与linezolid管理相关的不良药物事件:使用FAERS数据库从2004年到2023年的真实世界药监测研究
Fan Zou1, Zhiwei Cui2, Siyu Lou1
1Department of Tuberculosis, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China.
Frontiers in pharmacology
|March 4, 2024
概括
这项研究分析了现实世界的数据,以识别与线醇抗生素使用相关的不良事件. 关键的发现包括常见的副作用,如血小板缺血和贫血,以及意想不到的事件,如狂犬病溶解,告知更安全的临床应用.
科学领域:
- 药监和药物安全 药监和药物安全
- 传染病与微生物学
- 临床药理学 临床药理学
背景情况:
- 利尼佐利德是一种关键的oxazolidinone抗生素,有效对抗耐药格拉姆阳性细菌和多药耐药Mycobacterium结核病.
- 有限的现实世界数据存在于linezolid在大量患者群体的安全性概况.
- 了解linezolid的不良事件对于优化其临床使用和患者安全至关重要.
研究的目的:
- 在现实环境中调查和描述与linezolid相关的不良药物事件 (ADEs).
- 在各种患者亚组中分析线化物诱导的ADEs发病的时间.
- 识别药物标签上以前未列出的潜在安全信号.
主要方法:
- 从美国食品和药物管理局 (FDA) 的不良事件报告系统 (FAERS) 数据库 (Q1 2004Q1 2023) 中对不良药事件报告的回顾性分析.
- 使用报告几率比率 (ROR),比例报告比率 (PRR),贝叶斯信任传播神经网络 (BCPNN) 和多项性玛波森收缩器 (MGPS) 来检测显著的ADE信号的不成比例分析.
- 在一般人群和特定的人口和临床亚组中分析ADEs发病的时间.
主要成果:
- 确定了11176份报告,其中linezolid是主要的可疑药物,揭示了263个显著的ADEs.
- 常见的不良反应包括血小板缩 (ROR 21.98) 和贫血 (ROR 7.39);还检测到了像狂肌痛 (ROR 4.33) 和QT延长 (ROR 4.07) 等意想不到的信号.
- ADE的中位发病时间为6天,大多数发生在第一个月内,尽管有些人在治疗一年后出现. 在ADE信号中观察到性别差异.
结论:
- 本研究详细分析了linezolid诱导的不良反应,包括它们在系统器官类 (SOC) 和首选术语 (PT) 水平出现的时间.
- 这些发现突出了与linezolid相关的常见和意想不到的不良事件,为临床实践提供了宝贵的见解.
- 优化linezolid的使用和最大限度地减少潜在的副作用可以通过这些证据,促进更安全的患者管理.
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