性别和年龄差异在怀疑出血报告与乙酸:在全球药监数据库,Vigibase的描述性研究
Jean-Louis Montastruc1, Alessandra Bura-Rivière2
1Department of Clinical Pharmacology, Toulouse University Hospital and Faculty of Medicine, Université Toulouse III-Paul Sabatier, Toulouse, France.
Fundamental & clinical pharmacology
|October 7, 2025
概括
男人和65岁以上的老年人显示,报告与乙酸 (ASA) 相关的出血事件的风险更高. 这包括严重和致命的出血,特别是胃肠道和神经系统类型.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 公共卫生 公共卫生
背景情况:
- 乙盐酸 (ASA) 广泛使用,需要持续的安全监测.
- 药监数据库对于识别药物不良反应至关重要.
- 了解不良事件报告中的人口差异对于有针对性的安全干预至关重要.
研究的目的:
- 为了调查与乙盐酸 (ASA) 相关的出血事件报告的性别差异.
- 分析ASA相关出血报告中的与年龄相关的差异.
- 为了比较性别之间的出血位置和严重程度.
主要方法:
- 使用Vigibase,一个全球药监数据库,用于与ASA相关的出血报告.
- 包括2008年1月1日至2021年12月31日的成人报告.
- 计算报告几率比率 (RORs) 使用95%的置信区间来比较性别和年龄组.
主要成果:
- 分析了超过29,000个与ASA相关的出血事件.
- 与女性相比,男性对整体,胃肠道,神经,鼻腔和脏出血的概率比率更高.
- 严重和致命的神经出血事件在男性中更频繁地报告,在各个年龄段和65岁以上的人群中观察到类似的趋势.
结论:
- 与ASA相关的报告总体,严重和致命出血的风险在男性中比女性更高.
- 65岁及以上的个体表现出ASA相关出血事件的风险较高.
- 胃肠道,神经和鼻血是ASA相关出血的最常见地点,男性和老年人报告的风险更高.
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