PURPOSE The aim of this study was to evaluate the tolerability and efficacy of lacosamide (LCM) in Lebanese children with focal-onset seizures and to determine if specific variables are predictive of better effectiveness. METHODS This is a retrospective analysis from three medical centers on consecutive children diagnosed with focal onset seizures and initiated on LCM. The seizure frequencies following the introduction of LCM were recorded and compared to the baseline monthly frequency at 3, 6, 12, 18, and 24 months. The primary efficacy variables were the 50% responder and seizure-free rates. The secondary outcome variables included the terminal 6-month seizure remission and percentages of discontinuation due to lack of efficacy or tolerability. RESULTS 58 patients with a mean age of 10 years experiencing a mean of 36.2 seizures per month during baseline were included. The seizure-free rates were 32.8%, 29.7%, and 12.5% at 6, 12 and 24 months follow up, respectively. Patients concomitantly treated with a sodium channel blocker were less likely to achieve a terminal 6-month seizure remission while the early introduction of LCM resulted in a significantly higher likelihood of attaining such a remission. 74.1% of patients were still maintained on LCM at the last follow-up. The most common adverse events consisted of dizziness, somnolence, nausea, vomiting, and rarely double vision. CONCLUSIONS LCM is efficacious and overall well tolerated in children with focal-onset seizures and exhibits higher efficacy with early introduction and when added to a non-sodium channel blocker.

中文翻译：

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拉考沙胺治疗儿童的疗效和耐受性：来自中东的上市后经验。

目的本研究的目的是评估拉可酰胺（LCM）在患有局灶性发作的黎巴嫩儿童中的耐受性和疗效，并确定特定变量是否可预测更好的疗效。方法这是来自三个医疗中心对被诊断患有局灶性癫痫发作并开始LCM的连续儿童的回顾性分析。记录引入LCM后的癫痫发作频率，并与3、6、12、18和24个月的基线每月频率进行比较。主要功效变量为50％反应者和无癫痫发作率。次要结果变量包括终末6个月癫痫发作缓解和因缺乏疗效或耐受性而终止治疗的百分比。结果58例平均年龄为10岁的患者平均经历了36例。包括基线期间每月2次癫痫发作。在随访的6、12和24个月中，无癫痫发生率分别为32.8％，29.7％和12.5％。伴随使用钠通道阻滞剂治疗的患者实现终末6个月癫痫缓解的可能性较小，而早期引入LCM导致获得这种缓解的可能性明显更高。在最后一次随访中，仍有74.1％的患者仍接受LCM。最常见的不良事件包括头昏眼花，嗜睡，恶心，呕吐和很少出现复视。结论LCM对局灶性癫痫发作的儿童有效且总体耐受性良好，并且在早期引入时以及与非钠通道阻滞剂合用时表现出更高的疗效。分别进行12个月和24个月的随访。伴随使用钠通道阻滞剂治疗的患者实现终末6个月癫痫缓解的可能性较小，而早期引入LCM导致获得这种缓解的可能性明显更高。在最后一次随访中，仍有74.1％的患者接受LCM维持治疗。最常见的不良事件包括头昏眼花，嗜睡，恶心，呕吐和很少出现复视。结论LCM对局灶性癫痫发作的儿童有效且总体耐受性良好，并且在早期引入时以及与非钠通道阻滞剂合用时表现出更高的疗效。分别进行12个月和24个月的随访。伴随使用钠通道阻滞剂治疗的患者实现终末6个月癫痫缓解的可能性较小，而早期引入LCM导致获得这种缓解的可能性明显更高。在最后一次随访中，仍有74.1％的患者接受LCM维持治疗。最常见的不良事件包括头昏眼花，嗜睡，恶心，呕吐和很少出现复视。结论LCM对局灶性癫痫发作的儿童有效且总体耐受性良好，并且在早期引入时以及与非钠通道阻滞剂合用时表现出更高的疗效。伴随使用钠通道阻滞剂治疗的患者实现终末6个月癫痫缓解的可能性较小，而早期引入LCM导致获得这种缓解的可能性明显更高。在最后一次随访中，仍有74.1％的患者仍接受LCM。最常见的不良事件包括头昏眼花，嗜睡，恶心，呕吐和很少出现复视。结论LCM对局灶性癫痫发作的儿童有效且总体耐受性良好，并且在早期引入时以及与非钠通道阻滞剂合用时表现出更高的疗效。伴随使用钠通道阻滞剂治疗的患者实现终末6个月癫痫缓解的可能性较小，而早期引入LCM导致获得这种缓解的可能性明显更高。在最后一次随访中，仍有74.1％的患者仍接受LCM。最常见的不良事件包括头昏眼花，嗜睡，恶心，呕吐和很少出现复视。结论LCM对局灶性癫痫发作的儿童有效且总体耐受性良好，并且在早期引入时以及与非钠通道阻滞剂合用时表现出更高的疗效。很少有双眼。结论LCM对局灶性癫痫发作的儿童有效且总体耐受性良好，并且在早期引入时以及与非钠通道阻滞剂合用时表现出更高的疗效。很少有双眼。结论LCM对局灶性癫痫发作的儿童有效且总体耐受性良好，并且在早期引入时以及与非钠通道阻滞剂合用时表现出更高的疗效。