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托吡酯治疗儿童难治性癫痫的临床经验。

Clinical experiences with topiramate in children with intractable epilepsy.

作者信息

Uldall P, Buchholt J M

机构信息

Dianalund Epilepsy Hospital, Denmark.

出版信息

Eur J Paediatr Neurol. 1999;3(3):105-11. doi: 10.1016/s1090-3798(99)90097-1.

Abstract

At a tertial referral epilepsy centre 39 children were consecutively enrolled in an open add-on study with topiramate (TPM). All children had intractable epilepsy; the mean seizure frequency was 36 per month, and 31 children were treated with polypharmacy. All but five children were mentally retarded. The initial dose of TPM was 0.5-1 mg/kg daily, slowly titrated with 1-3 mg/kg daily every second week with an estimated target dose of 10 mg/kg daily. At latest follow-up 19 children continued on TPM, three (8%) were seizure-free, eight (21%) had a seizure reduction of more than 50% and eight (21%) improved their general condition. Mean follow-up was 13 months (range 9-36 months). Seizure reduction was seen in focal as well as generalized epilepsies. Adverse effects were reported in 21 cases (54%), weight loss and sedation being most frequent. The mean steady state dose in the children continuing on TPM was at latest follow-up: 14 mg/kg daily (< 5 years), 10 mg/kg daily (5-7 years), 5.8 mg/kg daily (8-17 years). The corresponding plasma level varied from 3 to 45 mumol/litre, and a significant correlation between the daily dose in mg/kg and the plasma level was found. Two patients with progressive myoclonus epilepsy are described separately; one had a dramatic general improvement. It is concluded that TPM seems to be a promising new broad-spectrum anti-epileptic drug, which is efficacious even in epilepsy syndromes, intractable to other new anti-epileptic drugs such as vigabatrin and lamotrigine.

摘要

在一家三级转诊癫痫中心,39名儿童连续入选一项托吡酯(TPM)的开放性添加治疗研究。所有儿童均患有难治性癫痫;平均每月发作频率为36次,31名儿童接受多种药物联合治疗。除5名儿童外,其余均有智力障碍。TPM初始剂量为每日0.5 - 1mg/kg,每隔一周以每日1 - 3mg/kg的剂量缓慢滴定,预计目标剂量为每日10mg/kg。在最近一次随访时,19名儿童继续服用TPM,3名(8%)无癫痫发作,8名(21%)癫痫发作减少超过50%,8名(21%)总体状况改善。平均随访时间为13个月(范围9 - 36个月)。局灶性癫痫和全身性癫痫均可见发作减少。21例(54%)报告有不良反应,体重减轻和镇静最为常见。在最近一次随访时,继续服用TPM的儿童的平均稳态剂量为:每日14mg/kg(<5岁),每日10mg/kg(5 - 7岁),每日5.8mg/kg(8 - 17岁)。相应的血浆水平在3至45μmol/升之间变化,且发现每日mg/kg剂量与血浆水平之间存在显著相关性。两名进行性肌阵挛癫痫患者单独描述;其中一名有显著的总体改善。结论是,TPM似乎是一种有前景的新型广谱抗癫痫药物,即使在对其他新型抗癫痫药物如氨己烯酸和拉莫三嗪难治的癫痫综合征中也有效。

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