艾拉莫德治疗类风湿关节炎随机对照试验的系统评价.pdfVIP

和 MTX 比较安全性指标无显著差异。2 篇 RCTs 将艾拉莫德与尼美舒利比较，结 果示艾拉莫德组分别在 ACR20 或 ACR50 方面优于尼美舒利组，而 ACR70 和安全性 方面两组无显著差异。这两篇 RCTs 提供的数据不完整，未纳入本文汇总分析。 结论：与安慰剂比较，艾拉莫德可增加 RA 患者 ACR 达标率且在次要指标受益， 50mg 组优于 25mg 组。艾拉莫德组副作用发生率和毒性相关退出率高于安慰剂组。 与 SSZ 的疗效和安全性相似。与MTX、尼美舒利比较的疗效和安全性尚需更多 RCT 证据。 关键词：艾拉莫德，类风湿关节炎，随机对照试验，系统评价，meta 分析 4 Abstract Objective: To evaluate the efficacy and safety of iguratimod for the treatment of rheumatoid arthritis (RA). Methods: Randomized controlled trials (RCT) about iguratimod for RA in any language were sought using the following sources: Pubmed,Cochrane Library, CENTRAL, Embase, CBM, CNKI, Weipu database, Wanfang database(up to January 2013).Two reviewers independently identified the eligible studies, assessed their risk of bias and extracted data. RevMan software 5.1 was used for meta-analysis.The primary outcomes were ACR20/50/70. There were 10 secondary outcomes, including rest pain, morning stiffness, tender joint count etc. The safety outcomes were adverse events, toxicity-related withdrawals and total of withdrawals and drop-outs. Results: Six RCTs met the inclusion criteria. Two of them were reported only as abstract and result data was imcomplete.The dosage of iguratimod was 25mg/d or 50mg/d with the duration of treatment ranged from 8 weeks to 28 weeks.These RCTs compared iguratimod with placebo,SSZ,MTX or nimesulide. One of them was of high quality. Others were not.Among them,2,1 and 3 RCTs did not offer detail information of randomization, allocation concealment and blinding,respectively.We were unable to assess the risk of bias of those two RCTs with only abstract report.Four RCTs compared iguratimod with placebo.One of them had only abstract report.The results showed that iguratimod was superior to placebo in both the primary and secondary outcomes. The RRs of ACR20,ACR50 and ACR70 were 2.35(1.87,2.96), 2.86(1.87,4.39) and 4.75(2.