Steinhoff Bernhard J, Trinka Eugen, Wieser Heinz-Gregor
Epilepsiezentrum Kork, Department of Adults, Landstrasse 1, 77694 Kehl-Kork, Germany.
Seizure. 2005 Oct;14(7):490-6. doi: 10.1016/j.seizure.2005.08.005. Epub 2005 Oct 5.
To further evaluate the safety, efficacy and optimal dose of levetiracetam (LEV) in daily clinical practice among patients with uncontrolled partial epilepsy with or without secondary generalization.
In this phase IV, open-label, 16-week community-based study, 178 at least 16-year-old patients with refractory focal epilepsy were treated with 1000, 2000 or 3000 mg levetiracetam as adjunctive therapy. All patients started with 500 mg LEV b.i.d. (1000 mg/day); the dose was adjusted in 2-week intervals up to 1500 b.i.d. (3000 mg/day) depending on seizure control and tolerability. The main objectives were the adverse events, the percentage reduction in partial and total seizure frequency per week from baseline and the retention rate, defined as the percentage of patients taking LEV at the end of the 16-week treatment period.
Of the 178 patients who took at least one dose of LEV 151 completed the study. Thus, the retention rate (number of patients taking LEV at the end of the 16-week treatment period) was 84.8%. Most frequently reported adverse events were asthenia, dizziness, headache, nausea, somnolence and hostility; the majority of these events were of mild to moderate intensity. The seizure-free rate of the ITT population with focal seizures was 16.7%, for all seizures 16.6%; the median reduction of focal seizure frequency was 47.6%, and 46.5% for all seizures. The 50% responder rate was 46.6% for focal seizures and 45.1% for all seizures.
Add-on treatment with LEV in patients with refractory partial epilepsy was safe and effective in this study.
在日常临床实践中，进一步评估左乙拉西坦（LEV）在伴有或不伴有继发性全身性发作的未控制部分性癫痫患者中的安全性、有效性及最佳剂量。
在这项IV期、开放标签、基于社区的为期16周的研究中，178例至少16岁的难治性局灶性癫痫患者接受1000、2000或3000mg左乙拉西坦作为辅助治疗。所有患者起始剂量为左乙拉西坦500mg，每日两次（1000mg/天）；根据癫痫控制情况和耐受性，每2周调整一次剂量，最高至每日两次1500mg（3000mg/天）。主要目标包括不良事件、与基线相比每周部分性发作和总发作频率的降低百分比以及留存率，留存率定义为在16周治疗期结束时服用左乙拉西坦的患者百分比。
178例至少服用一剂左乙拉西坦的患者中，151例完成了研究。因此，留存率（16周治疗期结束时服用左乙拉西坦的患者数量）为84.8%。最常报告的不良事件为乏力、头晕、头痛、恶心、嗜睡和敌意；这些事件大多为轻至中度。意向性分析人群中局灶性发作的无发作率为16.7%，所有发作的无发作率为16.6%；局灶性发作频率的中位数降低了47.6%，所有发作频率降低了46.5%。局灶性发作的50%缓解率为46.6%，所有发作的50%缓解率为45.1%。
在本研究中，左乙拉西坦对难治性部分性癫痫患者进行添加治疗是安全有效的。
