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Comprehensive Analysis of Drug Response using the FLICK Assay
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在现实世界中,FAERS对Pralsetinib的安全性分析
Dongdong Zhang1, Yixin Sun2, Ying Cai2
1Department of Thyroid Oncology, Chongqing Key Laboratory of Translational Research for Cancer Metastasis and Individualized Treatment, Chongqing University Cancer Hospital, Chongqing, 400030, People's Republic of China.
Scientific reports
|October 28, 2025
概括
用于甲状腺和肺癌的pralsetinib在一项大型安全性分析中显示了七个新的不良事件,如肺栓塞和认知障碍. 大多数事件发生在治疗的第一个月内.
科学领域:
- 药物监督 药物监督 药物监督
- 在瘤学瘤学.
- 药品安全 药品安全
背景情况:
- 普拉塞提尼布被FDA批准用于髓性甲状腺癌 (MTC),乳头性甲状腺癌 (PTC) 和非小细胞肺癌 (NSCLC).
- 有限的大型队列数据存在于pralsetinib的不良事件 (AE).
研究的目的:
- 使用FDA不良事件报告系统 (FAERS) 数据库调查与pralsetinib相关的不良事件.
- 为了确定pralsetinib之前没有记录的新安全信号.
主要方法:
- 使用了2020年第三季度至2023年第一季度的FAERS数据,用于pralsetinib.
- 采用了统计方法,包括报告比率比率 (ROR),比例报告比率 (PRR),贝叶斯信任传播神经网络 (BCPNN) 和多项马鱼缩小器 (MGPS).
- 使用SAS 9.4软件进行数据分析.
主要成果:
- 分析了802份报告,详细介绍了与pralsetinib相关的2733个副作用.
- 确定了七种新的AE:心肌亡标志物的增加,血中素的增加,肌素的增加,平衡障碍,认知障碍,肺栓塞和肺胸炎.
- 大多数与普拉塞替尼相关的副作用在治疗开始的第一个月内表现出来.
结论:
- 普拉塞提尼布治疗与一些新的和意想不到的不良事件有关.
- 定期监测长期安全性和前性试验是必要的,以实现最佳的pralsetinib使用.
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