Medical University Innsbruck, Department of Neurology, Innsbruck, Austria
Ther Adv Neurol Disord. 2009 Mar;2(2):79-91. doi: 10.1177/1756285608100460.
The effectiveness of Levetiracetam (LEV) in the treatment of focal and generalised epilepsies is well established. LEV has a wide spectrum of action, good tolerability and a favourable pharmacokinetic profile. An injectable formulation has been released as an intravenous (IV) infusion in 2006 for patients with epilepsy when oral administration is temporarily not feasible. Bioequivalence to the oral preparation has been demonstrated with good tolerability and safety enabling a smooth transition from oral to parenteral formulation and vice versa. Although IV LEV is not licensed for treatment of status epilepticus (SE), open-label experience in retrospective case series is accumulating. Until now (August 2008) 156 patients who were treated with IV LEV for various forms of SE have been reported with an overall success rate of 65.4%. The most often used initial dose was 2000-3000 mg over 15 minutes. Adverse events were reported in 7.1%, and were mild and transient. Although IV LEV is an interesting alternative for the treatment of SE due to the lack of centrally depressive effects and low potential of drug interactions, one has to be aware of the nonrandomised retrospective study design, the heterogenous patient population and treatment protocols, and the publication bias inherent in these type of studies. Only a large randomised controlled trial with an adequate comparator will reveal the efficacy and effectiveness of this promising new IV formulation.
左乙拉西坦（LEV）治疗局灶性和全面性癫痫的疗效已得到充分证实。LEV 具有广泛的作用谱、良好的耐受性和有利的药代动力学特性。一种注射用制剂于 2006 年作为静脉（IV）输注发布，用于当口服给药暂时不可行时的癫痫患者。已证明与口服制剂生物等效，具有良好的耐受性和安全性，能够顺利从口服制剂过渡到肠外制剂，反之亦然。尽管 IV LEV 未获准用于治疗癫痫持续状态（SE），但在回顾性病例系列中的开放性标签经验正在积累。截至 2008 年 8 月，已有 156 例患者接受 IV LEV 治疗各种形式的 SE 的报告，总体成功率为 65.4%。最常使用的初始剂量为 15 分钟内给予 2000-3000mg。报告了 7.1%的不良事件，且为轻度和短暂的。尽管由于缺乏中枢抑制作用和药物相互作用的低潜力，IV LEV 是治疗 SE 的一种有趣的替代方法，但必须意识到这是一项非随机回顾性研究设计，患者人群和治疗方案具有异质性，以及这些类型研究中固有的发表偏倚。只有一项具有足够对照的大型随机对照试验才能揭示这种有前途的新 IV 制剂的疗效和有效性。
