在FAERS中的数据挖掘:新一代H1抗组胺剂与神经系统疾病的关联
Weiping Hu1,2,3, Hailong Li1,2,3,4, Linan Zeng1,2,3,4
1Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, Sichuan, 610041, China.
BMC pharmacology & toxicology
|December 19, 2024
概括
在较新的H1抗组胺药物中,神经学副作用有所不同,嗜睡是最常见的. 利沃提里津和提里津具有较高的镇静剂风险,而芬阿丁与头痛有关.
科学领域:
- 药物监督 药物监督 药物监督
- 神经学 神经学
- 过敏和免疫学 过敏和免疫学
背景情况:
- H1抗组胺药物经常被处方用于与组胺相关的症状.
- 报告了神经系统不良事件 (AEs),但对新药的比较数据有限.
研究的目的:
- 为了比较分析与较新的H1抗组胺药物相关的神经系统疾病.
- 通过使用现实世界的数据来评估 cetirizine,loratadine,levocetirizine,desloratadine 和 fexofenadine.
主要方法:
- 2017-2021年FDA不良事件报告系统 (FAERS) 的不成比例分析.
- 使用比例报告比率 (PRR),千平方和报告几率比率 (ROR) 以95%的置信区间 (CI).
主要成果:
- 对43,815份AE报告的分析确定了12个类别中的42个神经学AE.
- 昏昏欲睡是最常见的副作用:勒沃赛蒂里辛 (ROR 28.5) 和塞蒂里辛 (ROR 11.8) 显示出显著的关联.
- 费克索芬纳丁与头痛有关 (ROR 5.0),而勒沃提里津/德斯洛拉塔丁与不常见的发作有关.
结论:
- 在较新的H1抗组胺药物中,神经性AE概况显著不同.
- 由于较高的镇静作用,Levocetirizine和Cetirizine需要谨慎使用.
- 费克索芬纳丁与头痛的关联以及与 cetirizine 相关的 dystonia/anticholinergic 综合征的潜在风险需要引起注意.
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