托吡酯多中心开放性治疗2岁以下小儿癫痫的临床观察

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...

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

Objective To assess the efficacy and safety of topiramate(TPM) in Chinese epileptic infants younger than 2 years old.Methods An open-label multicenter 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 fo...