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唑尼沙胺治疗进行性肌阵挛癫痫的肌阵挛发作:一项开放标签研究。

Zonisamide for the treatment of myoclonic seizures in progressive myoclonic epilepsy: an open-label study.

作者信息

Vossler David G, Conry Joan A, Murphy Jerome V

机构信息

Epilepsy Center, Washington Neuroscience Institute, Renton, Washington 98055, USA.

出版信息

Epileptic Disord. 2008 Mar;10(1):31-4. doi: 10.1684/epd.2008.0168.

DOI:10.1684/epd.2008.0168
PMID:18367429
Abstract

PURPOSE

To examine the safety and efficacy of zonisamide in treating myoclonic seizures associated with progressive myoclonic epilepsy (PME), in an open-label setting.

METHODS

Thirty patients with refractory PME (aged > or = 5 years), who were taking up to three antiepileptic drugs, received adjunctive zonisamide (< or = 6 mg/kg/day) therapy for 16 weeks. Myoclonic seizures were recorded daily over a 24-hour period or in 10-minute epochs in the morning, afternoon, and evening. Safety was assessed via adverse events (AEs); efficacy was measured by the percentage of patients experiencing a > or = 50% decrease in myoclonic seizure frequency from baseline.

RESULTS

Treatment-related AEs, experienced by 53% (n = 16/30) of patients, led to five patients discontinuing zonisamide. The most common AEs were decreased appetite, somnolence, and asthenia. Overall, 36% of patients (n = 10/28) had a > or = 50% reduction in myoclonic seizure frequency.

CONCLUSIONS

These results suggest that zonisamide may be useful in the treatment of patients with PME. However, due to the size and open-label character of this study, further research is required.

摘要

目的

在开放标签的情况下,研究唑尼沙胺治疗与进行性肌阵挛癫痫(PME)相关的肌阵挛发作的安全性和有效性。

方法

30例难治性PME患者(年龄≥5岁),正在服用多达三种抗癫痫药物,接受辅助唑尼沙胺(≤6mg/kg/天)治疗16周。在24小时内每天记录肌阵挛发作情况,或在上午、下午和晚上以10分钟为时段进行记录。通过不良事件(AE)评估安全性;通过肌阵挛发作频率较基线降低≥50%的患者百分比来衡量疗效。

结果

53%(n=16/30)的患者出现与治疗相关的不良事件,导致5例患者停用唑尼沙胺。最常见的不良事件是食欲减退、嗜睡和乏力。总体而言,36%的患者(n=10/28)肌阵挛发作频率降低≥50%。

结论

这些结果表明唑尼沙胺可能对PME患者的治疗有用。然而,由于本研究的规模和开放标签性质,需要进一步研究。

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