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与忍丹尼布相关的出血相关的不良事件:基于FAERS数据库的药监测研究
Qingyang Liu1, Wei Zuo2, Hui Huang3
1Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing; and Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
服用宁泰达尼布的老年患者 (≥65岁) 面临较高的出血相关不良事件 (HrAE) 风险,特别是严重的不良事件. 胃肠道出血是最常见的HRAE报告.
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
- 药品安全 药品安全
背景情况:
- 丁丁达尼布是治疗异常性肺纤维化和其他疾病的重要药物.
- 与出血相关的不良事件 (HrAE) 是已知的忍者达尼布治疗的副作用.
- 了解HRAE的特征和危险因素对于患者安全至关重要.
研究的目的:
- 分析与忍者达尼布相关的出血相关不良事件 (HrAE) 的特征并确定与忍者达尼布相关的积极安全信号.
- 为了调查影响hrae发生的因素,在服用宁泰丹尼布的患者中.
- 评估药物相互作用和HRAE之间的关联.
主要方法:
- 从FAERS数据库 (2014年第四季度 - 2024年第三季度) 提取了任天尼布的不良事件 (AE) 报告.
- 使用标准化医疗词典对监管活动查询 (SMQs) 识别了HRAE.
- 采用多变量和不成比例分析来识别风险因素和AE信号,包括药物相互作用 (DDI).
主要成果:
- 3,018名患者经历了忍者达尼布的HRAE.
- 65岁以上的患者和较低的每日剂量与HRAE风险增加有关.
- 胃肠道系统受到影响最大;与抗血小板药物,抗凝固剂或普德尼松联合使用增加了HRAE风险.
结论:
- 胃肠道出血是与nintedanib相关的最常见的HRAE.
- 老年患者 (≥65岁) 对HRAE更容易受到感染,尤其是危及生命或致命的事件.
- 宁泰达尼布安全性监测应集中在老年人和同时使用特定药物的患者身上.
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