使用FAERS数据库分析的HER2向药物肝毒性风险的现实世界药监测评估
Junli Dong1, Dan Chen2, Minyu Zhong2
1Department of Pharmacy, Tongji Medical College, Traditional Chinese and Western Medicine Hospital of Wuhan, Huazhong University of Science and Technology, Wuhan, China.
Scientific reports
|August 6, 2025
概括
肝毒性信号在针对HER2的疗法之间有所不同,抗体-药物合物如T-DM1显示最强的风险. 定期监测肝酶对于这些重要癌症治疗的安全管理至关重要.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 肝病学 肝病学是一种肝病学.
背景情况:
- 针对HER2的治疗方法 (mAbs,TKIs,ADCs) 可以改善HER2阳性癌症的治疗结果.
- 肝毒性是这些治疗方法的一个重要问题.
- 需要对不同针对HER2的药物的肝毒性进行比较分析.
研究的目的:
- 对与各种针对HER2的药物相关的肝毒性风险进行全面的比较分析.
- 评估不同HER2向药物的肝毒性信号的强度和发病时间.
主要方法:
- 使用FDA FAERS数据库 (2012年第一季度2024年第二季度) 的现实世界药监调查研究.
- 不成比例分析 (报告几率比率 - ROR) 来评估肝毒性信号.
- 对肝毒性开始的时间 (TTO) 的评估.
主要成果:
- 确定了2986例肝毒性病例.
- T-DM1表现出最强的肝毒性信号 (ROR 6.00),其次是trastuzumab (ROR 2.65),T-DXd (ROR 2.51),TKIs (ROR 2.36) 和pertuzumab (ROR 1.73). 这两种药物是最强的肝毒性信号之一,其次是trastuzumab (ROR 2.65),T-DXd (ROR 2.51),TKIs (ROR 2.36) 和pertuzumab (ROR 1.73).
- 肝毒性主要涉及ALT,AST和胆红素的升高;T-DM1和T-DXd具有特定的严重表现. 珀图祖马布的TTO时间最短 (21天),特拉斯图祖马布的TTO时间最长 (210天).
结论:
- 在针对HER2的治疗中存在显著的肝毒性信号,根据药物类别而异.
- 对接受这些治疗的患者来说,定期监测肝酶和胆红素是必不可少的.
- 需要谨慎管理,以平衡HER2阳性癌症中HER2向疗法的疗效和安全性.
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