Chakravarthi Sudheer, Goyal Manoj Kumar, Modi Manish, Bhalla Ashish, Singh Parampreet
Department of Neurology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India.
Department of Neurology, Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh 160012, India.
J Clin Neurosci. 2015 Jun;22(6):959-63. doi: 10.1016/j.jocn.2014.12.013. Epub 2015 Apr 18.
The purpose of this study was to compare safety and efficacy of intravenous (IV) levetiracetam (LEV) with IV phenytoin (PHT) in management of status epilepticus (SE). The second-line treatment of SE is limited to a few drugs available in an IV formulation such as PHT, fosphenytoin and valproate. The relative lack of serious side effects and favourable pharmacokinetics of LEV made it a promising option in management of SE. Randomized trials comparing relative efficacy of second-line agents are remarkably lacking. In this study, consecutive patients of SE (n=44) were randomized to receive either IV PHT (20mg/kg) or IV LEV (20mg/kg). The primary end point was successful clinical termination of seizure activity within 30min after the beginning of the drug infusion. Secondary end points included recurrence of seizures within 24 hours, drug related adverse effects, neurological outcome at discharge, need for ventilatory assistance, and mortality during hospitalization. Both LEV and PHT were equally effective with regard to primary and secondary outcome measures. PHT achieved control of SE in 15 (68.2%) patients compared to LEV in 13 (59.1%; p=0.53). Both the groups showed comparable results with respect to recurrence of seizures within 24 hours (p=0.34), outcome at discharge as assessed by functional independence measure (p=0.68), need of ventilatory assistance (p=0.47) and death (p=1). From this study it can be concluded that LEV may be an attractive and effective alternative to PHT in management of SE.
本研究的目的是比较静脉注射左乙拉西坦（LEV）与静脉注射苯妥英（PHT）治疗癫痫持续状态（SE）的安全性和有效性。SE的二线治疗仅限于几种可静脉注射的药物，如PHT、磷苯妥英和丙戊酸盐。LEV相对缺乏严重副作用且药代动力学良好，使其成为治疗SE的一个有前景的选择。比较二线药物相对疗效的随机试验非常缺乏。在本研究中，连续的SE患者（n = 44）被随机分为接受静脉注射PHT（20mg/kg）或静脉注射LEV（20mg/kg）。主要终点是在药物输注开始后30分钟内癫痫活动成功临床终止。次要终点包括24小时内癫痫复发、药物相关不良反应、出院时的神经功能结局、呼吸支持需求以及住院期间的死亡率。在主要和次要结局指标方面，LEV和PHT同样有效。PHT使15例（68.2%）患者的SE得到控制，而LEV使13例（59.1%）患者得到控制（p = 0.53）。两组在24小时内癫痫复发（p = 0.34）、通过功能独立性测量评估的出院结局（p = 0.68）、呼吸支持需求（p = 0.47）和死亡（p = 1）方面显示出相似的结果。从本研究可以得出结论，在治疗SE方面，LEV可能是PHT的一个有吸引力且有效的替代药物。
