使用FDA不良事件报告系统 (FAERS) 数据库对与白病药物相关的报道不良事件的描述性分析 2013-2023年
Saleh F Alqifari1, Musaab Habibulla Gari2, Jeff J Guo2
1Faculty of Pharmacy, University of Tabuk, Tabuk 47713, Saudi Arabia.
Diseases (Basel, Switzerland)
|July 25, 2025
概括
这项研究评估了局部白风治疗的安全性,如Tacrolimus,Pimecrolimus和Ruxolitinib. 虽然局部副作用是轻微的,但注意到住院和心周炎等系统性事件,突显了持续安全监测的必要性.
科学领域:
- 皮肤病学 皮肤病学
- 药物监督 药物监督 药物监督
- 自身免疫性疾病 自身免疫性疾病
背景情况:
- Vitiligo 是一种导致皮肤脱色的自身免疫性疾病,非细分性白风 (NSV) 以前是通过氨酸抑制剂进行非标签治疗的.
- 美国食品和药物管理局在2022年批准了Ruxolitinib奶油用于NSV,针对JAK/STAT通路.
研究的目的:
- 进行对Tacrolimus,Pimecrolimus和Ruxolitinib在白风治疗中的后续安全性评估.
- 分析来自FDA不良事件报告系统 (FAERS) 数据库的不良事件报告.
主要方法:
- 对2013-2023年FAERS数据进行了回顾性描述性分析.
- 包括2岁及以上的患者,考虑品牌和仿制药名称.
- 将844份不良事件报告 (388名患者) 分类为皮肤和全身事件.
主要成果:
- 塔克罗利莫斯:12次住院治疗,2次危及生命的事件,4次残疾.
- 皮梅克罗利斯:疹,颜色障碍,牙骨折 (主要的系统性事件).
- 鲁克索利提尼布: 主要是心膜炎,其次是贫血,头痛和尿液过敏;轻微的局部皮肤学影响.
结论:
- 局部白风治疗有不同的系统性安全性.
- 持续的营销后安全监测对于局部白风药物至关重要.
- Vitiligo 的心理影响强调了需要安全有效的治疗方法.
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