拉考沙胺治疗16岁以下儿童癫痫的有效性和 安全性

The Effectiveness and Safety of Lacosamide in Pediatric Epilepsy Patients Aged ≤ 16 Years

摘要: 癫痫是儿童常见的慢性神经系统疾病之一，部分患儿对传统抗癫痫药物(AEDs)反应不佳，可能导致耐药癫痫发生。拉考沙胺(lacosamide, LCM)作为新型第三代抗癫痫药，其独特的作用机制是选择性促进电压门控钠通道慢失活，从而稳定神经元膜电位，抑制神经元的异常放电，这种机制提供了独特的治疗优势，特别是在控制癫痫发作的同时，将对正常神经元活动的干扰降至最低。研究表明，LCM具有线性药代动力学特征、生物利用度高、相互作用少，适用于长期维持治疗。国内外临床证据显示，LCM在儿童局灶性癫痫中疗效确切，无论作为单药还是辅助治疗均能显著降低癫痫的发作频率，且不良反应多为轻中度中枢症状，比如头晕、嗜睡和恶心。真实世界研究进一步证实其在低龄及婴幼儿群体中安全有效。LCM的良好耐受性、可预测药动学与潜在神经保护效应，使其成为儿童癫痫精准管理的重要选择。未来应加强多中心随机对照试验与长期随访，结合药物基因组学和群体药动学，完善个体化用药策略，为不同年龄层儿童提供更安全、有效的治疗方案。

Abstract: Epilepsy is one of the most common chronic neurological disorders in children. Among these, a subset of patients demonstrate inadequate responses to conventional antiepileptic drugs (AEDs), which may lead to drug-resistant epilepsy. Lacosamide (LCM), a third-generation AED, is distinct for its mechanism of action, selectively enhancing the slow inactivation of voltage-gated sodium channels, which stabilizes neuronal membrane potential and suppresses abnormal neuronal discharge. This mechanism provides a unique therapeutic advantage, particularly in controlling seizures while minimizing disruption to normal neuronal activity. Studies have shown that LCM exhibits linear pharmacokinetics, high bioavailability, and minimal drug interactions, making it suitable for long-term maintenance therapy. Furthermore, accumulating evidence from both domestic and international clinical practice supports the effectiveness and tolerability of LCM. Whether used as monotherapy or adjunctive therapy, LCM significantly reduces seizure frequency in pediatric focal epilepsy, with the majority of adverse events being mild to moderate central nervous system-related symptoms, such as dizziness, drowsiness, and nausea. Real-world studies further confirm its safety and efficacy in infants and young children. With favorable tolerability, predictable pharmacokinetic properties, and potential neuroprotective effects, LCM has become an important option in the precision management of pediatric epilepsy. Future research should emphasize multicenter randomized controlled trials and long-term follow-ups, integrating pharmacogenomics and population pharmacokinetics to optimize individualized dosing strategies and ensure safer, more effective treatment for children of different age groups.