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左乙拉西坦(3000毫克/天)作为辅助治疗中国难治性部分性癫痫患者的疗效和安全性。

Efficacy and safety of levetiracetam (3,000 mg/Day) as an adjunctive therapy in Chinese patients with refractory partial seizures.

作者信息

Xiao Zheng, Li Jin-Mei, Wang Xue-Feng, Xiao Fei, Xi Zhi-Qin, Lv Yang, Sun Hong-Bin

机构信息

Department of Neurology, The First Affiliated Hospital, Chongqing Medical University, Chongqing Key Laboratory of Neurology, Chongqing, China.

出版信息

Eur Neurol. 2009;61(4):233-9. doi: 10.1159/000197109. Epub 2009 Jan 29.

Abstract

AIM

To evaluate the efficacy and safety of 3,000 mg daily levetiracetam (LEV; Keppra) as an adjunctive therapy for Chinese patients with refractory partial seizures.

METHODS

This randomized, placebo-controlled trial consisted of an 8-week baseline period followed by a 4-week titration interval and a 12-week maintenance period, and concluded with a 4-week medication withdrawal period or entered an open-label study. LEV was compared with placebo.

RESULTS

The 50% responder rate (the proportion of patients with a minimum of 50% reduction in partial seizure frequency) occurred in 46.4% of the LEV group, compared with 39.3% of the placebo group (p = 0.590). The median of the absolute weekly frequency reduction from baseline of partial seizures was 0.66 per week for LEV versus 0.48 per week for placebo (p = 0.187). The most common treatment-emergent adverse events, mostly mild to moderate in severity, were somnolence, dizziness and agitation.

CONCLUSION

In this study, adjunctive therapy with LEV 3,000 mg daily was well tolerated but not as effective as expected in controlling partial seizures in this study population. Considering the lower mean weight of this study population, we suggest the dosage of LEV 3,000 mg daily may contribute to the results.

摘要

目的

评估每日3000毫克左乙拉西坦(LEV;开浦兰)作为中国难治性部分性癫痫患者辅助治疗的疗效和安全性。

方法

这项随机、安慰剂对照试验包括一个为期8周的基线期,随后是一个为期4周的滴定间隔期和一个为期12周的维持期,最后是一个为期4周的撤药期或进入一项开放标签研究。将左乙拉西坦与安慰剂进行比较。

结果

左乙拉西坦组46.4%的患者出现50%应答率(部分性癫痫发作频率至少降低50%的患者比例),而安慰剂组为39.3%(p = 0.590)。左乙拉西坦组部分性癫痫发作绝对每周频率较基线降低的中位数为每周0.66次,而安慰剂组为每周0.48次(p = 0.187)。最常见的治疗中出现的不良事件,大多为轻至中度,是嗜睡、头晕和激越。

结论

在本研究中,每日3000毫克左乙拉西坦辅助治疗耐受性良好,但在该研究人群中控制部分性癫痫发作的效果不如预期。考虑到该研究人群的平均体重较低,我们认为每日3000毫克左乙拉西坦的剂量可能影响了结果。

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