从韩国不良事件报告系统数据库中对与新抗发作药物相关的不良药物反应进行比较分析
Hyun Kyung Kim1, Kyung Sik Jang1, Dong Wook Kim2
1Department of Neurology, National Medical Center, Seoul, South Korea.
Epilepsy & behavior : E&B
|April 18, 2024
概括
新抗发作药物 (ASM) 显示出显著的不良药物反应 (ADR),特别是皮肤反应和特异性作用. 儿科患者经历了更多的B型副作用,因此需要谨慎使用这些药物.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 神经学 神经学
背景情况:
- 抗发作药物 (ASM) 对管理至关重要.
- 了解新型ASM的长期安全概况对于临床实践至关重要.
- 全国范围内的药监数据为现实世界药物安全提供了宝贵的见解.
研究的目的:
- 为了比较和描述六个新的ASM的安全概况.
- 从长期的角度分析药物不良反应 (ADRs).
- 确定与不同ASM和患者人口统计相关的特定ADR模式.
主要方法:
- 描述性分析来自韩国不良事件报告系统 (2013-2022) 的5,733份ADR报告.
- 增加了六种新的ASM:lacosamide, levetiracetam,lamotrigine,oxcarbazepine,topiramate和zonisamide.这些新药包括在内.
- 使用MedDRA术语,器官系统类别和修改的WHO标准对ADRs的分类.
主要成果:
- 常见的副作用包括皮疹/尿疹 (31.8%),头 (7.1%),昏昏欲睡 (5.4%),肝毒性 (4.8%).
- 比A型 (机理相关) 效应 (45.6%) 更频繁的是B型 (异常) 效应 (51.1%).
- 拉莫特里金和牛炭bazepine与皮肤/皮下疾病和B型效应相关; 拉科萨米德,托皮拉米德和佐尼萨米德与神经系统疾病和A型效应相关. 儿科患者的皮肤/皮下疾病和B型影响的发病率更高.
结论:
- 过敏性皮肤反应和B型效应仍然是新ASM的显著ADR.
- 在某些ASM中,A型效应更为普遍.
- 儿童群体表现出较高的B型效应发病率,强调需要谨慎处方新的ASM.
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