左乙拉西坦口服液治疗儿童部分性癫痫的临床研究  

Clinical trial of levetiracetam oral solution in the treatment of partial-onset seizures in children

作　　者：王红梅[1] 王晓慧[1] 方方[1] 丁昌红[1] 吴沪生[1] 吕俊兰[1] 韩彤立[1] 陈春红[1] 肖静[1] 郑华[1] 金洪[1] 王旭[1] 伍妘[1] 杨欣英[1] 张炜华[1] 李久伟[1] 赵建波[1] 

机构地区：[1]首都医科大学附属北京儿童医院神经内科,北京100045

出　　处：《中国临床药理学杂志》2016年第19期1753-1755,1762,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察左乙拉西坦治疗儿童部分性癫痫的临床疗效及安全性。方法将57例部分性癫痫患儿分为对照组10例和试验组47例。对照组在保留原有药物剂量不变的情况下,予以口服左乙拉西坦,起始剂量10 mg·kg-1·d^(-1),每5~7 d增加5~10 mg·kg-1·d^(-1),经2~4周达到维持剂量为20~60mg·kg-1·d^(-1)。试验组予以左乙拉西坦单药治疗,用法用量和对照组一样。2组患儿治疗至少12个月。比较2组患儿的临床疗效和药物不良反应的发生情况。结果治疗3,6,12个月,试验组的癫痫完全控制率分别为53.19%,57.45%,48.94%,总有效率分别为80.85%,78.72%,68.09%;对照组的癫痫完全控制率均为20.00%,总有效率分别为30.00%,50.00%,30.00%。2组患儿治疗6个月的癫痫完全控制率及治疗3,12个月的总有效率比较差异均有统计学意义(P<0.05)。试验组发生的药物不良反应共11例,包括易激惹、皮疹、多动等,对照组发生的药物不良反应共4例,包括攻击行为、嗜睡、皮疹等,2组患儿的药物不良反应多数为一过性,症状轻微。试验组和对照组的药物不良反应发生率分别为23.40%和40.00%,差异无统计学意义(P>0.05)。结论左乙拉西坦治疗婴幼儿及年幼儿童部分性癫痫是有效的,且不增加药物不良反应的发生率。Objective To explore the clinical efficacy and safety of levetiracetam（LEV） oral solution in the treatment of partial-onset seizures in children.Methods Fifty-seven children with partial-onset seizures were divided into control group（n = 10） and treatment group（n = 47）.Control group was treated with adjunctive therapy,the starting dose was 10 mg·kg-1·d^（-1）,and increased by 5-10 mg·kg-1·d^（-1）per 5-7 d till the maintenance dose 20-60 mg·kg-1·d^（-1）with 2-4weeks.Treatment group was treated with LEV monotherapy,the dosage of LEV was the same as the control group.Two groups were treated for at least 12 months.The clinical efficacy and adverse drug reactions were compared between two groups.Results 3,6,12 months after treatment,complete control rates of epilepsy were 53.19%,57.45%,48.94%,and the total effective rates were 80.85%,78.72%,68.09%in treatment group;complete control rates of epilepsy were 20.00%,and the total effective rates were 30.00%,50.00%,30.00% in control group.There were significant differences with complete control rates of epilepsy 6 months after treatment and total effective rates 3,12 monthsafter treatment in two groups（P〈0.05）.The adverse drug reactions were based on irritable,skin rash,hyperactivity,etc in treatment group,which were aggressive behavior,lethargy,skin rash,etc in control group.Most of the symptoms were light and most transient.The incidence of adverse drug reactions in treatment and control groups were23.40% and 40.00% respectively,without significant difference（P〉0.05）.Conclusion LEV oral solution is effective and well-tolerated in infants and young children with partial-onset seizures.

关 键 词：左乙拉西坦 癫痫 儿童 临床疗效 药物不良反应 

分 类 号：R971.6[医药卫生—药品]