来氟米特治疗难治性肾病综合征的Meta分析  

Meta-analysis of efficacy and safety of leflunomide in refractory nephrotic syndrome

作　　者：陈丁[1] 孙波[1] 刘圆圆[1] 刘佑韧[1] 闫国强[1] 李晟[1] 

机构地区：[1]中国人民解放军空军航空医学研究所附属医院内二科,北京100089

出　　处：《中国新药与临床杂志》2011年第8期588-593,共6页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的评价来氟米特治疗难治性肾病综合征的疗效及安全性。方法制定原始文献的纳入标准与检索策略,在Cochrane library、PubMed、EMBASE、EBSCO及CBMdisc、CNKI内进行相关的检索,检索时间截止至2010年12月。将应用来氟米特治疗难治性肾病综合征的随机对照试验(RCT)纳入分析,对纳入的研究进行质量评价,应用REVMAN 4.3软件对纳入的有关来氟米特与其他免疫抑制药比较治疗难治性肾病综合征的RCT研究进行Meta分析。应用随机或固定效应模型处理疗效及安全性指标的优势比(OR)。结果共检索到278篇文献,符合纳入标准的11篇,均为中文随机对照研究,文献质量评价4篇为B级、7篇为C级。Meta分析结果显示:来氟米特治疗难治性肾病综合征的总有效率和完全缓解率均高于环磷酰胺(OR 2.1,95%CI 1.33～3.32,P=0.001;OR 1.64,95%CI 1.13～2.38,P=0.009);与吗替麦考酚酯对比,两者的总有效率与完全缓解率无显著差异(OR 1.0,95%CI 0.44～2.25,P=1.00;OR1.20,95%CI 0.66～2.17,P=0.55)。来氟米特的不良反应发生率低于环磷酰胺(OR 0.17,95%CI 0.10～0.29,P<0.000 01),而高于吗替麦考酚酯(OR 3.92,95%CI 1.57～9.82,P=0.004)。结论来氟米特用于治疗难治性肾病综合征有一定临床疗效,是一种相对较安全的免疫抑制药。由于纳入文献质量不高,需进一步行大样本随机对照研究来评价其疗效与安全性。AIM To access the efficacy and safety of leflunomide in the treatment of refractory nephrotic syndrome. METHODS The standard search strategy of the Cochrane Collaboration was used including searches of the Cochrane Controlled Trials Register （ Cochrane Library： Issue 12, 2010）, PubMed （ 1980-December 2010） , EMBASE （1980-December 2010）, EBSCO （1980-December 2010）, CBMdisc （1980-December 2010） and CNKI （1980-2010）. Randomized controlled trials （RCTs） comparing the efficacy and safety of leflunomide and other immunosuppressants in treating refractorg nephrotic syndrome were included. Quality assessments of clinical trials were carried out. Meta-analysis was performed using REVMAN 4.3. Pooled odds ratios （OR） and 95% CI were calculated by fixed or random-effects models. RESULTS Eleven trials were included in the analysis. The total effective rate and complete remission rate in leflunomide group was higher than cyclophosphamide （CTX） group （OR 2.1, 95% CI： 1.33 - 3.32, P= 0.001; OR 1.64, 95% CI： 1.13 - 2.38, P = 0.009）, while there were no statistical significances in curative effect between leflunomide group and mycophenolate mofetil （MMF） group （OR 1.0, 95%CI： 0.44- 2.25, P= 0.01; OR 1.20, 95% CI： 0.66- 2.17, P = 0.55）. The adverse drug reactions of leflunomide group were evidently lower than CTX group （OR 0.17, 95% CI： 0.10 - 0.29, P〈 0.000 01）, but higher than MMF group （OR 3.92, 95% CI： 1.57 - 9.82, P= 0.004）. CONCLUSION Leflunomide is a safe immunosuppressive agent, and is effective in the treatment of refractory nephrotic syndrome. However, the strength of this evidence is low because of the low methodological quality of the trials; therefore further RCTs should be carried out to confirm its efficacy and safety.

关 键 词：来氟米特 肾病综合征 META分析 

分 类 号：R976[医药卫生—药品]