Song Rongjing, Chen Ling, Chen Yue, Si Xia, Liu Yi, Liu Yue, Irwin David M, Feng Wanyu
Department of Pharmacy, Peking University People's Hospital, Beijing, China.
Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
PLoS One. 2017 Aug 3;12(8):e0182488. doi: 10.1371/journal.pone.0182488. eCollection 2017.
The aim of this meta-analysis was to determine the efficacy and safety of glyburide as a treatment for gestational diabetes mellitus (GDM) compared to insulin.
A meta-analysis was conducted to compare the management of gestational diabetes with glyburide and insulin. Studies fulfilling all of the following inclusion criteria were included in this meta-analysis: subjects were women with gestational diabetes requiring drug treatment; the comparison treatment included glyburide vs insulin; one or more outcomes (maternal or neonatal) should be provided in the individual study; the study design should be a randomized control trial. Exclusion criteria: non-RCT studies; non-human data. PubMed, Embase and CENTRAL databases were searched from inception until 10 October 2016.
Ten randomized control trials involving 1194 participants met the inclusion criteria and were included. 13 primary outcomes (6 maternal, 7 neonatal) and 26 secondary outcomes (9 maternal, 17 neonatal) were detected and analyzed in this study. Glyburide significantly increased the risk of any neonatal hypoglycemia [risk ratio (RR), 1.89; 95% confidence interval (95%CI), 1.26 to 2.82; p = 0.002]. Sensitivity analysis confirmed robustness of this result [RR, 2.29; 95%CI, 1.49 to 3.54; p = 0.0002]. No differences were observed between the two groups with respect to birth weights [mean difference (MD), 79; 95%CI, -64 to 221.99; p = 0.28] and the risk of macrosomia [RR, 1.69; 95%CI, 0.57 to 5.08; p = 0.35].
For women with gestational diabetes, no differences in maternal short term outcomes were observed in those treated with glyburide or insulin. However, the incidence of neonatal hypoglycemia was higher in the glyburide group compared to the insulin group.
本荟萃分析的目的是确定与胰岛素相比，格列本脲治疗妊娠期糖尿病（GDM）的疗效和安全性。
进行了一项荟萃分析，以比较格列本脲和胰岛素对妊娠期糖尿病的治疗效果。符合以下所有纳入标准的研究纳入本荟萃分析：受试者为需要药物治疗的妊娠期糖尿病女性；比较治疗包括格列本脲与胰岛素；个体研究应提供一个或多个结局（母体或新生儿）；研究设计应为随机对照试验。排除标准：非随机对照试验研究；非人类数据。检索了PubMed、Embase和CENTRAL数据库，检索时间从建库至2016年10月10日。
10项涉及1194名参与者的随机对照试验符合纳入标准并被纳入。本研究检测并分析了13项主要结局（6项母体结局、7项新生儿结局）和26项次要结局（9项母体结局、17项新生儿结局）。格列本脲显著增加了任何新生儿低血糖的风险[风险比（RR），1.89；95%置信区间（95%CI），1.26至2.82；p = 0.002]。敏感性分析证实了该结果的稳健性[RR，2.29；95%CI，1.49至3.54；p = 0.0002]。两组在出生体重[平均差（MD），79；95%CI，-64至221.99；p = 0.28]和巨大儿风险[RR，1.69；95%CI，0.57至5.08；p = 0.35]方面未观察到差异。
对于妊娠期糖尿病女性，使用格列本脲或胰岛素治疗的母体短期结局无差异。然而，与胰岛素组相比，格列本脲组新生儿低血糖的发生率更高。
