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药物诱导的肺:使用FDA不良事件报告系统 (FAERS) 的现实药监测研究

Zilan Zhong¹, Manting Liu², Qian Zhong³

¹Shenzhen Clinical Medical College, Guangzhou University of Chinese Medicine, Shenzhen, China.

Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica

|August 27, 2025

概括

这项研究使用FDA数据确定了37种具有药物诱导肺风险的药物. 临床医生应对患者进行DIPE监测,尤其是在处方纳洛和达沙替尼等高风险药物时.

科学领域:

药物监督管理
临床药理学
药物安全

背景情况:

药物诱导的肺 (DIPE) 是一个严重的不良事件.
在多种药物中缺乏对DIPE风险的系统评估.
美国食品和药物管理局 (FDA) 的不良事件报告系统 (FAERS) 数据库包含大量的安全数据.

研究的目的:

使用FAERS数据库系统评估药物诱导的肺 (DIPE) 的风险.
确定与DIPE风险增加相关的特定药物.
分析DIPE发病时间与患者人口统计数据的关系.

主要方法:

使用FAERS数据的回顾性药监研究 (2004年第一季度至2024年第二季度).
确定了≥10个DIPE病例的药物作为主要嫌疑人.
使用报告概率 (ROR),比例报告比率 (PRR),贝叶斯信心传播神经网络 (BCPNN) 和实证贝叶斯几何平均值 (EBGM) 评估DIPE信号.
多变量逻辑回归和DIPE发病时间的统计分析.

主要成果:

在173种向药物中,有37种与DIPE风险有关.
确定了前五种药物:纳洛,达沙替尼,尼菲迪平,抗血球蛋白和皮奥格利塔.
纳洛,达沙替尼,尼菲迪平和抗胸细胞球蛋白是DIPE的独立危险因素.
对于某些药物,DIPE的发病时间因年龄和性别而异.

结论:

这项研究系统地确定了多种对DIPE构成风险的药物.
纳洛,达沙替尼,尼菲迪平和抗血球蛋白被列为高风险药物.
提高对高危人群的认识和密切监测对于药物安全至关重要.

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