与CDK4/6抑制剂相关的肌肉骨不良事件:使用FDA不良事件报告系统 (FAERS) 数据库的现实研究
Zhenlin Chen1, Zhiwen Fu2, Nu Zhang1
1Department of Pharmacy, Fushun People's Hospital, Fushun, China.
BMC pharmacology & toxicology
|January 29, 2025
概括
循环素依赖性激酶 (CDK) 4/6 抑制剂可以导致显著的肌肉骨不良事件 (MSAE). 现实世界的数据显示,Ribociclib和Abemaciclib具有不同的毒性概况,而Palbociclib则具有较长的MSAE发作时间.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 肌肉骨医学 肌肉骨医学
背景情况:
- 循环素依赖性激酶 (CDK) 4/6 抑制剂在癌症治疗中至关重要.
- 这些药物可以引起显著的器官系统毒性,包括肌肉骨疾病.
研究的目的:
- 综合描述与CDK4/6抑制剂相关的肌肉骨不良事件 (MSAE).
- 分析现实世界的数据,寻找模式和特定的与毒品有关的信号.
主要方法:
- 从FAERS (2015-2023) 中提取的MSAE报告.
- 进行了描述性,不成比例性 (ROR) 和时间开始分析.
- 确定了特定的肌肉骨偏好术语 (PT) 和时间模式.
主要成果:
- 发现了10,095个MSAE报告;大多数涉及Palbociclib.
- 利博西克利布与骨疼痛/损伤有关;阿贝马西克利布与骨硬化/骨折有关.
- 帕尔博西克利布的MSAE发病时间较长 (平均82天),而Abemaciclib (32.5天) 和Ribociclib (34天).
结论:
- 肌肉骨毒性对CDK4/6抑制剂的安全性具有重要意义.
- 早期识别和管理MSAE至关重要.
- 需要进一步研究机制和降低风险.
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