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药物诱导皮肤颜色的调查 (超和低颜色)
Jia Tang1, Bing Lv2, Linli Liu1
1Department of Dermatology, Suining Central Hospital, Suining, Sichuan, People's Republic of China.
Clinical, cosmetic and investigational dermatology
|November 24, 2025
概括
药物诱导的皮肤色素变化是常见的不良事件 (AE). 这项研究确定了与多颜色或低颜色相关的特定药物,如米诺环素和氨,强调了监测的必要性.
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:
- 药物诱导的皮肤色素变化是未被认可的不良事件 (AE).
- 现有的药物标签往往未能充分解决这些色素性AE.
- 越来越多的人意识到这些事件的临床意义.
研究的目的:
- 对FDA不良事件报告系统 (FAERS) 数据库 (2010-2024) 进行药监测分析.
- 为了确定与皮肤多颜色和/或低颜色相关的药物.
- 探索已识别的药物的临床影响和重新利用潜力.
主要方法:
- 使用OpenVigil 2.1分析了FAERS数据库中的案例报告 (2010-2024年),使用OpenVigil 2.1.
- 使用MedDRA首选术语识别的色素性AE:"皮肤超色素化"和"皮肤低色素化".
- 在药物名称标准化后,对显著的药物-AE关联进行了报告几率比率 (ROR) 的不成比例分析.
主要成果:
- 确定了特定剂和色素变化之间的强烈关联.
- 米诺环素 (ROR 115.66) 和塞特梅拉诺提德 (ROR 1506.82) 与多颜色化有关.
- 氨 (ROR 37.20) 和利博西基布 (ROR 60.20) 与低颜色化有关;几种药物表现出双向作用.
- 有关药物的很大一部分缺乏对这些色素性AE的适当标签.
结论:
- 识别了与常见的处方药相关的显著的色素AE信号.
- 强调在长期药物治疗期间早期识别和皮肤病监测的重要性.
- 与高颜色或低颜色相关的药物需要进一步调查.
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