子宫内暴露于二甲双胍治疗 2 型糖尿病或多囊卵巢综合征：一项前瞻性比较观察研究。

In-utero exposure to metformin for type 2 diabetes or polycystic ovary syndrome: A prospective comparative observational study.

机构信息

The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel; The Hebrew University Hadassah Medical School, Jerusalem, Israel.

The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel; The Division of Clinical Pharmacy, the Hebrew University of Jerusalem, Israel.

出版信息

Reprod Toxicol. 2018 Sep;80:85-91. doi: 10.1016/j.reprotox.2018.05.007. Epub 2018 May 29.

DOI:10.1016/j.reprotox.2018.05.007

PMID:29857030

Abstract

OBJECTIVE

To evaluate the rate of major anomalies after first trimester (T1)-metformin exposure.

DESIGN

Comparative, observational cohort study done at the Israeli Teratology Information Service between 2000 and 2013.

RESULTS

170 T1-metformin-exposed pregnancies [119 for diabetes and 51 for polycystic ovary syndrome (PCOS)] were prospectively followed-up and compared with 93 pregnancies of T1-insulin treated women and 530 non-teratogenic exposed (NTE) pregnancies. The differences in the rate of major anomalies excluding genetic/cytogenetic, and spontaneously resolved cardiovascular anomalies were not significant [4.4% (2/45) - metformin-PCOS, 1.1% (1/90) - metformin-diabetes, 2.5% (2/80) - insulin, and 1.7% (9/519) - NTE; OR/ 1.77; 95% CI 0.45-7.01; OR/ 1.69; 95% CI 0.35-8.11]. The rate of Cesarean section was higher in both the metformin-diabetes 51/90 (56.7%) and insulin 45/79 (57.0%) groups compared with the NTE group [138/503 (27.4%)].

CONCLUSION

Metformin-T1-exposure per se is not associated with an increased risk of major anomalies.

摘要

目的

评估早孕期（T1）二甲双胍暴露后主要畸形的发生率。

设计

2000 年至 2013 年在以色列畸形信息服务处进行的比较性观察队列研究。

结果

170 例 T1-二甲双胍暴露妊娠[119 例糖尿病和 51 例多囊卵巢综合征（PCOS）]前瞻性随访，并与 93 例 T1-胰岛素治疗的妊娠和 530 例非致畸暴露（NTE）妊娠进行比较。主要畸形（不包括遗传/细胞遗传学和自发消退的心血管畸形）的发生率差异无统计学意义[4.4%（2/45）-二甲双胍-PCOS、1.1%（1/90）-二甲双胍-糖尿病、2.5%（2/80）-胰岛素和 1.7%（9/519）-NTE；OR/1.77；95%CI 0.45-7.01；OR/1.69；95%CI 0.35-8.11]。二甲双胍-糖尿病 51/90（56.7%）和胰岛素 45/79（57.0%）组的剖宫产率均高于 NTE 组[138/503（27.4%）]。