
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
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。
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.