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作为耐药性癫痫治疗药物的艾司利卡西平的上市后研究:初步结果。

Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary results.

作者信息

Massot A, Vivanco R, Principe A, Roquer J, Rocamora R

机构信息

Unidad de Epilepsia, Servicio de Neurología, Hospital del Mar, Barcelona, España.

Unidad de Epilepsia, Servicio de Neurología, Hospital del Mar, Barcelona, España.

出版信息

Neurologia. 2014 Mar;29(2):94-101. doi: 10.1016/j.nrl.2013.02.013. Epub 2013 Apr 25.

DOI:10.1016/j.nrl.2013.02.013
PMID:23623701
Abstract

INTRODUCTION

Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) and an analogue to carbamazepine (CBZ) and oxcarbazepine (OXC). In this study, we evaluate initial therapeutic response to ESL and events in the change from CBZ and OXC.

METHODS

We evaluated 61 patients with a broad spectrum of drug-resistant epilepsies in a cross-sectional study. The switch from CBZ and OXC to ESL was carried out in a single night at ratios of 1:1.3 and 1:1mg respectively.

RESULTS

The most common form of epilepsy was temporal lobe epilepsy (62.3%). The most common aetiology was mesial temporal sclerosis (26.2%). Mean follow-up time was 4.7±3.2 months. In 40 patients with a minimum follow-up period of 3 months, monthly median seizure frequency dropped by 63.6% (P<.001) and a reduction of 80% or more was recorded in 30%. Adverse events (AEs) occurred in 54%; all appeared during the titration phase. They were more frequent at doses in excess of 800mg (73.9% vs. 47.4%; P=.042). The most common AE was dizziness (34.4%), which was commonly associated with VPA, LTG and/or LCS consumption (19.2% vs. 45.7%; P=.031). The retention rate at 3 months was 75.4%. A total of 25 patients replaced CBZ or OXC treatment with ESL; any AEs were transient (69.2% for CBZ and 33% for OXC; P=.073). At 3 months after the treatment change, median seizure frequency had decreased by 20% (P<.075).

CONCLUSIONS

ESL is effective in the treatment of focal epilepsies and its early retention rate is > 70%. AEs occurred during the titration phase and corresponded to associated AEDs. A rapid change from CBZ and OXC to ESL treatment can be safely performed.

摘要

引言

醋酸艾司利卡西平(ESL)是一种新型抗癫痫药物(AED),是卡马西平(CBZ)和奥卡西平(OXC)的类似物。在本研究中,我们评估了ESL的初始治疗反应以及从CBZ和OXC转换过程中的相关情况。

方法

我们在一项横断面研究中评估了61例患有广泛耐药性癫痫的患者。从CBZ和OXC转换为ESL在一个晚上完成,转换比例分别为1:1.3和1:1mg。

结果

最常见的癫痫类型是颞叶癫痫(62.3%)。最常见的病因是内侧颞叶硬化(26.2%)。平均随访时间为4.7±3.2个月。在40例至少随访3个月的患者中,每月癫痫发作频率中位数下降了63.6%(P<0.001),30%的患者发作频率降低了80%或更多。54%的患者发生了不良事件(AE);所有不良事件均出现在滴定阶段。在剂量超过800mg时不良事件更频繁(73.9%对47.4%;P=0.042)。最常见的不良事件是头晕(34.4%),这通常与丙戊酸(VPA)、拉莫三嗪(LTG)和/或左乙拉西坦(LCS)的使用有关(19.2%对45.7%;P=0.031)。3个月时的保留率为75.4%。共有25例患者用ESL替代了CBZ或OXC治疗;任何不良事件都是短暂的(CBZ组为69.2%,OXC组为33%;P=0.073)。治疗改变后3个月,癫痫发作频率中位数下降了20%(P<0.075)。

结论

ESL在治疗局灶性癫痫方面有效,其早期保留率>70%。不良事件发生在滴定阶段,与相关抗癫痫药物有关。可以安全地从CBZ和OXC快速转换为ESL治疗。

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