汉防己甲素治疗类风湿关节炎有效性和安全性的meta分析

Efficacy and safety of tetrandrine in treatment of rheumatoid arthritis:a meta-analysis

目的:探索汉防己甲素治疗类风湿关节炎的有效性和安全性。方法:在中国知网、维普网、万方数据、SinoMed、PubMed、Springer、Web of Science、Cochrane Central Register of Controlled Trails数据库中检索汉防己甲素治疗类风湿关节炎的随机对照临床试验。采用R 3.5.3软件对有效率、红细胞沉降率(ESR)、C反应蛋白(CRP)、类风湿因子、视觉模拟评分(VAS)、疾病活动度评分(DAS)、压痛关节计数(TJC)、肿胀关节计数(SJC)和晨僵持续时间等临床指标,以及不良事件发生率进行meta分析。结果:最终纳入10篇研究。meta分析结果显示,汉防己甲素对治疗的有效率(OR=3.27,95%CI:2.01~5.37,P<0.01)、ESR(SMD=1.12,95%CI:0.06~2.19,P<0.05)、CRP(SMD=0.75,95%CI:0.28~1.22,P<0.01)、VAS(SMD=0.64,95%CI:0.29~1.00,P<0.01)、TJC(SMD=1.16,95%CI:0.58~1.74,P<0.01)、SJC(SMD=0.85,95%CI:0.40~1.31,P<0.01)、晨僵持续时间(SMD=1.09,95%CI:0.68~1.50,P<0.01)有一定的改善作用,对类风湿因子(SMD=1.70,95%CI:-1.10~4.51,P>0.05)和DAS(SMD=0.26,95%CI:-0.59~1.11,P>0.05)的改善与对照组差异无统计学意义。汉防己甲素治疗类风湿关节炎的不良事件总发生率为20%(95%CI:12%~27%,I^(2)=60%,P<0.05),不良事件的程度较轻,患者转归良好。结论:汉防己甲素能提高药物治疗类风湿关节炎的临床效果,且不良事件程度较轻。

Objective:To explore the efficacy and safety of tetrandrine in the treatment of rheumatoid arthritis.Methods:Randomized controlled studies of tetrandrine in the treatment of rheumatoid arthritis were searched in CNKI,VIP,Wanfang database,SinoMed,PubMed,Springer,Web of Science and Cochrane Central Register of Controlled Trails databases.A meta-analysis was conducted using R 3.5.3 software to evaluate the clinical outcomes,including the total effective rate,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF),visual analogue scale(VAS),disease activity score(DAS),tender joint count(TJC),swollen joint count(SJC),and morning stiffness duration,as well as adverse events of rheumatoid arthritis patients.Results:A total of 10 articles were included in the study.The meta-analysis indicated that tetrandrine significantly improved the total effective rate(OR=3.27,95%CI:2.01-5.37,P<0.01),ESR(SMD=1.12,95%CI:0.06-2.19,P<0.05),CRP(SMD=0.75,95%CI:0.28-1.22,P<0.01),VAS(SMD=0.64,95%CI:0.29-1.00,P<0.01),TJC(SMD=1.16,95%CI:0.58-1.74,P<0.01),SJC(SMD=0.85,95%CI:0.40-1.31,P<0.01),and morning stiffness(SMD=1.09,95%CI:0.68-1.50,P<0.01).However,no statistical significance was found in RF(SMD=1.70,95%CI:-1.10-4.51,P>0.05)and DAS(SMD=0.26,95%CI:-0.59-1.11,P>0.05).The overall incidence of adverse events associated with tetrandrine treatment for rheumatoid arthritis was 20%(95%CI:12%-27%,I^(2)=60%,P<0.05),with mild severity and favorable outcomes.Conclusion:Tetrandrine is effective in the treatment of RA patients with a mild degree of adverse events.