与银病的阿普雷米拉斯特和德乌克拉维西提尼布相关的不良事件:基于FAERS数据库的药监测研究
Yuanyuan Xu1,2, Xinjin Liu1,2, Linghong Guo1,2
1Department of Dermatology, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.
Clinical, cosmetic and investigational dermatology
|May 12, 2025
概括
阿普雷米拉斯特和德乌克拉维西丁尼是口服牛皮治疗的药物. 阿普雷米拉斯特与胃肠道问题和头痛有关,而德克拉维西丁尼与皮肤疾病有关,女性患德克拉维西丁尼风险更高.
科学领域:
- 皮肤病学 皮肤病学
- 药物监督 药物监督 药物监督
- 临床研究 临床研究
背景情况:
- 牛皮治疗药物阿普雷米拉斯和德乌克拉维西提尼是口服小分子抑制剂.
- 营销后的安全数据对于优化患者护理至关重要.
研究的目的:
- 使用现实世界营销后数据,比较阿普雷米拉斯特和德乌克拉维西提尼的不良事件 (AE) 概况.
- 为了确定两种牛皮药物之间的潜在安全信号和差异.
主要方法:
- 从FDA不良事件报告系统 (FAERS) 数据库 (2014年第一季度 - 2023年第四季度) 分析了95524份阿普雷米拉斯和754份德克拉瓦西替尼AE报告.
- 利用不成比例和贝叶斯分析来比较安全信号.
主要成果:
- 阿普雷米拉斯与胃肠道AE (腹,恶心),牛皮复发和神经系统疾病 (头痛) 相关.
- 德乌克拉维西提尼与皮肤AE (,毛囊炎,皮疹,红斑) 和口腔疾病有关.
- 确定了未在药物标签上的新副作用,包括阿普雷米拉斯特的鼻头痛和德乌克拉维西提尼布的形皮肤炎.
- 女性患者在使用deucravacitinib时表现出皮肤AE的风险更高.
结论:
- 现实世界的数据提供了对阿普雷米拉斯特和杜克拉瓦西提尼布安全性概况的见解.
- 在AE中观察到的性别差异需要在临床和现实环境中进一步调查.
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