甲氨蝶呤联合艾拉莫德治疗类风湿关节炎的疗效与安全性的系统评价

Efficacy and safety of methotrexate in combination with Iguratimod in treatment of rheumatoid arthritis:a systematic review

目的系统评价甲氨蝶呤联合艾拉莫德治疗类风湿关节炎的疗效与安全性。方法制定相应的纳入标准、排除标准及检索策略,检索Pub Med、Cochrance Library、Wiley Online Library、CNKI、CBM、万方数据知识服务平台等电子数据库,时间截止2016年12月,收集甲氨蝶呤联合艾拉莫德治疗类风湿关节炎的随机对照试验。根据美国风湿病学会推荐的类风湿关节炎相关评分的核心标准(ACR20、ACR50、ACR70即28个肿胀和触痛关节数改善率达20%、50%、70%)和疾病活动度计算法(DAS28即对28个关节进行评估),采用Revman5.3软件对其进行Meta分析。结果通过检索初步获得154篇相关文献,经纳入和排除标准筛选,共纳入15篇文献,共1 382例受试者,15项试验的Jadad评分均超过4分。其中6篇文献Meta分析结果显示:甲氨蝶呤联合艾拉莫德治疗类风湿关节炎后ACR20、ACR50缓解率高于对照组(OR=3.54、2.85,95%CI:2.47～5.08、1.96～4.13,均P<0.01)。其中4篇文献Meta分析结果显示:ACR70缓解率较对照组高(OR=1.84,95%CI:1.02～3.29,P<0.05)。其中8篇文献Meta分析结果显示:甲氨蝶呤联合艾拉莫德治疗RA后DAS28低于对照组(OR=-0.99,95%CI:-1.23～-0.74,P<0.01)。结论甲氨蝶呤联合艾拉莫德治疗类风湿关节炎患者的疗效优于甲氨蝶呤组,安全性与甲氨蝶呤组比无统计学差异。

Objective To evaluate the efficacy and safety of methotrexate combined with Iguratimod in treatment ofrheumatoid arthritis. Methods We searched PubMed, Cochrance Library, Wiley Online Library, CNKI, CBM, Wanfangdatabase up to 31 December 2016. The randomized controlled trials of methotrexate combined with Iguratimod in thetreatment of RA were included, the data were screened and extracted by two reviewers independently. The efficacy wasassessed with the core criteria recommended by the National Institute of Rheumatology （ACR20, 50, 70 the remission ofswelling and tender in 28 joints to 20%, 50%, 70%） and the disease activity in 28 joints （DAS28）. Meta-analysis wasperformed using Revman 5.3 software. Results A total of 154 studies were found, 15 trials had Jadad score〉4 and wereincluded in the analysis with 1382 subjects involved. The meta-analysis based on 6 studies showed that ACR20 and ACR50respond rates in trial group were higher than those in the control group （OR=3.54, 95%CI：2.47~5.08, P〈0.01; OR=2.85, 95% CI：1.96-4.13, P〈0.01）. The meta-analysis bases on 4 studies showed that ACR70 respond rate was higher in trial group than that ofcontrol group （OR=1.84, 95%CI：1.02-3.29, P〈0.05）. The meta-analysis based on 8 studies showed that DAS28 was lower in trialgroup than in control group （OR=-0.99, 95%CI：-1.23--0.74, P〈0.01）. Conclusion The efficacy of methotrexate combined withIguratimod is better than that of methotrexate alone in treatment of RA patients without compromising on the safety.