药物诱导的白风:对FAERS数据库的现实世界药监测分析
Nonger Shen1, Qingxia Fang1, Yue Wu1
1Center for Clinical Pharmacy, Cancer Center, Department of Pharmacy, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, Zhejiang, China.
PloS one
|September 8, 2025
概括
像免疫检查点抑制剂这样的新疗法越来越多地与药物诱导的白风有关. 这项研究确定了46种具有白风信号的药物,许多药物缺乏FDA标签警告,强调了对患者监测的必要性.
科学领域:
- 药物监督 药物监督 药物监督
- 皮肤病学 皮肤病学
- 药品安全 药品安全
背景情况:
- 越来越多的关于与新疗法相关的药物诱导白风的报告.
- 免疫检查点抑制剂和单克隆抗体经常涉及.
- 需要系统地识别致病原体.
研究的目的:
- 使用FDA不良事件报告系统 (FAERS) 识别与白风相关的药物.
- 评估特定药物与白风发育之间的关联强度.
- 将已识别的药物信号与现有的FDA批准的标签警告进行比较.
主要方法:
- 对FAERS数据的回顾性不成比例分析 (2004年第一季度 - 2024年第四季度).
- 使用报告几率比率 (ROR) 和贝叶斯信心传播神经网络 (BCPNN) 进行信号检测.
- 分析了1910个报告的白风病例.
主要成果:
- 确定了46种具有显著阳性白风信号的药物.
- 最受欢迎的药物包括mogamulizumab,imiquimod和chloroquine,具有强烈的关联信号.
- 80.4%的确定的药物缺乏FDA标签上的白风预先警告.
结论:
- 已经确定了大量可能诱发白风的药物清单.
- 这些发现凸显了多种药物的潜在安全问题.
- 对于服用这些药物的个人,建议对白风进行密切的患者监测.
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