Laboratory of Clinical Pharmacy, Tohoku University Graduate School of Pharmaceutical Sciences, Sendai, Miyagi, Japan.
Department of Pharmaceutical Sciences, Tohoku University Hospital, Sendai, Miyagi, Japan.
Pharmacoepidemiol Drug Saf. 2022 Feb;31(2):196-205. doi: 10.1002/pds.5370. Epub 2021 Oct 20.
To evaluate the risk of major congenital malformations (MCMs) associated with first-trimester exposure to propulsives with a special focus on domperidone using a large administrative database in Japan.
A large claims database was used from January 2005 to August 2016. The dates of pregnancy onset and delivery were estimated using the developed algorithms. MCMs were defined according to the International Classification of Diseases, 10th revision codes. We compared the infants' risk of overall MCMs between women with or without first-trimester prescriptions of propulsives and estimated the odds ratios (ORs) with unadjusted and adjusted analyses. We also compared the risk of overall MCMs between women with domperidone prescriptions and those with other propulsive prescriptions during the first trimester.
Among 38 270 women, propulsives were prescribed to 3197 women (8.4%) in the first trimester, including domperidone to 371 women (1.0%). Propulsive prescriptions in the first trimester were not significantly associated with an increased risk of overall MCMs (adjusted OR [aOR] 1.030, 95% confidence interval [CI] 0.843-1.257). Compared to the prescription of other propulsives in the first trimester, the prescription of domperidone in the first trimester was not associated with an increased risk of overall MCMs (aOR 0.724, 95% CI 0.363-1.447).
The first-trimester prescription of propulsives, including domperidone, was not associated with an increased risk of overall MCMs.
使用日本大型行政数据库，专门评估与孕早期使用推动剂相关的主要先天性畸形（MCM）风险，尤其关注多潘立酮。
使用大型理赔数据库，时间范围为 2005 年 1 月至 2016 年 8 月。使用开发的算法估计妊娠开始和分娩日期。根据国际疾病分类，第 10 版代码定义 MCM。我们比较了有或无孕早期推动剂处方的女性中婴儿整体 MCM 的风险，并使用未调整和调整分析估计了比值比（OR）。我们还比较了孕早期多潘立酮处方和其他推动剂处方女性的整体 MCM 风险。
在 38270 名女性中，3197 名（8.4%）女性在孕早期开了推动剂，其中 371 名（1.0%）开了多潘立酮。孕早期使用推动剂与整体 MCM 风险增加无关（调整后的 OR [aOR] 1.030，95%置信区间 [CI] 0.843-1.257）。与孕早期其他推动剂处方相比，孕早期多潘立酮处方与整体 MCM 风险增加无关（aOR 0.724，95% CI 0.363-1.447）。
孕早期使用推动剂，包括多潘立酮，与整体 MCM 风险增加无关。
