与氧化相关的不良事件的年龄相关差异:基于FDA不良事件报告系统的药监测研究
Guanghan Sun1, Jingrong Yang1, Lei Wan2
1The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.
British journal of clinical pharmacology
|October 9, 2025
概括
氧化 (HCQ) 的不良事件 (AEs) 显示了显著的年龄差异. 儿科患者经历早期发病和独特的风险,如心脏毒性,而老年人面临不断升级的累积毒性,需要年龄分层监测.
科学领域:
- 药监和药物安全 药监和药物安全
- 现实世界的证据 现实世界的证据
- 儿科和老年医疗药理学
背景情况:
- 氧化 (HCQ) 被广泛使用,但其在不同年龄组的安全性概况尚未完全理解.
- 现有的药监数据往往缺乏对HCQ相关不良事件 (AE) 的详细年龄分层风险评估.
研究的目的:
- 使用现实世界的数据来描述HCQ相关的AE中与年龄相关的差异.
- 为了比较儿科和老年人群之间的AE信号和时间到发病概况.
- 确定特定于年龄的风险,并为年龄分层的药监策略提供信息.
主要方法:
- 从2004年到2024年,利用了FDA不良事件报告系统 (FAERS) 数据库,分析了22249476份与HCQ有关的报告.
- 使用不成比例分析 (报告赔率比率,ROR) 来识别AE信号.
- 应用参数Weibull建模来比较儿科 (≤18岁) 和老年 (≥60岁) 队列之间的时间到发病概况和风险轨迹.
主要成果:
- 与HCQ相关的儿科AE与老年人AE (中位数19天) 相比,具有显著较早的发病 (中位数9.5天).
- 确定了十种新的儿科特异性信号,包括COVID-19相关的心脏毒性和低血症,具有不同的报告模式.
- 韦布尔的分析揭示了不同的风险轨迹:儿童的恒定危险概况 (α=0.52) 与老年人 (α=0.40) 的不断升级的风险形成对比,表明有毒性进展机制不同.
结论:
- 在HCQAE概况,时间动态和风险演变中,与年龄相关的显著变化需要年龄分层的药物监测.
- 儿科特异性心脏毒性和代谢风险,以及老年人累积毒性模式,需要量身定制的治疗监测.
- 优化所有年龄组的HCQ安全要求根据特定年龄的风险概况制定定制的监测策略.
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