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【medical-news】《NEJM》：二甲双胍治疗GDM效果和安
ABSTRACT
Background
Metformin is a logical treatment for women with gestational diabetes mellitus, but randomized trials to assess the efficacy and safety of its use for this condition are lacking.
Methods
We randomly assigned 751 women with gestational diabetes mellitus at 20 to 33 weeks of gestation to open treatment with metformin (with supplemental insulin if required) or insulin. The primary outcome was a composite of neonatal hypoglycemia, respiratory distress, need for phototherapy, birth trauma, 5-minute Apgar score less than 7, or prematurity. The trial was designed to rule out a 33% increase (from 30% to 40%) in this composite outcome in infants of women treated with metformin as compared with those treated with insulin. Secondary outcomes included neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance, and acceptability of treatment.
Results
Of the 363 women assigned to metformin, 92.6% continued to receive metformin until delivery and 46.3% received supplemental insulin. The rate of the primary composite outcome was 32.0% in the group assigned to metformin and 32.2% in the insulin group (relative risk, 1.00; 95% confidence interval, 0.90 to 1.10). More women in the metformin group than in the insulin group stated that they would choose to receive their assigned treatment again (76.6% vs. 27.2%, P<0.001). The rates of other secondary outcomes did not differ significantly between the groups. There were no serious adverse events associated with the use of metformin.
Conclusions
In women with gestational diabetes mellitus, metformin (alone or with supplemental insulin) is not associated with increased perinatal complications as compared with insulin. The women preferred metformin to insulin treatment.
http://content.nejm.org/cgi/content/short/358/19/2003 本人已认领该文翻译，48小时后若未提交译文，请其他战友自由认领 Metformin versus Insulin for the Treatment of Gestational Diabetes
二甲双胍和胰岛素治疗妊娠糖尿病比较
ABSTRACT
Background
Metformin is a logical treatment for women with gestational diabetes mellitus, but randomized trials to assess the efficacy and safety of its use for this condition are lacking.
背景：二甲双胍是妊娠糖尿病一种合乎逻辑的治疗药物，但还缺乏评估它的疗效和安全性的临床随机对照实验。
Methods
We randomly assigned 751 women with gestational diabetes mellitus at 20 to 33 weeks of gestation to open treatment with metformin (with supplemental insulin if required) or insulin. The primary outcome was a composite of neonatal hypoglycemia, respiratory distress, need for phototherapy, birth trauma, 5-minute Apgar score less than 7, or prematurity. The trial was designed to rule out a 33% increase (from 30% to 40%) in this composite outcome in infants of women treated with metformin as compared with those treated with insulin. Secondary outcomes included neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance, and acceptability of treatment.
方法：随机抽取患有妊娠期高血糖的妇女751名，在怀孕20周到33周，对她们进行二甲双胍（在需要情况下补充胰岛素）和胰岛素的开放治疗。主要检测的综合症有：新生儿低血糖、呼吸窘迫、需要光疗法支持，产伤，5分钟新生儿Apgar评分小于7，早产。这个实验旨在推翻的这样的结论——接受二甲双胍治疗的妇女比那些接受胰岛素治疗的妇女出现这些复合反应的概率大33%（平均30%—40%）。次要的结果包括：新生儿体位测量，产妇血糖控制，产妇高血压并发症，产后糖耐量及认受治疗。
Results
Of the 363 women assigned to metformin, 92.6% continued to receive metformin until delivery and 46.3% received supplemental insulin. The rate of the primary composite outcome was 32.0% in the group assigned to metformin and 32.2% in the insulin group (relative risk, 1.00; 95% confidence interval, 0.90 to 1.10). More women in the metformin group than in the insulin group stated that they would choose to receive their assigned treatment again (76.6% vs. 27.2%, P<0.001). The rates of other secondary outcomes did not differ significantly between the groups. There were no serious adverse events associated with the use of metformin.
结果：363名接受二甲双胍治疗的妇女中，92.6%在分娩前一直使用二甲双胍，46.3%接受了胰岛素的辅助治疗。二甲双胍组主要综合症发生率为32.0%，而胰岛素组为32.2%（现对危险系数，1.00；95%可信区间0.90—1.10）。二甲双胍组比胰岛素组有更多妇女称如果给她们选择，她们还会选择目前的治疗药物（76.6% vs. 27.2%, P<0.001）。其他次要表现在这两组发生率没有显著性差异。二甲双胍组没有发生严重不良反应事件。
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作者:admin@医学,生命科学 2010-11-26 17:11
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