Department of Pharmacy, Beijing You An Hospital, Capital Medical University, Beijing, 100069, China.
College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, 68198, USA.
Int J Clin Pharm. 2022 Oct;44(5):1102-1113. doi: 10.1007/s11096-022-01438-z. Epub 2022 Jul 14.
Metformin is widely used for the treatment of gestational diabetes. Although some meta-analyses are conducted on the efficacy and safety of metformin, none of them are focused on the Chinese population. The efficacy and safety of metformin in the Chinese GDM population are unknown.
The study aimed to compare metformin to insulin regarding the safety and efficacy in Chinese GDM patients using randomized controlled trials (RCTs) conducted in China.
Chinese databases (Wanfang, CNKI, VIP, and CBM), PubMed, Embase, Cochrane library, and Scopus were searched for RCTs. The last search date was October 18, 2021.
Fifty RCTs (4663 patients) were included in this study after screening. Six outcomes were analyzed. In the main analysis, metformin had lower risk of respiratory distress syndrome (RDS, OR, 0.28; 95% CI 0.16-0.51; P < 0.0001), premature birth (OR, 0.42; 95% CI 0.21-0.85, P = 0.02), and neonatal hypoglycemia (OR, 0.34; 95% CI 0.24-0.48; P < 0.00001) compared to insulin. Moreover, the metformin group is better than the insulin group concerning all other outcomes such as maternal glycemic control and glycated hemoglobin. Subgroup analysis confirmed that metformin has better outcomes than all types of insulin except for RDS, premature birth, 2 h postprandial blood glucose, and glycated hemoglobin.
Metformin is considered to be a safe and effective alternative to insulin for the management of GDM if patients refuse insulin due to any reasons in China.
二甲双胍被广泛用于治疗妊娠期糖尿病。尽管已经有一些关于二甲双胍疗效和安全性的荟萃分析,但没有一个是针对中国人群的。二甲双胍在中国人妊娠期糖尿病患者中的疗效和安全性尚不清楚。
本研究旨在通过在中国进行的随机对照试验(RCT)比较二甲双胍与胰岛素在中国人妊娠期糖尿病患者中的安全性和疗效。
中文数据库(万方、中国知网、维普、中国生物医学文献数据库)、PubMed、Embase、Cochrane 图书馆和 Scopus 均被检索纳入 RCT。最后一次检索日期为 2021 年 10 月 18 日。
经过筛选,本研究共纳入 50 项 RCT(4663 名患者)。分析了 6 个结局。在主要分析中,与胰岛素相比,二甲双胍可降低呼吸窘迫综合征(RDS,OR,0.28;95%CI,0.16-0.51;P<0.0001)、早产(OR,0.42;95%CI,0.21-0.85,P=0.02)和新生儿低血糖(OR,0.34;95%CI,0.24-0.48;P<0.00001)的发生风险。此外,与胰岛素组相比,二甲双胍组的产妇血糖控制和糖化血红蛋白水平等其他结局更好。亚组分析证实,二甲双胍的疗效优于除 RDS、早产、餐后 2 小时血糖和糖化血红蛋白外的所有类型胰岛素。
如果患者由于任何原因拒绝使用胰岛素,在中国,二甲双胍被认为是治疗妊娠期糖尿病的一种安全有效的替代方法。