新一代抗药和重大出生缺陷的风险
Ditte Mølgaard-Nielsen1, Anders Hviid
1Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark. dnl@ssi.dk
在一项大规模的丹麦研究中,在第一季度暴露于更新的抗药物,如拉莫特里金和 levetiracetam,与重大出生缺陷无关. 这项研究为怀孕期间的治疗提供了关键的安全数据.
科学领域:
- 产科和妇科 产科和妇科
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
背景情况:
- 怀孕期间的治疗存在重大挑战.
- 对较新的抗药物 (AED) 存在有限的安全数据,涉及第一季度暴露和先天缺陷.
研究的目的:
- 调查胎儿在头三个月内接触新一代AED和重大先天性形风险之间的联系.
主要方法:
- 丹麦的一项基于人口的队列研究包括837,795名活产婴儿 (1996-2008).
- 全国卫生登记处提供了关于母亲发放AED,出生缺陷和混因素的数据.
- 患病概率比率 (PORs) 计算了在第一季度AED暴露后出现的重大出生缺陷.
主要成果:
- 在1532名暴露于拉莫特里金,牛炭bazepine,托皮拉胺, gabapentin,或 levetiracetam的婴儿中,3.2%的婴儿患有严重的出生缺陷,而未暴露的婴儿有2.4% (调整后的POR,0.99;95% CI,0.72-1.36).
- 特定的AEDs没有显示显著增加风险:拉莫特里金 (3.7%),牛炭巴兹平 (2.8%),和托皮拉 (4.6%).
- 甲巴丁和 levetiracetam 的暴露很少,观察到的出生缺陷率很低.
结论:
- 在第一季度暴露于拉莫特里金,牛炭bazepine,托皮拉胺, gabapentin,或 levetiracetam 并没有与重大出生缺陷的风险增加有关.
- 这些发现支持了这些较新的AEDs在重大先天性形方面的安全性.
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