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托吡酯的临床研究。

Clinical studies of topiramate.

作者信息

Faught E

机构信息

Univ. Alabama Birmingham Epilepsy Center, University of Alabama School of Medicine, 35294-0021, USA.

出版信息

Drugs Today (Barc). 1999 Jan;35(1):49-57. doi: 10.1358/dot.1999.35.1.522948.

Abstract

Topiramate had well-documented efficacy as an adjunctive agent for partial-onset seizures in 5 double-blind, parallel trials, reducing seizure frequency by 35-47% at 400 mg/day, the optimal dose for most patients. It can also be used as monotherapy for partial-onset seizures. A broad spectrum of action is suggested by studies showing efficacy against a variety of generalized-onset seizure types, including primary generalized tonic-clonic seizures and the component seizures of Lennox-Gastaut syndrome. The major adverse effects of topiramate are of CNS origin. Psychomotor slowing is most common, but disappears in most patients with time or dosage adjustments; 11-28% of patients discontinue the drug because of side effects. No serious skin, liver or blood toxicity has been identified. Efficacy and adverse effect profiles are similar for children and adults. Introduction at rates not exceeding 25-50 mg increases per week will minimize adverse effects and be satisfactory for most adults.

摘要

在5项双盲、平行试验中,托吡酯作为部分性发作的辅助用药疗效得到充分证实,在400毫克/天(大多数患者的最佳剂量)时可使发作频率降低35%-47%。它也可作为部分性发作的单药治疗。多项研究表明托吡酯对多种全身性发作类型有效,包括原发性全身性强直阵挛发作和Lennox-Gastaut综合征的组成性发作,提示其作用谱广泛。托吡酯的主要不良反应源于中枢神经系统。精神运动迟缓最为常见,但大多数患者随时间推移或调整剂量后会消失;11%-28%的患者因副作用停药。未发现严重的皮肤、肝脏或血液毒性。儿童和成人的疗效及不良反应情况相似。以每周增加不超过25-50毫克的速率给药可将不良反应降至最低,对大多数成年人来说是令人满意的。

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