托吡酯用于儿童、青少年及青年难治性部分性发作：一项多中心开放性试验

Topiramate in refractory partial-onset seizures in children, adolescents and young adults: a multicentric open trial.

作者信息

Coppola G, Caliendo G, Terracciano M M, Buono S, Pellegrino L, Pascotto A

机构信息

Clinic of Child Neuropsychiatry, Department of Pediatrics, Second University of Naples, Via Pansini, 5, 80131, Naples, Italy.

出版信息

Epilepsy Res. 2001 Mar;43(3):255-60. doi: 10.1016/s0920-1211(00)00202-3.

DOI:10.1016/s0920-1211(00)00202-3

PMID:11248537

Abstract

PURPOSE

This study was to evaluate the efficacy and safety of topiramate (TPM) in refractory partial epilepsy in children, adolescents and young adults.

METHODS

We performed a prospective open label add-on study in 55 patients (age 2-30 years, mean 15 years) with refractory partial seizures. Topiramate was added to one or two other baseline drugs and the efficacy was rated according to seizure type and frequency.

RESULTS

TPM was initiated at a daily dose of 0.5-1 mg/kg, followed by a 2-week titration at increments of 1-3 mg/kg/24h, up to a maximum daily dose of 12 mg/kg. After 9 months of treatment, 11 patients (20%) had 100% fewer seizures and 25 patients (45%) had a more than 50% seizure reduction. TPM appeared to be effective both in cryptogenic (76.2%) and symptomatic (58.8%) partial epilepsies. Mild to moderate adverse events were present in 25 patients (45.4%), mostly represented by drowsiness, nervousness and hyporexia with or without weight loss.

CONCLUSION

TPM was an overall effective and safe add-on drug both in cryptogenic and symptomatic childhood refractory partial seizures, the adverse reactions being generally mild or moderate.

摘要

目的

本研究旨在评估托吡酯（TPM）治疗儿童、青少年及青年难治性部分性癫痫的疗效和安全性。

方法

我们对55例（年龄2 - 30岁，平均15岁）难治性部分性癫痫患者进行了一项前瞻性开放标签附加治疗研究。将托吡酯添加到一种或两种其他基线药物中，并根据癫痫发作类型和频率对疗效进行评估。

结果

托吡酯起始剂量为每日0.5 - 1 mg/kg，随后以1 - 3 mg/kg/24小时的增量进行为期2周的滴定，最大日剂量达12 mg/kg。治疗9个月后，11例患者（20%）癫痫发作次数减少100%，25例患者（45%）癫痫发作次数减少超过50%。托吡酯在特发性（76.2%）和症状性（58.8%）部分性癫痫中均显示有效。25例患者（45.4%）出现轻至中度不良事件，主要表现为嗜睡、紧张及食欲减退，伴或不伴有体重减轻。