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对自行使用地西泮鼻喷雾剂进行癫痫丛集性发作急性治疗的患者的分析。

Analyses of patients who self-administered diazepam nasal spray for acute treatment of seizure clusters.

作者信息

Misra Sunita N, Sperling Michael R, Rao Vikram R, Peters Jurriaan M, Penovich Patricia, Wheless James, Hogan R Edward, Davis Charles S, Carrazana Enrique, Rabinowicz Adrian L

机构信息

Formerly of Neurelis, Inc., 3430 Carmel Mountain Rd, Ste 300, San Diego, CA 92121, USA.

Thomas Jefferson University, 909 Walnut St., Philadelphia, PA 19107, USA.

出版信息

Epilepsy Behav Rep. 2024 Jan 2;25:100644. doi: 10.1016/j.ebr.2024.100644. eCollection 2024.

DOI:10.1016/j.ebr.2024.100644
PMID:38274142
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10808926/
Abstract

For acute treatment of seizure clusters in patients with epilepsy, intranasal administration of acute seizure therapies has been shown to provide accessibility and ease of use to care partners as well as the potential for self-administration by patients. Diazepam nasal spray (Valtoco®) was approved by the US Food and Drug Administration for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) in patients with epilepsy aged ≥6 years. Self-administration consistent with the prescribing information is feasible and was reported by a subgroup of patients (n = 27 of 163) in a long-term phase 3 safety study. Data regarding self-administration among these patients with seizure clusters are examined here to explore the safety profiles and measures of effectiveness, as well as the quality of life of those who self-treated. In addition, this focused look at patients who self-administered diazepam nasal spray may offer some insights into the characteristics of patients who may be appropriate for self-administration.

摘要

对于癫痫患者癫痫发作丛集的急性治疗,已证明经鼻给予急性癫痫治疗药物可为护理人员提供便利且易于使用,患者也有自行给药的可能。地西泮鼻喷雾剂(Valtoco®)已获美国食品药品监督管理局批准,用于急性治疗≥6岁癫痫患者的间歇性、刻板性频繁癫痫发作(即癫痫发作丛集、急性重复性癫痫发作)。在一项长期3期安全性研究中,一组患者(163例中的27例)报告称,按照处方信息自行给药是可行的。本文研究了这些癫痫发作丛集患者的自行给药数据,以探讨安全性、有效性指标以及自行治疗患者的生活质量。此外,对自行使用地西泮鼻喷雾剂患者的重点观察,可能会为适合自行给药的患者特征提供一些见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2515/10808926/f84a723ca028/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2515/10808926/f84a723ca028/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2515/10808926/f84a723ca028/gr1.jpg

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本文引用的文献

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2
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Epilepsy Behav. 2022 Sep;134:108811. doi: 10.1016/j.yebeh.2022.108811. Epub 2022 Jul 8.
3
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Theranostics. 2024 Jan 27;14(4):1534-1560. doi: 10.7150/thno.91829. eCollection 2024.
Use of second doses of Valtoco® (diazepam nasal spray) across 24 hours after the initial dose for out-of-hospital seizure clusters: Results from a phase 3, open-label, repeat-dose safety study.
在初始剂量后 24 小时内使用第二剂 Valtoco®(地西泮鼻喷雾剂)治疗院外发作群:一项 3 期、开放标签、重复剂量安全性研究的结果。
Epilepsia. 2022 Apr;63(4):836-843. doi: 10.1111/epi.17177. Epub 2022 Feb 2.
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