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不成比例分析比较sonidegib和vismodegib的安全性概况,基于FAERS数据库
Zhixing Zheng1, Zhengeng Wang1,2, Qinghui Guo1
1Cancer Center, Yongding District Hospital of Longyan, Longyan, 364100, China.
Scientific reports
|November 1, 2025
概括
这项研究分析了刺途径抑制剂 (HPI) sonidegib和vismodegib的安全数据. 检测到癌症和心脏阻塞等意想不到的不良事件,突出了进一步临床研究的需要.
科学领域:
- 药理学和瘤学 药理学和瘤学
- 药物安全和药物监督 药物安全和药物监督
背景情况:
- 像sonidegib和vismodegib这样的刺途径抑制剂 (HPIs) 已被批准用于基底细胞癌.
- 对于这些HPI,现实世界安全数据有限.
- 了解长期安全性概况对于临床实践至关重要.
研究的目的:
- 综合评估sonidegib和vismodegib的长期安全性概况.
- 使用现实数据识别常见和意想不到的不良事件 (AE).
- 探索潜在的性别差异和AEs的发病时间 (TTO).
主要方法:
- 对2012年至2024年FDA不良事件报告系统 (FAERS) 数据的分析.
- 在25个系统器官类别 (SOC) 中使用了四个不成比例分析算法 (ROR,PRR,BCPNN,MGPS).
- 调查了性别差异,并计算了已确定的AE的中位数TTO.
主要成果:
- 常见的副作用包括肌肉,脱发和老年症.
- 检测到意想不到的副作用:三重阴性乳腺癌 (TNBC),状细胞癌和sonidegib的完整心房静脉阻塞;缩性眼球炎,眼睛的恶性瘤和vismodegib的聋.
- 在AE信号和中位数TTO (sonidegib:67天,vismodegib:56天) 中确定了性别差异.
结论:
- 索尼迪吉布和维斯莫迪吉布表现出不同的AE报告模式.
- 这些发现产生了前性研究的假设,以确认安全信号.
- 这项研究为临床医生提供了新的安全见解,可能改善患者护理,但FAERS数据是产生假设的,而不是因果的.
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