药物诱导心周溢出风险:FAERS数据库的不成比例性分析
Gaocan Ren1,2, Pingping Huang1,2, Yanqiu Ding3
1Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
BMC pharmacology & toxicology
|February 7, 2025
概括
这项研究确定了拉,达沙替尼和梅萨拉是与心周溢血显著相关的药物. 调查结果为临床药物管理提供信息,并促进与药物不良事件相关的药物的更安全使用.
科学领域:
- 药监和药物安全 药监和药物安全
- 药物对心血管系统的影响
- 临床药理学 临床药理学
背景情况:
- 心周溢出是一种严重的不良药物事件 (ADE),具有显著的发病率和死亡率.
- 鉴定与心周溢出相关的药物对于患者安全和合理的药物使用至关重要.
研究的目的:
- 使用FAERS数据库识别和评估可能导致心周溢血的药物不良事件 (ADEs) 的风险信号.
- 为临床药物管理提供信息,并通过突出与心周溢出相关的药物来促进合理的药物使用.
主要方法:
- 利用FAERS数据库 (2004年第一季度 - 2024年第二季度) 来识别心周溢出事件.
- 根据报告频率或信号强度,使用了四种信号检测算法 (ROR,PRR,BCPNN,MGPS) 来检测前50种药物.
- 对具有积极信号的药物进行了时间到发病 (TTO) 分析.
主要成果:
- 在19693名患者中,确定了与心周溢出相关的20057个不良事件;50.4%需要住院治疗,14.1%导致死亡.
- 根据ROR风险信号强度排名前三的药物包括拉,达沙替尼和梅萨拉.
- 对于诸如cytarabine,selexipag和dabigatran etexilate之类的药物,TTO分析表明心周输液的早期发作.
结论:
- 建立了一份具有引起心周溢血的潜在风险的药物清单.
- 证实了心周溢血和拉,达沙替尼和梅萨拉之间的显著关联.
- 腹心输液在抗瘤药物和免疫调节剂中更为普遍.
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