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胰岛素地特胰岛素与 NPH 在治疗妊娠糖尿病中的安全性和有效性:系统评价和随机对照试验的荟萃分析。

Safety and efficacy of insulin detemir versus NPH in the treatment of diabetes during pregnancy: Systematic review and meta-analysis of randomized controlled trials.

机构信息

2(nd) Department of Internal Medicine and Diabetes Centre, 417 Veteran's Fund Military Hospital NIMTS, Athens, Greece.

Endocrine Unit and Diabetes Centre, Department of Clinical Therapeutics, Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece.

出版信息

Diabetes Res Clin Pract. 2022 Aug;190:110020. doi: 10.1016/j.diabres.2022.110020. Epub 2022 Jul 22.

Abstract

AIMS

To compare the safety and efficacy of insulin detemir versus neutral protamine Hagedorn (NPH) in pregnant women with diabetes.

METHODS

MEDLINE, CENTRAL, Google Scholar databases, and ClinicalTrials.gov registry were searched from inception to December 2021 to identify randomized controlled trials (RCTs) concerning adult women with singleton pregnancies, gestational or pregestational diabetes, and the need for insulin therapy. A systematic review and a meta-analysis (weighted data, random-effects model) were performed. Continuous outcomes were expressed as mean difference (MD) with 95% confidence interval (CI) (inverse variance method); dichotomous outcomes were expressed as risk ratio (RR) with 95% CI (Mantel-Haenszel method). Heterogeneity was quantified using the I index.

RESULTS

Five RCTs involving 1450 participants met the inclusion criteria. Outcomes that showed significant results in favor of insulin detemir over NPH were maternal hypoglycemic events (RR 0.64, 95% CI 0.48-0.86, p = 0.003; I = 0%) and gestational age at delivery (MD 0.48, 95% CI 0.16-0.81, p = 0.003; I = 0%).

CONCLUSIONS

Insulin detemir was associated with less maternal hypoglycemic events and decreased risk for prematurity compared with NPH insulin. More research should be conducted to reach a safe conclusion about the optimal insulin regimen for women with diabetes in pregnancy.

摘要

目的

比较在妊娠糖尿病女性中使用地特胰岛素和中性鱼精蛋白锌胰岛素(NPH)的安全性和疗效。

方法

从建库到 2021 年 12 月,检索 MEDLINE、CENTRAL、Google Scholar 数据库和 ClinicalTrials.gov 注册中心,以确定关于患有单胎妊娠、妊娠或孕前糖尿病且需要胰岛素治疗的成年女性的随机对照试验(RCT)。进行了系统评价和荟萃分析(加权数据,随机效应模型)。连续结局以均数差(MD)表示,95%置信区间(CI)(倒数方差法);二分类结局以风险比(RR)表示,95%CI(Mantel-Haenszel 法)。使用 I 指数量化异质性。

结果

符合纳入标准的 5 项 RCT 共纳入 1450 名参与者。结果显示,地特胰岛素优于 NPH 的结局有母体低血糖事件(RR 0.64,95%CI 0.48-0.86,p=0.003;I=0%)和分娩时的胎龄(MD 0.48,95%CI 0.16-0.81,p=0.003;I=0%)。

结论

与 NPH 胰岛素相比,地特胰岛素与母体低血糖事件减少和早产风险降低相关。应该进行更多的研究,以得出关于妊娠糖尿病女性最佳胰岛素治疗方案的安全结论。

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