芬太尼的安全概况与不同的管理途径:使用EudraVigilance数据库的不成比例分析
Raffaella Di Napoli1,2, Annamaria Mascolo1,2,3, Nunzia Balzano4,5
1Department of Experimental Medicine, - Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", Costantinopoli 16, 80138, Naples, Italy.
Naunyn-Schmiedeberg's archives of pharmacology
|February 26, 2026
概括
芬太尼的安全性因服用途径而异. 与其他方法相比,静脉和鼻腔芬太尼显示神经和心血管不良事件的风险更高. 确诊了大脑病变,但没有显示出基于路线的显著差异.
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
- 神经科学是一个神经科学.
背景情况:
- 芬太尼是一种强大的阿片类止痛药,与严重的不良事件 (AE) 相关,影响呼吸,心血管和神经系统.
- 了解芬太尼在各种管理途径上的安全性,对于临床实践和患者安全至关重要.
研究的目的:
- 综合描述芬太尼的安全性,重点关注包括脑损伤在内的神经系统不良事件,跨越不同的给药途径.
- 确定与某些不良事件的不成比例报告率较高相关的特定管理途径.
主要方法:
- 为了报告芬太尼安全性,利用了EudraVigilance数据库的数据,截至2024年3月7日.
- 对6441例病例进行了描述性和不成比例性分析,并根据药物使用途径进行了分类.
- 分析了特定不良事件的报告频率,包括"神经系统疾病"和"中枢神经系统血管疾病".
主要成果:
- 透皮芬太尼是报告最多的途径 (80.9%). 总体而言,92.8%报告的副作用是严重的.
- 静脉注射显示,与通过皮肤和口服透道相比",神经系统疾病"的不成比例报告率更高.
- 通过鼻子给药的"中枢神经系统血管疾病"报告频率更高,而静脉输入途径显示""报告频率更高.
结论:
- 芬太尼的施用途径影响不良事件的发生模式,静脉和鼻腔途径显示中枢神经和心血管AE的不成比例报告增加.
- 虽然确定了50个大脑病变,但在给药途径之间没有观察到统计学上显著的差异.
- 这项研究为芬太尼的细微安全概况提供了关键的见解,有助于风险管理和明智的临床决策.
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