Division of Endocrinology and Metabolism, Department of Internal Medicine, New Taipei Municipal TuCheng Hospital, New Taipei City, Taiwan.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
BMC Pregnancy Childbirth. 2020 Sep 4;20(1):512. doi: 10.1186/s12884-020-03207-0.
Metformin use in pregnancy is controversial because metformin crosses the placenta and the safety on the fetus has not been well-established. This retrospective study aimed to compare pregnancy outcomes in women with preexisting type 2 diabetes receiving metformin or standard insulin treatment.
The cohort of this population-based study includes women of age 20-44 years with preexisting type 2 diabetes and singleton pregnancies in Taiwan between 2003 and 2014. Subjects were classified into three mutually exclusive groups according to glucose-lowering treatments received before and after becoming pregnant: insulin group, switching group (metformin to insulin), and metformin group. A generalized estimating equation model adjusted for patient age, duration of type 2 diabetes, hypertension, hyperlipidemia, retinopathy, and aspirin use was used to estimate the adjusted odds ratio (aOR) and 95% confidence interval (CI) of adverse pregnancy outcomes.
A total of 1166 pregnancies were identified in the insulin group (n = 222), the switching group (n = 318) and the metformin group (n = 626). The insulin group and the switching group had similar pregnancy outcomes for both the mother and fetus, including risk of primary cesarean section, pregnancy-related hypertension, preeclampsia, preterm birth (< 37 weeks), very preterm birth (< 32 weeks), low birth weight (< 2500 g), high birth weight (> 4000 g), large for gestational age, and congenital malformations. The metformin group had a lower risk of primary cesarean section (aOR = 0.57; 95% CI, 0.40-0.82) and congenital malformations (aOR, 0.51; 95% CI; 0.27-0.94) and similar risk for the other outcomes as compared with the insulin group.
Metformin therapy was not associated with increased adverse pregnancy outcomes in women with type 2 diabetes as compared with standard insulin therapy.
二甲双胍在孕期的使用存在争议,因为二甲双胍可以穿过胎盘,其对胎儿的安全性尚未得到充分证实。本回顾性研究旨在比较接受二甲双胍或标准胰岛素治疗的患有 2 型糖尿病的孕妇的妊娠结局。
本基于人群的研究队列包括 2003 年至 2014 年间年龄在 20-44 岁之间、患有 2 型糖尿病且单胎妊娠的台湾女性。根据妊娠前后接受的降糖治疗,将受试者分为三组:胰岛素组、转换组(二甲双胍转换为胰岛素)和二甲双胍组。采用广义估计方程模型调整患者年龄、2 型糖尿病病程、高血压、高血脂、视网膜病变和阿司匹林使用情况,估计不良妊娠结局的调整优势比(aOR)和 95%置信区间(CI)。
胰岛素组(n=222)、转换组(n=318)和二甲双胍组(n=626)共确定了 1166 例妊娠。胰岛素组和转换组的母婴妊娠结局相似,包括初次剖宫产、妊娠相关高血压、子痫前期、早产(<37 周)、极早产(<32 周)、低出生体重(<2500g)、巨大儿(>4000g)、大于胎龄儿和先天性畸形。与胰岛素组相比,二甲双胍组初次剖宫产(aOR=0.57;95%CI,0.40-0.82)和先天性畸形(aOR,0.51;95%CI;0.27-0.94)的风险较低,其他结局的风险相似。
与标准胰岛素治疗相比,二甲双胍治疗与患有 2 型糖尿病的女性不良妊娠结局的增加无关。