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高剂量静脉推注拉科酰胺的安全性概况

Safety Profile of High-Dose Intravenous Push Lacosamide.

作者信息

Torian Sterling C, Jones G Morgan

机构信息

Department of Pharmacy, Tristar Centennial Medical Center, Nashville, TN, USA.

University of Tennessee Health Science Center College of Pharmacy, Memphis, TN, USA.

出版信息

Neurohospitalist. 2023 Jul;13(3):278-282. doi: 10.1177/19418744231166984. Epub 2023 May 17.

DOI:10.1177/19418744231166984
PMID:37441206
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10334045/
Abstract

Lacosamide (LCM) is an antiseizure medication used to manage status epilepticus (SE). Previous retrospective analyses have demonstrated safety and efficiency in intravenous push (IVP) administration at 80 mg per minute. Quick administration can be achieved in a high-acuity setting without the additional time required for compounding. However, previous literature only partially represents high doses of IVP LCM, which limits the understanding of the safety profile of these doses. Our study was a single-center, retrospective, single-arm analysis of patients who received IVP LCM 300 mg or 400 mg during admission. The primary outcome was the incidence of infusion site reactions, hypotension, and bradycardia within 2 hours of IVP administration. Secondary outcomes included the incidence of PR prolongation. A total of 113 patients were evaluated for infusion site reactions. Of these, 108 patients had vital signs assessed within 2 hours of IVP LCM and could be evaluated for hypotension and bradycardia. The sample primarily consisted of LCM 400 mg IVP (85.8%). The primary outcome consisted of 7 (6.2%) infusion reactions, 12 (11.1%) hypotensive events, and no reports of bradycardia. Each adverse event was assessed using the Naranjo Adverse Drug Probability Scale. All events scored less than two, suggesting the possibility was likely related to factors other than the medication. In conclusion, LCM 300 mg and 400 mg IVP administration have the potential to facilitate more rapid treatment of seizures without additional risk of infusion site reactions, hypotension, and bradycardia.

摘要

拉科酰胺(LCM)是一种用于治疗癫痫持续状态(SE)的抗癫痫药物。既往回顾性分析已证明静脉推注(IVP)给药时,每分钟80毫克的剂量具有安全性和有效性。在高急症情况下可以快速给药,无需额外的配制时间。然而,既往文献仅部分代表了高剂量的IVP拉科酰胺,这限制了对这些剂量安全性的了解。我们的研究是一项单中心、回顾性、单臂分析,纳入了入院期间接受300毫克或400毫克IVP拉科酰胺治疗的患者。主要结局是IVP给药后2小时内输注部位反应、低血压和心动过缓的发生率。次要结局包括PR间期延长的发生率。共有113例患者接受了输注部位反应评估。其中,108例患者在IVP拉科酰胺给药后2小时内进行了生命体征评估,可评估低血压和心动过缓情况。样本主要由400毫克IVP拉科酰胺组成(85.8%)。主要结局包括7例(6.2%)输注反应、12例(11.1%)低血压事件,且无心动过缓报告。使用Naranjo药物不良反应概率量表对每例不良事件进行评估。所有事件得分均低于2分,表明可能性很可能与药物以外的因素有关。总之,300毫克和400毫克IVP拉科酰胺给药有可能促进癫痫发作的更快速治疗,而不会增加输注部位反应、低血压和心动过缓的额外风险。

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