Ruangritkul Preechaya, Tiamkao Siriporn, Chainirun Nanthaphan, Pranboon Sineenard, Tiamkao Somsak, Sawanyawisuth Kittisak, Khamsai Sittichai
Pharmacy Department, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand.
Department of Pharmacology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Curr Ther Res Clin Exp. 2021 Oct 24;95:100648. doi: 10.1016/j.curtheres.2021.100648. eCollection 2021.
There are 3 main epileptic conditions in hospital settings that may require intravenous antiepileptic treatment: status epilepticus, acute repetitive convulsive seizures, and postoperative seizures. Generic intravenous levetiracetam (IV LEV) (Focale; Great Eastern Drug Co, Bangkok, Thailand), has been reported to have comparable efficacy to original IV LEV for treating status epilepticus and acute repetitive convulsive seizures in a randomized controlled trial. At present, there are limited data on the efficacy and tolerability of generic intravenous LEV in real-world situations.
This study aimed to evaluate the clinical outcomes of generic IV LEV in a real-world setting.
A retrospective study and analyses were conducted. All adult patients who used IV LEV at University Hospital, Khon Kaen University, Thailand from June 1, 2019, until February 15, 2020, were included. Data were analyzed and reported in terms of the efficacy and tolerability of generic IV LEV.
Ninety-three patients received IV LEV by 3 indications: status epilepticus, acute repetitive convulsive seizures, and postoperative seizures. The proportions of these 3 indications were 41.94% (39 patients), 9.67% (9 patients), and 48.39% (45 patients), respectively. The average seizure control rate at 24 hours was 89.25%. The seizure control rate was significantly higher in the acute repetitive convulsive seizures and postoperative seizure groups than in the status epilepticus group when generic IV LEV was given as the first-line treatment (75.00%; 88.37% vs 50.00%; 0.035). The average length of hospital stay was 18.24 (25.40) days. There was no significant discharge status among the 3 groups ( = 0.348). Moreover, the average mortality rate was 5.38%. Side effects were reported in 14 patients (15.05%). The 2 most common side effects were vomiting and bronchospasm (3 patients; 3.22%). There were 10 patients with uncontrolled seizures at 24 hours (10.75%). The only factor associated with uncontrolled seizures at 24 hours was a history of epilepsy. The uncontrolled seizure group had a higher proportion of epilepsy patients than the seizure-controlled group (70.00% vs 33.73%; = 0.037). Poor discharge status (not improved/death) was 18.28% (17 patients). There was no significant factor between those with an improved or poor discharge status.
Generic IV LEV was effective and relatively well tolerated in the 3 clinical settings (ie, status epilepticus, acute repetitive convulsive seizures, and postoperative seizures). Further clinical data are still required to confirm the results of this study.(. 2022; 83:XXX-XXX).
在医院环境中，有3种主要的癫痫病症可能需要静脉注射抗癫痫药物治疗：癫痫持续状态、急性重复性惊厥发作和术后癫痫发作。据报道，在一项随机对照试验中，通用型静脉注射左乙拉西坦（IV LEV）（Focale；泰国曼谷大东方制药公司）在治疗癫痫持续状态和急性重复性惊厥发作方面与原研IV LEV具有相当的疗效。目前，关于通用型静脉注射左乙拉西坦在实际临床中的疗效和耐受性的数据有限。
本研究旨在评估通用型IV LEV在实际临床中的治疗效果。
进行了一项回顾性研究与分析。纳入了2019年6月1日至2020年2月15日在泰国孔敬大学医院使用IV LEV的所有成年患者。分析并报告了通用型IV LEV的疗效和耐受性数据。
93例患者因3种适应症接受了IV LEV治疗：癫痫持续状态、急性重复性惊厥发作和术后癫痫发作。这3种适应症的比例分别为41.94%（39例患者）、9.67%（9例患者）和48.39%（45例患者）。24小时时的平均癫痫控制率为89.25%。当通用型IV LEV作为一线治疗药物时，急性重复性惊厥发作组和术后癫痫发作组的癫痫控制率显著高于癫痫持续状态组（75.00%；88.37% 对50.00%；P = 0.035）。平均住院时间为18.24（25.40）天。3组之间的出院状态无显著差异（P = 0.348）。此外，平均死亡率为5.38%。14例患者（15.05%）报告有副作用。最常见的2种副作用是呕吐和支气管痉挛（3例患者；3.22%）。24小时时有10例患者癫痫发作未得到控制（10.75%）。与24小时癫痫发作未得到控制相关的唯一因素是癫痫病史。癫痫发作未得到控制组的癫痫患者比例高于癫痫发作得到控制组（70.00% 对33.73%；P = 0.037）。出院状态不佳（未改善/死亡）为18.28%（17例患者）。出院状态改善或不佳的患者之间无显著因素。
通用型IV LEV在3种临床情况（即癫痫持续状态、急性重复性惊厥发作和术后癫痫发作）中有效且耐受性相对良好。仍需要进一步的临床数据来证实本研究的结果。（. 2022；83：XXX - XXX）
