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EVOLVE 研究中使用注射用降糖药物的妊娠糖尿病患者的特征。

Characteristics of pregnant women with diabetes using injectable glucose-lowering drugs in the EVOLVE study.

机构信息

Center for Pregnant Women with Diabetes, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Masjid Tanah Health Clinic, Malacca, Malaysia.

出版信息

J Matern Fetal Neonatal Med. 2022 Dec;35(25):7992-8000. doi: 10.1080/14767058.2021.1940132. Epub 2021 Jun 28.

Abstract

AIMS

To examine clinical parameters, glycemic control, folic acid supplementation, and the presence of other chronic diseases during early pregnancy in the EVOLVE study population (women with pre-existing diabetes treated with injectable glucose-lowering drugs).

METHODS

Cross-sectional baseline evaluation of EVOLVE: an international, multicenter, non-interventional study investigating the safety of injectable glucose-lowering drugs in pregnant women with pre-existing type 1 (T1D) or type 2 diabetes (T2D). Data were collected at enrollment visit interviews before gestational week 16.

RESULTS

In total, 2383 women from 17 mainly European countries were enrolled in the study: 2122 with T1D and 261 with T2D; mean age was 31 and 33 years, and duration of diabetes was 15 and 6 years, respectively. For women with T1D or T2D, 63% and 75%, respectively, received basal and rapid-acting insulin, 36% and 3% rapid-acting insulin only, 0.7% and 14.0% basal insulin only, 0.2% and 5.4% premix insulin, 0.0% and 1.2% injectable glucagon-like peptide-1 receptor agonist treatment without insulin. In women with T1D or T2D, respectively, during early pregnancy, 59% and 62% had HbA <7.0% (53 mmol/mol); 16% and 36% reported not taking folic acid before or during early pregnancy. Overall, >40% of women had ≥1 chronic concomitant condition (predominantly thyroid disease or hypertension). Retinopathy was the most commonly reported diabetic complication. The most commonly reported previous pregnancy complication was miscarriage.

CONCLUSIONS

Baseline data from this large multinational population of women with pre-existing diabetes indicate that sub-optimal glycemic control, poor pregnancy planning, and chronic concomitant conditions were common in early pregnancy.

摘要

目的

在 EVOLVE 研究人群(接受注射用降血糖药物治疗的患有既往糖尿病的女性)中检查妊娠早期的临床参数、血糖控制、叶酸补充以及其他慢性疾病的存在情况。

方法

EVOLVE 的横断面基线评估:一项国际性、多中心、非干预性研究,调查了注射用降血糖药物在患有既往 1 型(T1D)或 2 型糖尿病(T2D)的孕妇中的安全性。数据在妊娠 16 周前的入组访视时收集。

结果

这项研究共纳入了来自 17 个主要欧洲国家的 2383 名女性:2122 名患有 T1D,261 名患有 T2D;平均年龄分别为 31 岁和 33 岁,糖尿病病程分别为 15 年和 6 年。对于患有 T1D 或 T2D 的女性,分别有 63%和 75%接受基础胰岛素和速效胰岛素,36%和 3%仅接受速效胰岛素,0.7%和 14.0%仅接受基础胰岛素,0.2%和 5.4%接受预混胰岛素,0.0%和 1.2%接受无胰岛素的注射用胰高血糖素样肽-1 受体激动剂治疗。患有 T1D 或 T2D 的女性在妊娠早期,分别有 59%和 62%的 HbA1c<7.0%(53mmol/mol);16%和 36%报告在妊娠前或妊娠早期未服用叶酸。总体而言,超过 40%的女性患有≥1 种慢性合并症(主要为甲状腺疾病或高血压)。视网膜病变是最常见的糖尿病并发症。最常见的既往妊娠并发症是流产。

结论

来自这个患有既往糖尿病的大型跨国女性人群的基线数据表明,妊娠早期血糖控制不佳、妊娠计划不良以及慢性合并症较为常见。

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