Affiliated Hospital of Qingdao, University, Qingdao University, Qingdao, People's Republic of China.
J Matern Fetal Neonatal Med. 2021 Aug;34(16):2741-2753. doi: 10.1080/14767058.2019.1670804. Epub 2019 Sep 26.
Metformin is increasingly used in clinical practice for the treatment of gestational diabetes mellitus. However, its safety and long-term effects on fetuses exposed to metformin in uterus remain controversial.
We systematically searched PubMed, Embase, and the Cochrane database (last search was updated on 1 May 2019) for randomized controlled trials comparing metformin with insulin. Two reviewers extracted the data and calculated pooled estimates by use of a random-effects model.
Twenty-four studies were included. Among these, seventeen RCTs ( = 2828 participants) were included for quantitative analyses and seven studies were included only for qualitative synthesis. Metformin lowered the risk of pregnancy-induced hypertension ( = .03; risk ratio (RR) = 0.64; confidence interval (95%CI) [0.44, 0.95]), large for gestational age babies ( = .04; RR = 0.82; 95% CI [0.68, 0.99]), macrosomia ( = .01; RR = 0.63; 95%CI [0.45, 0.90]), neonatal hypoglycemia ( = .001; RR = 0.72; 95%CI [0.59, 0.88]), and neonatal intensive care unit admission ( = .01; RR = 0.74; 95%CI [0.58, 0.94]). Metformin did not increase premature delivery ( = .11; RR = 1.28; 95%CI [0.95, 1.73]), preeclampsia ( = .45; RR = 0.89; 95%CI [0.65, 1.21]), caesarean delivery ( = .20; RR = 0.94; 95%CI [0.85, 1.04]), small for gestational age babies ( = .95; RR = 0.99; 95%CI [0.69, 1.42]). The long-term results seemed to have no adverse effect, but the information was still limited.
According to our review, metformin may have potential benefits for pregnant women and newborns with no obvious adverse effects. However, even more studies are needed to provide evidence for the future use of metformin.
二甲双胍在临床上越来越多地用于治疗妊娠期糖尿病。然而，其在子宫内暴露于二甲双胍的胎儿的安全性和长期影响仍存在争议。
我们系统地检索了 PubMed、Embase 和 Cochrane 数据库（最后一次检索更新于 2019 年 5 月 1 日），以比较二甲双胍与胰岛素的随机对照试验。两名审查员提取数据并使用随机效应模型计算汇总估计值。
共纳入 24 项研究。其中，17 项 RCT（=2828 名参与者）纳入定量分析，7 项研究仅纳入定性综合分析。二甲双胍降低了妊娠高血压的风险（=0.03；风险比（RR）=0.64；95%置信区间（95%CI）[0.44，0.95]）、巨大儿（=0.04；RR=0.82；95%CI [0.68，0.99]）、巨大儿（=0.01；RR=0.63；95%CI [0.45，0.90]）、新生儿低血糖（=0.001；RR=0.72；95%CI [0.59，0.88]）和新生儿重症监护病房入院（=0.01；RR=0.74；95%CI [0.58，0.94]）。二甲双胍并未增加早产（=0.11；RR=1.28；95%CI [0.95，1.73]）、子痫前期（=0.45；RR=0.89；95%CI [0.65，1.21]）、剖宫产（=0.20；RR=0.94；95%CI [0.85，1.04]）、小于胎龄儿（=0.95；RR=0.99；95%CI [0.69，1.42]）。长期结果似乎没有不良影响，但信息仍然有限。
根据我们的综述，二甲双胍可能对孕妇和新生儿有潜在的益处，且没有明显的不良影响。然而，仍需要更多的研究来为未来使用二甲双胍提供证据。
