左乙拉西坦单药治疗小儿癫癎的疗效和安全性随访研究

Follow up study on levetiracetam monotherapy in children with epilepsy

摘要:

目的：评价左乙拉西坦(LEV)单药治疗小儿癫癎的疗效和安全性。方法：对该院2007年3月至2008年3月LEV单药治疗的32例癫癎患儿进行开放性自身对照随访研究，起始量每日10 mg/kg，每1周增加上述剂量1次，3~4周增加至维持剂量每日20～60 mg/kg，平均剂量为每日35 mg/kg。结果：LEV 单药治疗32例，失访1例，其余随访均在3个月以上。 80.6%（25/31）患儿发作减少≥50%，70.9%（22/31）患儿无发作，16.1%（5/31）患儿因发作控制不满意或者加重而停药。不良反应包括情绪异常19.4%（6/31），乏力6.5%（2/31），嗜睡6.5%（2/31），皮疹3.2%（1/31）。上述不良反应均为一过性，在1～4 周内自然消失或者减量后消失，未导致停药，未发现过敏以及血液、肝、肾功能异常等严重不良反应。结论：LEV用于癫癎患儿（包括<4岁的婴幼儿）的部分性发作及全身性发作的单药治疗，疗效肯定、安全性好，是一个很有希望的用于儿童单药治疗的广谱抗癫癎药。

Abstract:

OBJECTIVE: To evaluate the efficacy and tolerability of levetiracetam (LEV) in the treatment of epilepsy as a monotherapy in children. METHODS: hirty-two children with epilepsy (age ranged from 8 months to 12 years) and who had received LEV monotherapy were investigated by a self-controlled and open-label research. LEV was administered at a dose of 10 mg/kg?d, and increased by 10 mg/kg?d per week till to the target dose (20-40 mg/kg?d), with a mean dose of 35 mg/kg?d. RESULTS: Thirty-one patients were followed up for more than three months. Twenty-five patients (80.6%) had at least 50% reduction in seizures, 22 cases (70.9%) became seizure-free, and LEV therapy was discontinued in 5 patients (16.1%) due to either an inadequate seizure control or aggravated seizures. The therapy-related adverse events included mood and behavioral changes (6/31, 19.4%), asthenia (2/31, 6.5%), somnolence (2/31, 6.5%), and skin rashes (1/31, 3.2%). The adverse effects were spontaneously disappeared or disappeared after reducing the LEV dose. CONCLUSIONS: LEV monotherapy is effective and safe for the control of partial and generalized tonic-clonic seizures in children with epilepsy. LEV appears to be a promising anti-epileptic drug for monotherapy in children with epilepsy.