格列苯脲与胰岛素治疗妊娠糖尿病安全性的Meta分析

Safety of glyburide and insulin in the treatment of gestational diabetes mellitus: a meta-analysis

目的系统评价格列苯脲与胰岛素治疗妊娠糖尿病的安全性,为临床治疗提供参考和依据。方法计算机检索CNKI中国期刊全文数据库、CBM中国生物医学文献数据库、万方全文数据库、Embase、Cochrane中心注册的对照试验(cochrane central register of controlled trials,CENTRAL)、Pub Med,检索时间为建库至2018-11,严格按照纳入与排除标准收集相关随机对照研究,由2名评价员独立筛选文献,采用Endnote X8纳入符合标准的文献并提取资料进行质量评估,使用Rev Man5. 3软件进行Meta分析和描述统计分析,计算纳入研究的结局指标。结果共纳入7项随机对照研究,共2115例患者,共分析了6个结局指标。Meta分析结果显示,与胰岛素组相比,格列苯脲组显著增大了新生儿低血糖的比例(OR=1. 93,95%CI=1. 10～3. 39),而在巨大儿(OR=0. 89,95%CI=0. 68～1. 17)、新生儿入重症监护室(OR=0. 71,95%CI=0. 44～1. 14)、早产(OR=1. 26,95%CI=0. 88～1. 99)、新生儿高胆红素血症(OR=0. 77,95%CI=0. 52～1. 16)和患者剖宫产(OR=0. 87,95%CI=0. 67～1. 13)方面无统计学意义。结论在密切检测新生儿低血糖的情况下,使用格列苯脲与胰岛素治疗妊娠糖尿病在安全性上无明显差别。

Objective To systematically evaluate the safety of glyburide and insulin in the treatment of gestational diabetes mellitus in order to provide reference for clinical treatment.Methods Related articles were retrieved from CNKI,CBM,Wan Fang Database,Embase,Cochrane and Pub Med from inception to November of 2018.Randomized controlled trials were collected in strict accordance with the inclusion and exclusion criteria.Two reviewers independently screened the literature.Endnote X8 was adopted to select eligible literature and data was extracted for quality assessment.Rev Man 5.3 software was used for meta-analysis and descriptive statistical analysis.Outcome indicators included in this study were calculated.Results A total of 2115 patients were enrolled in seven randomized controlled trials.A total of six outcome indicators were analyzed.Meta-analysis showed that compared with the insulin group,the proportion of neonatal hypoglycemia was significantly increased in the glyburide group(OR=1.93,95%CI=1.10-3.39),but there was no statistically significant difference in macrosomia(OR=0.89,95%CI=0.68-1.17),the number of newborns admitted to the neonatal intensive care unit(OR=0.71,95%CI=0.44-1.14),premature delivery(OR=1.26,95%CI=0.88-1.99),neonatal hyperbilirubinemia(OR=0.77,95%CI=0.52-1.16)or the number of cases of cesarean section(OR=0.87,95%CI=0.67-1.13).Conclusions Studies of pregnant women with gestational diabetes have shown that there is no significant difference in safety between glyburide and insulin therapies as long as neonatal hypoglycemia is detected without delay.