托吡酯多中心开放性治疗2岁以下小儿癫痫的临床观察  

An open-label multicenter trial of topiramate therapy in Chinese infants younger than 2 years of age

作　　者：中国托吡酯协作研究组 于辛[1,2] 黄远桂[1] 

机构地区：[1]第四军医大学西京医院神经内科,西安市710032 [2]解放军第401医院神经内科,山东省青岛市266071

出　　处：《实用医学杂志》2009年第1期62-65,共4页The Journal of Practical Medicine

摘　　要：目的:评价托吡酯(topiramate,TPM)对2岁以下癫痫患儿的疗效及安全性。方法:采用多中心开放性试验的方法对全国186家医院的493例2岁以下患儿进行TPM单用和添加治疗。研究包括8周回顾性基础期、8周加量期及12周稳定观察期。在加量期,TPM开始量为0.5～1mg/(kg·d),随后每周增加0.5～1mg/(kg·d),直到目标剂量达到4～9mg/(kg·d),维持此剂量12周为稳定观察期。结果:在493例患儿中,TPM单一用药302例(61.3%),添加治疗191例(38.7%)。癫痫发作频率减少≥50%者为438例(88.8%),发作频率增加>25%有16例(3.2%)。按发作类型统计,发作减少≥50%的患者中,简单部分性发作34例(94.4%),复杂部分性作33例(86.8%),部分继发全身发作163例(91.1%),全身强直-阵挛发作30例(93.8%),West综合征112例(84.2%)。无论单药或添加治疗,经统计学分析,TPM对各类型癫痫发作的疗效无明显差异(P>0.05)。不良事件发生者189例(38.3%),绝大多数为轻至中度损害,需住院治疗的仅2例(0.4%)。结论:TPM对2岁以下癫痫患儿各类型的癫痫发作有效,耐受性良好。Objective To assess the efficacy and safety of topiramate （TPM） in Chinese epileptic infants younger than 2 years old. Methods An open-label muhicenter trial was conducted in 493 cases in 186 hospitals by TPM-single and TPM-added treatment. The study included an 8-week baseline period followed by 8-week titration period and 12-week stabilization period. During the. titration period, the initial dose of TPM was 0.5 - 1 mg/（kg, d）, and added weekly by the same dose until the target dosage of 4 - 9 mg/kg stably for 12 weeks as the stabilization period. Results 302 cases （61.3%） were treated by TPM-single while 191 cases （38.7%） were treated by TPM-added methods. Seizure frequency in 438 cases （88.8%） reduced ≥ 50 %, while 16 cases （3.2%） increased 〉 25%. For the seizure types, among those cases with seizure frequency reduction ≥50%, 34 cases （94.4%） were SPS, 33 cases （86.8%） were CPS, 163 cases （91.1%） were partial seizure secondary to generalized seizure, 30 cases （93.8%） were tonic clonic seizures, 112 cases （84.2%） were West syndrome. There was no significant difference in all these subtypes, no matter by TPM-single or TPM-added treatment （P 〉 0.05）. Adverse events occurred in 189 cases （38.3%） and most cases were mild to moderate. Only 2 cases （0.4%） needed to be in hospital. Conclusion TPM has good efficacy and safety in epileptic infants younger than 2 years old.

关 键 词：癫痫 儿童 托吡酯 托吡酯多中心 开放性治疗 临床观察 

分 类 号：R742.1[医药卫生—神经病学与精神病学] R57[医药卫生—临床医学]