Nicholson Wanda, Bolen Shari, Witkop Catherine Takacs, Neale Donna, Wilson Lisa, Bass Eric
From the Departments of Gynecology and Obstetrics, Internal Medicine, and the Johns Hopkins Evidence-based Practice Center, The Johns Hopkins School of Medicine, Department of General Preventive Medicine, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Obstet Gynecol. 2009 Jan;113(1):193-205. doi: 10.1097/AOG.0b013e318190a459.
Little is known about the comparative risks and benefits of medical treatments for gestational diabetes mellitus (GDM). We conducted a systematic review of randomized controlled trials and observational studies of maternal and neonatal outcomes in women with GDM treated with oral diabetes agents compared with all types of insulin.
We searched four electronic databases from inception through January 2007. Terms for GDM, insulins, and oral hypoglycemic agents were used in the search. Two investigators independently reviewed titles and abstracts, performed data abstraction on full articles, and assessed study quality.
Articles were excluded if they had no comparison group or did not use a standard diagnosis of GDM (3-hour, 100-g oral glucose tolerance test or 2-hour, 75-g oral glucose tolerance test). Nine studies met our inclusion criteria, four randomized controlled trials (n=1,229 participants) and five observational studies (n=831 participants). Data were abstracted on study characteristics, gestational age at treatment, medication dosage, and length of follow-up. Outcomes included glycemic control, infant birth weight, neonatal hypoglycemia, and congenital anomalies.
TABULATION, INTEGRATION, AND RESULTS: Two trials compared insulin to glyburide; one trial compared insulin, glyburide, and acarbose; and one trial compared insulin to metformin. No significant differences were found in maternal glycemic control or cesarean delivery rates between the insulin and glyburide groups. A meta-analysis showed similar infant birth weights between women treated with glyburide and women treated with insulin (mean difference -93 g) (95% confidence interval -191 to 5 g). There was a higher proportion of infants with neonatal hypoglycemia in the insulin group (8.1%) compared with the metformin group (3.3%) (P=.008). The rate of congenital malformations did not differ between pregnancies treated with insulin and those treated with oral agents. Observational studies were limited by selection bias and confounding.
No substantial maternal or neonatal outcome differences were found with the use of glyburide or metformin compared with use of insulin in women with GDM.
对于妊娠期糖尿病(GDM)医学治疗的相对风险和益处,人们了解甚少。我们对口服降糖药与各类胰岛素治疗GDM的女性的母婴结局的随机对照试验和观察性研究进行了系统综述。
我们检索了从起始至2007年1月的四个电子数据库。检索中使用了GDM、胰岛素和口服降糖药的检索词。两名研究者独立审阅标题和摘要,对全文进行数据提取,并评估研究质量。
如果文章没有比较组或未采用GDM的标准诊断(3小时、100克口服葡萄糖耐量试验或2小时、75克口服葡萄糖耐量试验),则将其排除。九项研究符合我们的纳入标准,四项随机对照试验(n = 1229名参与者)和五项观察性研究(n = 831名参与者)。提取了关于研究特征、治疗时的孕周、药物剂量和随访时长的数据。结局包括血糖控制、婴儿出生体重、新生儿低血糖和先天性异常。
制表、整合与结果:两项试验将胰岛素与格列本脲进行了比较;一项试验将胰岛素、格列本脲和阿卡波糖进行了比较;一项试验将胰岛素与二甲双胍进行了比较。胰岛素组和格列本脲组在母体血糖控制或剖宫产率方面未发现显著差异。一项荟萃分析显示,使用格列本脲治疗的女性与使用胰岛素治疗的女性的婴儿出生体重相似(平均差异 -93克)(95%置信区间 -191至5克)。与二甲双胍组(3.3%)相比,胰岛素组新生儿低血糖婴儿的比例更高(8.1%)(P = 0.008)。胰岛素治疗的妊娠与口服药物治疗的妊娠之间先天性畸形的发生率没有差异。观察性研究受选择偏倚和混杂因素的限制。
在GDM女性中,使用格列本脲或二甲双胍与使用胰岛素相比,在母婴结局方面未发现实质性差异。