与trastuzumab emtansine相关的长期肝胆道疾病使用FDA不良事件报告系统数据库进行药监测研究
Hyo Jung Kim1,2, Jeong-Hwa Yoon3,4, Yeon Hee Park5,6
1Department of Digital Health, Samsung Advanced Institute for Health Science and Technology, Sungkyunkwan University, Seoul, Republic of Korea.
Scientific reports
|August 23, 2024
概括
在HER2+乳腺癌患者中,trastuzumab emtansine (T-DM1) 可能会造成肝损伤的风险. 这项研究发现了T-DM1相关的肝胆道疾病的显著安全信号,平均发病时间为41天.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 肝病学 肝病学是一种肝病学.
背景情况:
- 特拉斯图祖马布 (T-DM1) 是对HER2阳性转移性乳腺癌的关键治疗方法.
- 对可能的长期肝脏不良反应 (ADRs) 存在担忧,这些不良反应在临床试验中没有完全被捕捉到.
- 现实世界的数据分析对于了解T-DM1的安全概况至关重要.
研究的目的:
- 使用FDA不良事件报告系统 (FAERS) 调查T-DM1在肝胆道疾病中的潜在安全信号.
- 为了确定T-DM1相关的肝胆性ADR的发病时间.
- 根据T-DM1治疗持续时间和风险-益处评估的临床决策.
主要方法:
- 利用FAERS数据库提取涉嫌与T-DM1和其他药物相关的副作用.
- 采用统计方法,包括报告几率比率 (ROR) 和信息组件 (IC),以识别安全信号.
- 对乳腺癌患者进行了子组分析,并计算了肝胆道疾病发病时间的中位数.
主要成果:
- 在肝胆道疾病中发现了T-DM1的显著安全信号 (ROR=5.66,IC=2.35).
- 乳腺癌患者的亚组分析也揭示了潜在的安全信号 (ROR=3.28,IC=1.53).
- 与T-DM1相关的肝胆道疾病的中位数发病时间为41天,长期和慢性病例出现的时间较晚.
结论:
- T-DM1与肝胆道疾病的显著风险有关.
- 这些发现强调了在接受T-DM1.1的患者中监测肝功能的重要性.
- 需要进一步的研究来优化T-DM1治疗持续时间,平衡疗效与潜在的肝毒性.
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