左乙拉西坦治疗婴幼儿癫痫疗效和安全性评价

Preliminary Study on Efficacy and Safety of Levetiracetam in Infant with Epilepsy

目的:探讨左乙拉西坦治疗婴幼儿癫痫疗效及安全性。方法:选取我院收治的96例癫痫患儿按照随机数字表法分为实验组和对照组,每组48例,实验组患儿给予丙戊酸钠+左乙拉西坦治疗,对照组患儿给予丙戊酸钠+拉莫三嗪治疗,比较两组患儿临床治疗效果、治疗后脑电图恢复时间及不良反应发生情况,并对比实验组患儿脑电图异常者治疗情况。结果:两组患儿临床疗效和不良反应发生率比较,差异无统计学意义(P>0.05);实验组患儿治疗后脑电图平均恢复时间较对照组短,差异具有统计学意义(P<0.05);两组患儿治疗期间不良反应发生率比较,差异无统计学意义(P>0.05);背景异常但无痫性放电波患儿治疗效果最佳、有痫性放电波但背景无异常者次之,有痫性放电波且背景异常者临床治疗效果最差,提示痫性放电波越多、背景越异常治疗效果越差。结论:在丙戊酸钠基础上加用左乙拉西坦治疗婴幼儿癫痫可有效缩短患儿脑电图恢复时间且不会增加不良反应,临床疗效显著,安全性高,应用价值较高。

Objective To explore the efficacy and safety of levetiracetam in infant with epilepsy. Methods Ninety-six infants with epilepsy were randomly divided into experimental group （48 cases） and control group （48 cases）. The experimental group were treated by sodium valproate and levetiracetam, while the control group were treated by sodium valproate and lamotrigine. The clinical effects, electroencephalography （EEG） recovery time, adverse reactions were compared between the two groups, and the treatment condition of the infants with abnormal and normal electroencephalogram were compared within the experimental group. Results There was no significant difference on the clinical effects between the two groups（ P 〉 0. 05 ）. The average recovery time of electroencephalogram of patients in experimental group was shorter than that of control group （ P 〈 0.05 ）. There was no significant difference on the adverse reactions between the two groups （ P 〉 0.05 ）. The curative effect of infants with non-epileptic waves and abnormal background was best ,which was followed by that of epileptic waves and normal background. It worked worst on infants with epileptic waves and abnormal. These results indicated that the more abnormal background and epileptiform wave of EEG, the worse the curative effect was. Conclusion Administration with levetiracetam combined sodium valproate could effectively shorten the recovery time of EEG without increasing the incidence of adverse reaction, which is worth for clinical application for its efficacy and safety.