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患有妊娠糖尿病风险的孕妇进行肌醇补充的临床和代谢结局:3 项 RCT 的二次分析。

Clinical and metabolic outcomes in pregnant women at risk for gestational diabetes mellitus supplemented with myo-inositol: a secondary analysis from 3 RCTs.

机构信息

Department of Human Pathology, University Hospital of Messina, Messina, Italy.

Department of Economics, Unit of Statistics and Mathematical Sciences, University of Messina, Messina, Italy.

出版信息

Am J Obstet Gynecol. 2018 Sep;219(3):300.e1-300.e6. doi: 10.1016/j.ajog.2018.05.018. Epub 2018 May 30.

DOI:10.1016/j.ajog.2018.05.018
PMID:29859136
Abstract

BACKGROUND

Gestational diabetes mellitus is defined as carbohydrate intolerance that begins or is first recognized during pregnancy. Insulin sensitizing substances such as myo-inositol have been considered for the prevention of gestational diabetes mellitus and related complications.

OBJECTIVE

Because previous studies failed to show a clear reduction of gestational diabetes mellitus complications, the aim of this study was to evaluate clinical and metabolic outcomes in women who are at risk for gestational diabetes mellitus supplemented with myo-inositol since the first trimester.

STUDY DESIGN

A secondary analysis of databases from 3 randomized, controlled trials (595 women enrolled) in which women who were at risk for gestational diabetes mellitus (a parent with type 2 diabetes mellitus, obese, or overweight) were supplemented with myo-inositol (4 g/d) throughout pregnancy. Main measures were the rate of adverse clinical outcomes: macrosomia (birthweight, ≥4000 g), large-for-gestational-age babies (fetal growth, ≥90 percentile), fetal growth restriction (fetal growth, ≤3 percentile), preterm birth (delivery before week 37 since the last menstruation), gestational hypertension, and gestational diabetes mellitus.

RESULTS

A significant reduction was observed for preterm birth (10/291 [3.4%] vs 23/304 [7.6%]; P=.03), macrosomia (6/291 [2.1%] vs 16/304 [5.3%]; P=.04), Large-for-gestational-age babies (14/291 [4.8%] vs 27/304 [8.9%]; P=.04) with only a trend to significance for gestational hypertension (4/291 [1.4%] vs 12/304 [3.9%]; P=.07). Gestational diabetes mellitus diagnosis was also decreased when compared with the control group (32/291 [11.0%] vs 77/304 [25.3%]; P<.001). At univariate logistic regression analysis, myo-inositol treatment reduced the risk for preterm birth (odds ratio, 0.44; 95% confidence interval, 0.20-0.93), macrosomia (odds ratio, 0.38; 95% confidence interval, 0.14-0.98), and gestational diabetes mellitus diagnosis (odds ratio, 0.36; 95% confidence interval, 0.23-0.57).

CONCLUSION

Myo-inositol treatment in early pregnancy is associated with a reduction in the rate of gestational diabetes mellitus and in the risk of preterm birth and macrosomia in women who are at risk for gestational diabetes mellitus.

摘要

背景

妊娠期糖尿病是指在妊娠期间出现或首次诊断的碳水化合物不耐受。肌醇等胰岛素增敏物质已被考虑用于预防妊娠期糖尿病及其相关并发症。

目的

由于先前的研究未能显示出妊娠期糖尿病并发症明显减少,因此本研究旨在评估在妊娠早期开始补充肌醇的有患妊娠期糖尿病风险的女性的临床和代谢结局。

研究设计

对 3 项随机对照试验(共纳入 595 名女性)的数据库进行二次分析,这些女性有患妊娠期糖尿病的风险(父母一方患有 2 型糖尿病、肥胖或超重),整个孕期均补充肌醇(4g/d)。主要观察指标为不良临床结局的发生率:巨大儿(出生体重≥4000g)、胎儿大于胎龄儿(胎儿生长≥第 90 百分位数)、胎儿生长受限(胎儿生长≤第 3 百分位数)、早产(末次月经后第 37 周前分娩)、妊娠期高血压和妊娠期糖尿病。

结果

早产(10/291[3.4%] vs 23/304[7.6%];P=.03)、巨大儿(6/291[2.1%] vs 16/304[5.3%];P=.04)、胎儿大于胎龄儿(14/291[4.8%] vs 27/304[8.9%];P=.04)的发生率显著降低,妊娠期高血压的发生率虽有下降趋势但无统计学意义(4/291[1.4%] vs 12/304[3.9%];P=.07)。与对照组相比,妊娠期糖尿病的诊断也有所减少(32/291[11.0%] vs 77/304[25.3%];P<.001)。单因素逻辑回归分析显示,肌醇治疗降低了早产(比值比,0.44;95%置信区间,0.20-0.93)、巨大儿(比值比,0.38;95%置信区间,0.14-0.98)和妊娠期糖尿病诊断(比值比,0.36;95%置信区间,0.23-0.57)的风险。

结论

在有患妊娠期糖尿病风险的女性中,妊娠早期补充肌醇与降低妊娠期糖尿病的发生率以及早产和巨大儿的风险有关。

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