来氟米特治疗紫癜性肾炎Meta分析

A Meta⁃analysis of leflunomide in the treatment of purpuric nephritis

目的评价应用来氟米特治疗紫癜性肾炎病人的疗效及安全性。方法检索中国知网(CNKI)、万方数据知识服务平台(WangFang Data)、维普全文数据库(VIP)、生物医学文献数据库(CBM)、PubMed、Cochrane Libary、Embase以及中国临床试验注册中心中来氟米特治疗紫癜性肾炎的随机对照试验(RCT),检索时间从建库至2019年5月。两名研究员独立筛选文献,提取资料并评估偏倚风险,应用RevMan5.3软件进行Meta分析。结果共纳入15篇文献,其中2篇文献含有2个对照组,共17项随机对照实验,1095例病人。Meta分析结果显示:与对照组相比,来氟米特治疗紫癜性肾炎有效率更高(OR=3.15,95%CI:2.11~4.72,P<0.00001)、复发率更低(RR=0.65,95%CI:0.44~0.97,P=0.04),不良反应更少(RR=0.55,95%CI:0.32~0.96,P=0.03);与对照组相比,来氟米特更能降低紫癜性肾炎病人的24 h尿蛋白定量(MD=-0.45,95%CI:-0.59^-0.30,P<0.00001)、尿红细胞计数(MD=-7.70,95%CI:-13.48^-1.92,P=0.009),升高病人血浆白蛋白水平(MD=4.98,95%CI:3.34~6.62,P<0.00001)。结论来氟米特治疗紫癜性肾炎存在一定的优势,且更安全,但仍需要进行高质量、大样本的RCT研究加以证实。

Objective To evaluate the efficacy and safety of leflunomide in the treatment of patients with purpuric nephritis.Methods Literatures of randomized controlled trials(RCT)of leflunomide in the treatment of purpuric nephritis were retrieved in China National Knowledge Infrastructure(CNKI),Wanfang Data Knowledge Service Platform(WangFang Data),VIP,CBM,PubMed,Cochrane Library,Embase,and the China Clinical Trial Registry.The retrieval time was from the establishment of the databases to May 2019.Two investigators independently screened the literatures,extracted data,assessed the risk of bias,and applied RevMan5.3 software for meta-analysis.Results A total of 15 papers were included,2 of which contained 2 control groups,so the meta-analysis included 17 randomized controlled trials,comprising 1095 participants.Meta-analysis showed that in comparison with the control group,leflunomide was more effective in the treatment of purpuric nephritis(OR=3.15,95%CI:2.11-4.72,P<0.00001),and had a lower recurrence rate(RR=0.65,95%CI:0.44-0.97,P=0.04)and fewer adverse reactions(RR=0.55,95%CI:0.32-0.96,P=0.03);compared with the control group,leflunomide was more capable of reducing 24-hour urine protein quantitation(MD=-0.45,95%CI:-0.59--0.30,P<0.00001)and urinary red blood cell count(MD=-7.70,95%CI:-13.48--1.92,P=0.009)in patients with purpuric nephritis,and increasing plasma albumin levels in patients(MD=4.98,95%CI:3.34-6.62,P<0.00001).Conclusion Leflunomide has certain advantages in treating purpuric nephritis and is safer,but it still needs to be confirmed by high-quality,large-sample RCT studies.