托吡酯：新适应症。一份更详尽的评估文件。

Topiramate: new indication. A bulkier assessment file.

出版信息

Prescrire Int. 1999 Oct;8(43):141-2.

Abstract

(1) The licensed indications of topiramate have been extended to cover treatment (in combination with an inadequately effective ongoing treatment) of generalised tonic-clonic epilepsy in adults and children over four years, and partial epilepsy in children over four. (2) The efficacy of topiramate was established in two double-blind, placebo-controlled trials in patients with generalised tonic-clonic epilepsy, and in a double-blind, placebo-controlled trial in patients with partial epilepsy. (3) Topiramate has not been compared with other antiepileptics with similar indications, i.e. lamotrigine and vigabatrin. (4) Topiramate appears to be relatively well tolerated.

摘要

(1) 托吡酯的许可适应症已扩大，涵盖（与疗效欠佳的现行治疗联合使用）治疗4岁以上成人和儿童的全身强直阵挛性癫痫，以及4岁以上儿童的部分性癫痫。(2) 托吡酯的疗效在两项针对全身强直阵挛性癫痫患者的双盲、安慰剂对照试验以及一项针对部分性癫痫患者的双盲、安慰剂对照试验中得到确立。(3) 托吡酯尚未与其他具有类似适应症的抗癫痫药物（即拉莫三嗪和氨己烯酸）进行比较。(4) 托吡酯的耐受性似乎相对良好。