银杏叶提取物治疗早期糖尿病肾病的Meta分析

Ginkgo biloba extract for patients with early diabetic nephropathy: a systematic review of randomized controlled trials

目的采用Cochrane系统评价方法,评价银杏叶提取物治疗早期糖尿病肾病的疗效和安全性。方法检索Cochrane图书馆临床对照试验数据库（2013年第2期）、PubMed（1978~2013年）、维普中文期刊数据库（1989~2013年）、中国期刊全文数据库（1979~2013年）等数据库和相关会议论文集及查阅检索到的所有文献的参考文献,对纳入文献进行评价及资料提取。按照国际Cochrane协作网推荐的方法进行系统评价。结果共纳入22个试验包括1 649例患者。大多试验方法学质量较差且样本量小,Meta分析结果显示：（1）银杏叶提取物联合常规治疗与常规治疗的比较：能减少糖尿病肾病患者24 h尿微量白蛋白排泄率和24 h尿蛋白,能降低血清肌酐（P〈0.000 01、P=0.002、P=0.001）;（2）银杏叶提取物联合ACEI或ARB治疗与ACEI或ARB治疗的比较,能减少糖尿病肾病患者24 h尿微量白蛋白排泄率,能降低血清肌酐（P〈0.000 1、P=0.04）。结论银杏叶提取物治疗糖尿病肾病有一定的疗效。但由于本系统评价纳入的试验样本量较小且方法学质量低下,现有的证据尚不足以推荐临床常规应用银杏叶提取物治疗糖尿病肾病,仍需大量循证医学证据的进一步积累,从而指导临床实践。

Objective To determine the effectiveness and safety of Ginkgo biloba extract therapy in the management of early Type 2 diabetics nephropathy. Methods We searched Cochrane Central Register of Controlled Trails（CENTRAL）, PUBMED database, CNKI, Chinese VIP Database et al. and hand searched the bibliographies of retrieved articles and correlated proceedings.Systematic review was conducted using the method recommended by The Cochrane Collaboration. Results Twenty-two trials involving 1 649 patients were included in the systematic review.Meta analysis showed：（1） Gingko biloba extract plus conventional treatment versus conventional treatment only： Gingko biloba extract had some effects on the decrease of the 24-hour UAER, 24-hour urinary protein, and Scr（P〈0.000 01, P=0.002, P=0.001）;（2）Gingko biloba extract combined with ACEI/ARB versus ACEI/ARB alone： had some effects on the decrease of the 24-hour UAER and Scr（P〈0.000 1, P=0.04）. Conclusions Ginkgo biloba extract has some effect and is relatively safe in treating patients with diabetic nephropathy. However, the present evidence was not enough to support the recommendation of Ginkgo biloba extract as a routine drug in the clinical management of diabetic nephropathy. Since most included trials are small and of low quality, high-quality, large sample, multi-centre, randomized, double-blind and placebo controlled trials of Ginkgo biloba extract for diabetic nephropathy are needed.