中国循证医学杂志

中国循证医学杂志

艾拉莫德与甲氨蝶呤比较治疗类风湿关节炎有效性和安全性的 Meta 分析

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目的 系统评价艾拉莫德与甲氨蝶呤比较治疗类风湿关节炎的有效性和安全性。 方法 计算机检索 PubMed、EMbase、The Cochrane Library、VIP、CBM、WangFang Data、CNKI 数据库,搜集有关艾拉莫德与甲氨蝶呤比较治疗类风湿关节炎的随机对照试验(RCT),检索时限均从建库至 2018 年 6 月。由 2 名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 RevMan 5.3 软件进行 Meta 分析。 结果 共纳入 10 个 RCT,包括 970 例患者。Meta 分析结果显示:两组在 ACR20[RR=1.06,95%CI(0.91,1.23),P=0.49]、ACR50[RR=0.93,95%CI(0.73,1.19),P=0.55]、ACR70[RR=0.92,95%CI(0.62,1.39),P=0.70]、晨僵时间[MD=0.45,95%CI(–0.26,1.16),P=0.22]、关节压痛数[MD=0.07,95%CI(–2.31,2.45),P=0.95]、关节肿胀数[MD=–0.30,95%CI(–1.44,0.84),P=0.61]、健康评定问卷得分[MD=0.01,95%CI(–0.05,0.07),P=0.73]及不良反应发生上的差异均无统计学意义。2 个采用双盲法的 RCT 的 Meta 分析结果显示,艾拉莫德在患者[MD=4.11,95%CI(0.11,8.10),P=0.04]和医生[MD=4.81,95%CI(0.93,8.69),P=0.01]对疾病活动的综合评价方面,比甲氨蝶呤更优,其差异有统计学意义。 结论 当前证据表明,艾拉莫德治疗类风湿关节炎的疗效和安全性与甲氨蝶呤相当,且在患者和医生对疾病活动的综合评价方面更优。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objective To systematically review the efficacy and safety of iguratimod compared with methotrexate in the treatment of rheumatoid arthritis. Methods PubMed, EMbase, The Cochrane Library, VIP, CBM, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) of the efficacy and safety of iguratimod compared with methotrexate in the treatment of rheumatoid arthritis from inception to June 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software. Results A total of 10 RCTs involving 970 patients were included. The results of the meta-analysis showed that: there were no statistical differences between iguratimod and methotrexate in ACR20 (RR=1.06, 95%CI 0.91 to 1.23, P=0.49), ACR50 (RR=0.93, 95%CI 0.73 to 1.19, P=0.55), ACR70 (RR=0.92, 95%CI 0.62 to 1.39, P=0.70), morning stiffness time (MD=0.45, 95%CI –0.26 to 1.16, P=0.22), tender joint count (MD=0.07, 95%CI –2.31 to 2.45, P=0.95), swollen joint count (MD=–0.30, 95%CI –1.44 to 0.84, P=0.61), health assessment questionnaire (MD=0.01, 95%CI –0.05 to 0.07, P=0.73) and the rate of adverse event. And iguratimod was superior to methotrexat in the patient (MD=4.11, 95%CI 0.11 to 8.10, P=0.04) and physician (MD=4.81, 95%CI 0.93 to 8.69, P=0.01) global assessment of disease activity. Conclusion Current evidence shows that the efficacy and safety of iguratimod in the treatment of rheumatoid arthritis are similar to methotrexate. And iguratimod is better in global assessment of disease activity by patients and doctors. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.

关键词: 艾拉莫德; 甲氨蝶呤; 类风湿关节炎; 疗效; 安全性; Meta 分析; 系统评价; 随机对照试验

Key words: Iguratimod; Methotrexate; Rheumatoid arthritis; Efficacy; Safety; Meta-analysis; Systematic review; Randomized controlled trial

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