药物诱导的头痛报告:使用FAERS数据库 (2018-2024) 进行了全面的不成比例性和时间到发作的药监测研究
Abdulaziz Ibrahim Alzarea1, Azfar Athar Ishaqui2, Muhammad Bilal Maqsood3
1Department of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka, Al-Jouf, Saudi Arabia.
Frontiers in pain research (Lausanne, Switzerland)
|November 24, 2025
概括
这项研究发现,某些药物,如glecaprevir/pibrentasvir和sofosbuvir/velpatasvir,与头痛有关,作为药物不良反应. 建议主动监测与药物相关的头痛,特别是在治疗的早期.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 现实世界的证据.
背景情况:
- 头痛是许多药物类别中常见的不良药物反应 (ADR).
- 对药物相关头痛的系统的现实世界评估是有限的.
- 这项研究利用了FDA的不良事件报告系统 (FAERS) 来调查药物和头痛的关联.
研究的目的:
- 为了探索各种药物和头痛之间的联系,将其报告为ADR.
- 确定与头痛风险增加相关的特定药物和治疗类.
- 分析与药物使用有关的头痛发作的时间.
主要方法:
- 对FAERS数据的回顾性不成比例性分析 (2018年第一季度至2024年第四季度).
- 为了检测安全信号,计算报告几率比率 (ROR) 和比例报告比率 (PRR).
- 使用解剖治疗化学 (ATC) 系统和时间开始分析对药物的分类.
主要成果:
- 确定了超过31.3万个与头痛相关的病例,主要是51-65岁的女性.
- 格莱卡普雷维尔/皮布伦塔斯维尔 (ROR=10.445) 和索福斯布维尔/韦尔帕塔斯维尔 (ROR=9.729) 显示了高头痛风险.
- 平衡剂和全身抗病毒药物是具有显著头痛信号的ATC类;早期发作的头痛与ofatumumab有关,晚期发作与treprostinil有关.
结论:
- 多种药物和治疗类与头痛作为ADR显著相关.
- 积极的头痛监测至关重要,尤其是在早期治疗阶段.
- 需要进一步的前性研究来阐明机制并制定预防策略.
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