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目的:采用Meta分析方法评价托珠单抗(tocilizumab,TCZ)单用与联合甲氨蝶呤(tethotrexate,MTX)治疗类风湿性关节炎(active rheumatoid arthritis,RA)的疗效和安全性,为甲氨蝶呤耐受的RA患者用药调整提供参考。方法:检索中文数据库“中国生物医学文献服务系统(SinoM ed)”、“维普数据库(VIP)”及外文数据库“PubM ed”、“Cochrane Library”、“OVID”从建库至2016年3月23日公开发表的相关研究文献。根据设定的纳入和排除标准筛选文献并提取数据,采用RevMan5.3.5,对数据进行Meta分析。结果:共纳入随机对照临床试验(Randomized Controlled Trial,RCT)文献7篇,共计1 534例类风湿关节炎患者。Meta分析结果显示,在治疗RA的有效性方面,TCZ+MTX组较TCZ组的DAS28≤2.6的缓解率高,RR=1.17[95%CI(1.09,1.25),P<0.000 1];CDAI≤2.8缓解率TCZ+MTX也高于TCZ,RR=1.29[95%CI(1.14,1.45),P<0.000 1]。在安全性方面,不良事件(AE)发生率、严重不良事件(SAE)发生率、严重感染(SI)发生率TCZ+MTX组均高于TCZ组,但差异无统计学意义。结论:TCZ联合MTX治疗RA的疗效略优于单用TCZ,虽然联合用药安全性有降低趋势,但差异无统计学意义。该结论仍需大样本、高质量的临床研究进一步验证。
OBJECTIVE: To evaluate the efficacy and safety of tocilizumab (TCZ) combined with tethotrexate (MTX) in the treatment of rheumatoid arthritis (RA) by meta-analysis. Methotrexate-resistant RA patients with medication adjustment provide a reference. Methods: We searched Chinese database “SinoMed”, “VIP” and “Foreign Language Database” “PubM ed”, “Cochrane Library”, “OVID ”From the database to March 23, 2016 published relevant research literature. According to the set inclusion and exclusion criteria screening documents and data extraction, the use of RevMan5.3.5, Meta-analysis of the data. Results: A total of 7 randomized controlled trials (RCTs) were included in the literature, totaling 1 534 patients with rheumatoid arthritis. Meta-analysis showed that in the treatment of RA, the response rate of TCZ + MTX group was higher than that of TCZ group with DAS28≤2.6 (RR = 1.17 [95% CI (1.09,1.25), P <0.0001] 2.8 The response rate was also higher for TCZ + MTX than for TCZ, RR = 1.29 [95% CI (1.14, 1.45), P <0.0001]. In terms of safety, the incidence of adverse events (AE), the incidence of serious adverse events (SAE) and the incidence of serious infections (TC) in TCZ + MTX group were higher than those in TCZ group, but the difference was not statistically significant. CONCLUSION: TCZ combined with MTX is superior to TCZ alone in the treatment of RA. Although there is a decreasing trend in the safety of combination therapy, the difference is not statistically significant. This conclusion still requires large sample, high-quality clinical studies to further verify.