来氟米特治疗难治性肾病综合征的系统评价

Systematic review on leflunomide treating refractory nephrotic syndrome

目的评价来氟米特治疗难治性肾病综合征的疗效和安全性。方法电子检索Medline、Embase、Cochrane系统评价和临床试验数据库,CBM和CNKI等数据库,收集来氟米特治疗肾病综合征的随机或半随机对照试验,检索时间均截止至2007年12月。对纳入研究进行质量评价,并用RevMan 4.2软件进行Meta分析。结果共纳入7个研究,均为中文文献,其中3个试验质量评分为C级,4个试验质量评分为B级。Meta分析结果显示,与对照组相比,来氟米特治疗难治性肾病综合征的完全缓解率和有效率差别无统计学意义(P>0.05),来氟米特的不良反应发生率高于吗替麦考酚酯。结论来氟米特治疗难治性肾病综合征是具有一定临床疗效的,由于纳入的研究质量不高,存在着选择性偏倚、测量性偏倚的可能性,有必要进一步开展高质量、大样本随机对照试验评价其疗效和安全性。

AIM To assess the effectiveness and safety of leflunomide in the treatment of refractory nephrotic syndrome. METHODS Biomedical databases, including Medline, Embase, Cochrane systematic evaluation and controlled trials register, CBMdisc and CNKI to Dec 2007 were searched. Clinical trials were collected. Quality assessments of clinical trials were carried out. Randomized controlled trials with relieving rate and the incidence of adverse drug reactions were selected for meta-analysis with RevMan 4.2. RESULTS Seven RCTs were included, and all were done in China. In Juni scale, 3 trials were scaled by C, 4 trials were scaled by B. There were no statistical significances in curative effect between leflunomide group and control group, but the adverse drug reactions of leflunomide were evidently higher than those of mycophenolate mofetil. CONCLUSION Leflnomide shows some considerable positive effects on nephmtic syndrome, due to the bad selection bias and detection bias of studies included, it is necessary to develop the contrast experiment with higher quality, larger scale clinical trials to evaluate its effectiveness and safety.