左乙拉西坦与苯妥英钠作为苯二氮䓬类药物难治性癫痫持续状态患儿二线抗癫痫药物的疗效比较。

Efficacy Of Levetiracetam Versus Phenytoin As A Second-Line Antiepileptic Drug In The Management Of Benzodiazepine-Refractory Status Epilepticus Among Children.

机构信息

Paediatrics Department, Jinnah Hospital Lahore, Pakistan.

出版信息

J Ayub Med Coll Abbottabad. 2023 Jul-Sep;35(3):410-414. doi: 10.55519/JAMC-03-11897.

DOI:10.55519/JAMC-03-11897

PMID:38404082

Abstract

BACKGROUND

Status Epilepticus (SE) is a life-threatening neurological emergency requiring appropriate therapy to terminate seizure activity. SE is managed with supportive measures and ultra-short-acting benzodiazepines. However, limited data is available in the paediatric population regarding the next best option when this fails. This study aimed at finding new data to recommend levetiracetam or phenytoin as the second-line option.

METHODS

One hundred and thirty-seven patients with status epilepticus were randomized into two groups; group-I was given IV Levetiracetam (LEV) at 20 mg/kg/dose over 5 minutes followed by a maintenance dose of 20mg/kg/dose BID, whereas Group II received phenytoin at 20mg/kg IV loading dose followed by a maintenance dose of 5-8 mg/kg/day divided BID. The primary outcome was seizure cessation, defined as the termination of the apparent convulsion 30 min after the administration of phenytoin or levetiracetam. Secondary outcomes were the use of different anti-convulsants for continued management, admittance to critical treatment, and severe adverse events (including mortality, Stevens-Johnson syndrome, rash, airway problems, cardiovascular instability, extravasation, and severe agitation). Data was recorded via a clinical proforma and was analyzed by SPSS software version 25. All numerical data were expressed in mean±SD forms, and frequency was determined for qualitative baseline data. Secondary outcomes were tested through the χ2 test, A p-value of ≤0.05 was considered statistical significance.

RESULTS

Levetiracetam terminated seizures in 94% of children compared to 77% in those treated with phenytoin. The mean time to seizure termination was 19.94±3.76 minutes for the LEV Group as compared to 23.791±9.1 min for the PHT group. (p=0.046). Regarding safety, a profile study shows LEV has fewer and less severe side effects compared to Phenytoin.

CONCLUSIONS

Levetiracetam is a safe, well-tolerated, and effective treatment as a second-line antiepileptic drug in the management of status epilepticus.

摘要

背景

癫痫持续状态（SE）是一种危及生命的神经系统紧急情况，需要适当的治疗来终止癫痫发作。SE 通过支持性治疗和超短效苯二氮䓬类药物进行治疗。然而，关于这种方法失败时的下一个最佳选择，在儿科人群中可用的数据有限。本研究旨在寻找新的数据，推荐左乙拉西坦或苯妥英作为二线选择。

方法

137 名癫痫持续状态患者被随机分为两组；I 组给予静脉注射左乙拉西坦（LEV）20mg/kg/剂量，5 分钟内给药，然后维持剂量 20mg/kg/剂量，每日 2 次；而 II 组给予静脉注射苯妥英 20mg/kg 负荷剂量，然后维持剂量 5-8mg/kg/天，每日 2 次。主要结局是癫痫发作停止，定义为苯妥英或左乙拉西坦给药后 30 分钟内明显抽搐终止。次要结局是继续使用不同的抗惊厥药物进行管理、入住重症监护病房和严重不良事件（包括死亡率、史蒂文斯-约翰逊综合征、皮疹、气道问题、心血管不稳定、外渗和严重激越）。通过临床记录表格记录数据，并使用 SPSS 软件版本 25 进行分析。所有数值数据均以平均值±标准差形式表示，定性基线数据以频率表示。通过 χ2 检验测试次要结局，p 值≤0.05 认为具有统计学意义。