三七皂甙治疗原发性肾病综合征的Meta分析

Panax notoginosedes for primary nephrotic syndrome:A Systematic Review

目的:评价三七皂甙治疗原发性肾病综合征的有效性及临床安全性,为临床实践提供循证医学证据。方法:计算机检索中国生物医学文献光盘数据库、中国循证医学/Cochrane中心数据库、Cochrane图书馆等数据库,收集三七皂甙与激素/免疫抑制剂治疗原发性肾病综合征的随机对照试验。选择近期疗效、远期疗效和发生副作用的病例数等作为评价指标,采用Handbook4.2.2推荐的方法评价纳入研究的质量,对符合纳入标准的研究采用RevMan4.2.7进行Meta分析。结果:检索到符合纳入标准的随机对照试验8篇,共352例病人。结论:目前较低质量研究的Meta分析提示,在激素/免疫抑制剂基础上使用三七皂甙有提高原发性肾病综合征近期疗效的作用,尤其是对高凝状态患者。无三七皂甙降低原发性肾病综合征复发率的有力证据。尚未发现三七皂甙的严重副作用,但并不能认为三七皂甙治疗原发性肾病综合征安全。其远期疗效和安全性还有待于设计严格的多中心、大样本随机对照试验进一步证实。

Objective：To provide evidence for clinical practice by assessing the effectiveness and safety of panax notoginosedes for primary nephrotic syndrome. Methods： We searched CBM, Chinese Evidence - Based Medicine/Cochrane Centre Database, Cochrane Library for the randomized controlled trials （RCTs）. Jadad score was used to assessthe quality of RCTs. The total clinical efficiency and short term effectiveness, and adverse effect of the treatment were analyzed by RevMan4. 2. 7. Results：Eight RCTs involving 352 patients met inclusion criterial. Meta- analysis showed that panax notoginosedes lowered 24 h urine protein [ OR6： 80,95% CI（ 1.88, 12.35） ] ,improved hypercoagulation condition. Whether panax notoginosedes had long term side effect was not confirmed. No adequate evidence showed that panax notoginosedes could reduce the relapse rate of primary nephrotic syndrome. Conclusions： Meta - analysis of low quality RCTs suggest that panax notoginosedes does work in primary nephritic syndrome in short term observation. No adequate evidence shows that panax notoginosedes has severe side effect or can reduce the relapse rate of primary nephrotic syndrome. A rigorously designed, randomized, double blind, placebo controlled trial are required.