与第一季度抗精神病药物暴露相关的重大先天性形风险:一个大索赔数据库研究
Ryo Obara1, Takamasa Sakai2, Tomofumi Ishikawa3
1Division of Molecular Epidemiology, Graduate School of Medicine, Tohoku University, Sendai, Miyagi, Japan.
Pharmacology research & perspectives
|March 12, 2026
概括
孕妇在第一季度服用抗精神病药物并没有显著增加重大先天性形 (MCMs) 的风险. 这项研究发现,在怀孕早期使用抗精神病药物与婴儿不良结果之间没有联系.
科学领域:
- 药物监督 药物监督 药物监督
- 生殖毒理学 生殖毒理学
- 孕产妇和胎儿医学 孕产妇和胎儿医学
背景情况:
- 抗精神病药物经常被处方用于怀孕期间的精神疾病.
- 了解这些药物的潜在风险,特别是重大先天性形 (MCMs),对于明智的临床决策至关重要.
研究的目的:
- 评估第一季度抗精神病药物暴露与婴儿重大先天性形风险之间的关联.
- 通过使用日本索赔数据库,在大量孕妇队列中评估这种风险.
主要方法:
- 一项使用日本索赔数据库 (2010-2019) 的回顾性队列研究.
- 怀孕开始和分娩日期通过算法估计.
- 主要先天性形 (MCMs) 使用ICD-10代码进行识别.
- 倾向性得分重叠重量被用于调整精神疾病患者因指示而混的情况.
主要成果:
- 该研究包括91,390例分娩;6,291名妇女在第一季度结束前被诊断为精神病患者.
- 其中,317名妇女在怀孕的第一季度接受了抗精神病药物治疗.
- 在未暴露的婴儿中,MCM的患病率为6.9%,在暴露的婴儿中为7.6%.
- 第一个三个月的抗精神病药物暴露与整体MCM没有显著的关联 (wOR 1.144,95% CI 0.727-1.799).
结论:
- 第一季度接受抗精神病药物的暴露与整体重大先天性形的风险增加无关.
- 这些发现有助于在怀孕早期使用抗精神病药物的安全性.
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