TCM syndrome elements before and after treatment

[0139]

[0140] 4.5 Analysis of serum uric acid levels in the two groups of patients

[0141] Comparison between groups: After 4 weeks of treatment, the blood uric acid levels of the control group and the observation group were compared, expressed as median and interquartile range M (P25-P75). The comparison between the two groups was performed by rank sum test, P = 0.864 (P > 0.05), which was not statistically significant, indicating that there was no significant difference in the uric acid lowering efficacy between the two groups after 4 weeks of treatment. After 8 weeks of treatment, the blood uric acid levels of the control group and the observation group were compared, P = 0.174 (P > 0.05), which was not statistically significant, indicating that there was no significant difference in the uric acid lowering efficacy between the two groups at 8 weeks of treatment.

[0142] Intra-group comparison showed that the blood uric acid levels decreased after 4 and 8 weeks of treatment compared with those before treatment, *P<0.05, #P<0.05, and the difference was statistically significant. See Table 11.

[0143] Table 11. Analysis of uric acid levels in the two groups of patients after treatment

[0144]

[0145] Note: Paired rank sum test was used for comparison within the group after 4 and 8 weeks of treatment, *P<0.05, # P<0.05.

[0146] 4.6 Safety during treatment

[0147] The vital signs of the two groups of patients were stable before and after treatment, and no abnormal safety indicators or adverse events occurred.

[0148] Analysis of basic conditions of the two groups of patients

[0149] A total of 60 patients with non-acute gout (spleen deficiency with damp-heat syndrome) were included in this study. A total of 30 patients were included in the control group, 1 of whom dropped out, and 29 patients were completed; a total of 30 patients were included in the observation group, 1 of whom dropped out, and 29 patients were completed. A total of 58 patients were finally completed in both groups. The gender, age, gout attack frequency, and blood uric acid of the two groups of patients were analyzed. The results showed that P>0.05, there was no significant difference, and they were comparable.

[0150] 4.2 Analysis of efficacy indicators

[0151] (1) Comparison of acute gout attacks between the two groups of patients during treatment and follow-up:

[0152] According to the statistics of acute attacks during the treatment period (0-8 weeks), there were 7 cases in the control group during 0-4 weeks, 4 cases during 4-8 weeks, and the total attack frequency was 37.93%; there were 3 cases in the observation group during 0-4 weeks, 1 case during 4-8 weeks, and the total attack frequency was 13.80%. According to the chi-square test, the total frequency of acute attacks of gout in the observation group during the treatment period (0-8 weeks) was lower than that in the control group, P<0.05, and the difference was statistically significant, indicating that the observation group had a certain effect on improving the recurrence of gout compared with the control group.

[0153] During the follow-up period, there were 13 cases of gout recurrence in the control group between 8 and 20 weeks, with a total attack frequency of 44.8%. There were 5 cases of gout recurrence in the observation group between 8 and 20 weeks, with a total attack frequency of 17.2%. According to the chi-square test, the frequency of acute gout attacks in the observation group during the follow-up period was lower than that in the control group, P<0.05, and the difference was statistically significant, indicating that the observation group had a certain therapeutic effect on improving the recurrence of gout compared with the control group.

[0154] Through the observation and data analysis of gout recurrence in the two groups of patients, it can be seen that the recurrence rate of the two groups was higher in the early stage of uric acid-lowering treatment, which is considered to be related to the acute attack of gout caused by the large fluctuation of uric acid levels. Compared with the control group, the recurrence rate of the observation group was lower in 0-4 weeks, indicating that the Chinese medicine composition of the present invention can slow down the attack of gout to a certain extent. The overall recurrence rate of the observation group was lower than that of the control group, indicating that the Chinese medicine composition of the present invention has a certain effect on reducing the recurrence of gout.

