关于infigratinib的药监测研究:FDA不良事件报告系统的安全分析
Dehua Zhao1, Xiaoqing Long2, Jiping Zhou2
1Department of Clinical Pharmacy, The Third Hospital of Mianyang (Sichuan Mental Health Center), Mianyang, 621000, Sichuan, People's Republic of China. zhaoyaoshi0566@163.com.
Drugs in R&D
|September 12, 2023
概括
这项研究分析了癌症药物infigratinib的现实世界不良事件 (AE). 胃肠道和皮肤毒性是最常见的,脱水和皮肤脱皮是需要临床关注的意想不到的副作用.
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:
- 印菲格拉提尼布是一种针对胆管癌的FGFR特异性铁氨酸激酶抑制剂.
- 对于infigratinib的真实安全数据仍然有限.
- 这项研究使用了FAERS数据库来评估infigratinib的不良事件.
研究的目的:
- 在现实环境中评估infigratinib的安全性.
- 为了识别和描述与infigratinib治疗相关的不良事件.
- 通过药监方法检测潜在的安全信号.
主要方法:
- 使用FDA不良事件报告系统 (FAERS) 数据库进行的一项药监测研究.
- 对因菲格拉提尼布相关不良事件报告的描述性分析.
- 不成比例性分析 (PRR,ROR,BCPNN) 以检测安全信号.
主要成果:
- 分析了149份不良事件报告,确定了36个重要的安全信号.
- 胃肠道疾病 (26个报告) 和皮肤/皮下组织疾病 (21个报告) 是最常见的.
- 具有高信号强度的意外不良事件包括脱水和皮肤脱皮;较低的infigratinib剂量与非严重事件相关.
结论:
- 胃肠道和皮肤毒性是infigratinib的主要不良反应.
- 临床医生应注意意外的不良事件,如皮肤脱皮和脱水.
- 因菲格拉提尼布的剂量可能会影响不良事件的严重程度,这表明需要调整剂量.
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