基于FDA的不良事件报告系统的CDK4/6抑制剂相关不良事件的比较分析:一个病例控制药监测研究
Wanlong Lin1, Yanbin Zeng1, Lizhu Weng1
1Department of Pharmacy, Women and Children's Hospital, School of Medicine, Xiamen University, 10# Zhenhai Road, Xiamen, China.
BMC pharmacology & toxicology
|August 9, 2024
概括
循环素依赖性激酶4/6 (CDK4/6) 抑制剂在乳腺癌治疗中具有不同的安全性. 帕尔博西克利布可能会导致血液毒性,里博西克利布可能会导致肝毒性和QT延长,而阿贝马西克利布可能会导致胃肠道影响和间歇性肺病.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床研究 临床研究
背景情况:
- 循环素依赖性激酶4/6 (CDK4/6) 抑制剂代表了乳腺癌治疗的重大进展.
- 了解palbociclib,abemaciclib和ribociclib的独特不良事件 (AE) 概况对于优化患者的治疗结果至关重要.
- 需要现实世界的安全数据来补充关于CDK4/6抑制剂毒性的临床试验结果.
研究的目的:
- 分析和比较三个已批准的CDK4/6抑制剂的不良事件概况:palbociclib,ribociclib和abemaciclib.
- 通过使用现实数据,识别与每个CDK4/6抑制剂相关的常见和特定的安全信号.
- 为CDK4/6抑制剂的知情临床选择提供基于证据的见解.
主要方法:
- 分析2015年至2022年期间来自FDA不良事件报告系统 (FAERS) 的AE数据.
- 采用了四种不成比例的方法 (ROR,PRR,BNNP,MGPS) 进行可靠的安全信号检测.
- 采用Venn分析来比较和划分三种抑制剂中常见和独特的副作用.
主要成果:
- 这项研究包括一个庞大的队列:73,042名患者接受了palbociclib,25,142名患者接受了ribociclib,7563名患者接受了abemaciclib.
- 帕尔博西克利布对血液毒性的风险最高; 里博西克利布对宏细胞瘤,指甲疾病和肝损伤的风险最高; 亚贝马西克利布对粘膜毒性的风险最高.
- 具体的不良反应包括对 ribociclib 的 QT 延长和对 abemaciclib 的间歇性肺病,而 palbociclib 与血液毒性有关.
结论:
- 帕尔博西克利布与更高的血液毒性风险有关.
- 利博西克利布显示肝毒性,毒性和QT延长的风险增加.
- 阿贝马西克利布与肝毒性,胃肠道问题,间歇性肺病和血栓形成的风险增加有关,指导临床药物选择.
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