左乙拉西坦治疗儿童失神癫痫的疗效及安全性观察

Monotherapy with levetiracetam for absence epilepsy in children

目的观察左乙拉西坦治疗儿童失神癫痫的疗效及安全性。方法2009年1月至2010年6月前瞻性入选我院收治的55例儿童典型失神癫痫患者，分组采用左乙拉西坦（研究组）、丙戊酸（对照组）单药治疗，并进行1年的治疗和随访观察，比较两组患者治疗前、治疗6个月及12个月时的癫痫发作频率、脑电图异常率、临床有效率及不良反应发生情况。结果研究组25例、对照组30例均完成了治疗1年的随访评估。两组患者治疗后癫痫发作频率均无较治疗前加重情况；两组治疗6个月和12个月时癫痫发作频率（t值分别为0．760、0．670，P值分别为0．450、0．504）和脑电图异常率（χ2值分别为0．120、0．043，P值分别为0．729、0．836）比较差异无统计学意义；两组患者治疗后6个月、12个月时临床有效率比较差异无统计学意义（χ2值分别为0．051、0．078，P值分别为0．821、0．780）。研究组2例（8．0％）出现轻微不良反应（1例烦躁，1例嗜睡）；对照组2例（6．7％）出现轻微不良反应（1例体重明显增加，1例出现恶心、呕吐）。两组患者治疗后无死亡等严重不良事件发生。结论左乙拉西坦作为一种新型抗癫痫药物对于儿童失神癫痫的单药治疗疗效肯定，并显示了较好的安全性。

Objective To assess the efficacy and safety of levetiracetam （LEV） monotherapy in children with absence epilepsy. Methods Fifty five children [ 34 males, 21 females, aged （8.1 ±4. 8 ）y ] with typical absence seizures were treated with LEV （ n = 25 ） or valproic acid （ VPA, n = 30） from Jan 2009 to Jun 2010. Patients were followed up for ly; the seizure frequency, electroencephalogram （EEG） and side effect were observed at 6th month and 12th month after the initiation of therapy. Results During the follow-up, none bad aggravated symptoms of epilepsy. There were no significant differences in seizure frequency（ t = 0. 76, P = O. 450 ; t = 0. 67, P = 0. 504 ）, abnormal EEG （ χ2 = 0. 120, P = 0. 729 ; χ2 = 0. 043, P = 0. 836 ） and seizure control （ χ2 = 0. 051, P = 0. 821 ; χ2 = 0. 078, P = 0. 780 ） after 6 and 12 months of treatment between two groups. No death or severe side effects were observed; 2 cases （8.0%） in LEV group had mild adverse effect（ drowsiness and restlessness）and 2 cases （6. 7% ） in VPA group had weight gain and nausea. Conclusion The results suggest that monotherapy with LEV is effective and safe for treatment of childhood absence epilepsy.