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二甲双胍与胰岛素治疗妊娠期糖尿病:一项随机临床试验。

Metformin compared with insulin in the management of gestational diabetes mellitus: a randomized clinical trial.

机构信息

Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Women Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Diabetes Res Clin Pract. 2012 Dec;98(3):422-9. doi: 10.1016/j.diabres.2012.09.031. Epub 2012 Oct 12.

Abstract

AIMS

To evaluate the effect of metformin and insulin in glycemic control and compare pregnancy outcome in women with gestational diabetes mellitus (GDM).

METHODS

This randomized controlled trial was conducted in GDM women with singleton pregnancy and gestational age between 20 and 34 weeks who did not achieve glycemic control on diet were assigned randomly to receive either metformin (n=80) or insulin (n=80). The primary outcomes were maternal glycemic control and birth weight. The secondary outcomes were neonatal and obstetric complications.

RESULTS

Two groups were comparable regarding the maternal characteristics. Two groups were similar in mean FBS (P=0.68) and postprandial measurements (P=0.87) throughout GDM treatment. The neonates of metformin group had less rate of birth weight centile >90 than insulin group (RR: 0.5, 95% CI: 0.3-0.9, P=0.012). Maternal weight gain was reduced in the metformin group (P<0.001). Two groups were comparable according to neonatal and obstetric complications (P>0.05). In metformin group 14% of women needed to supplemental insulin to achieve euglycemia.

CONCLUSION

Metformin is an effective and safe alternative treatment to insulin for women with GDM. This study does not show significant risk of maternal or neonatal adverse outcome with the use of metformin.

摘要

目的

评估二甲双胍和胰岛素在血糖控制方面的效果,并比较患有妊娠期糖尿病(GDM)的女性的妊娠结局。

方法

本随机对照试验纳入了单胎妊娠且孕龄在 20 至 34 周之间、饮食控制未能使血糖达标 GDM 女性,将其随机分为接受二甲双胍(n=80)或胰岛素(n=80)治疗。主要结局为母体血糖控制和出生体重。次要结局为新生儿和产科并发症。

结果

两组母体特征相当。两组在整个 GDM 治疗期间的平均空腹血糖(P=0.68)和餐后测量值(P=0.87)均相似。与胰岛素组相比,二甲双胍组新生儿体重百分位数>90%的比例较低(RR:0.5,95%CI:0.3-0.9,P=0.012)。二甲双胍组的母体体重增加减少(P<0.001)。两组的新生儿和产科并发症相当(P>0.05)。在二甲双胍组,有 14%的女性需要补充胰岛素以达到血糖正常。

结论

对于患有 GDM 的女性,二甲双胍是胰岛素的有效且安全的替代治疗方法。本研究未显示使用二甲双胍有明显的母体或新生儿不良结局风险。

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