研究与非选择性RET多基因酶抑制剂相关的药物诱导甲状腺功能障碍不良事件:利用FDA不良事件报告系统数据的药物监测分析
Zhuda Meng1, Liying Song2, Shuang Wang3
1Department of Thyroid Surgery, Changzhi People's Hospital, Changzhi, People's Republic of China.
Clinical epidemiology
|February 24, 2025
概括
非选择性的RET激酶抑制剂与甲状腺功能障碍有关,早期发病和因患者因素而异的风险. 需要进一步的临床研究来证实这些发现.
科学领域:
- 药监和药物安全 药监和药物安全
- 瘤学和内分泌学.
- 临床药理学 临床药理学
背景情况:
- 甲状腺功能障碍 (TD) 是与向癌症治疗相关的潜在不良事件.
- 非选择性RET激酶抑制剂 (MKIs) 越来越多地用于癌症治疗,需要了解它们的安全性.
- 非选择性MKI和TD之间的关联需要进行彻底的调查.
研究的目的:
- 研究非选择性RET激酶抑制剂与甲状腺功能障碍 (TD) 之间的潜在关联.
- 使用美国FDA不良事件报告系统 (FAERS) 数据进行药监测分析.
- 确定与非选择性MKI使用相关的特定TD不良事件和影响因素.
主要方法:
- 使用了2015年第一季度至2023年第四季度的FAERS数据,用于非选择性的RETMKI.
- 使用不成比例分析 (ROR,PRR,BCPNN,EBGM) 来检测TD的AE信号.
- 进行了子组分析,多变量后勤回归和时间到发病 (TTO) 分析.
主要成果:
- 描述性分析显示,非选择性RET MKIs的TD不良事件的趋势越来越高,包括严重反应.
- 不成比例性分析始终表明苏尼提尼布,卡博赞提尼布和伦瓦提尼布与TD之间的积极关联.
- 亚组和后勤回归分析确定年龄,性别和体重是影响TD发生的重要因素,观察到早期的TTO.
结论:
- 该研究表明,非选择性的RET MKIs和TD不良事件之间存在相关性.
- 这些发现支持加强对服用这些抑制剂的患者的临床监测和风险识别.
- 建议进行进一步的临床研究,以验证这些药监发现.
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