在固体瘤中与Trastuzumab Deruxtecan相关的疲劳:元分析和药监信号检测研究
Yinyin Ye1, Yuyao Tang1, Yongxin Li1
1Breast Disease Diagnosis and Treatment Center of Affiliated Hospital of Qinghai University & Affiliated Cancer Hospital of Qinghai University, Xining, 810000, China.
Current drug safety
|January 8, 2026
概括
特拉斯图祖马布德鲁克斯泰干 (T-DXd) 在固体瘤患者中显著增加疲劳风险. 这种常见的副作用很早就出现,需要主动管理以改善生活质量.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 证据综合 证据综合
背景情况:
- 特拉斯图祖马布德鲁克斯泰干 (T-DXd) 越来越多地用于固体瘤.
- 疲劳是与T-DXd治疗相关的重要和常见的毒性.
研究的目的:
- 量化T-DXd相关疲劳的风险和发病率.
- 用随机对照试验,单臂研究和药监数据来证实研究结果.
主要方法:
- 随机对照试验 (RCT) 和单臂研究的系统审查和元分析.
- 使用FAERS和JADER进行不成比例性评估的药监数据分析.
- 韦布尔建模用于时间到发病分析.
主要成果:
- 与对照组相比,T-DXd显著增加了疲劳风险 (OR 1.51).
- 在单臂研究中,累积疲劳的发病率为49%,乳腺癌的发病率更高.
- 药监数据显示,对疲劳的不成比例信号一致.
结论:
- T-DXd与常见的,早期发作的,临床上显著的疲劳有关.
- 需要标准化的评估和缓解策略.
- 建议主动管理和监测患者报告的结果.
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