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胰岛素类似物在孕期的安全性:一项荟萃分析。

Safety of insulin analogs during pregnancy: a meta-analysis.

作者信息

Lv ShiShi, Wang JiYing, Xu Yong

机构信息

Department of Endocrinology, Affiliated Hospital of Luzhou Medical College, Luzhou, 646000, Sichuan, China.

出版信息

Arch Gynecol Obstet. 2015 Oct;292(4):749-56. doi: 10.1007/s00404-015-3692-3. Epub 2015 Apr 9.

Abstract

OBJECTIVE

The objective of this study was to assess the safety of four insulin analogs (aspart, lispro, glargine, and detemir) for the treatment of diabetes in pregnancy.

METHODS

We searched Embase, Pubmed, and the Cochrane Central Register for Controlled Trials database through May 31, 2014. All articles were reviewed by two independent researchers, and if a discrepancy was noted, a third researcher was consulted. Results data were summarized by RevMan 5.2 software.

RESULTS

Our search resulted in the retrieval and screening of 3519 studies. Of those, 24 studies met the eligibility criteria; the studies reported on a total of 3734 women with pre-gestational or gestational diabetes during pregnancy. The use of lispro was associated with lower rates of neonatal jaundice (RR = 0.63) and severe maternal hypoglycemia (RR = 0.33) than regular insulin. Lispro use was also associated with higher birth weight (WMD = 116.44) and an increased incidence of large for gestational age (LGA) births (RR = 1.42) compared with regular insulin. Rates of cesarean section and macrosomia were similar in pregnant women treated with aspart and regular insulin. Birth weights and rates of severe maternal hypoglycemia, respiratory dysfunction syndrome, and neonatal intensive care unit admission were similar after pregnant women were treated with glargine and NPH insulin. Rates of LGA, macrosomia, and neonatal hypoglycemia were similar after pregnant women were treated with detemir and NPH insulin.

CONCLUSIONS

Aspart, glargine, and detemir are safe treatment options for diabetes during pregnancy; these insulin analogs did not increase complications for the mothers or fetuses in our study. However, lispro was related to higher birth weight and increased rate of LGA in neonates. More high-quality randomized controlled trials are needed to clarify the best treatment options for diabetes during pregnancy.

摘要

目的

本研究的目的是评估四种胰岛素类似物(门冬胰岛素、赖脯胰岛素、甘精胰岛素和地特胰岛素)用于治疗妊娠期糖尿病的安全性。

方法

我们检索了截至2014年5月31日的Embase、Pubmed和Cochrane对照试验中央注册数据库。所有文章均由两名独立研究人员进行审查,如有分歧,则咨询第三名研究人员。结果数据由RevMan 5.2软件汇总。

结果

我们的检索共检索并筛选了3519项研究。其中,24项研究符合纳入标准;这些研究共报告了3734例孕前或孕期患有糖尿病的女性。与常规胰岛素相比,使用赖脯胰岛素可降低新生儿黄疸发生率(RR = 0.63)和严重母体低血糖发生率(RR = 0.33)。与常规胰岛素相比,使用赖脯胰岛素还与出生体重增加(WMD = 116.44)和大于胎龄儿(LGA)出生发生率增加(RR = 1.42)相关。门冬胰岛素治疗的孕妇与常规胰岛素治疗的孕妇剖宫产率和巨大儿发生率相似。甘精胰岛素和中性鱼精蛋白锌胰岛素治疗孕妇后,出生体重、严重母体低血糖发生率、呼吸功能障碍综合征发生率和新生儿重症监护病房入住率相似。地特胰岛素和中性鱼精蛋白锌胰岛素治疗孕妇后,LGA、巨大儿和新生儿低血糖发生率相似。

结论

门冬胰岛素、甘精胰岛素和地特胰岛素是妊娠期糖尿病的安全治疗选择;在我们的研究中,这些胰岛素类似物并未增加母亲或胎儿的并发症。然而,赖脯胰岛素与新生儿出生体重增加和LGA发生率升高有关。需要更多高质量的随机对照试验来明确妊娠期糖尿病的最佳治疗方案。

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