Malek Rana, Davis Stephen N
Department of Internal Medicine, Division of Endocrinology, Diabetes, and Nutrition, University of Maryland School of Medicine, Baltimore, MD, USA.
Theodore E. Woodward Professor of Medicine, Chairman, Department of Medicine, University of Maryland School of Medicine, Physician-in-Chief, University of Maryland Medical Center, Baltimore, MD, USA.
Expert Opin Drug Saf. 2025 Jan;24(1):5-8. doi: 10.1080/14740338.2024.2424410. Epub 2024 Nov 4.
Metformin has been part of treatment algorithms for type 2 diabetes mellitus (T2DM) for decades. While it has formal approval in the U.S.A. for treatment of T2DM, it is used off-label in gestational diabetes mellitus (GDM), polycystic ovarian syndrome (PCOS), and ovarian hyperstimulation prevention. Its role as an insulin sensitizer has made it an attractive therapeutic to address the insulin resistance seen in these syndromes. In 2022, the European Union approved metformin as the only oral antidiabetic medication for diabetes in pregnancy. While its safety and benefits for the mother are well documented, it does cross the placenta with plasma concentrations comparable between mother and child at delivery.
This special report will focus on major randomized control trials investigating metformin use in pregnancies impacted by PCOS, GDM, T2DM, and obesity and their offspring follow-up trials.
For the mother, metformin can be beneficial, with reduction in insulin therapeutic burden, weight gain, hypoglycemia and in certain situations, pre-eclampsia. For the neonate, benefits may include reduction in hypoglycemia and no increased risk of congenital anomalies. It is the long-term data in the offspring that remains unknown with some areas of concerns (SGA, altered anthropometrics) requiring continued research.
几十年来,二甲双胍一直是2型糖尿病(T2DM)治疗方案的一部分。虽然它在美国已获正式批准用于治疗T2DM,但在妊娠糖尿病(GDM)、多囊卵巢综合征(PCOS)和预防卵巢过度刺激综合征中属于超说明书用药。其作为胰岛素增敏剂的作用使其成为治疗这些综合征中胰岛素抵抗的有吸引力的疗法。2022年,欧盟批准二甲双胍作为唯一用于孕期糖尿病的口服抗糖尿病药物。虽然其对母亲的安全性和益处有充分记录,但它确实会穿过胎盘,分娩时母婴血浆浓度相当。
本专题报告将重点关注调查二甲双胍在受PCOS、GDM、T2DM和肥胖影响的妊娠中使用情况的主要随机对照试验及其后代随访试验。
对母亲而言,二甲双胍可能有益,可减轻胰岛素治疗负担、体重增加、低血糖,在某些情况下还可预防子痫前期。对新生儿来说,益处可能包括降低低血糖风险且不增加先天性异常风险。后代的长期数据仍然未知,一些令人担忧的领域(小于胎龄儿、人体测量学改变)需要持续研究。