摘要
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 explore the clinical effect and safety of levetiracetam （LEV） in patients with every kind of epilepsy.Methods Prospective,multicenter and open-label study was performed,and this study enrolled 164 patients with different kinds of epilepsy,who began LEV treatment in monotherapy（monotherapy group） or combined with other antiepileptic drugs （polytherapy group） to assess the seizure frequency and safety.The average initial dose of LEV was （15.8±7.4） mg·kg^-1·d^-1wice a day;being increased by 10 mg·kg^-1·d^-1very 2-4 weeks and the average maintenance dosage was （47.0±11.6） mg·kg^-1·d^-1he seizure frequency reduction and adverse events were observed for （4.2±1.1） months on average,on the basis of seizure frequency before treatment.Ten patients withdrew the treatment for inefficacy,aggravation or economic problems.SPSS 15.0 was used to analyze the data including descriptive and analysis statistics.Results Among 164 epilepsy children,86 cases were seizure free,28 cases had apparent efficacy,18 cases had efficacy,27 cases had inefficacy and 5 cases had aggravation.The difference in the number of seizures before and after the study was statistically significant,both overall and for each type of epilepsy,regardless of whether the treatment was given as monotherapy or polytherapy.Only a few adverse events were observed, and there was no difference in the means of maximum doses received as adverse events were concerned.Conclusions LEV therapy for many kinds of childhood epilepsies was useful in seizure frequency reduction,especially for secondary general seizure,general tonic clonic seizure,myoclonic seizure,complex seizure,and few adverse events.
出处
《实用儿科临床杂志》
CAS
CSCD
北大核心
2010年第16期1270-1272,共3页
Journal of Applied Clinical Pediatrics
