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目的探讨左乙拉西坦(LEV)治疗不同类型儿童癫癎的疗效和安全性。方法采用前瞻性、多中心、开放性研究,共纳入164例癫癎患儿,分别接受LEV单药治疗(单药治疗组)及联合治疗(多药治疗组)。LEV起始剂量为(15.8±7.4)mg·kg-1·d-1,分2次服用,每2～4周增加10mg·kg-1·d-1,维持剂量为(47.0±11.6)mg·kg-1·d-1。以治疗前的发作频率为基础,随访(4.2±1.1)个月,观察发作频率变化及不良反应。10例患儿因无效、发作加重或经济因素终止LEV治疗。采用SPSS15.0软件分析癫癎患儿LEV治疗前后发作频率变化及安全性。结果 164例癫癎患儿中控制86例,显效28例,有效18例,无效27例,加重5例。单药治疗组和多药治疗组患儿治疗前后的平均发作频率比较差异均有统计学意义,单药治疗组平均最大剂量较多药治疗组低。仅少数患儿出现不良事件,出现不良事件和未出现不良事件患儿间接受的给药剂量(最大剂量)比较差异无统计学意义。结论 LEV作为单药治疗或添加治疗对多种癫癎均有疗效,尤其对继发全面性发作、全面性强直阵挛发作、肌阵挛发作、复杂局限性发作等具有较好治疗效果,且不良反应少。
Objective To investigate the efficacy and safety of levetiracetam (LEV) in the treatment of different types of children with epilepsy. Methods A prospective, multicenter, open-label study of 164 children with epilepsy was enrolled in this study. Patients received LEV monotherapy (single-agent treatment) and combination therapy (multi-agent treatment), respectively. The initial dose of LEV was (15.8 ± 7.4) mg · kg-1 · d-1 and was administered in 2 doses. The dosage of LEV was increased by 10 mg · kg-1 · d-1 every 2 to 4 weeks and the maintenance dose was (47.0 ± 11.6) mg · Kg -1 · d -1. Based on the frequency of pre-treatment seizures, follow-up (4.2 ± 1.1) months was performed to observe the frequency of seizures and adverse reactions. Ten patients discontinued LEV because of ineffectiveness, exacerbations, or economic reasons. SPSS15.0 software was used to analyze the changes of seizure frequency and safety before and after LEV treatment in children with epilepsy. Results 164 cases of epilepsy in children control 86 cases, 28 cases markedly effective in 18 cases, 27 cases ineffective, aggravated in 5 cases. The mean seizure frequency of single-drug treatment group and multi-drug treatment group before and after treatment were statistically significant difference, the single-drug treatment group average maximum dose than the low-drug treatment group. Only a small number of children with adverse events, the occurrence of adverse events and no adverse events in children received dose (maximum dose) was no significant difference. Conclusions LEV, as a monotherapy or adjuvant therapy, has therapeutic effects on various epilepsy, especially for secondary full-blown episodes, comprehensive tonic-clonic seizures, myoclonic seizures and complicated and limited seizures. Adverse reactions.