拉科萨米德和怀孕:来自自发和征求报告的数据
Piero Perucca1,2, Dimitrios Bourikas3, P Emanuela Voinescu4
1Epilepsy Research Centre, Department of Medicine (Austin Health), University of Melbourne, Melbourne, Victoria, Australia.
Epilepsia
|February 27, 2024
概括
初步数据表明,在怀孕期间使用lacosamide (LCM) 通常是安全的,大多数情况下会导致健康的活产. 需要进一步的研究,以充分证实这种抗发作药物在妊娠期间的安全性.
科学领域:
- 神经学 神经学
- 药物监督 药物监督 药物监督
- 生殖医学 生殖医学
背景情况:
- 在怀孕期间平衡抗发作药物 (ASM) 性作用的控制风险至关重要.
- 有限的数据存在于lacosamide (LCM) 的妊娠结果,特别是作为单一疗法.
- 在孕妇中评估LCM安全性对于明智的临床决策至关重要.
研究的目的:
- 为了评估怀孕期间暴露于lacosamide (LCM) 的个体的怀孕结果.
- 具体评估与LCM单疗与多疗相关的结果.
- 为了解 ASM 在怀孕期间的安全性作出贡献.
主要方法:
- 从药监数据库 (UCB Pharma) 分析了202个潜在怀孕病例.
- 包括来自临床研究和营销后监测的自发和请求的报告.
- 对前性和后性报告的单独分析,重点关注母亲的LCM暴露和怀孕结果.
主要成果:
- 在202个潜在病例中,44个 (21.8%) 接受了LCM单疗法,158个 (78.2%) 接受了多疗法.
- 在LCM单疗法中,活产率为84.1%,在多疗法中为76.3%.
- 在单疗法中,先天性形发生率为2.3%,在多疗法中为6.9%.
结论:
- 初步调查结果并没有表明怀孕期间使用lacosamide的安全性存在重大问题.
- 大多数暴露于LCM的怀孕结果是健康的活产,没有发现新的安全信号.
- 需要进一步的数据来全面评估lacosamide在怀孕中的安全性.
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