复发性缓解性多发性硬化症患者的fingolimod安全性:从EudraVigilance数据库中对数据的描述性分析
Victoria Nikitina1, Greta Santi Laurini1, Nicola Montanaro2
1Unit of Pharmacology, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, via Irnerio 48, 40126 Bologna, Italy.
Journal of the neurological sciences
|July 13, 2024
概括
这项研究分析了欧洲12年的fingolimod安全数据,发现虽然大多数不良事件不是严重的,但持续的药物监测对于长期治疗多发性硬化症至关重要.
科学领域:
- 药物监督 药物监督 药物监督
- 神经学 神经学
- 临床药理学 临床药理学
背景情况:
- 复发性复发性多发性硬化 (RRMS) 是MS最常见的形式.
- 芬戈利莫德是第一个被批准用于RRMS的口服疾病修饰疗法.
- 长期治疗需要持续的安全评估.
研究的目的:
- 在12年的时间内分析欧洲fingolimod的营销后药监数据.
- 识别和描述与fingolimod治疗相关的不良事件 (AE) 和严重不良事件 (SAE).
主要方法:
- 从EudraVigilance数据库中对药物反应对进行描述性分析.
- 包括2011年1月1日至2023年6月19日的数据.
- 总共收集和分析了22,957份报告.
主要成果:
- 大多数报告的副作用都涉及神经系统疾病 (例如,多发性硬化复发,头痛) 和淋巴细胞/白细胞数量的减少.
- 严重的不良事件 (SAE) 占报告的23%,其中MS复发,黄斑胀和胸是最常见的.
- 副作用的发生率,包括心脏,眼科和传染性SAEs,与现有文献一致,支持fingolimod的整体安全性.
结论:
- 芬戈利莫德证明了长期RRMS管理的总体可接受的安全性.
- 持续的药物监测对于检测MS患者的罕见,长期不良药物反应 (ADR) 至关重要.
- 对心脏,眼科和传染病事件的监测尤其重要.
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