来氟米特和环磷酰胺治疗难治性肾病综合征临床对照研究的Meta分析

Leflunomide and cyclophosphamide in treatment of refractory nephrotic syndrome:A meta-analysis of the efficacy and safety

目的评价来氟米特(LEF)与环磷酰胺(CTX)治疗难治性肾病综合征(RNS)的有效性和安全性。方法运用Cochrane图书馆(Cochrane Library)、医学检索系统(PUBMED)、医学检索数据库(EMBASE)、中国生物医学文献数据库(CBMdisc)、中国知识基础设施工程(CNKI)、中国科技期刊数据库(VIP)等电子数据库,检索英文、中文检索词检索时间截止至2015年12月30日,由2名评价员对资料进行提取和质量评价,再进行数据分析,数据采用Rev Man 5.0软件进行统计。结果最终纳入10篇文献,共包括511例RNS患者,治疗组261例,对照组250例。Meta分析结果显示,治疗后两组完全缓解率(RR=1.14,95%CI 0.93~1.40,Z=1.23,P=0.22)、部分缓解率(RR=1.04,95%CI 0.84~1.29,Z=0.39,P=0.70)及总缓解率(RR=1.08,95%CI 1.00~1.18,Z=1.91,P=0.06)均差异无统计学意义。6篇文献报道了不良反应发生率,Meta分析结果显示,两组不良反应发生率(RR=0.40,95%CI 0.27~0.58,Z=4.80,P<0.000 01)差异有统计学意义。结论 LEF治疗RNS的有效性与CTX相当,但LEF的安全性优于CTX。但是纳入的文献质量偏差,存在着选择性及测量性偏倚的可能性,需要进一步开展高质量、大样本随机对照试验进行评价。

Objective To evaluate the efficacy and safety of Leflunomide （LEF） and Cyclophosphamide （CTX） in treating refractory nephrotic syndrome （RNS）.Methods The data of Cochrane library ,PUBMED,EMBASE,CBMdisc,CNKI and VIP until 30 December 2015 were retrieved and qualitatively assessed by two systematic reviewers ,and RevMan 5.0 software was used to perform statistical a-nalysis.Results A total of 10 literatures were enrolled,including 511 RNS patients （261 in study group,250 in control group）.Analy-sis showed that there was no significant difference between two groups in complete remission rate （RR =1.14,95%CI 0.93 -1.40, Z =1.23,P =0.22）,partial response rate （RR =1.04,95%CI 0.84 -1.29,Z =0.39,P =0.70）,and total remission rate （RR =1.08,95%CI 1.00 -1.18,Z =1.91,P =0.06）.The incidence of adverse reactions was reported in 6 articles.Meta-analysis showed that there was significant difference between two groups in adverse reaction rate （RR =0.40,95%CI 0.27 -0.58,Z =4.80,P 〈0.00001）.Conclusions The effectiveness of LEF in the treatment of RNS is similar to that of CTX ,but the safety of LEF is superior to that of CTX.However,due to the bias in the quality of the included literature ,there is a possibility of selectivity and measurement bi -as,so it is necessary to develop the higher quality and larger sample randomized controlled trials to evaluate its effectiveness and safety .