重大先天性异常和β抑制剂的风险:来自EFEMERIS数据库的比较研究
Laurane Delteil1, Thierry Vial2, Sophie Gautier3
1Réseau Regards, Pharmacologie Médicale Et Clinique, Centre Hospitalier Universitaire De Toulouse, INSERM Cerpop, France.
British journal of clinical pharmacology
|November 14, 2025
概括
与通道阻塞剂相比,在怀孕期间在第一季度暴露于β-阻塞剂并没有增加重大先天性异常风险. 然而,β抑制剂的风险较高,而非抗高血压药物.
科学领域:
- 产科和妇科 产科和妇科
- 心脏病学 心脏病学
- 甲状腺学 甲状腺学
背景情况:
- 贝塔抑制剂通常用于怀孕期间的高血压.
- 人们对第一季度药物暴露的潜在原性影响存在担忧.
- 不同类抗高血压药物之间的比较安全性数据至关重要.
研究的目的:
- 评估在第一季度暴露于β-阻断剂后出现重大先天性异常的风险.
- 为了比较β阻塞剂使用者,通道阻塞剂使用者和未暴露的怀孕之间的风险.
主要方法:
- 使用EFEMERIS医疗行政数据库 (2004-2021) 进行的观察性比较研究.
- 在2004年至2021年的数据中包括孕妇.
- 后勤回归模型被用来计算主要先天性异常的调整几率比率 (ORa).
主要成果:
- 与未暴露的怀孕相比,在暴露于β阻断剂 (ORa=1.56) 的情况下,观察到具有统计学意义的重大先天性异常风险增加.
- 在将β阻断剂暴露与通道阻断剂暴露 (ORa=0.71) 进行比较时,没有发现增加的风险.
- 与未暴露者相比,Labetalol暴露的风险增加 (ORa=2.00),但与通道阻断剂相比没有 (ORa=1.06).
结论:
- 与通道阻断剂相比,在头三个月内使用β-阻断剂与重大先天性异常的风险增加无关.
- 该研究强调了怀孕期间使用药物的比较安全性评估的重要性.
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