长期保留,有效性和安全性:扩展访问计划的结果
Anetta Lasek-Bal1, Barbara Kściuk2, Tomasz Zieliński2
1Medical University of Silesia, Katowice, Poland.
在波兰的扩大接入计划 (EAP) 中,辅助性赛诺巴 (CNB) 在耐药性患者中显示出持续的长期有效性. 该研究显示,在41个月内,100%的保留率和明显的发作减少,没有新的安全问题.
科学领域:
- 神经学 神经学
- 发病学 (Epileptology) 是一个专业的学科.
- 药理学 药理学是指药理学的学科.
背景情况:
- 耐药性在患者管理中构成了重大挑战.
- 抗发作药物的长期保留率是治疗有效性的关键指标,包括疗效,安全性和耐受性.
- 波兰扩大获取计划 (EAP) 为符合条件的患者提供了一条继续获得青酸盐 (CNB) 的途径.
研究的目的:
- 为了评估药物耐药性患者中辅助性赛诺巴 (CNB) 的长期保留率,疗效和耐受性.
- 在波兰扩展访问计划 (EAP) 的框架内评估CNB待遇的持续益处.
主要方法:
- 对2020年1月至2023年5月在EAP中接受CNB的焦点患者进行了多中心的回顾性分析.
- 收集的数据包括酸的保留率,发作结果 (频率减少,发作自由) 和不良事件.
- 患者包括那些完成了相关临床试验的开放扩展阶段并继续在EAP中使用CNB的患者.
主要成果:
- 38名患者接受了中位数41个月的CNB治疗,观察到100%的保留率.
- 辅助CNB治疗可以将每月平均发作频率从8.1降低到3.0.
- 超过63%的患者实现了≥50%的发作减少,21%的患者实现了至少12个月的发作自由. 常见的不良事件包括头,昏昏欲睡和头痛,这些通常是可以控制的.
结论:
- 在EAP中,在耐药性患者中,长期使用辅助赛诺巴治疗具有持续的显著疗效,由≥50%的发作减少和超过41个月的100%保留率证明.
- 在长期跟踪期间,没有发现新的安全问题.
- 这些发现支持塞诺巴马特在耐火性患者中提供长期实质性临床益处的可能性.
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