Clinical study of Santeng Shujin Formula in the treatment of rheumatoid arthritis with rheumatic syndrome and stasis
Objective To observe the efficacy and safety of Santeng Shujin Formula in the treatment of rheumatoid arthritis(RA)with rheumatic syndrome and stasis.Methods A total of 62 RA patients(rheumatic syndrome and stasis)were divided into control group(n=30)and treatment group(n=32)according to their willingness and medication history.All patients were managed by routine Western medicine(RWM),and those in treatment group were additionally treated with Santeng Shujin Formula.Treated for 12 weeks,the aim was to compare the curative effect of traditional Chinese medicine(TCM)syndrome,TCM syndrome score,visual analogue scale(VAS)for pain,Patient Global Assessment(PGA),Physician Global Assessment(MDGA),Health Assessment Questionnaire-Disability Index(HAQ-DI),erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),20％/50％/70％improvement in American College of Rheumatology response criteria(ACR20/50/70).The curative effect and incidence of adverse reactions were assessed.Results The curative effect of TCM syndrome in the treatment group was better than that in the control group(93.75％[30/32]vs 43.33％[13/30],P＜0.05).After treatment,the number of joint swelling and pain,tender joint count,duration of morning stiffness in the treatment group were significantly decreased than before treatment(P＜0.05).The tender joint count,duration of morning stiffness in the control group were significantly decreased(P＜0.05),which were significantly decreased in the treatment group than in the control group(P＜0.05).After treatment,TCM symptom scores in the both groups were significantly decreased(P＜0.05),which were significantly decreased in the treatment group relevant to the control group(P＜0.05).After treatment,significantly lower VAS,PGA,MDGA,HAQ-DI scores in the treatment group,and significantly lower HAQ-DI scores in the control group were found than those before treatment(all P＜0.05).VAS,PGA and MDGA scores in the treatment group were significantly lower than those in the control group(P＜0.05).ESR and CRP levels in the treatment group after treatment were significantly lower than those before treatment(P＜0.05).None of the ESR and CRP levels differed significantly in the control group before and after treatment(P＞0.05).The difference was not statistically significant in the ESR and CRP levels between groups(P＞0.05).ACR20/50/70 response rates were significantly higher in the treatment group than in the control group(P＜0.05).None of the incidence of adverse reactions differed significantly between groups(P＞0.05).Conclusion For RA patients(rheumatic syndrome and stasis),Santeng Shujin Formula combined with RWM has better efficacy than RWM alone,which can improve the ACR20/50/70 response rates,TCM symptoms and quality of life,and with good safety and no serious adverse reactions.It is worthy of clinical promotion.
Rheumatoid arthritisRheumatic syndrome and stasisIntegrated traditional Chinese and Western medicine therapy
万方数据
维普
