从2004年到2024年的药监测研究利用FDA不良事件报告系统 (FAERS) 检查了与偏头痛治疗中使用类药物相关的缺血不良事件

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Nuo Xu¹, Xiaowen Lu²

¹Department of Clinical Nutrition, The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, People's Republic of China.

Journal of pain research

|October 17, 2025

概括

治疗偏头痛的三药物可能会增加缺血不良事件 (IAE) 的风险,例如中风. 像阿尔莫特里普坦 (almotriptan) 这样的特异性三类药物表现出更强烈的关联,突出了需要仔细评估患者的风险.

科学领域:

药监和药物安全药监和药物安全
评估心血管风险评估
神经学和头痛管理管理

背景情况:

三剂广泛用于急性偏头痛治疗.
人们担心三类药物可能导致缺血性不良事件 (IAE).
现实世界的数据对于评估药物安全性概况至关重要.

研究的目的:

调查三剂使用与IAE之间的关联.
分析来自FDA不良事件报告系统 (FAERS) 的现实数据.
识别具有较高IAE风险的特定三.

主要方法:

对FAERS数据的回顾性药监分析 (2004年第一季度 - 2024年第三季度).
分析报告的IAEs (中风,心肌梗塞,其他缺血事件) 与triptan使用相关.
使用报告几率比率 (ROR) 和贝叶斯信心传播神经网络 (BCPNN) 来评估信号强度的不成比例分析.

主要成果:

1305个IAE与三有关,占三相关不良事件的6.60%.
纳拉特里普坦 (12.23%) 和阿尔莫特里普坦 (12.15%) 的IAE报告率最高;苏马特里普坦的IAE报告率最低 (4.74%).
在阿尔莫特里普坦 (ROR=3.34),纳拉特里普坦 (ROR=2.96) 和瑞扎特里普坦 (ROR=2.41) 发现了IAE的显著不成比例信号,其中阿尔莫特里普坦显示了最强的关联. 冠状动脉,可逆脑血管收缩综合征和冠状动脉剖析等特定事件显示RORs非常高. 缺血性中风和心肌梗塞的死亡率超过6%.

结论:

三胺使用与潜在的缺血安全信号有关,特别是某些亚型.
临床医生应在开药前评估心血管风险因素.
需要进一步的前性研究来证实这些发现并指导临床实践.

关键词:

公平的人是公平的.心血管疾病的风险.缺血性不良事件不良事件偏头痛偏头痛偏头痛偏头痛药物监督和药物监督三位一体的三位一体.

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