摘要
目的研究托吡酯(TPM)单药长疗程治疗婴幼儿癫的效果及安全性。方法对2岁以下各种发作类型的癫患儿共131例进行长期开放性研究,予TPM片单药口服治疗:其中117例按照0.5～1.0 mg/(kg.d)起始,间隔1～2周增加剂量0.5～1.0 mg/(kg.d)1次,直至目标剂量或最大耐受程度为止;14例发作频繁的患儿采用快速加量法,即住院密切观察下间隔2～3 d增加TPM剂量[0.5～1.0 mg/(kg.d)]1次。随访1～7 a,观察有效率、无发作率及用药剂量等,分析TPM单药治疗的疗效,终止TPM治疗的原因、添加或转换其他药物治疗,TPM长期治疗的不良反应。结果1.第1次发作至开始用药时间为1.0 d～1.5 a,平均3个月。末次随访年龄1.5～9.0岁。最终51.15%患儿保留单药治疗,4.58%患儿已停药。2.婴幼儿131例中,73例单药治疗有效,有效率为55.73%,其中64例无发作,无发作率48.85%;58.33%全面性发作单药治疗有效,51.05%无发作;局限性发作有效率为51.52%,45.45%无发作;TPM有效剂量为(2.85±1.31)mg/(kg.d),无效剂量为(4.27±2.08)mg/(kg.d),无效剂量显著高于有效剂量(P<0.01)。3.随访1、3、5、7 a,总有效率(无发作率)分别为60.47%(51.94%)、59.60%(52.53%)、55.0%(47.50%)、68.42%(47.37%)。4.不能耐受患儿占10.68%,不良反应主要为无汗及发热,食欲明显下降,体质量不增,易哭闹,睡眠不安。结论采用TPM单药长疗程治疗婴幼儿癫疗效好,安全性较好。
Objective To evaluate long - term efficacy and safety of topiramate （TPM） as monotherapy in infants with various types of epilepsy. Methods One hundred and thirty - one infants, aged lower 2 years, with various types of epilepsy were underwent open - label experience with topiramate table as monotherapy ： 117 infants recepted TPM began as 0.5 - 1.0 mg/（ kg· d）, their dose had been added 0.5 - 1.0 mg/（ kg·d） every 1 - 2 weeks until they got to the subject doses or the most endurece doses, 14 infants with often seizures recepted the rapid dose adding, their TPM doses had been added 0.5 - 1.0 mg/（ kg·d） every 2 - 3 days. The ratio of effective and seizure free were assessed after 1 to 7 years ; the curative effects of TPM, the reason for which TPM therapy had been stopped or translated to other drugs or added by other drugs, and the side effects were also evaluated during open - label treatment period. Results 1. The period from the first attach to TPM therapy had been accepted were 1.0 day to 1.5 year, mean was 3 months, children were 1.5 - 9.0 years old when the last follow - up time, there Were 51.15 % of the patients being still taking TPM as monotherapy at last in this follow - up study, there were 4.58 % of the patients had stopped their therapy. 2. There were 73 children active to TPM ate monotherapy in 131 children in this investigation, the effective rate was 55.73%, there were 64 children had no attach, the seizure free rate was 48.85% ;the effective rate was 58.33% ,and the seizure free rate was 51.05 % in generalized seizure, those in local seizures were 51.52% and 45.45 %. The optinal dosage in effective patients was （ 2.85 ± 1.31 ） mg/（ kg·d）, the dosage in uneffective children was （4.27 ± 2.08 ） mg/（ kg·d）, there was significance different between them （ P 〈 0.01 ）. 3. The effective rate （ seizure - free rate ） in 1,3,5,7 years later were 60.47 % （51.94% ）, 59.60% （52.53%） ,55.0% （47.50%） ,68.42% （47.37%）. 4. Side effects were observed in 10.68% of 131 cases of epilepsy, the side effects included no sweat and fever, no appetite, lose of weight, disphoria as well as somnipathy. Conclusion TPM is a widespread antiepileptic drug with high efficacy and safetv for Ions - term ate as monotheraDv administration in infants with various types of epilepsy.
出处
《实用儿科临床杂志》
CAS
CSCD
北大核心
2009年第18期1439-1441,共3页
Journal of Applied Clinical Pediatrics
关键词
托吡酯
癫痫
疗效
婴幼儿
topiramate
epilepsy
efficacy
infant
