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目的:评价来氟米特(LEF)治疗Ig A肾病(Ig AN)的安全性和有效性。方法:采用电子检索数据库Medline、Embase、Cochrane Library、Clinical trails和中国生物医学数据库(CBM)、中国知网(CNKI)、中文科技期刊全文数据库(VIP)、万方数据库(wanfang),同时手检国内相关期刊及会议资料,纳入所有含LEF的随机对照试验(RCTs),按照Cochrane中的工具对其进行风险评估,并用Revman 5.3软件对其分析。结果:共纳入11个RCTs,589名患者,Meta分析结果显示LEF+Ped组的完全缓解率[RR 1.40,95%CI(1.02~1.93),P=0.04]、总有效率[RR 1.18,95%CI(1.06~1.32),P=0.004]均优于单用Ped组,不良反应(ADR)发生率无统计学差异。LEF+Ped组与CTX/MMF+Ped组在有效性方面类似,但ADR[RR 0.21,95%CI(0.11~0.39),P<0.000 01]显著少于CTX+Ped组。LEF+ACEI组与单用ACEI组有效性和安全性均无统计学差异,但可降低24 h尿蛋白(UTP),提高白蛋白(Alb)。结论:LEF与CTX、MMF联合Ped治疗Ig AN在有效性方面类似,但优于单用Ped,安全性方面也具有一定优势,可以作为临床的选择之一。
Objective: To evaluate the safety and efficacy of leflunomide (LEF) in the treatment of IgA nephropathy (IgAN). Methods: Medline, Embase, Cochrane Library, Clinical trails and CBM, CNKI, VIP, wanfang, Domestic journals and conference materials were included in all randomized controlled trials (RCTs) containing LEFs, risk assessed according to the tools in Cochrane and analyzed using Revman 5.3 software. Results: A total of 11 RCTs and 589 patients were enrolled in the study. Meta-analysis showed that the complete response rate (RR 1.40, 95% CI 1.02-1.93, P 0.04) in LEF + Ped group was significantly higher than that in LEF + Ped group [RR 1.18, % CI (1.06 ~ 1.32), P = 0.004] were better than Ped alone group, the incidence of adverse reactions (ADR) was no significant difference. The LEF + Ped group was similar in efficacy to the CTX / MMF + Ped group, but ADR [RR 0.21, 95% CI (0.11-0.39, P <0.000 01] was significantly less than the CTX + Ped group. There was no significant difference in the efficacy and safety between LEF + ACEI group and ACEI group alone, but it could reduce 24 h urinary protein (UTP) and increase albumin (Alb). Conclusion: The combination of LEF, CTX and MMF with Ped treatment of Ig AN is similar in effectiveness, but it is superior to Ped alone in the aspect of safety. It can be used as one of the clinical options.