Landon Mark B, Spong Catherine Y, Thom Elizabeth, Carpenter Marshall W, Ramin Susan M, Casey Brian, Wapner Ronald J, Varner Michael W, Rouse Dwight J, Thorp John M, Sciscione Anthony, Catalano Patrick, Harper Margaret, Saade George, Lain Kristine Y, Sorokin Yoram, Peaceman Alan M, Tolosa Jorge E, Anderson Garland B
Department of Obstetrics and Gynecology, Ohio State University, Columbus, USA.
N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.
It is uncertain whether treatment of mild gestational diabetes mellitus improves pregnancy outcomes.
Women who were in the 24th to 31st week of gestation and who met the criteria for mild gestational diabetes mellitus (i.e., an abnormal result on an oral glucose-tolerance test but a fasting glucose level below 95 mg per deciliter [5.3 mmol per liter]) were randomly assigned to usual prenatal care (control group) or dietary intervention, self-monitoring of blood glucose, and insulin therapy, if necessary (treatment group). The primary outcome was a composite of stillbirth or perinatal death and neonatal complications, including hyperbilirubinemia, hypoglycemia, hyperinsulinemia, and birth trauma.
A total of 958 women were randomly assigned to a study group--485 to the treatment group and 473 to the control group. We observed no significant difference between groups in the frequency of the composite outcome (32.4% and 37.0% in the treatment and control groups, respectively; P=0.14). There were no perinatal deaths. However, there were significant reductions with treatment as compared with usual care in several prespecified secondary outcomes, including mean birth weight (3302 vs. 3408 g), neonatal fat mass (427 vs. 464 g), the frequency of large-for-gestational-age infants (7.1% vs. 14.5%), birth weight greater than 4000 g (5.9% vs. 14.3%), shoulder dystocia (1.5% vs. 4.0%), and cesarean delivery (26.9% vs. 33.8%). Treatment of gestational diabetes mellitus, as compared with usual care, was also associated with reduced rates of preeclampsia and gestational hypertension (combined rates for the two conditions, 8.6% vs. 13.6%; P=0.01).
Although treatment of mild gestational diabetes mellitus did not significantly reduce the frequency of a composite outcome that included stillbirth or perinatal death and several neonatal complications, it did reduce the risks of fetal overgrowth, shoulder dystocia, cesarean delivery, and hypertensive disorders. (ClinicalTrials.gov number, NCT00069576.)
轻度妊娠期糖尿病的治疗是否能改善妊娠结局尚不确定。
孕周在24至31周且符合轻度妊娠期糖尿病标准（即口服葡萄糖耐量试验结果异常但空腹血糖水平低于95毫克/分升[5.3毫摩尔/升]）的女性被随机分配至常规产前护理组（对照组）或饮食干预、血糖自我监测组，必要时接受胰岛素治疗（治疗组）。主要结局是死产或围产儿死亡以及新生儿并发症的综合情况，包括高胆红素血症、低血糖、高胰岛素血症和产伤。
共有958名女性被随机分配至研究组，485名进入治疗组，473名进入对照组。我们观察到两组在综合结局发生频率上无显著差异（治疗组和对照组分别为32.4%和37.0%；P = 0.14）。无围产儿死亡。然而，与常规护理相比，治疗在几个预先设定的次要结局方面有显著降低，包括平均出生体重（3302克对3408克）、新生儿脂肪量（427克对464克）、大于胎龄儿的频率（7.1%对14.5%）、出生体重超过4000克（5.9%对14.3%）、肩难产（1.5%对4.0%）以及剖宫产（26.9%对33.8%）。与常规护理相比，妊娠期糖尿病的治疗还与子痫前期和妊娠期高血压发生率降低相关（两种情况的合并发生率，8.6%对13.6%；P = 0.01）。
尽管轻度妊娠期糖尿病的治疗并未显著降低包括死产或围产儿死亡以及几种新生儿并发症在内综合结局的发生频率，但确实降低了胎儿过度生长、肩难产、剖宫产和高血压疾病的风险。（ClinicalTrials.gov编号，NCT00069576。）
