怀孕和先天性缺陷中的处方药:基于人口的安全查研究
Anne Broe1,2,3, Anton Pottegård4, Trine Munk-Olsen4,5
1Department of Clinical Pharmacology, Odense University Hospital, Odense, Denmark.
Pharmacoepidemiology and drug safety
|August 27, 2025
概括
这项研究发现超过100种处方药在怀孕的第一季度是安全的, 然而,它发现了克洛皮多格勒和利拉格卢提德的潜在风险,需要进一步调查.
科学领域:
- 产科和妇科
- 临床药理学
- 公共卫生
背景情况:
- 怀孕期间使用毒品可能会对胎儿造成伤害.
- 历史上的担忧,如thalidomide悲剧,突出了安全数据的需要.
- 准确的信息对于孕妇处方药的建议至关重要.
研究的目的:
- 评估第一季度处方药暴露导致的重大先天性形的风险.
- 为孕妇使用药物提供基于证据的指导.
主要方法:
- 基于人口的队列研究在丹麦 (2004-2017).
- 相关的国家卫生登记处提供有关活产和药物暴露的综合数据.
- 用物流回归分析来比较暴露和未暴露的婴儿的结果.
主要成果:
- 超过100种药物没有增加重大先天性缺陷的风险.
- 31药物与增加的风险有关 (调整后的几率比率 (aOR) ≥2. 0).
- 胰岛素是治疗整体发育不良症的唯一药物,该药物被处方给≥1000名女性,aOR≥2.
结论:
- 广泛的数据证实了第一季度药物暴露与重大先天性缺陷之间的100多个无关联.
- 为孕妇提供安慰,并支持有关药物的共同决策.
- 鉴定了克洛皮多格勒和利拉格卢提德是需要进一步研究的潜在原体.
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