Department of Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore2Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.
Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill.
JAMA Pediatr. 2015 May;169(5):452-8. doi: 10.1001/jamapediatrics.2015.74.
Glyburide is thought to be safe for use during pregnancy for treatment of gestational diabetes mellitus (GDM). However, there are limited data on the effectiveness of glyburide when compared with insulin as used in a real-world setting.
To estimate the risk of adverse maternal and neonatal outcomes in women with GDM treated with glyburide compared with insulin.
DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of a population-based cohort from a nationwide US employer-based insurance claims database from January 1, 2000, to December 31, 2011. We identified women with GDM and their newborns. We excluded those with type 1 or 2 diabetes and those younger than 15 years or older than 45 years.
Treatment with glyburide or insulin during pregnancy within 150 days before delivery.
We used binomial regression to estimate risk ratios (RRs) and risk differences with 95% confidence intervals for the association of glyburide with diagnosis codes for obstetric trauma, cesarean delivery, birth injury, preterm birth, hypoglycemia, respiratory distress, jaundice, large for gestational age, and hospitalization in the neonatal intensive care unit. Inverse probability of treatment weights were used to adjust for maternal characteristics that differed between the treatment groups.
Among 110,879 women with GDM, 9173 women (8.3%) were treated with glyburide (n = 4982) or insulin (n = 4191). After adjusting for differences at baseline, newborns of women treated with glyburide were at increased risk for neonatal intensive care unit admission (RR = 1.41; 95% CI, 1.23-1.62), respiratory distress (RR = 1.63; 95% CI, 1.23-2.15), hypoglycemia (RR = 1.40; 95% CI, 1.00-1.95), birth injury (RR = 1.35; 95% CI, 1.00-1.82), and large for gestational age (RR = 1.43; 95% CI, 1.16-1.76) compared with those treated with insulin; they were not at increased risk for obstetric trauma (RR = 0.92; 95% CI, 0.71-1.20), preterm birth (RR = 1.06; 95% CI, 0.93-1.21), or jaundice (RR = 0.96; 95% CI, 0.48-1.91). The risk of cesarean delivery was 3% lower in the glyburide group (adjusted RR = 0.97; 95% CI, 0.93-1.00). The risk difference associated with glyburide was 2.97% (95% CI, 1.82-4.12) for neonatal intensive care unit admission, 1.41% (95% CI, 0.61-2.20) for large for gestational age, and 1.11% (95% CI, 0.50-1.72) for respiratory distress.
Newborns from privately insured mothers treated with glyburide were more likely to experience adverse outcomes than those from mothers treated with insulin. Given the widespread use of glyburide, further investigation of these differences in pregnancy outcomes is a public health priority.
人们认为在治疗妊娠糖尿病（GDM）期间使用格列本脲是安全的。然而，与在现实环境中使用的胰岛素相比，关于格列本脲的有效性的数据有限。
评估与胰岛素相比，GDM 女性使用格列本脲治疗的不良母婴结局风险。
设计、地点和参与者：这是一项来自美国全国性雇主保险索赔数据库的基于人群的回顾性队列研究，研究时间为 2000 年 1 月 1 日至 2011 年 12 月 31 日。我们确定了患有 GDM 的女性及其新生儿。我们排除了患有 1 型或 2 型糖尿病以及年龄小于 15 岁或大于 45 岁的患者。
分娩前 150 天内使用格列本脲或胰岛素治疗。
我们使用二项回归估计与格列本脲相关的诊断代码为产科创伤、剖宫产、分娩损伤、早产、低血糖、呼吸窘迫、黄疸、巨大儿和新生儿重症监护病房住院的比值比（RR）和风险差异，并使用逆概率治疗权重调整治疗组之间存在差异的产妇特征。
在 110879 名患有 GDM 的女性中，9173 名女性（8.3%）接受了格列本脲（n=4982）或胰岛素（n=4191）治疗。在调整了基线差异后，接受格列本脲治疗的女性新生儿更有可能入住新生儿重症监护病房（RR=1.41；95%置信区间，1.23-1.62）、呼吸窘迫（RR=1.63；95%置信区间，1.23-2.15）、低血糖（RR=1.40；95%置信区间，1.00-1.95）、分娩损伤（RR=1.35；95%置信区间，1.00-1.82）和巨大儿（RR=1.43；95%置信区间，1.16-1.76），而不是胰岛素治疗的新生儿；他们没有更高的产科创伤（RR=0.92；95%置信区间，0.71-1.20）、早产（RR=1.06；95%置信区间，0.93-1.21）或黄疸（RR=0.96；95%置信区间，0.48-1.91）风险。格列本脲组剖宫产率降低 3%（调整后的 RR=0.97；95%置信区间，0.93-1.00）。与胰岛素相比，与格列本脲相关的风险差异为新生儿重症监护病房入住率增加 2.97%（95%置信区间，1.82-4.12%）、巨大儿增加 1.41%（95%置信区间，0.61-2.20%）和呼吸窘迫增加 1.11%（95%置信区间，0.50-1.72%）。
接受私人保险的母亲使用格列本脲治疗的新生儿更有可能出现不良结局，而不是接受胰岛素治疗的新生儿。鉴于格列本脲的广泛使用，进一步调查这些妊娠结局差异是一个公共卫生优先事项。
