华法林使用与国际标准化比率增加之间的关联:FDA不良事件报告系统 (FAERS) 的系统分析
Robert Morris1,2, Megan Todd1, Nicole Zapata Aponte1
1Department of Pharmaceutical Sciences, Taneja College of Pharmacy, University of South Florida, Tampa, FL 33612, USA.
概括
华法林患者国际正常化比率 (INR) 的升高与血红蛋白降低,药物相互作用和跌倒有关. 风险随着年龄的增长而增加,特别是80岁以上,以及同时使用药物.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床药理学 临床药理学
背景情况:
- 国际正常化比率 (INR) 的升高是接受华法林抗凝剂治疗的患者常见的不良药物事件 (ADE).
- 了解与INR升高相关的因素对于患者安全和优化华法林治疗至关重要.
研究的目的:
- 通过使用FDA不良事件报告系统 (FAERS) 数据来确定INR增加和华法林使用之间的关联.
- 确定与华法林使用者INR升高相关的特定ADE和药物相互作用 (DDI).
主要方法:
- 分析来自FAERS数据的77,010次瓦法林每年出现的病例.
- 应用关联规则挖掘和提升值来识别与升高的INR相关的华法林相关的ADE和DDI.
- 报告几率比率 (ROR) 的计算,以评估性别,年龄和其他因素对INR风险的影响.
主要成果:
- 与INR升高相关的顶级ADEs:血红蛋白降低,药物相互作用,出血,喘息和跌倒.
- 随着年龄的增加 (特别是80岁以上),男性性别以及同时使用多种药物的增加,观察到INR风险增加.
- 与INR升高相关的频繁的DDI包括乙氨基,拉米普里尔和罗西米德.
结论:
- 患者的年龄和多种药物显著增加了华法林使用者的INR升高的风险.
- 升高的INR与特定的ADEs有关,如血红蛋白降低和血,以及潜在的DDI.
- 研究结果强调需要对INR进行警监测,特别是在老年患者和服用多种药物的患者中.
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