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药物引起的听力损失:使用FDA不良事件报告系统数据库的现实世界药物监测研究
Tingxi Wu1, Zhigang Zhao1, Peng Wang2
1Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.
Hearing research
|April 6, 2025
概括
这项研究分析了2004年至2023年间的108,435份听力损失报告,以确定导致耳毒性的药物. 它发现了432种具有潜在风险的药物,强调了乙酸和塔芬诺基因作为药物诱导的听力损失的关键问题.
科学领域:
- 药物监督 药物监督 药物监督
- 耳部毒理学 耳部毒理学
- 现实世界的数据分析分析.
背景情况:
- 药物诱导性听力损失 (DIHL) 是一个重要的临床问题,许多药物的耳毒性概况不完整.
- 现实世界的数据为了解药物安全性和不良事件提供了宝贵的资源.
研究的目的:
- 使用现实世界的数据,全面总结当前药物的听力安全信息.
- 识别和评估与FDA不良事件报告系统 (FAERS) 数据库中报告的各种药物相关的耳毒性风险.
主要方法:
- 从FAERS数据库 (2004-2023) 中利用现实世界的数据来提取听力损伤的不良事件 (AE) 报告.
- 应用不成比例分析来评估与1300种报告的药物相关的听力损伤风险.
主要成果:
- 确定了108,435个涉及1300种药物的听力障碍AE报告;最常见的报告是乙盐酸.
- 在432种药物中检测到潜在的耳毒性风险,其中tafenoquine显示出最强的信号;全身使用的抗菌药物具有最多的药物具有积极的风险信号.
结论:
- 这项研究提供了1300种已报告的耳毒性药物的综合清单,并描述了它们的风险.
- 这些发现可以帮助临床医生监测和管理药物诱导性听力损失 (DIHL).
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