格列本脲治疗妊娠糖尿病的系统评价

Glibenclamide treatment for gestational diabetes mellitus： A systematic review

目的 系统评价格列本脲治疗妊娠糖尿病的有效性及安全性.方法 网络检索CochraneCentral Register of Controlled Trials （CENTRAL）、Medline、EMBASE、Science Citation Index、CNKI、VIP、Wanfang 等数据库,检索时间均为建库至2013年3月.筛选用格列本脲治疗妊娠糖尿病的临床随机对照试验（randomized controlled trial,RCT）,同时追索纳入文献的参考文献.根据GRADE系统推荐分级方法,对纳入研究的质量进行严格评价和资料提取,对符合质量标准的RCT进行meta分析.统计学分析采用RevMan5.1软件和GRADEprofiler 3.2.2软件.结果 共纳入5个RCT.发现格列本脲与单用胰岛素治疗在有效性（如母体餐后血糖、HbA1C）及不良围生期结局（如孕妇体重的变化、剖腹产率、母体低血糖发生率、新生儿出生体长、低血糖发生率、黄疸、监护病房入住率、先天畸形、死胎、死亡率）方面差异无统计学意义（P＞0.05）,但其母体空腹血糖、新生儿出生体重较后者高,且巨大儿发生率较后者显著升高.结论 格列本脲可以有效控制妊娠糖尿病患者的血糖,可以作为妊娠糖尿病一个有效的治疗方法,对胎儿的生长发育无不良影响,但会引起新生儿巨大儿的发生率增高.但鉴于纳入研究较少,样本量小,且质量不高,故仍需开展大样本、多中心、方法科学和规范的高质量RCT,以求进一步验证格列本脲治疗妊娠糖尿病的有效性及安全性.

Objective To evaluate the effect and safety of glibenclamide for gestational diabetes mellitus （GDM）.Methods Cochrane Central Register of Controlled Trials （CENTRAL）,Medline,EMBASE,Science Citation Index,CNKI,VIP,Wanfang Data,and CBM were searched for the randomized controlled trials （RCTs） of glibenclamide for gestational diabetes from the date of establishment of the databases to March 2013.The bibliographies of the included studies were searched,too.The included studies were evaluated by GRADE.The extracted data were analyzed by Rev-Man 5.1 and GRADEprofiler 3.2.2.Results Five RCTs were included.Effectiveness （such as maternal postprandial glucose,HbA1C） and adverse perinatal outcomes （such as the change of the pregnant women body weight,cesarean section rate,maternal hypoglycemia incidence,birth body length,incidence of hypoglycemia,jaundice,newborn being in the care unit,congenital malformations,stillbirth,and mortality neonatal） showed no differences between glibenclamide （alone or complemented with insulin） group and insulin group （P＞0.05）.However,compared with insulin group,higher maternal fasting blood glucose,higher birth weight of newborn infants,and incidence of macrosomia were shown in glibenclamide group.Conclusion Glibenclamide can effectively control maternal blood sugar,and would be a promising alternative therapy for GDM,without adverse effect on fetal growth and development,but with the higher incidence of neonatal macrosomia.Due to the limitations of the included studies,more large-sample,high-quality RCTs are required.