Department of Neurology, Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts 02115, USA.
Pediatr Neurol. 2011 Jun;44(6):414-9. doi: 10.1016/j.pediatrneurol.2010.12.003.
We report our pediatric experience with lacosamide, a new antiepileptic drug, approved by the US Food and Drug Administration as adjunctive therapy in focal epilepsy in patients more than 17 years old. We retrospectively reviewed charts for lacosamide use and seizure frequency outcome in patients with focal epilepsy (Wilcoxon signed rank test). Sixteen patients (7 boys) were identified (median dose 275 mg daily, 4.7 mg/kg daily; mean age 14.9 years, range 8-21 years). Patients were receiving a median of 2 antiepileptic drugs (interquartile range [IQR] 1.7-3) in addition to having undergone previous epilepsy surgery (n=3), vagus nerve stimulation (n=9), and ketogenic diet (n=3). Causes included structural (encephalomalacia and diffuse encephalitis, 1 each; stroke in 2) and genetic abnormalities (Aarskog and Rett syndromes, 1 each) or cause not known (n=10). Median seizure frequency at baseline was 57 per month (IQR 7-75), and after a median follow-up of 4 months (range 1-13 months) of receiving lacosamide, it was 12.5 per month (IQR 3-75), (P<0.01). Six patients (37.5%; 3 seizure free) were classified as having disease that responded to therapy (≥50% reduction seizure frequency) and 10 as having disease that did not respond to therapy (<50% in 3; increase in 1; unchanged in 6). Adverse events (tics, behavioral disturbance, seizure worsening, and depression with suicidal ideation in 1 patient each) prompted lacosamide discontinuation in 4/16 (25%). This retrospective study of 16 children with drug-resistant focal epilepsy demonstrated good response to adjunctive lacosamide therapy (median seizure reduction of 39.6%; 37.5% with ≥50% seizure reduction) without severe adverse events.
我们报告了我们在小儿科使用拉考沙胺的经验，这是一种新的抗癫痫药物，已被美国食品和药物管理局批准作为 17 岁以上局灶性癫痫患者的附加治疗药物。我们回顾性地分析了使用拉考沙胺的图表和癫痫发作频率的结果（Wilcoxon 符号秩检验）。确定了 16 例患者（7 名男性）（中位数剂量 275mg/天，4.7mg/kg/天；平均年龄 14.9 岁，范围 8-21 岁）。患者正在接受中位数为 2 种抗癫痫药物（四分位距[IQR]1.7-3），此外还进行了以前的癫痫手术（n=3）、迷走神经刺激（n=9）和生酮饮食（n=3）。病因包括结构性（脑软化和弥漫性脑炎各 1 例；2 例中风）和遗传异常（Aarskog 和 Rett 综合征各 1 例）或病因不明（n=10）。基线时的中位癫痫发作频率为每月 57 次（IQR7-75），在接受拉考沙胺中位数 4 个月（范围 1-13 个月）的中位随访后，为每月 12.5 次（IQR3-75），（P<0.01）。6 例患者（37.5%；3 例无癫痫发作）被归类为对治疗有反应（癫痫发作频率降低≥50%），10 例对治疗无反应（3 例降低<50%；1 例增加；6 例无变化）。不良反应（抽搐、行为障碍、癫痫恶化和 1 例有自杀意念的抑郁症）促使 4/16（25%）例患者停用拉考沙胺。这项对 16 例耐药性局灶性癫痫儿童的回顾性研究表明，辅助拉考沙胺治疗效果良好（中位数癫痫发作减少 39.6%；37.5%癫痫发作减少≥50%），且无严重不良反应。
