托法替尼治疗类风湿关节炎临床疗效的荟萃分析

Efficacy and safety of tofacitinib in treating rheumatoid arthritis： a Meta-analysis

目的 系统评价托法替尼治疗RA的临床疗效和安全性，为托法替尼的临床应用提供科学依据。方法在Medline、EMbase、Cochrane图书馆临床对照试验资料库、CBM、CNKI和万方数据库检索1989年1月至2014年8月有关托法替尼治疗RA的随机对照试验（RCT），由2位研究者按照纳入与排除标准进行文献筛选、资料提取和质量评价后，采用RevMan5．2软件进行Meta分析。结果共纳入8个RCT，合计2909例患者，其中托法替尼组2166例，安慰剂组743例。Meta分析结果显示：托法替尼治疗效果优于安慰剂，差异具有统计学意义ERR（95％CI）为1．92（1．42，2．59），P〈0．01]，而不良反应差异无统计学意义[R尺（95％CI）为0．62（0.31，1．24），P=0．17]。结论托法替尼治疗RA疗效优于安慰剂，而安全性与安慰剂相似，是一种安全、有效的治疗用药。由于纳入研究受国界及试验时程的限制，其疗效和安全性尚需更多高质量的国内随机双盲试验加以验证。

Objective To enrich scientific basis for clinical treatment of tofacitinib, the current systematic review is made by evaluating the efficacy and safety of tofacitinib on the treatment of rheumatoid arthritis （RA）. Methods RevMan 5.2 was employed for recta-analysis, two researchers extracted medical science materials and evaluated their qualities based on the standards of inclusion and exclusion criteria independently. Databases including Medline, EMbase, the Cochrane library, CBM and CNKI were searched, with the retrieval time spanning from January 1989 to August 2014. Results Two thousand nine hundred and nine patients participated in the trail, among which 2 166 patients were in the tofacitinib group and 743 inthe placebo group. By the application of 8 Randomized controlled trials （RCTs）, meta-analysis suggested that tofacitinib gave better results than placebo for RA [RR（95%CI）=1.92（1.42, 2.59）, P〈0.01], and no significant difference was shown in thesafety between them [RR （95%C/）=0.62 （0.31, 1.24）, P=0.17]. Conclusion Tofacitinib is effective for the treatment of RA and equal to placebo in safety. It is a safe and effective therapy for RA. However, as the short duration and the limited sources may somewhat affect the results, more high-quality double-blind RCTs may be required for further assessment of the effects.