甲氨蝶呤治疗系统性硬皮病的Meta分析

Effect of Methotrexate for Systemic Sclerosis: A Meta-analysis

目的系统评价甲氨蝶呤(Methotrexate,MTX)治疗系统性硬皮病的临床疗效。方法通过计算机检索Embase,Cochrane Central Register of Controlled Trails,Pub Med,万方数据库和中国期刊全文数据库(CNKI),搜索时间均从1968年1月—2017年6月。纳入甲氨蝶呤为实验组治疗系统性硬皮病的随机对照及前瞻性队列研究。由2名评价员独立筛选文献,严格依据Cochrane系统评价的方法,评价纳入研究的偏倚风险后采用Rev Man 5.3软件进行Meta分析。结果共纳入4篇研究,包括3篇随机对照试验及1篇前瞻性队列研究。Meta分析结果显示:MTX组能降低系统性硬皮病患者改良Rodnan评分(m RSS),具有统计学意义:MD=-1.95,95%CI(-3.6,-0.27),P=0.02;可降低健康评估问卷-残疾指数量表(HAQ-DI),具有统计学意义:MD=-0.20,95%CI(-0.30,-0.10),P<0.000 1;能提高双手握力,具有统计学意义:MD=25.86 mm Hg,95%CI(18.60,33.12),P<0.000 01;一氧化碳弥散量在2组之间无明显差别:MD=0.02%,95%CI(-0.10,0.07),P=0.65。结论甲氨蝶呤可降低系统性硬皮病患者的改良Rodnan评分、HAQ-DI,提高握力,治疗系统性硬皮病优于对照组,但仍然需要更多的大样本、多中心的随机双盲对照试验予以验。

Objective In order to systematically evaluate the efficacy of Methotrexate on systemic sclerosis patients.Methods We included randomized controlled trial and prospective cohort studies on Methotrexate in Embase, Cochrane Central Register of Controlled Trails, Pubmed, Wanfang Data and CNKI for studies published between Jan 1968 to June 2017.Two reviewers independently evaluated the quality of the included studies and extracted data. Meta analyses were performed using Rev Man 5.3 software. Results Four studies including three RCTs and one prospective cohort study were referred. Meta analyses showed that in MTX group, m RSS was reduced with statistical significance： MD=-1.95, 95%CI（-3.6,-0.27）, P =0.02; HAQ-DI was also reduced with statistical significance： MD=-0.20, 95%CI（-0.30,-0.10）, P=0.000 1. Grip strength was improved with statistical significance： MD=25.86 mm Hg, 95%CI（18.60, 33.12）, P=0.000 1. DLco was similar between the two groups： MD =0.02%, 95% CI（-0.10, 0.07）, P =0.65. Conclusion In the present study, MTX could reduce MRSS,HAQ-DI and improve the grip strength, showing significant efficacy in the treatment group of systemic scleroderma. But more large-scale, multi-center, randomized control trails are needed to verify the quality of evidences.