针对HER2的药物和间歇性肺病:使用FAERS数据进行现实世界药监测分析
Huahua Zhang1, Yandong Zhang1, Xiaoying Wang2
1Department of Pharmacy, Fuyang Hospital of Traditional Chinese Medicine, Hangzhou, China.
间歇性肺病 (ILD) 是对HER2向药物的关注. 这项研究发现,使用trastuzumab deruxtecan (T-Dxd) 和trastuzumab emtansine (T-DM1) 等药物存在显著的ILD风险,老年患者和非乳腺癌治疗增加了死亡风险.
科学领域:
- 在瘤学瘤学.
- 肺部病理学 肺部病理学
- 药物监督 药物监督 药物监督
背景情况:
- 人们越来越担心接受HER2向治疗的患者的间歇性肺病 (ILD).
- 了解与这些药物相关的ILD的特定风险和特征对于患者安全至关重要.
研究的目的:
- 评估与HER2向药物相关的ILD风险和特征.
- 为了确定这些药物治疗患者的ILD死亡率和发病时间的风险因素.
主要方法:
- 从2004年第一季度到2024年第二季度利用了FDA不良事件报告系统 (FAERS) 数据库.
- 使用报告几率比 (ROR) 来评估HER2向药物与ILD之间的关联.
- 进行了后勤回归来分析死亡率和发病时间的风险因素.
主要成果:
- 确定了2262例与HER2向剂相关的ILD病例.
- 特拉斯图祖马布德鲁克斯泰干 (T-Dxd) 显示ILD风险最高 (ROR = 31.28),其次是T-DM1,珀图祖马布和特拉斯图祖马布.
- 老年患者,T-Dxd治疗和非乳腺癌的迹象是致命ILD结局的重要风险因素.
结论:
- 在ILD和几个针对HER2的药物之间存在显著的关联,包括T-Dxd,T-DM1,珀图祖马布和特鲁祖马布.
- 这些发现强调了在接受这些治疗的患者中监测ILD的重要性.
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