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普拉塞替尼的营销后安全性:基于FDA不良事件报告系统数据库的现实世界不成比例分析
Zheng Shi1,2,3, Keda Shao1,2,3, Ke Wang1,4,3
1Department of Clinical Trial, Zhejiang Cancer Hospital, No. 1 Banshan East Road, Gongshu District, Hangzhou, 310022, China.
International journal of clinical pharmacy
|April 26, 2025
概括
这项研究分析了FAERS中pralsetinib的不良事件,确定了已知的问题,如高血压和新的安全信号,如血中酸的增加. 持续的药物监测对于pralsetinib的安全性至关重要.
科学领域:
- 药监和药物安全 药监和药物安全
- 在瘤学瘤学.
- 临床药理学 临床药理学
背景情况:
- 普拉塞提尼布是一种已批准的肺癌和甲状腺癌的转移过程中重新排列 (RET) 抑制剂.
- 尽管已经确立了临床疗效,但pralsetinib的真实安全数据仍然有限.
研究的目的:
- 通过分析FDA不良事件报告系统 (FAERS) 中报告的不良事件 (AE) 来识别pralsetinib的潜在安全信号.
主要方法:
- 从2020年第三季度到2024年第二季度的FAERS数据的回顾性药监分析.
- 使用四种算法进行不成比例分析:ROR,PRR,BCNN和EBG. 使用了四种算法:报告赔率比率 (ROR),比例报告比率 (PRR),贝叶斯信心传播神经网络 (BCNN) 和经验贝叶斯几何平均值 (EBG).
主要成果:
- 确定了与pralsetinib相关的1064份报告,其中有3608个副作用.
- 常见的副作用包括高血压,喘息和贫血. 新的信号包括血中的增加,心肌缩标志物,细菌性囊炎,真菌性足部感染,肺结核和心肌损伤.
- 高血压在女性和老年患者 (≥65岁) 中更频繁.
结论:
- 该研究确定了已知和新的显著不良事件信号对pralsetinib.
- 这些发现强调了持续对普拉塞西尼布的药物监测的重要性.
- 建议通过前性研究进一步验证以确认这些安全信号.
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