在两种类型的单吸入器三重疗法中发生的高风险不良事件:基于FAERS数据库的药监测研究
Zhishen Ruan1, Chunbin Wang2, Shasha Yuan1
1Respiratory Department, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Beijing, China.
这项研究比较了COPD和喘中两种三重吸入器治疗的不良事件. 布德索尼德/甘皮龙/甲醇酸盐显示出更高的设备问题风险,而弗鲁塔西松酸盐/乌梅克利迪尼/维兰特罗尔则增加了肺炎和疹感染的风险.
科学领域:
- 药物监督 药物监督 药物监督
- 呼吸系统医学 呼吸系统医学
- 临床药理学 临床药理学
背景情况:
- 单个吸入器三重疗法是慢性阻塞性肺病 (COPD) 和喘的基石治疗.
- 了解不同三重疗法组合的不良事件概况对于患者安全和最佳治疗选择至关重要.
研究的目的:
- 进行与两种广泛使用的单个吸入器三重疗法相关的不良事件 (AE) 的比较分析:布德索尼德/甘皮龙/甲醇酸盐 (BUD/GLY/FOR) 和酸盐/乌梅克利/维兰特醇 (FF/UMEC/VI).
- 通过使用现实数据,识别与每个组合相关的特定安全问题和潜在风险.
主要方法:
- 一项采用美国食品和药物管理局 (FDA) 的不良事件报告系统 (FAERS) 数据的横截面研究.
- 使用报告几率比率 (ROR),比例报告比率 (PRR) 和贝叶斯信心传播神经网络 (BCPNN) 进行了不成比例分析,以评估特定药物和不良事件之间的关联.
- 分析侧重于包括肺炎在内的首选术语 (PT) 以及每个药物组合的前10个BCPNN (IC) 效果值.
主要成果:
- 分析了BUD/GLY/FOR的16355个AE和FF/UMEC/VI的39110个AE.
- BUD/GLY/FOR与更高的设备使用问题风险,口腔喉/声道问题,体高降低和低音有关.
- FF/UMEC/VI显示肺炎和*Candida*感染的风险更高. 这两种疗法都显示出血管疾病的风险增加,FF/UMEC/VI也显示出尿的风险增加.
结论:
- 这项研究提供了BUD/GLY/FOR和FF/UMEC/VI的初步安全概况比较,突出了不同的AE模式.
- 临床医生在开处方这些三重吸入器疗法时,应保持对这些潜在不良影响的认识.
- 建议进行进一步的纵向研究,以确认这些药物事件关联之间的因果关系.
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