| Objective:Gouty arthritis is a common inflammatory disease caused by the accumulation of uric acid crystals in joints,leading to joint pain,inflammation,and damage.Traditional Chinese medicine(TCM)considers gouty arthritis as a result of kidney deficiency and phlegm stasis.The formula of Beneficial Kidney,Activating Blood and Dispelling Phlegm has been used in TCM to treat gouty arthritis with kidney deficiency and phlegm stasis.This study aimed to evaluate the clinical efficacy of this formula in treating gouty arthritis.Methods:Sixty-four patients with gouty arthritis and kidney deficiency and phlegm stasis were recruited and randomly divided into two groups,a treatment group(n=32)and a control group(n=32).The control group received febuxostat and loxoprofen sodium tablets,while the treatment group received the self-formulated formula "Benefit Kidney,Invigorate Blood and Dispel Phlegm." The patients underwent the gastrointestinal symptom rating scale(GIS)survey before treatment.Clinical symptoms,laboratory indexes,and adverse reactions of the two groups were recorded and observed after 4and 8 weeks of continuous treatment.The changes in clinical efficacy,symptoms and signs,TCM syndrome score,number of episodes,VAS score,and laboratory indices of the patients before and after treatment were observed,and the relevant data of the patients were compiled and analyzed statistically.Results:1,64 people were screened into the group,and finally a total of 60 patients participated in the study throughout,including 29 in the control group and 31 in the treatment group.After statistical analysis,no statistical differences were found between the two groups in general condition,clinical symptom scores and laboratory tests before treatment(P > 0.05),which were comparable.2,After 4 weeks of treatment,the various observation indexes(such as TCM symptom scores,laboratory tests and VAS)of the two groups were better than those before treatment(p < 0.05)compared with those before treatment,except for joint pain in TCM symptoms(p > 0.05);in the inter-group comparison between the treatment and control groups,no statistical differences were found in some small items of TCM symptom scores(p > 0.05),such as joint pain,limitation of joint movement and skin color.However,there was a significant difference in the total TCM symptom score(p < 0.05),and all other observed indexes were significant(p < 0.05).3.After 8 weeks of treatment,all kinds of observed indexes in both groups were better than those before treatment(p < 0.05)and statistically significant(p < 0.05);in the comparison between the treatment and control groups,a significant difference was found between the treatment and control groups(p < 0.05),and all observed indexes in the treatment group were better than those in the control group.4.At the end of the treatment,the total effective rate of the treatment group reached 90.32%,and the total effective rate of the control group was 79.31%,and the effective rate of the treatment group was better than that of the control group,with a statistically significant difference(p < 0.05).5.In terms of safety,the incidence rate of 10% in the control group was higher than the incidence rate of 6.7% in the treatment group.No abnormalities were found in other safety indicators in both groups.No significant differences were found by statistical tests(p > 0.05).Conclusion:The formula of Beneficial Kidney,Activating Blood and Dispelling Phlegm can effectively alleviate the symptoms and signs and TCM syndrome points of gout patients,and positively affect the laboratory examination indexes,with better efficacy than conventional treatment methods.These findings suggest that the formula can be considered as a complementary therapy for gouty arthritis with kidney deficiency and phlegm stasis. |
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