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目的:评价左乙拉西坦作为添加剂治疗儿科难治性癫痫部分性发作的疗效和安全性。方法:本试验为单盲、安慰剂对照,前瞻性研究,25例难治性癫痫患者在原用药基础上加用安慰剂16周,停用安慰剂,再加用左乙拉西坦16周,χ2检验比较左乙拉西坦添加治疗期疗效与安慰剂疗效的差别,并观察其不良反应。结果:左乙拉西坦治疗总有效率为84%,安慰剂治疗总有效率为52%,左乙拉西坦治疗总有效率明显高于安慰剂(P<0.05)。左乙拉西坦添加治疗期19例(76%)出现不良反应,安慰剂添加期18例(72%)出现不良反应。左乙拉西坦添加治疗期的不良反应主要有头晕、胃肠不适、精神异常,部分患儿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。未发现其他明显不良反应。结论:左乙拉西坦可使其中48%的患儿达到无发作,可作为难治性癫痫的添加治疗,且儿童使用无明显不良反应,值得推广应用。
Objective: To evaluate the efficacy and safety of levetiracetam as an additive in the treatment of partial seizures in pediatric refractory epilepsy. METHODS: This trial was a single-blind, placebo-controlled, prospective study of 25 patients with refractory epilepsy plus placebo for 16 weeks on placebo, placebo-stopped, and levetiracetam for 16 weeks, Chi-square test was used to compare the curative effect of levetiracetam with placebo and to observe the adverse reactions. Results: The total effective rate of levetiracetam was 84%, and the total effective rate of placebo was 52%. The total effective rate of levetiracetam was significantly higher than that of placebo (P <0.05). Adverse reactions occurred in 19 patients (76%) treated with levetiracetam, and 18 (72%) in placebo. Adverse reactions during the treatment with levetiracetam were mainly dizziness, gastrointestinal discomfort, mental disorders, and some children had transient mild leucopenia, and no patients exited due to serious adverse reactions. No other obvious adverse reactions were found. Conclusion: Levetiracetam can make 48% of the children reach no seizure, which can be used as addictive treatment for refractory epilepsy, and there is no obvious side effect in children. It is worth to be popularized and applied.