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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 and valproate in the treatment of children with epilepsy. Methods Fifty-four children with epilepsy were randomly divided into topiramate treatment group (n = 30) and sodium valproate treatment group (n = 24). Topiramate treatment group received topiramate treatment, the dose from 1 to 3 mg.kg-1.d-1 (maximum: 25mg) per night increased to 5-9mg.kg-1.d-1, 2 times; valproic acid Sodium treatment group received sodium valproate 20mg / kg (divided 2 times), gradually increase the amount of serious cases in the detection of plasma concentrations, the amount can be increased up to 40mg / kg. Record possible side effects during hospitalization. Results The total effective rates of the two groups were 70% and 66.7% respectively, with no significant difference (P = 0.793). The incidence of adverse reactions were 26.67% and 16.67% respectively, with no significant difference (P = 0.583) . Conclusion There is no significant difference in the efficacy and safety of topiramate and valproate in the treatment of children with epilepsy.