正清风痛宁治疗类风湿关节炎疗效及安全性系统评价和GRADE证据级别评价

Systematic review and GRADE profile of efficacy and safety of Zhengqing Fengtongning in the treatment of rheumatoid arthritis

目的:系统评价正清风痛宁联合用药治疗类风湿关节炎(RA)的临床疗效和安全性。方法:检索数据库中关于正清风痛宁治疗RA的随机对照试验(RCT),筛选后对其进行Meta分析并运用证据评价等级系统(GRADE)进行证据级别评价。结果:共纳入17个RCTs,涉及1365例患者,纳入的研究质量较低;Meta结果显示:正清风痛宁联合用药在治疗RA的总有效率、晨僵时间、关节压痛数、红细胞沉降率(ESR)、类风湿因子(RF)、C-反应蛋白(CRP)、28关节疾病活动评分(DAS28)、美国风湿病学会20%改善标准(ACR20)、ACR50均优于对照组;联合用药不良反应发生率也低于对照组;证据质量评分均为低级。结论:正清风痛宁联合用药在治疗RA中有较好的疗效及安全性,但纳入文献质量较低,仍需高质量RCT佐证。

Objective:To systemically evaluate the effectiveness and safety of Zhengqing Fengtongning combined therapy in treatment of rheumatoid arthritis(RA).Methods:Randomized controlled trials(RCT)on Zhengqing Fengtongning in treatment of RA were searched from database,Meta analysis and grading of recommendations,assessment,development and evaluation(GRADE)were performed after screening.Results:A total of 1365 patients were included in 17 RCTs,quality of included studys is low.Results of Meta analysis showed that Zhengqing Fengtongning combined therapy had significant effectiveness on overall response rate,morning stiffness,tender joints count,erythrocyte sedimentation rate(ESR),rheumatoid factor(RF),disease activity score in 28 joints(DAS 28),American College of Rheumatology(ACR 20),ACR 50 compared with controls.And the adverse reactions were superior to control group.According to GRADE method,the quality of evidence was low.Conclusion:Zhengqing Fengtongning combined therapy have favorable effectiveness and safety for treatment of RA,however,higher quality clinical trials and rigorous design RCTs are still be required.