基于FAERS数据库的Dupilumab不良事件的分析和挖掘
Hui Gao1, Liqiang Cao1, Chengying Liu2
1Jiangyin People's Hospital Affiliated to Southeast University, Jiangyin, China.
Scientific reports
|March 13, 2025
概括
这项研究分析了来自美国FDA数据库的Dupilumab不良事件 (AE),确定了常见和新风险,如眼部刺激和反弹性湿疹. 这些发现突出了潜在的滥用,并指导了未来的Dupilumab安全研究.
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:
- 杜皮卢马布是一种用于治疗亚托皮炎和其他炎症状况的生物疗法.
- 了解其不良事件概况对于安全的临床使用至关重要.
- 美国FDA不良事件报告系统 (FAERS) 是营销后监测的宝贵资源.
研究的目的:
- 识别和描述与Dupilumab相关的潜在不良事件 (AE).
- 评估与杜皮卢马布相关的副作用的人口因素和趋势.
- 使用已建立的药监方法检测安全信号.
主要方法:
- 使用FAERS数据库从2017年第二季度到2023年第四季度.
- 提取了5335份疑似与Dupilumab相关的不良事件报告.
- 采用信号检测算法,包括PRR,ROR,BCNN和EMGM.
主要成果:
- 在27个系统器官类别中确定了307个首选术语.
- 大多数报告来自女性患者 (56.08%) 和45-65岁患者 (21.34%).
- 常见的副作用包括,皮疹和产品滥用;高信号的副作用包括反弹性皮肤炎和注射部位反应;新的潜在副作用包括眼睛和睡眠相关问题.
结论:
- 杜皮卢马布与一系列不良事件有关,包括以前未被识别的风险,如干眼和视力模糊.
- 有证据表明产品被滥用 (例如,遗漏剂量) 值得注意.
- 为了优化患者护理,需要进一步调查dupilumab的安全性.
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