[0155] (2) TCM syndrome score analysis: Before treatment, the TCM syndrome scores of the two groups of patients were compared, P>0.05, with no statistical difference, indicating comparability. The TCM syndrome scores of the control group and the observation group were compared before and after treatment, P<0.05, with a statistically significant difference, indicating that both groups had a certain effect on improving the TCM syndrome of spleen deficiency with damp-heat syndrome. After treatment, the TCM syndrome scores of the control group and the observation group were compared, P<0.05, with a statistically significant difference, indicating that the observation group had an advantage over the control group in improving the TCM syndrome of spleen deficiency with damp-heat syndrome. In the formula, Smilax glabra, papaya, cherry, and lotus leaf remove dampness, and honeysuckle clears heat and detoxifies. The combination of these medicines has a significant effect on improving the syndrome score.

[0156] (3) Analysis of TCM syndrome efficacy: According to the TCM syndrome efficacy index, combined with the nimodipine analysis method, the control group had 2 cases of marked effect, 14 cases of effective, 13 cases of ineffective, and a total effective rate of 55.17%; the observation group had 12 cases of marked effect, 13 cases of effective, 4 cases of ineffective, and a total effective rate of 86.21%. The total effective rate of the two groups was compared, P < 0.05, indicating that the TCM syndrome of the two groups was statistically significant after treatment. The total effective rate of the observation group was higher than that of the control group, indicating that the observation group was more effective in improving the TCM syndrome of spleen deficiency and damp-heat syndrome than the control group using Western medicine alone.

[0157] (4) Comparison of the scores of various TCM syndrome elements: The rank sum test was used for inter-group comparison. Before treatment, the scores of the two groups of patients were P>0.05, with no statistical difference and comparability. After treatment, the observation group showed an advantage over the control group in the scores of fever, thirst, restlessness, and yellow urine, with a statistical difference (P<0.05). However, there was no statistical difference in the scores of joint soreness and swelling between the two groups (P>0.05). The paired rank sum test was used for intra-group comparison. The scores of the two groups before and after treatment were P<0.05, with a statistical difference.

[0158] (5) Comparison of blood uric acid levels: Intergroup comparison: After 4 and 8 weeks of treatment, the uric acid levels of the control group and the observation group were compared between groups. The rank sum test showed that P>0.05, which was not statistically significant, indicating that there was no significant difference in the uric acid-lowering efficacy between the two groups after 4 and 8 weeks of treatment. Intragroup comparison: After 4 and 8 weeks of treatment, the blood uric acid levels were lower than those before treatment, P<0.05, and the difference was statistically significant.

[0159] There was no statistical difference in blood uric acid levels between the two groups of patients before and after treatment. This may be because during the treatment, the dose of febuxostat was adjusted according to the reexamination results, which was related to the maintenance of uric acid levels at around 360 μmol / L.

[0160] (6) Safety comparison: The vital signs of the two groups of patients were stable before and after treatment, and no abnormal safety indicators or adverse events occurred.

[0161] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the purpose and scope of the technical solution of the present invention, which should be included in the scope of the claims of the present invention.

Claims

1. A Chinese medicine composition for the treatment of non-acute gout, characterized in that: The raw materials are composed of the following components by weight: 40-60 parts of cherry juice, 20-40 parts of smilax glabra, 10-20 parts of papaya, 10-20 parts of honeysuckle and 10-20 parts of lotus leaves.

2. The Chinese medicine composition for treating gout in the non-acute phase according to claim 1, characterized in that: The raw materials are composed of the following components by weight: 50 parts of cherry juice, 30 parts of smilax glabra, 15 parts of papaya, 15 parts of honeysuckle and 15 parts of lotus leaves.

3. The Chinese medicine composition for treating gout in the non-acute phase according to claim 1, characterized in that: The traditional Chinese medicine composition can be added with a medically acceptable carrier to prepare a preparation.

4. Use of the Chinese medicine composition for the treatment of gout in the non-acute phase according to any one of claims 1 to 3 in the preparation of a medicament for the prevention and treatment of gout in the non-acute phase.

Images