使用FDA不良事件报告系统数据库对与质子抑制剂相关的与怀孕有关的不良事件进行比较评估
Wenjuan Dong1, Yuye Ran1, Yiwen Cai1
1Department of Pharmacy, People's Hospital of Chongqing Liangjiang New Area, Chongqing, 401121, China.
International journal of clinical pharmacy
|October 23, 2025
概括
在怀孕期间使用质子抑制剂 (PPI) 可能与低出生体重和早产等不良事件有关. 奥梅普拉和潘托普拉显示出特定的安全信号,需要进一步研究.
科学领域:
- 药物监督 药物监督 药物监督
- 孕产妇和胎儿医学 孕产妇和胎儿医学
- 药品安全 药品安全
背景情况:
- 质子抑制剂 (PPI) 通常用于妊娠期间的酸性抑制.
- 存在对潜在的孕产妇和胎儿风险的担忧,特别是与其他个人防护剂 (B类) 相比,欧美药监会 (FDA) 的C类的奥梅普拉 (omeprazole).
研究的目的:
- 为了评估与怀孕相关的不良事件 (AE) 信号对奥梅普拉,埃索梅普拉,兰索普拉,拉贝普拉和潘托普拉.
- 使用美国FDA不良事件报告系统 (FAERS) 从2004年第一季度到2025年第一季度的数据.
主要方法:
- 从625,127份PPI报告中分析了1,099份与怀孕相关的AE报告.
- 使用不成比例算法 (ROR和BCPNN) 进行信号检测.
- 对比所有其他药物,其他PPI和ranitidine的PPI.
主要成果:
- 确定了AE信号,包括早产,低出生体重,胎儿生长限制 (FGR),堕胎和子宫前.
- 奥梅普拉显示出产后出血,FGR和孕前的信号.
- 潘托普拉表明过早分娩,低出生体重和早晨恶心的风险信号.
结论:
- 在怀孕期间使用PPI和报告的副作用之间检测到潜在的关联.
- 一些信号看起来是药物特定的 (例如,奥梅普拉,潘托普拉).
- 这些发现是探索性的,需要通过严格的流行病学和临床研究来确认.
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