三藤舒筋方佐治类风湿关节炎风湿夹瘀证的临床研究

Clinical study of Santeng Shujin Formula in the treatment of rheumatoid arthritis with rheumatic syndrome and stasis

目的观察三藤舒筋方佐治类风湿关节炎(RA)风湿夹瘀证的疗效及安全性。方法将62例RA风湿夹瘀证患者按照其意愿和既往用药情况分为2组,对照组30例予常规西药治疗,治疗组32例在对照组治疗基础上联合三藤舒筋方治疗。疗程12周。比较2组治疗前后中医证候评分、患者和医生评价量表[疼痛视觉模拟评分(VAS)、患者总体病情评估(PGA)、医生总体病情评估(MDGA)]、健康评定问卷-残疾指数(HAQ-DI)、红细胞沉降率(ESR)、C反应蛋白(CRP),记录2组疾病活动度改善20%、50%和70%的美国风湿病学会分类缓解标准(ACR20/50/70)的改善情况,并统计2组疗效和不良反应发生率。结果治疗组总有效率93.75%(30/32),对照组总有效率43.33%(13/30),治疗组中医证候疗效优于对照组(P<0.05)。治疗组治疗后关节肿痛胀数、关节压痛数、晨僵时间均较本组治疗前降低(P<0.05),对照组治疗后关节压痛数、晨僵时间均降低(P<0.05),治疗组治疗前后关节压痛数、晨僵时间差值高于对照组(P<0.05)。2组治疗后中医证候评分均较本组治疗前降低(P<0.05),治疗组治疗前后评分差值高于对照组(P<0.05)。治疗组治疗后疼痛VAS、PGA、MDGA、HAQ-DI评分均较本组治疗前降低(P<0.05),对照组治疗后HAQ-DI评分降低(P<0.05),治疗组治疗前后疼痛VAS、PGA、MDGA评分差值均高于对照组(P<0.05)。治疗组治疗后ESR、CRP均较本组治疗前降低(P<0.05),对照组治疗前后ESR、CRP比较差异无统计学意义(P>0.05),2组治疗前后ESR、CRP差值组间比较差异无统计学意义(P>0.05)。治疗组ACR20/50/70应答率均高于对照组(P<0.05)。2组不良反应发生率比较差异无统计学意义(P>0.05)。结论三藤舒筋方联合常规西药治疗RA风湿夹瘀证较常规西药治疗可提高患者ACR20/50/70的达标率,改善风湿夹瘀证中医证候,总体提高患者生活质量,且安全性良好,无严重不良反应,值得临床推广。

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.