Operative Unit of Neurology, Jazzolino Hospital, IT–89900 Vibo Valentia, Italy.
Cerebrovasc Dis. 2012;34(4):282-9. doi: 10.1159/000342669. Epub 2012 Nov 1.
Strokes are the leading cause of epileptic seizures in adults and account for 50% of seizures in those over the age of 65 years. The use of antiepileptic drugs to prevent recurrent poststroke seizures is recommended.
One hundred and twenty-eight patients with poststroke seizures were randomly allocated to treatment with either levetiracetam (LEV) or sustained-release carbamazepine (CBZ) in a multicenter randomized open-label study. After a titration study phase (2 weeks), the optimal individual dose of trial medication was determined and treatment was continued for another 52 weeks. The primary endpoint was defined as the proportion of seizure-free patients; the secondary endpoints were: evaluation of time recurrence to the first seizure, EEG tracings, cognitive functions and side effects.
Of 128 patients, 22 discontinued the trial prematurely; thus a total of 106 patients (52 treated with LEV and 54 treated with CBZ) were included in the analysis. The results of the study were as follows: no significant difference in number of seizure-free patients between LEV and CBZ (p = 0.08); time to the first recurrence tended to be longer among patients on LEV; there was no correlation between the therapeutic effect and the EEG findings in either treatment group; LEV caused significantly fewer (p = 0.02) side effects than CBZ; attention deficit, frontal executive functions and functional scales (Activities of Daily Living and Instrumental Activities of Daily Living indices) were significantly worse in the CBZ group.
This trial suggests that LEV may be a valid alternative to CBZ in poststroke seizures, particularly in terms of efficacy and safety. In addition, our results show that LEV has significant advantages over CBZ on cognitive functions. This trial also indicates that LEV in monotherapy is a safe and effective therapeutic option in elderly patients who have suffered epileptic seizures following a stroke.
中风是成年人癫痫发作的主要原因，占 65 岁以上人群癫痫发作的 50%。建议使用抗癫痫药物预防中风后复发性癫痫发作。
128 例中风后癫痫发作患者在一项多中心随机开放标签研究中被随机分配接受左乙拉西坦（LEV）或卡马西平控释片（CBZ）治疗。在滴定研究阶段（2 周）后，确定了试验药物的最佳个体剂量，并继续治疗 52 周。主要终点定义为无癫痫发作患者的比例；次要终点包括：评估首次癫痫发作复发时间、脑电图描记、认知功能和副作用。
128 例患者中有 22 例提前退出试验；因此，共有 106 例患者（52 例接受 LEV 治疗，54 例接受 CBZ 治疗）纳入分析。研究结果如下：LEV 和 CBZ 组无癫痫发作患者数量无显著差异（p=0.08）；LEV 组患者首次复发时间较长；两组治疗组的疗效与脑电图结果均无相关性；LEV 引起的副作用明显少于 CBZ（p=0.02）；注意力缺陷、额叶执行功能和功能量表（日常生活活动和工具性日常生活活动指数）在 CBZ 组明显较差。
本试验表明，LEV 可能是中风后癫痫发作的 CBZ 有效替代药物，尤其是在疗效和安全性方面。此外，我们的结果表明，LEV 在认知功能方面明显优于 CBZ。该试验还表明，LEV 单药治疗在老年中风后癫痫发作患者中是一种安全有效的治疗选择。
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