青藤碱联合甲氨蝶呤治疗类风湿关节炎有效性和安全性的Meta分析

为系统评价青藤碱联合甲氨蝶呤治疗类风湿关节炎(rheumatoid arthritis,RA)有效性和安全性,该研究利用计算机全面检索万方医药期刊数据库(Wanfang)、中国期刊全文数据库(CNKI)、维普中文科技期刊全文数据库(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrance Library和Web of Science等数据库建库至2020年2月4日所有关于青藤碱联合甲氨蝶呤治疗RA的研究型文献。并基于Cochrane协作网偏倚风险评价标准,运用RevMan 5.3软件对文献进行Meta分析。该研究纳入文献20篇,大多数文献具有不明确的偏倚风险。Meta分析结果显示,青藤碱联合甲氨蝶呤可显著降低DAS28评分(MD=-0.85,95%CI-1.03,-0.67],P<0.00001);提高临床总有效率(P<0.00001);并可抑制关节肿胀数(MD=-1.19,95%CI-1.75,-0.63],P<0.0001)、关节压痛数(MD=-1.58,95%CI-2.89,-0.28],P=0.02),减少晨僵时间(MD=-8.44,95%CI-11.82,-5.07],P<0.00001),但不能有效改善握力(SMD=0.20,95%CI-1.11,1.51],P=0.77);在改善ESR(MD=-9.87,95%CI-14.52,-5.22],P<0.0001),CRP(SMD=-0.30,95%CI-0.51,-0.09],P=0.005),RF(MD=-11.23,95%CI-13.81,-8.65],P<0.00001)方面均优于对照组。青藤碱联合甲氨蝶呤能明显降低不良反应发生率(P<0.00001)。结果表明,青藤碱联合甲氨蝶呤治疗RA不仅能有效改善临床症状及实验室检测指标,而且能有效降低不良反应发生率。由于纳入文献质量、数量的限制,建议增加更多高质量随机对照试验,提升其临床循证证据。

Meta-analysis of efficacy and safety of sinomenine combined with methotrexate in treatment of rheumatoid arthritis

To systemically evaluate the efficacy and safety of sinomenine combined with methotrexate(SIN+MTX)in the treatment of rheumatoid arthritis(RA).Literature databases of Wanfang,CNKI,VIP,SinoMed,PubMed,Cochrane Library and Web of Science were retrieved comprehensively for relevant clinical trials.The literature retrieval time was from database establishment to February 4,2020.The quality of literatures was assessed by the Cochrane Evaluation Handbook 5.1.0,and qualified literature was reviewed and analyzed by using the RevMan 5.3 statistical software.Twenty randomized controlled trials met the inclusion criteria,and were enrolled in the Meta-analysis.The results showed that SIN+MTX remarkably reduced DAS28(MD=-0.85,95%CI-1.03,-0.67],P<0.00001),and improved total efficiency(P<0.00001).SIN+MTX could inhibit swollen joint count(MD=-1.19,95%CI-1.75,-0.63],P<0.0001),tender joint count(MD=-1.58,95%CI-2.89,-0.28],P=0.02)and reduce morning stiffness time(MD=-8.44,95%CI-11.82,-5.07],P<0.00001)compared with control group.The results showed that SIN+MTX was equal to control group in grip strength(SMD=0.20,95%CI-1.11,1.51],P=0.77).SIN+MTX remarkably alleviated the erythrocyte sedimentation rate(MD=-9.87,95%CI-14.52,-5.22],P<0.0001),C-reactive protein(SMD=-0.30,95%CI-0.51,-0.09],P=0.005),and rheumatoid factor(MD=-11.23,95%CI-13.81,-8.65],P<0.00001).The frequency of adverse reactions were reduced compared with that in the control group(P<0.00001).Current clinical studies demonstrate that the efficacy and safety of SIN+MTX in the treatment of RA were superior to control group.However,due to the low quality and quantity of the included studies,highquality randomized controlled trials are necessary to support the clinical evidences.