吗替麦考酚酯与环磷酰胺治疗结缔组织病相关性肺间质疾病疗效与安全性比较的系统评价

Systematic Review of Efficacy and Safety of Mycophenolate Mofetil and Cyclophosphamide in Treatment of Connective Tissue Diseases Associated with Interstitial Lung Disease

目的:系统比较吗替麦考酚酯与环磷酰胺治疗结缔组织病相关性肺间质疾病(connective tissue diseases associated with interstitial lung disease,CTD-ILD)的疗效和安全性,为临床用药提供依据。方法:计算机检索PubMed、the Cochrane Library、EMBase、中国期刊全文数据库、维普数据库及万方数据库发表的有关直接比较吗替麦考酚酯与环磷酰胺治疗CTD-ILD疗效和安全性的随机对照试验及观察性研究,检索时间为建库至2018年6月。按纳入与排除标准纳入文献、提取资料并评价文献质量后,根据不同研究类型采用RevMan 5.3软件分别进行文献荟萃分析(Meta分析)。结果:最终纳入6篇文献,其中3篇为随机对照试验,3篇为回顾性研究,共380例患者。随机对照试验与回顾性研究的Meta分析结果均表明,吗替麦考酚酯与环磷酰胺在改善患者用力肺活量、一氧化碳弥散方面的差异均无统计学意义(P>0.05)。随机对照试验的Meta分析结果表明,吗替麦考酚酯组患者的血液系统不良反应发生率明显低于环磷酰胺组,差异有统计学意义(P<0.05),但两组患者病死率的差异无统计学意义(P>0.05);回顾性研究的Meta分析结果显示,吗替麦考酚酯组患者感染发生率明显低于环磷酰胺组,差异有统计学意义(P<0.05)。结论:吗替麦考酚酯改善或稳定CTD-ILD患者肺功能的疗效与环磷酰胺相当,但其安全性总体上优于环磷酰胺。

OBJECTIVE:To systematically compare the efficacy and safety of mycophenolate mofetil and cyclophosphamide in treatment of connective tissue diseases associated with interstitial lung disease(CTD-ILD),so as to provide reference for clinical drug use.METHODS:PubMed,the Cochrane Library,EMBase,CNKI,VIP database and Wanfang database were retrieved to collect the randomized controlled trials(RCT)and observational studies of mycophenolate mofetil and cyclophosphamide in treatment of CTD-ILD from the date of database establishment to Jun.2018.Literature were included according to the inclusion and exclusion criteria,and extraction of data and evaluation of literature quality were conducted,the RevMan5.3software was used for Meta analysis via different research types.RESULTS:A total of6literature were included,3of which were RCT and3were retrospective studies with380patients.The results of RCT and retrospective meta-analysis showed that there was no significant difference in the improvement of forced vital capacity and carbon monoxide diffusion between mycophenolate mofetil and cyclophosphamide(P>0.05).The incidence of adverse drug reactions of the blood system in mycophenolate group was significantly lower than that in cyclophosphamide group(P<0.05),but there was no significant difference in mortality between two groups(P>0.05).The meta-analysis of retrospective studies showed that the incidence of infection in mycophenolate group was significantly lower than that in cyclophosphamide group,and the difference was statistically significant(P<0.05).CONCLUSIONS:The efficacy of mycophenolate mofetil in treatment of CTD-ILD is comparable to cyclophosphamide,but its safety is generally superior to cyclophosphamide.