长期有效性,安全性和耐受性,包括行为和执行功能,在儿科患者的辅助lacosamide治疗期间,患有不受控制的
Mark Kristof Farkas1, Iryna Makedonska2, Cynthia Beller3
1Pediatric Center, Semmelweis University, Bókay János u. 53-54, Budapest 1083, Hungary.
长期的辅助拉科萨米德 (LCM) 对于儿科是有效的,耐受性很好,显示持续的控制和稳定的行为. 这种治疗没有证明儿童的执行功能恶化.
科学领域:
- 儿科神经学 儿科神经学
- 的治疗方法 治疗
- 药理学 药理学是指药理学的学科.
背景情况:
- 症影响着全球相当数量的儿童.
- 儿童的长期治疗选择对于治疗慢性疾病至关重要.
- 对儿科患者来说,评估抗药对行为和认知的影响至关重要.
研究的目的:
- 评估辅助拉科萨米德 (LCM) 的长期疗效,安全性和耐受性,在患有焦点发作或泛发作的儿科患者中.
- 评估LCM对儿童长期治疗期间行为和执行功能的影响.
主要方法:
- 两项开放扩展试验 (NCT00938912,NCT01964560) 涉及905名患有的儿科患者.
- 结果包括治疗的延续,发作频率的减少和不良事件的评估.
- 行为和执行功能使用阿肯巴赫儿童行为检查清单 (CBCL) 和执行功能的行为评级清单 (BRIEF) 进行了评估.
主要成果:
- 在焦点发作的发作中,高1年保留率 (80%) 和显著的发作频率减少 (中位数为60.4%).
- 超过75%的患者表现出改善,根据医生和护理人员的全球印象尺度.
- 治疗引起的不良事件很常见 (82.8%),最常见的是炎症和上呼吸道感染;行为和执行功能保持稳定或改善.
结论:
- 长期的辅助拉科萨米德 (LCM) 是有效的,并且在患有焦点发作或泛发作的儿童中通常耐受良好.
- 辅助LCM治疗没有导致儿科患者的行为或执行功能明显恶化.
- 这项研究支持使用LCM作为儿科的长期治疗选择.
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