黄连素与二甲双胍治疗2型糖尿病随机对照试验系统评价

Berberine Versus Metformin in Treatment of Type 2 Diabetes:A Systematic Review of Randomized Controlled Trials

目的:系统评价黄连素与二甲双胍治疗2型糖尿病的疗效和安全性。方法:计算机检索PUBMED、Cochrane图书馆、CNKI、维普、万方数据库,从建库至2014年3月,选择疗程大于8周的随机对照试验(RCT)。按Cochrane系统评价方法筛选试验、评价质量,用Rev Man 5.0软件进行统计分析。结果:共纳入6篇文献,包括344例患者,其中治疗组192人,对照组152人,质量等级均为C级,应用辨证论治的有1篇。单纯黄连素与二甲双胍比较,降低FBG、PBG、Hb A1c和升高HDL-C方面,疗效尚不明确,且并不优于二甲双胍组;降低TG、TC和LDL-C方面,黄连素组优于二甲双胍组。黄连素联合二甲双胍治疗,在降低FBG、PBG、Hb A1c和调节TC、HDL-C、LDL-C方面,疗效优于二甲双胍组,降低TG两组疗效相当。结论:黄连素降糖疗效不确切,但调脂优于二甲双胍;黄连素与二甲双胍联用,在降糖和调脂方面优于单用二甲双胍。但因纳入研究方法学质量不均,上述结论尚需更多大样本、多中心、设计严格的高质量RCT加以验证。

Objective ： To systematically compare the efficacy and safety of berberine versus metformin （ Met ） in the treatment of type 2 diabetes mellitus （ T2DM ）. Methods ： Based on the principles and methods of Cochrane systematic reviews, we searched PUBMED, the Cochrane Central Register of Controlled Trials, CNKI, VIP and WanFang database from inception to March 2014, and we also handsearched references and relevant journals. The quality evaluation of the included RCTs were evaluated according to the Cochrane Handbook for systematic reviews. The Cochrane Collaboration＇s software RevMan 5.0 was used for Meta- analysis. Results ： Six RCTs involving 344 patients were identified. The methodological quality of all the studies were low. The berberine group was not superior to metformin group in lowing FBG, PBG, HbAlc and regulating HDL-C, but in lowing TG, TC and LDL-C. It was superior to metformin group. While in berberine combined with metformin group, it was superior in lowing FBG, PBG, HbA lc and regulating TC, HDL-C, LDL-C to metformin mono-therapy group. Side effects were reported in 3 articles, mainly were gastrointestinal symptoms in metformin group. Conclusion： Compare to metformin mono-therapy group, it was superior in lowing FBG, PBG, HbAlc and regulating TC, HDL-C and LDL-C of berberine combined with metformin group. There was no adequate evidence to confirm that berberine was good at lowing blood suger. More large-sample, multicentre, high quality RCTs to confirm this conclusion are needed.