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二甲双胍与胰岛素在妊娠期糖尿病患者血糖调节中的疗效比较:一项随机临床试验。

The efficacy of metformin compared with insulin in regulating blood glucose levels during gestational diabetes mellitus: A randomized clinical trial.

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

Birjand University of Medical Sciences, Birjand, Iran.

出版信息

J Cell Physiol. 2019 Apr;234(4):4695-4701. doi: 10.1002/jcp.27238. Epub 2018 Sep 7.

Abstract

BACKGROUND

Insulin has been a conventional medication in the treatment of female patients suffering from gestational diabetes mellitus (GDM). However, the need for a large number of insulin injections in these patients causes them a lot of discomforts. Recently, an alternative medication, metformin, has received considerable attention in the treatment of GDM. The aim of this study was to compare the efficacy of metformin and insulin in regulating blood glucose levels and fetal outcomes in GDM.

METHODS

This randomized clinical trial included 286 pregnant women diagnosed with positive GDM at 24-28 weeks of pregnancy. The subjects were randomly divided into two groups of 143 patients, with one group receiving insulin and the other undergoing a treatment plan using metformin. Fasting plasma glucose (FPG), 2-hr plasma glucose (PG) and glycated hemoglobin (HbA1c) were recorded twice a month until delivery. Other variables, including birth delivery method, cause of cesarean section, gestational age at the delivery time, birth trauma, Apgar score, birth weight, admission at neonatal intensive care unit (NICU), and neonatal hypoglycemia were also registered.

RESULTS

Age of mother, body mass index, history of diabetes in the family, previous history of GDM, parity, FPG, 1- and 2-hr PG after meals, and 75-g glucose tolerance test before treatment were not statistically different between the two groups. FPG, PG, and HbA1c did not show significant differences between the two groups after completing the course of treatment. There was also no significant difference between two groups regarding the birth delivery method, the cause of cesarean section, birth trauma, Apgar score, birth weight, admission at NICU, and neonatal hypoglycemia.

CONCLUSION

As mean FPG and 2-hr PG were not significantly different between the two groups, it seems that metformin can be recommended as an effective substitute for insulin in the treatment of GDM. However, there are still some undesirable risk factors with both treatments that may threaten the mother and the newborn.

摘要

背景

胰岛素一直是治疗女性妊娠期糖尿病(GDM)患者的常规药物。然而,这些患者需要大量注射胰岛素,给她们带来了很多不适。最近,二甲双胍作为一种替代药物,在治疗 GDM 方面受到了广泛关注。本研究旨在比较二甲双胍和胰岛素在调节 GDM 患者血糖水平和胎儿结局方面的疗效。

方法

这项随机临床试验纳入了 286 名在 24-28 周妊娠时被诊断为 GDM 阳性的孕妇。将受试者随机分为两组,每组 143 例,一组接受胰岛素治疗,另一组接受二甲双胍治疗方案。每月记录两次空腹血糖(FPG)、餐后 2 小时血糖(PG)和糖化血红蛋白(HbA1c),直至分娩。其他变量,包括分娩方式、剖宫产原因、分娩时的胎龄、分娩创伤、阿普加评分、出生体重、新生儿重症监护病房(NICU)入住率和新生儿低血糖症也被记录。

结果

母亲年龄、体重指数、家族糖尿病史、既往 GDM 史、产次、FPG、餐后 1 小时和 2 小时 PG 以及治疗前 75g 葡萄糖耐量试验在两组间无统计学差异。完成疗程后,两组 FPG、PG 和 HbA1c 无显著差异。两组分娩方式、剖宫产原因、分娩创伤、阿普加评分、出生体重、NICU 入住率和新生儿低血糖症无显著差异。

结论

由于两组间平均 FPG 和 2 小时 PG 无显著差异,似乎二甲双胍可以作为治疗 GDM 的有效胰岛素替代药物。然而,两种治疗方法仍存在一些不良的危险因素,可能会威胁到母婴健康。

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