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使用FDA不良事件报告系统评估药物诱导的高尿血和痛风风险
Guihao Zheng1,2, Meifeng Lu1,2, Yulong Ouyang1
1Department of Sports Medicine, Orthopaedic Hospital, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, 17 Yongwai Zhengjie, Donghu District, Nanchang City, Jiangxi Province, China.
Scientific reports
|July 2, 2025
概括
这项研究分析了药物诱导的高尿血和痛风报告,确定了特定的药物和风险因素,如男性性别和年龄. 超过一半的病例发生在药物开始后的30天内,突出显示了对药物监测的需要.
科学领域:
- 药监和药物安全 药监和药物安全
- 临床药理学 临床药理学
- 流行病学 流行病学
背景情况:
- 高尿路血症是痛风的前体,是全球日益严重的健康问题.
- 虽然生活方式影响高尿血和痛风,但药物的作用需要进一步调查.
- 现有的研究不足以解决药物诱导的高尿血和痛风的具体风险和机制.
研究的目的:
- 系统地识别与高尿血和痛风相关的药物,使用不成比例性分析.
- 通过机器学习和多变量回归来确定药物诱导的高尿血和痛风的独立风险因素.
- 分析这些不良药物反应的发病时间.
主要方法:
- 从2004年第一季度到2023年第三季度使用了FDA不良事件报告系统 (FAERS) 数据库.
- 使用不成比例分析 (ROR,PRR,BCPNN) 进行信号检测.
- 应用单变量分析,LASSO,XGBoost和多变量回归用于风险因素识别和时间到发病分析.
主要成果:
- 确定了18531份高尿血和痛风报告;男性性别和年龄较大是独立的风险因素.
- 检测到131种药物与高尿血相关 (telaprevir最高) 和177种与痛风相关 (lenalidomide最高).
- 干扰素α-2b是高尿血症的危险因素;20种药物,包括格洛酶和费布克索斯塔特,用于痛风. 超过50%的病例发生在30天内.
结论:
- 这项研究系统地确定了与药物相关的高尿血和痛风风险.
- 男性的性别,年龄较大,以及特定的药物,如干扰素α-2b,格洛,和febuxostat是关键的危险因素.
- 这些发现有助于加强药物监测,并为临床药物管理策略提供信息.
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