伊来西胺单药治疗儿童癫痫部分性发作的临床疗效及安全性的研究

目的:评价伊来西胺(Ilepcimide)单药治疗儿童癫痫部分性发作的临床疗效及依从性。方法:收集2011年3～9月吉林大学第一医院小儿神经内科门诊癫痫部分性发作的患儿,2～5岁年幼组27例,5～15岁的年长组39例。所有患儿的伊来西胺初始计量均为5 mg·kg-1·d-1,如发作未被控制则每周加量<5 mg·kg-1·d-1,目标剂量为10 mg·kg-1·d-1,最大剂量<300 mg/d。观察期为6月,进行自身对照开放性研究,观察各组的维持期累计疗效,并进行安全性评估。结果:服药3个月后,年幼组的有效率、控制率分别为62.96%、40.74%,年长组的分别为64.10%、41.03%。服药6个月后,年幼组的有效率、控制率分别为77.78%、48.15%;年长组的分别为79.49%、51.28%。66例患儿在服药前及服药后第4周、3和6月时分别查血常规、尿常规、肝功能、肾功能、血液电解质及心电图,各项指标均未见异常改变。15.15%(10/66例)的患儿出现不良反应,主要表现为胃部不适、食欲差或恶心、疲倦、头晕、嗜睡的症状。结论:伊来西胺作为一种新型中药类抗癫痫药物对儿童癫痫部分性发作疗效良好,安全范围大,不良反应少,患者耐受性好,尤其适用伴有其他系统疾病的患者。

Study on clinical efficacy and safety of Ilepcimide monotherapy for treatment of children with partial seizures of epilepsy

Objective:To evaluate the clinical efficacy and compliance of Ilepcimide monotherapy for treatment of children with partial seizures of epilepsy.Methods:The children with partial seizures of epilepsy from outpatient department of Internal Medicine-Neurology of the first hospital of Jilin university from March to September in 2011 were collected,including 27 children aged 2-5 years old in younger group and 39 children aged 5-15 years old in older group.All the children were treated with Ilepcimide(initial dose: 5 mg·kg-1·d-1),if onset of epilepsy didn't be controlled very well,the dose added every week was less than 5 mg·kg-1·d-1,the target dose was 10 mg·kg-1·d-1,the maximum dose was less than 300 mg/d.All the children were observed for six months,then a self control open study was performed,the cumulative effects during maintenance stage in the two groups were observed,and evaluation of safety was conducted.Results:After three months,the effective rate and control rate in younger group were 62.96% and 40.74%,respectively;the effective rate and control rate in older group were 64.10% and 41.03%,respectively.After six months,the effective rate and control rate in younger group were 77.78% and 48.15%,respectively;the effective rate and control rate in older group were 79.49% and 51.28%,respectively.Before treatment and at four weeks,three and six months after treatment,the indexes of blood routine test,urine routine test,live function detection,renal function detection,blood electrolyte detection,and electrocardiogram were not found with any changes.Among 66 children,15.15%(10 children) of them were found with adverse reactions,the main manifestations included stomach discomfort,poor appetite or nausea,tired,dizzy giddy,and sleepiness.Conclusion:As a new antiepileptics,Ilepcimide has the advantages of good curative effect,larger safety range,less adverse reactions,and good tolerance for treatment of children with partial seizures of epilepsy,which is suitable for the patients combined with diseases of other systems.