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关于inclisiran的营销后药监测研究:从FDA不良事件报告系统数据库中挖掘和分析不良事件数据
Dan Zou1, Qiaozhi Hu1, Ying Liu1
1Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
International journal of clinical pharmacy
|August 27, 2024
概括
英克利西兰是一种新的降脂药物. 现实世界的数据分析发现了新的不良事件,如肌肉疼痛和肝脏问题,除了已知的副作用之外,有助于安全使用药物.
科学领域:
- 药物监督 药物监督 药物监督
- 心血管医学 心血管医学
- 药品安全 药品安全
背景情况:
- 英克利西兰是一种新型的降脂药物,在上市后安全性数据有限.
- 主要的临床试验表明安全性概况有利,但实际的不良事件 (AE) 数据仍在出现.
研究的目的:
- 进行与inclisiran相关的不良事件 (AE) 的信号检测分析.
- 使用FDA不良事件报告系统 (FAERS) 数据库进行全面的安全监测.
主要方法:
- 从FAERS (2021-2023) 收集了inclisiran相关的AE数据.
- 员工报告概率比率 (ROR) 和信息组件 (IC) 用于信号检测.
- 使用医学监管活动词典 (MedDRA) 进行系统器官类别 (SOC) 和首选术语的标准化分析.
主要成果:
- 从超过1700万份报告中分析了2,976个与inclisiran相关的AE.
- 在15个SOC中识别了102个AE信号.
- 新信号包括肌肉损伤,肝损伤,糖尿病和神经认知功能障碍,其中86个事件以前没有在药物标签上列出.
结论:
- 从inclisiran药物标签和临床试验中确认已知的副作用.
- 确定了新的安全信号,包括肌肉疼痛,肝酶升高,高血糖和神经认知问题.
- 这种现实世界的证据为合理和安全使用inclisiran提供了关键的见解.
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