Zhao Li-Ping, Sheng Xiao-Yan, Zhou Shuang, Yang Ting, Ma Ling-Yue, Zhou Ying, Cui Yi-Min
Department of Pharmacy, Peking University First Hospital, Beijing, China.
Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing, China.
Br J Clin Pharmacol. 2015 Nov;80(5):1224-34. doi: 10.1111/bcp.12672. Epub 2015 Jul 14.
The aim of the present meta-analysis was to determine the efficacy and safety of metformin for the treatment of women with gestational diabetes mellitus (GDM). We searched databases, including PubMed, Embase and the Cochrane Central Register of Controlled Trials, for randomized controlled trials (RCTs) comparing metformin and insulin treatments in women with GDM. We carried out statistical analyses using RevMan 2011 and used the Grading of Recommendations, Assessment, Development, and Evaluations profiler to rate the quality of evidence of the primary outcomes. We analysed eight studies involving 1592 subjects. Meta-analysis of the RCTs showed that metformin had statistically significant effects on pregnancy-induced hypertension [PIH; risk ratio (RR) 0.54; 95% confidence interval (CI) 0.31, 0.91]. However, its effects on neonatal hypoglycaemia (RR 0.80; 95% CI 0.62, 1.02), rate of large-for-gestational age infants (RR 0.77; 95% CI 0.55, 1.08), respiratory distress syndrome (RR 1.26; 95% CI 0.67, 2.37), phototherapy (RR 0.94; 95% CI 0.67, 1.31) and perinatal death (RR 1.01; 95% CI 0.11, 9.53) were not significant. Our analyses suggest that there is no clinically relevant difference in efficacy or safety between metformin and insulin; however, metformin may be a good choice for GDM because of the lower risk of PIH. The advantages of metformin in terms of glycaemic control, PIH incidence and gestational age at birth are unclear, and should be verified in further trials.
本荟萃分析的目的是确定二甲双胍治疗妊娠期糖尿病(GDM)女性的疗效和安全性。我们检索了包括PubMed、Embase和Cochrane对照试验中央注册库在内的数据库,以查找比较二甲双胍与胰岛素治疗GDM女性的随机对照试验(RCT)。我们使用RevMan 2011进行统计分析,并使用推荐分级、评估、制定和评价工具对主要结局的证据质量进行评分。我们分析了八项涉及1592名受试者的研究。RCT的荟萃分析表明,二甲双胍对妊娠高血压综合征[PIH;风险比(RR)0.54;95%置信区间(CI)0.31,0.91]有统计学显著影响。然而,其对新生儿低血糖(RR 0.80;95%CI 0.62,1.02)、大于胎龄儿发生率(RR 0.77;95%CI 0.55,1.08)、呼吸窘迫综合征(RR 1.26;95%CI 0.67,2.37)、光疗(RR 0.94;95%CI 0.67,1.31)和围产期死亡(RR 1.01;95%CI 0.11,9.53)的影响不显著。我们的分析表明,二甲双胍和胰岛素在疗效或安全性方面没有临床相关差异;然而,由于PIH风险较低,二甲双胍可能是GDM的一个好选择。二甲双胍在血糖控制、PIH发生率和出生孕周方面的优势尚不清楚,应在进一步试验中加以验证。