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格隆溴铵/依氟鸟氨酸 CS:首个获批用于治疗慢性阻塞性肺疾病的雾化长效抗毒蕈碱药物。

Glycopyrrolate/eFlow CS: The First Nebulized Long-Acting Muscarinic Antagonist Approved to Treat Chronic Obstructive Pulmonary Disease.

机构信息

1 Duke Clinical Research Institute and Durham Veterans Administration Medical Center, Durham, NC, USA.

出版信息

Ann Pharmacother. 2019 Mar;53(3):285-293. doi: 10.1177/1060028018798753. Epub 2018 Sep 1.

Abstract

OBJECTIVE

To review the pharmacology, efficacy, and safety of the first nebulized long-acting muscarinic antagonist (LAMA), glycopyrrolate (GLY)/eFlow closed system (CS) nebulizer, approved for maintenance treatment of chronic obstructive pulmonary disease (COPD).

DATA SOURCES

A PubMed search was conducted (January 2000 to July 2018) using the following terms/phrases: nebulized glycopyrrolate, inhalation devices in COPD, long-acting muscarinic antagonists COPD, and COPD survey. Retrieved articles were reviewed to identify additional references.

STUDY SELECTION AND DATA EXTRACTION

Primary and review articles on GLY/eFlow CS and other treatment options for patients with COPD were selected.

DATA SYNTHESIS

Guidelines recommend the use of LAMAs, alone or in combination with long-acting β-agonists, as maintenance therapy for the majority of patients with COPD. With the range of different devices and bronchodilators now available, treatment can be tailored based on individual needs. The eFlow CS nebulizer delivers GLY rapidly over a 2- to 3-minute period and provides bronchodilation within 30 minutes, lasting 12 hours. Phase 2 dose-finding and phase 3 studies demonstrated sustained statistically significant and clinically important improvements in pulmonary function and patient-reported outcomes with GLY/eFlow CS. Relevance to Patient Care and Clinical Practice: GLY/eFlow CS provides a novel, portable, efficient, and rapid drug delivery system.

CONCLUSIONS

The recently approved GLY/eFlow CS drug-device combination provides a viable treatment option for patients with COPD, particularly those with conditions that may impair proper use of traditional handheld inhalers.

摘要

目的

综述首个雾化长效毒蕈碱受体拮抗剂(LAMA),即格隆溴铵(GLY)/eFlow 密闭系统(CS)雾化器的药理学、疗效和安全性,该药获批用于慢性阻塞性肺疾病(COPD)的维持治疗。

资料来源

采用以下术语/词组在 PubMed 上进行检索(2000 年 1 月至 2018 年 7 月):雾化格隆溴铵、COPD 中的吸入装置、长效毒蕈碱受体拮抗剂 COPD、COPD 调查。检索到的文章进行了回顾,以确定其他参考文献。

研究选择和数据提取

选择了关于 GLY/eFlow CS 以及 COPD 患者其他治疗选择的原始研究和综述文章。

数据综合

指南建议将 LAMA 单独或与长效β激动剂联合使用作为大多数 COPD 患者的维持治疗。随着目前不同设备和支气管扩张剂的出现,可以根据个人需求定制治疗方案。eFlow CS 雾化器在 2-3 分钟内快速输送 GLY,并在 30 分钟内提供支气管扩张作用,持续 12 小时。2 期剂量发现和 3 期研究表明,GLY/eFlow CS 可显著改善肺功能和患者报告的结局,且具有统计学意义和临床意义。

与患者护理和临床实践的相关性

GLY/eFlow CS 提供了一种新颖、便携、高效且快速的药物输送系统。

结论

最近批准的 GLY/eFlow CS 药物-设备组合为 COPD 患者,特别是那些可能影响传统手动吸入器正确使用的患者,提供了一种可行的治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3122/6357169/00aac8b861db/10.1177_1060028018798753-fig1.jpg

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