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氯巴占:对不同亚组癫痫患儿癫痫发作频率及安全性的影响

Clobazam: effect on frequency of seizures and safety profile in different subgroups of children with epilepsy.

作者信息

Klehm Jacquelyn, Thome-Souza Sigride, Sánchez Fernández Iván, Bergin Ann M, Bolton Jeffrey, Harini Chellamani, Kadish Navah E, Libenson Mark, Peters Jurriaan, Poduri Annapurna, Rotenberg Alexander, Takeoka Masanori, Bourgeois Blaise, Loddenkemper Tobias

机构信息

Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts.

Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, Boston, Massachusetts; Psychiatry Department, Clinics Hospital of University of Sao Paulo, Sao Paulo, Sao Paulo, Brazil.

出版信息

Pediatr Neurol. 2014 Jul;51(1):60-6. doi: 10.1016/j.pediatrneurol.2014.01.025. Epub 2014 Jan 16.

DOI:10.1016/j.pediatrneurol.2014.01.025
PMID:24830765
Abstract

BACKGROUND

Clobazam has been used in clinical practice as an adjunctive treatment for diverse seizure types and epilepsy syndromes. We evaluated the efficacy and safety of clobazam in a large sample of patients with refractory epilepsy at a tertiary pediatric center.

METHODS

We retrospectively reviewed patients treated with clobazam between January 2001 and July 2013 who had a follow-up visit at least one month after starting clobazam. Response was defined as ≥50% reduction in seizure frequency compared with baseline seizure frequency during the 3 months before the introduction of clobazam. We examined the relationship between dose range and response rate.

RESULTS

Four-hundred twenty-five patients were prescribed clobazam, of whom 300 (median age 9.1 years, interquartile range 4.7-13.3 years) had follow-up data greater than 1 month. Median follow-up was 5 months (interquartile range 3-11 months). Response to treatment with clobazam was observed in 203 of 300 (67.7%) patients, of whom 84 (28%) became seizure-free. The median starting dose was 0.2 (interquartile range 0.13-0.33) mg/kg/day with a target dose of 0.48 (0.26-0.80) mg/kg/day. Twenty-seven (9%) patients discontinued clobazam, 16 (59.3%) because adverse effects, 10 (37%) because of a lack of efficacy, and one (3.7%) because of a combination of adverse effects and lack of efficacy. The most common adverse effects were tiredness in 44 of 300 (14.6%) and mood or behavioral changes in 23 (7.7%).

CONCLUSIONS

Clobazam is a well-tolerated antiepileptic drug with good response rates in pediatric patients with refractory epilepsy.

摘要

背景

氯巴占已在临床实践中用作多种癫痫发作类型和癫痫综合征的辅助治疗药物。我们在一家三级儿科中心对大量难治性癫痫患者样本评估了氯巴占的疗效和安全性。

方法

我们回顾性分析了2001年1月至2013年7月期间接受氯巴占治疗且在开始使用氯巴占后至少随访1个月的患者。反应定义为与引入氯巴占前3个月的基线癫痫发作频率相比,癫痫发作频率降低≥50%。我们研究了剂量范围与反应率之间的关系。

结果

425例患者被处方使用氯巴占,其中300例(中位年龄9.1岁,四分位间距4.7 - 13.3岁)有超过1个月的随访数据。中位随访时间为5个月(四分位间距3 - 11个月)。300例患者中有203例(67.7%)对氯巴占治疗有反应,其中84例(28%)无癫痫发作。起始中位剂量为0.2(四分位间距0.13 - 0.33)mg/kg/天,目标剂量为0.48(0.26 - 0.80)mg/kg/天。27例(9%)患者停用氯巴占,16例(59.3%)因不良反应停药,10例(37%)因缺乏疗效停药,1例(3.7%)因不良反应和缺乏疗效共同作用停药。最常见的不良反应是300例中有44例(14.6%)出现疲倦,23例(7.7%)出现情绪或行为改变。

结论

氯巴占是一种耐受性良好的抗癫痫药物,在难治性癫痫儿科患者中反应率良好。

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