托珠单抗单用与联合甲氨蝶呤治疗类风湿性关节炎疗效和安全性比较的Meta分析  

Meta-Analysisof Efficacy and Safety of Tocilizumab Used Alone and Combined with Methotrexate in Rheumatoid Arthritis Patients

作　　者：杨洋[1] 李伟杰[1] 刘金玉[1] 郭敏[1] 唐芳[1] 李娟[1] 

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,武汉430030

出　　处：《中国药师》2017年第5期854-859,共6页China Pharmacist

摘　　要：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 compare the clinical efficacy and safety between tocilizumab （TCZ） combined with methotrexate （MTX） and TCZ used alone in the patients with active rheumatoid arthritis （RA） by meta-analysis to provide reference for the treatment adjustment for the patients with poor response to MTX. Methods： Literature searches were conducted in sinoMed, VIP, PubMed, Cochrane Library and OVID, and then identified according to the inclusion and exclusion criteria. Meta-analysis was conducted using Rev Man 5.3.5 software. Results： Totally 7 randomized controlled trials （RCTs） were included in the analysis. A total number of patients were 1534 cases. The meta-analysis showed that in the treatment of RA, TCZ combined with MTX had significantly higher odds of DAS28 ≤ 2.6 remission and CDAI ≤ 2.8 remission when compared with TCZ alone [ RR = 1.17, 95 % CI（ 1.09,1.25 ）, P 〈 0. 000 1;RR=1.29, 95% CI（ 1.14,1.45）, P 〈 0. 000 1, respectively], and the incidence of adverse events （AE）, serious adverse events （SAE） and serious inection had no statistical differences. Conclusion： The efficacy of TCZ combined with MTX is higher than that of TCZ alone in RA patients, and the safety is similar. The conclusion still needs further confirmation by RCTs with large samples and high quality.

关 键 词：类风湿性关节炎 甲氨蝶呤 托珠单抗 META分析 

分 类 号：R593.22[医药卫生—内科学]