他克莫司治疗重症肌无力的系统性回顾及Meta分析

Systematic review and meta-analysis of Tacrolimus for myasthenia gravis

目的通过Meta分析方法系统评价不同研究中小剂量他克莫司治疗重症肌无力患者的疗效及安全性。方法计算机检索Elsevier Sciencedirect、Web of Science、Pubmed、中国知网数据库知(CNKI)、万方数据库及维普中文科技期刊数据库,全面搜索他克莫司治疗重症肌无力相关文献。使用Rev Man5.3软件对提取资料进行统计分析。结果 3篇对照试验文献分析结果显示,他克莫司跟对照组相比不能显著降低重症肌无力的QMG评分[MDIV(95%CI)=-0.91(-8.37,6.55),Z=0.24(P=0.81)];他克莫司治疗组不良反应发生率和对照组无统计学意义[OR(95%CI)=1.29(0.59,2.81),Z=0.64(P=0.52)];分析其余自身对照试验文献显示,加用他克莫司可以显著改善重症肌无力的严重程度[亚洲组:MDIV(95%CI)=-8.16(-10.61,-5.72),Z=6.55(P<0.01);欧洲组:MD IV(95%CI)=-20.49(-21.40,-19.57),Z=43.80(P<0.01)]。结论研究结果显示加用小剂量他克莫司可短期改善重症肌无力患者的严重程度,安全性可靠。受纳入研究文献质量限制,他克莫司的安全性及有效性仍需要大型多中心随机对照研究及基于高质量文献的meta分析来认证。

Objective To assess the effect and safety of Tacrolimus in treatment of Myasthenia gravis by Metaanalysis. Methods The data of Elsevier Sciencedirect, Web of Science, Pubmed, cNKI, VIP and WF were retrieved to search the articles about the Tacrolimus in treatment of Myasthenia Gravis. The Rev Manager Version 5.3 was used to analyze the selected articles. Results Meta-analysis in 3 included controlled studies showed that Tacrolimus could not reduce the QMG score significantly comparing with the controlled arm.[MD IV （95% CI） =-0.91（-8.37, 6.55）, Z=0.24 （P=0.81）]. Meta-analysis in the other included self-controlled studies showed that Tacrolimus could reduce the QMG score significantly after intervention. [Asia Group： MD IV （95% CI） = -8.16（-10.61, -5.72）, Z=6.55 （P 〈 0.01）; Europe Group： MD IV （95% CI） = -20.49（-21.40, -19.57）, Z=43.80 （P 〈 0.01）.]. The rate of adverse events was not significantly different between the experimental arm and the controlled arm. /OR（95% C1）=1.29 （0.59, 2.81）, Z=0.64 （P=0.52）]. Conchlsion The meta-analysis suggestes that the low dose of Tacrolimus is effective and safe in the treatment of Myasthenia Gravis in a short term. Limited to the poor quality of current published articles, the safety and effect of Tacrolimus in treatment of Myasthenia gravis needs to be proved by the multi-center randomized controlled studies of large scale and the recta-analysis on the randomized controlled studies with high quality.