二甲双胍治疗多囊卵巢综合征的系统评价

Systematic Evaluation of Metformin in Treatment for Polycystic Ovary Syndrome

目的:系统分析二甲双胍联合氯米芬(clomiphene,CC)治疗多囊卵巢综合征(Polycystic ovary syndrome,PCOS)的有效性、安全性,以期做出客观、可信的评价,指导临床用药,提出临床研究中存在的问题,拟采取的对策。方法:全面检索中国二甲双胍联合CC治疗PCOS的随机对照试验文献资料并进行系统评价,按文献可靠性的分级、试验分配的隐藏方案和JADAD量表评价文献的质量。采用Cochrane协作网提供的Revman4.2软件进行统计分析。结果:二甲双胍联合CC治疗PCOS临床排卵率(P<0.00001)、妊娠率(P<0.00001)与单独CC组比较有显著意义;与单独二甲双胍组比较,排卵率(P=0.0009)、妊娠率(P=0.02),疗效优于单独应用二甲双胍组,二甲双胍治疗PCOS总体疗效肯定,为指导以后的临床用药提供了理论支持。倒漏斗图显示不对称,可能与发表偏倚及临床试验设计有关。结论:二甲双胍联合CC治疗PCOS是一种有效的方法。但临床随机对照试验的方法学质量较低,存在潜在的发表偏倚。

Objective： To make a systematic analysis of the effects and safety of metformin combined with clomiphene （CC） in treatment of polycystic ovary syndrome （PCOS）, and to guide clinical medication based on an objective and believable evaluation, raise existed problems of clinical research as well as the potential countermeasures. Methods： The domestic documents and literatures of randomized controlled trials about PCOS treatment using metformin combined with CC were retrieved and systematically evaluated. The qualities of all literatures were assessed according to reliability classification, concealment of research allocation, and JADAD scale. All data were analyzed using Revman4.2 software. Results： The differences of ovulation rates and pregnancy rates between the metformin combined with CC group and the single CC group were significant, （P〈 0.00001）. Compared with the simple mefformin group, the clinical effects of combined therapy were obviously better, with P=0.0009 （ovulation rate） and P=-0.02 （pregnancy rate）, respectively. The effects of combined therapy for PCOS using metformin and CC were positive, which provided theoretical evidences for clinical medication. The asymmetry presented in the funel plot might be related to the publication bias and design of clinical trials. Conclusions： The combined therapy for PCOS using metformin and CC is effective. However, publication bias is present because of the low quality of methodology in clinical randomized controlled trials.