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咪达唑仑鼻喷雾剂治疗癫痫丛集性发作患者的批判性评估。

A critical evaluation of midazolam nasal spray for the treatment of patients with seizure clusters.

作者信息

Wheless James W

机构信息

Le Bonheur Comprehensive Epilepsy Program & Neuroscience Institute, Le Bonheur Children's Hospital, University of Tennessee Health Science Center, Memphis, Tennessee, USA.

出版信息

Expert Rev Neurother. 2021 Nov;21(11):1195-1205. doi: 10.1080/14737175.2021.1890033. Epub 2021 Mar 12.

DOI:10.1080/14737175.2021.1890033
PMID:33593228
Abstract

: Patients with epilepsy may experience seizure clusters (SCs), which are considered a medical emergency requiring immediate treatment. Besides seizures and seizure-related injuries, patients with SCs experience impaired quality of life and have a greater need for healthcare resources. Midazolam nasal spray (MDZ-NS) was approved by the United States Food and Drug Administration (FDA) for the treatment of SCs in 2019, and was the first FDA-approved nasally administered formulation for treating SCs.: This article provides a critical evaluation of MDZ-NS for the treatment of patients with SCs. It covers the chemistry, pharmacodynamic and pharmacokinetic properties of MDZ-NS, and safety, tolerability, and efficacy data from phase I and phase III trials. SC treatment guidelines in different countries and for alternative therapies are also discussed.: Midazolam is a well-established drug that is familiar to physicians. The newer MDZ-NS formulation offers the benefits of intranasal administration, which allows for outpatient treatment by caregivers and other non-healthcare professionals when an SC occurs, and may be particularly meaningful to patients with limited treatment options because other routes of administration are unsuitable. MDZ-NS is effective and patients are known to return to baseline alertness and psychomotor function within 240 minutes after administration.

摘要

癫痫患者可能会经历癫痫发作丛集(SCs),这被视为需要立即治疗的医疗紧急情况。除了癫痫发作及与发作相关的损伤外,患有癫痫发作丛集的患者生活质量受损,对医疗资源的需求也更大。咪达唑仑鼻喷雾剂(MDZ - NS)于2019年获得美国食品药品监督管理局(FDA)批准用于治疗癫痫发作丛集,是首个获FDA批准用于治疗癫痫发作丛集的鼻用制剂。本文对MDZ - NS治疗癫痫发作丛集患者进行了批判性评估。它涵盖了MDZ - NS的化学、药效学和药代动力学特性,以及来自I期和III期试验的安全性、耐受性和疗效数据。还讨论了不同国家的癫痫发作丛集治疗指南及替代疗法。咪达唑仑是一种医生熟知的成熟药物。较新的MDZ - NS制剂具有鼻内给药的优点,当癫痫发作丛集发生时,护理人员和其他非医疗专业人员可在门诊进行治疗,对于因其他给药途径不合适而治疗选择有限的患者可能特别有意义。MDZ - NS是有效的,已知患者在给药后240分钟内恢复到基线警觉性和精神运动功能。

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