摘要
目的:评价左乙拉西坦作为添加剂治疗成人耐药性癫痫部分性发作的疗效和安全性。方法:本试验为单盲、前瞻性研究,27例耐药性癫痫病人在原用药基础上加用安慰剂16 wk,停用安慰剂,再加用左乙拉西坦治疗16 wk,X^2检验比较左乙拉西坦添加期疗效与安慰剂期疗效的差别,并观察其不良反应。结果:左乙拉西坦治疗有效而安慰剂无效的病例13例(48%),安慰剂治疗有效而左乙拉西坦无效的病例5例(19%),左乙拉西坦治疗有效的病例数明显高于安慰剂治疗有效的病例数(P＜0．05)。左乙拉西坦添加治疗期21例(78%)出现不良反应,安慰剂添加期20例(74%)出现不良反应。左乙拉西坦添加治疗期的不良反应主要有情绪异常、头晕、胃肠不适,部分病人有短暂性轻度血白细胞减少,没有病例因严重不良反应退出。结论:左乙拉西坦治疗成人耐药性癫痫部分性发作有效,且不良反应轻,对耐药性癫痫病人是一种有益的选择。
AIM： To evaluate the therapeutic effect and safety of levetiracetam as an additive therapy in patients with focal drug resistance epilepsy. METHODS： A single-blind prospective trial was carried out, 27 patients by administrating placebo as additive treatment together with basic drugs for 16 wk, and then the placebo was replaced by levetiracetam for another 16 wk. The X^2 test was used to compare the therapeutic effects between the additive treatment and the placebo administration; and simultaneously with evaluation of drug safety. RESULTS： In the 27 patients, 13 patients （48 %） had good therapeutic effect with levetiracetam and no effect by placebo; 5 patients （19 % ） had good therapeutic effect with placebo and no effect through levetiracetam; showing significantly difference between the two （P 〈 0.05）. Adverse reactions occurred in 21 patients （78 %） and 20 patients （74 %） in levetiracetam and placebo therapy groups respectively. Somnolence, mood upset, dizziness and gastro-intestinal disfunction were the commonly seen symptoms; and sometimes having a transient leucocytes reduction in a few patients. CONCLUSION： Levetiracetam is a new anti-epileptic drug of mild adverse reaction and ought to be the beneficial choice for adult patients with drug resistance epilepsy.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2007年第5期381-384,共4页
Chinese Journal of New Drugs and Clinical Remedies
关键词
左乙拉西坦
癫痫
药物疗法
安全
抗药性
levetiracetam
epilepsy
drug therapy
safety
drug resistance
