与EGFR和HER2双重TKI相关的心血管不良事件:基于FAERS数据库的药监测研究
Henan Qin1, Yibin Teng1, Peiyao Yu1
1Department of Oncology, The First Affiliated Hospital of Dalian Medical University, Dalian, China.
拉帕提尼布是一种EGFR和HER2双TKI,在晚期乳腺癌患者中显示心力衰竭和栓塞事件等心血管风险增加. 涅拉替尼没有显示这些心血管安全信号.
科学领域:
- 在瘤学瘤学.
- 心脏病学 心脏病学
- 药物监督 药物监督 药物监督
背景情况:
- 皮表皮生长因子受体 (EGFR) 和人体皮表皮生长因子受体2 (HER2) 双氨酸激酶抑制剂 (TKI) 已被批准用于先进的HER2阳性乳腺癌.
- 与这些双重TKI相关的心血管不良事件 (AE) 需要进一步调查.
研究的目的:
- 研究EGFR和HER2双重TKI的心血管安全概况.
- 为了比较lapatinib和neratinib的心血管AE报告率.
主要方法:
- 从2007年3月到2024年6月使用了FDA不良事件报告系统 (FAERS) 数据库.
- 使用报告赔率比率,比例报告比率和贝叶斯信任传播神经网络进行了不成比例分析.
主要成果:
- 心血管AE与更严重的结果有关,包括住院治疗,危及生命的事件,残疾和死亡.
- 拉帕提尼布的心力衰竭,栓塞/血栓事件和心肌病报告率高于预期.
- 涅拉替尼没有显示出显著的心血管安全信号.
结论:
- 拉帕提尼布在心力衰竭,栓塞性/血栓性事件和心肌病症方面呈现出积极的安全信号.
- 对于涅拉替尼,没有发现任何显著的心血管安全信号.
- 建议对与lapatinib相关的高风险心血管事件进行临床监测.
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