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妊娠期使用二甲双胍的真实世界经验:来自北领地妊娠糖尿病临床注册的观察性数据。

Real-world experience of metformin use in pregnancy: Observational data from the Northern Territory Diabetes in Pregnancy Clinical Register.

机构信息

Wellbeing and Preventable Chronic Diseases Division, Menzies School of Health Research, Darwin, Northern Territory, Australia.

Division of Medicine, Royal Darwin Hospital, Darwin, Northern Territory, Australia.

出版信息

J Diabetes. 2019 Sep;11(9):761-770. doi: 10.1111/1753-0407.12905. Epub 2019 Feb 19.

DOI:10.1111/1753-0407.12905
PMID:30680949
Abstract

BACKGROUND

In Australia's Northern Territory, Indigenous mothers account for 33% of births and have high rates of hyperglycemia in pregnancy. The prevalence of type 2 diabetes (T2D) in pregnancy is up to 10-fold higher in Indigenous than non-Indigenous Australian mothers, and the use of metformin is common. We assessed birth outcomes in relation to metformin use during pregnancy from a clinical register.

METHODS

The study included women with gestational diabetes (GDM), newly diagnosed diabetes in pregnancy (DIP), or pre-existing T2D from 2012 to 2016. Data were analyzed for metformin use in the third trimester. Regression models were adjusted for maternal age, body mass index, parity, and insulin use.

RESULTS

Of 1649 pregnancies, 814 (49.4%) were to Indigenous women, of whom 234 (28.7%) had T2D (vs 4.6% non-Indigenous women; P < 0.001). Metformin use was high in Indigenous women (84%-90% T2D, 42%-48% GDM/DIP) and increased over time in non-Indigenous women (43%-100% T2D, 14%-35% GDM/DIP). Among Indigenous women with GDM/DIP, there were no significant differences between groups with and without metformin in cesarean section (51% vs 39%; adjusted odds ratio [aOR] 1.25, 95% confidence interval [CI] 0.87-1.81), large for gestational age (24% vs 13%; aOR 1.5, 95% CI 0.9-2.5), or serious neonatal adverse events (9.4% vs 5.9%; aOR 1.32, 95% CI 0.68-2.57). Metformin use was independently associated with earlier gestational age (37.7 vs 38.5 weeks), but the risk did not remain independently higher after exclusion of women managed with medical nutrition therapy alone, and the increase in births <37 weeks was not significant on multivariate analysis.

CONCLUSIONS

We found no clear evidence of any adverse outcomes related to the use of metformin for the treatment of hyperglycemia in pregnancy.

摘要

背景

在澳大利亚北部地区,土著母亲占分娩总数的 33%,且妊娠期间高血糖的发生率较高。与非土著澳大利亚母亲相比,妊娠期间 2 型糖尿病(T2D)的患病率高达 10 倍,且普遍使用二甲双胍。我们从临床登记处评估了与妊娠期间使用二甲双胍相关的分娩结局。

方法

该研究纳入了 2012 年至 2016 年期间患有妊娠期糖尿病(GDM)、新诊断的妊娠糖尿病(DIP)或孕前 T2D 的女性。分析了孕晚期使用二甲双胍的数据。回归模型调整了母亲的年龄、体重指数、产次和胰岛素使用情况。

结果

在 1649 例妊娠中,814 例(49.4%)为土著女性,其中 234 例(28.7%)患有 T2D(而非土著女性为 4.6%;P<0.001)。土著女性使用二甲双胍的比例较高(T2D 为 84%-90%,GDM/DIP 为 42%-48%),而非土著女性的使用比例随时间增加(T2D 为 43%-100%,GDM/DIP 为 14%-35%)。在患有 GDM/DIP 的土著女性中,使用和未使用二甲双胍的女性在剖宫产(51% vs 39%;调整后的优势比[aOR]1.25,95%置信区间[CI]0.87-1.81)、胎儿大于胎龄(24% vs 13%;aOR 1.5,95% CI 0.9-2.5)或严重新生儿不良事件(9.4% vs 5.9%;aOR 1.32,95% CI 0.68-2.57)方面无显著差异。二甲双胍的使用与较早的妊娠周数相关(37.7 周 vs 38.5 周),但在排除单独接受医学营养治疗的女性后,这种风险不再显著升高,多变量分析也未显示<37 周的分娩增加。

结论

我们未发现使用二甲双胍治疗妊娠高血糖与任何不良结局相关的明确证据。

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