左乙拉西坦添加治疗4岁以下儿童难治性癫癎的疗效和安全性研究

Efficacy and safety of adjunctive levetiracetam in children younger than 4 years with refractory epilepsy

摘要:

目的：评价左乙拉西坦（LEV）添加治疗4岁以下小儿难治性癫癎的疗效和安全性。方法：采用开放性自身对照研究对112例不同发作类型的难治性癫癎患儿进行LEV添加治疗，原抗癫癎药物继续服用。起始剂量为每日10 mg/kg，每1～2周增加上述剂量一次，3～4周加至目标剂量每日20～40 mg/kg，分2次服用，随访观察其疗效和不良反应。结果：全部病例平均随访时间13月（6～22月）。完全控制14例（12.5％），有效43例（38.4％），总有效率50.9％；无效53例（47.3％），加重2例（1.8％）。主要不良反应有不同程度的情绪异常（烦躁、睡眠时间减少、夜惊）、乏力、嗜睡及胃肠道反应。大多数患儿均可耐受，仅3例因此停药。结论：LEV作为添加治疗4岁以下儿童的难治性癫癎有确切的疗效，良好的耐受性，可在临床进一步推广使用。［中国当代儿科杂志，2010，12（4）：256-258］

Abstract:

OBJECTIVE: To evaluate of the efficacy and safety of adjunctive levetiracetam (LEV) in children younger than 4 years with refractory epilepsy. METHODS: One hundred and twelve children at age of 4 months to 4 years with refractory epilepsy received LEV as adjunctive therapy. LEV was administered in two equal daily doses of 10 mg/kg. The dose was increased by 10 mg/kg every week up to the target dose (20-40 mg/kg). The efficacy and tolerability were evaluated. RESULTS: At an average follow-up period of 13 months (6-22 months), LEV administration was found to be effective in 43 children (38.4%) (responders showing more than a 50% decrease in seizure frequency) and 14 children (12.5%) became seizure-free. Fifty-three children (47.3%) did not respond to the treatment and 2 children (1.8%) worsened. The therapy-related adverse events were mild, including restlessness,. reduction in sleep time, night terrors, debility, somnolence, nausea and vomiting. The adverse events were either tolerable or resolved in time with dosage reduction in most of children, and only 3 cases required discontinuation. CONCLUSIONS: LEV as adjunctive therapy is effective and well-tolerated in children younger than 4 years with refractory epilepsy, suggesting that it represents a valid option for the treatment of refractory epilepsy in this age group.［Chin J Contemp Pediatr, 2010, 12 (4):256-258］