托吡酯与丙戊酸钠治疗小儿癫痫的有效性及安全性对照研究  

A study to compare the efficacy and safety of topiramate versus sodium valproate in children with epilepsy

作　　者：农凤秋[1] 李薇[1] 陈艳玲[1] 钟顺平[1] 

机构地区：[1]广东省东莞市太平人民医院,523905

出　　处：《中国医疗前沿》2012年第24期43-44,共2页China Healthcare Innovation

摘　　要：目的评估托吡酯与丙戊酸钠在治疗小儿癫痫的疗效及安全性的差异。方法 54名癫痫患儿随机分为托吡酯治疗组(n=30)与丙戊酸钠治疗组(n=24)。托吡酯治疗组接受托吡酯治疗,剂量从每晚1次1-3mg.kg-1.d-1(最大:25mg)增加到5-9mg.kg-1.d-1,分2次;丙戊酸钠治疗组接受丙戊酸钠20mg/kg(分2次),逐渐加量,严重病例在检测血药浓度情况下,可加量至最高40mg/kg。记录住院期间的可能副作用。结果两组总有效率分别为70%、66.7%%,差异不具有统计学意义(P=0.793);不良反应发生率分别为26.67%和16.67%,差异不具有统计学意义(P=0.583)。结论治疗小儿癫痫,托吡酯与丙戊酸钠的有效性及安全性不存在明显差异。Objective To evaluate the efficacy and safety of topiramate versus sodium valproate in children with epilepsy. Methods 54 cases children with epilepsy randomly divided into topiramate group（n=30） and sodium valproate group（n=24）, Topiramate group received topiramate from 1-3·kg-1·d-1 ;（maximum： 25mg） given nightly, increased to 5-9mg·kg-1·d-1; given in 2 divided doses, Sodium valproate group was given sodium valproate 20mg/kg daily in 2 divided doses, increased gradually to 40mg/kg daily with serum valproic acid monitoring in severe cases. Suspected adverse drug reactions（ADRs） occurring during hospitalization were documented. Results The total effectiveness of topiramate group, sodium valproate group were 70%, 66.67%, no significant differences in two groups（P=0. 793）. There was no significant difference in ADRs between the two groups（26.67% Vs 16.67%, P=0.583）. Conclusion There is no substantial differences in efficacy and safety appear to exist when topiramate is compared with sodium valproate in treating children with epilepsy.

关 键 词：托吡酯 小儿 癫痫 丙戊酸钠 

分 类 号：R971.6[医药卫生—药品]