症中品牌与通用lacosamide的有效性和安全性:一个回顾性的现实世界研究
Giuseppe Salafica1, Diana Tilenni1, Attilio Vinaccia1
1Neurophysiopatology and Movement Disorders Clinic, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
概括
仿制乳胺 (Stutan®) 的疗效和安全性与品牌Vimpat®对患者的疗效和安全性相当. 这项现实世界的研究支持仿制性lacosamide作为一个可行的替代方案来管理焦点发作和普遍性.
科学领域:
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
- 发病学 (Epileptology) 是一个专业的学科.
背景情况:
- 拉科萨米德 (LCS) 是第三代抗发作药物 (ASM),用于治疗焦点发作和普遍性.
- 品牌Vimpat®已经确立了有效性和安全性,但像Stutan®这样的仿制配方引发了关于临床等价性的问题.
- 与通用ASM的潜在治疗波动可能导致突破性发作或不良事件.
研究的目的:
- 为了比较品牌lacosamide (Vimpat®) 与其通用对应物 (Stutan®) 的实际有效性,安全性和耐受性.
- 评估用任何一种配方治疗的焦点或泛性患者的临床结果.
主要方法:
- 这是一项多中心,回顾性,观察性研究,涉及60名成年患者.
- 患者被分为两组,30组接受品牌LCS (Vimpat®) 和30组接受通用LCS (Stutan®).
- 收集的数据包括发作频率,不良事件和剂量调整,主要结果是响应率 (≥50%的发作减少).
主要成果:
- 品牌和仿制乳胺组的基线特征在品牌和仿制乳胺组之间类似.
- 尽管Vimpat®组的平均每日剂量 (275毫克与168毫克) 显著更高,但疗效结果相似.
- 对Vimpat®的响应率为60.0%,对Stutan®的响应率为43.3% (p=0.08),在两组中报告了轻度至中度不良事件.
结论:
- 在现实环境中,通用拉科萨米德 (Stutan®) 的疗效,安全性和耐受性与品牌拉科萨米德 (Vimpat®) 相同.
- 这些发现支持临床使用仿制乳胺作为管理的有效替代品.
- 进一步的研究可能会探索长期的结果和患者报告的与通用ASM的经验.
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