使用FDA不良事件报告系统对多发性硬化症进行dalfampridine的营销后安全监测
Rui Xiong1, Jing Lei2, Sicen Pan1
1Department of Pharmacy, The 958th Hospital of Chinese People's Liberation Army, Chongqing, China.
Frontiers in pharmacology
|October 2, 2023
概括
这项研究使用FAERS数据分析了dalfampridine不良事件,确定了多发性硬化症 (MS) 治疗的新安全信号. 这些发现为更安全的dalfampridine使用提供了洞察力.
科学领域:
- 药监和药物安全 药监和药物安全
- 临床药理学 临床药理学
- 神经学 神经学
背景情况:
- 达尔法姆普林是用于多发性硬化症 (MS) 的治疗药物.
- 营销后监测对于识别真实世界的不良事件至关重要.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 是药物监测的关键数据来源.
研究的目的:
- 为了调查和分析dalfampridine的营销后不良事件 (AE) 数据.
- 使用FAERS数据识别与dalfampridine相关的潜在新安全信号.
- 为达尔法姆普里丁在多发性硬化症治疗中提供临床安全应用参考.
主要方法:
- 利用OpenVigil2.1平台从FAERS (2010年2月 - 2022年9月) 中提取达尔法姆普里丁AE数据.
- 使用监管活动医学词典 (MedDRA) 进行AE术语匹配和分类.
- 应用了统计方法,包括报告几率比率 (ROR),比例报告比率 (PRR) 和贝叶斯信任传播神经网络 (BCPNN),以检测积极的AE信号.
主要成果:
- 分析了44092份与达尔法姆普里丁相关的AE报告,确定了335个显著的AE信号.
- 副作用在女性和45-65岁年龄组中更为普遍,与多发性硬化症的人口统计数据保持一致.
- 确定了药物说明书中以前没有详细介绍的新型AE信号,包括尿路感染,头,恶化的情况以及脊髓损伤等罕见事件.
结论:
- 通过FAERS的数据挖掘,成功地发现了dalfampridine的新不良事件信号.
- 这些发现强调了持续对达尔法姆普里丁药物监测的重要性.
- 这项研究为增强多发性硬化症管理中的dalfampridine安全临床应用提供了宝贵的见解.
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