怀孕期间ifosfamide的安全性:全面分析
Charlotte Devant1, Tessa Pietri2, Marine Auffret3
1Centre Régional de Pharmacovigilance, Service de Pharmacologie périnatale, pédiatrique et adulte, Hopital Cochin, Assistance Publique-Hopitaux de Paris (AP-HP), Paris, France.
概括
怀孕期间使用伊福斯法米德可能会导致胎儿并发症,包括子宫内生长限制和橄水. 早期暴露会增加胎儿死亡和新生儿急性功能衰竭的风险.
科学领域:
- 产科和妇科 产科和妇科
- 药理学 药理学是指药理学的学科.
- 新生儿科学 新生儿科学
背景情况:
- 关于ifosfamide对孕妇的安全性存在有限的数据.
- 之前的报道表明,ifosfamide和oligohydramnios之间存在联系.
研究的目的:
- 综合分析ifosfamide在孕妇中的安全性.
- 评估怀孕期间与ifosfamide暴露相关的不良事件.
主要方法:
- 对法国药监数据库报告的逐案审查.
- 在怀孕期间使用ifosfamide的文献综述.
- 对VigiBase (世卫组织全球安全数据库) 的不成比例分析.
主要成果:
- 在怀孕期间发现了27例ifosfamide使用情况;没有先天性形.
- 主要不良事件:子宫内生长限制 (56%) 和橄水 (56%).
- 与其他抗质药物相比,ifosfamide显著增加了报告的脂水,子宫内生长限制和新生儿急性功能衰竭.
结论:
- 伊福斯法米德可能会在孕妇中诱导胎儿毒性.
- 与此相关的风险包括子宫内生长限制,橄水,新生儿急性功能衰竭和胎儿死亡.
- 怀孕早期 (21周前) 的暴露特别与胎儿死亡有关.
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