中文摘要：

目的 评价来氟米特（LEF）治疗狼疮肾炎的疗效和安全性.方法 检索Cochrane图书馆、PubMed、Medline、中国学术期刊全文数据库、万方数据库、中国生物医学文献光盘数据库和维普中文科技期刊数据库等,检索文献时间截至2012年9月.利用纳入和排除标准对检索到的文献进行筛选,对纳入文献进行质量评价.采用STATA12.0软件进行Meta分析.结果 共检索到151篇文献,最终14篇纳入Meta分析,其中3篇为非随机对照试验.Meta分析结果示,与环磷酰胺（CTX）组相比,LEF组可显著提高狼疮肾炎的完全缓解率（RR=1.38,95％CI：1.11～1.73,P=0.004）和总缓解率（RR=1.16,95％CI：1.02～1.32,P=0.029）；尿蛋白定量（24h）、尿肌酐值、系统性红斑狼疮疾病活动性指数（SLEDAI）评分次要结局指标显著低于CTX组,血清白蛋白含量明显高于CTX组,C3水平、抗双链DNA抗体阳性率与CTX组差异无统计学意义；安全性方面,LEF组较CTX组可显著降低胃肠道不良反应和肝酶升高的发生率,但2组间其他不良反应的发生率差异无统计学意义.结论现有证据提示,LEF治疗狼疮肾炎的疗效优于CTX,不良反应发生率较CTX小.但鉴于纳入文献的数量有限,样本量较小,仍需多中心随机对照临床试验研究迸一步验证.

英文摘要：

Objective To evaluate the efficacy and safety of leflunomide （LEF） for the treatment of lupus nephritis （LN）.Methods Database searches,including Cochrane library,PubMed,Medline,CNKI,WanFang,CBMdisc and Vip database,were performed up to September 2012.The quality of retrieved literatures was evaluated based on the inclusion criterion.STATA12.0 software was used for Meta-analysis.Results Of 151 literatures retrieved,14 were included in the final analysis,of which 3 were non-randomized controlled trals.Meta-analysis suggested that the complete remission rate （RR=1.38,95％CI：1.11-1.73,P=0.004） and total remission rate （RR=1.16,95％CI：1.02-1.32,P=0.029） were significantly higher in LEF group than that in CTX group.Secondary outcomes,including the 24-hour urine protein,serum creatinine levels and SLEDAI scores in LEF group were significantly lower whilst albumin levels were markedly higher than those in CTX group （all P＜0.05）.There was no significant difference in C3,positivity of anti-dsDNA antibody between LEF and CTX group.When observed with safety profiles,LEF group was associated with a significantly lower incidence of gastrointestinal reactions and elevated hepatic enzyme,but not miscellaneous adverse drug reactions,when compared with CTX group.Conclusion Our findings suggest that when compared with CTX,LEF is associated with a superior efficacy and safety as well as a lower incidence of adverse events for the treatment of LN.However,in light of the limited sample size in most studies,further evidence from multi-center randomized controlled trials are warranted.