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经鼻高流量或无创通气?——探寻高碳酸血症 COPD 加重治疗方法:一项随机非劣效性临床试验。

Nasal high flow or noninvasive ventilation? navigating hypercapnic COPD exacerbation treatment: A randomized noninferiority clinical trial.

机构信息

Department of Emergency Medicine, University of Thessaly, 41500, Greece; Department of Respiratory Medicine, University of Thessaly, 41500, Greece.

Department of Respiratory Medicine, University of Thessaly, 41500, Greece.

出版信息

Respir Med. 2024 Oct;232:107762. doi: 10.1016/j.rmed.2024.107762. Epub 2024 Aug 5.

Abstract

BACKGROUND

Noninvasive ventilation (NIV) has been the cornerstone for managing acute exacerbations of COPD (AECOPD) with hypercapnic respiratory failure. Nasal high flow (NHF) oxygen therapy has emerged as a potential alternative, offering a more tolerable modality with promising outcomes. The aim of the present study was to evaluate whether NHF respiratory support is noninferior to NIV with respect to treatment failure, in patients with mild-to-moderate hypercapnic AECOPD.

METHODS

In this multi-center, randomized, noninferiority trial, 105 patients with AECOPD and respiratory failure type II were enrolled. Participants were randomly assigned to receive either NHF therapy or NIV. The primary endpoint was the frequency of treatment failure, defined as the need for intubation and invasive mechanical ventilation or a switch to the alternative treatment group. Secondary endpoints included changes in respiratory parameters, patient comfort indicators, and the occurrence of complications.

RESULTS

The findings revealed no significant difference in the primary outcome between the groups, with a treatment failure rate of 19.6 % (10 out of 51) in the NHF group and 14.8 % (8 out of 54) in the NIV group. Interestingly, NHF users reported significantly lower levels of dyspnea and discomfort at multiple follow-up points. Despite the differences in patient comfort, respiratory parameters such as respiratory rate, arterial blood gases, and use of accessory muscles of respiration showed no significant disparities between the groups throughout the study period.

CONCLUSIONS

NHF therapy was similar to NIV in preventing treatment failure among patients with hypercapnic AECOPD, offering a viable alternative with enhanced comfort.

TRIAL REGISTRATION

The study was prospectively registered in ClinicalTrials.gov (Identifier: NCT03466385) on March 15, 2018.

摘要

背景

无创通气(NIV)一直是治疗伴有高碳酸血症的 COPD 急性加重(AECOPD)的基石。鼻高流量(NHF)氧疗已成为一种潜在的替代方法,提供了一种更耐受的模式,并带来了有希望的结果。本研究旨在评估 NHF 呼吸支持在治疗轻度至中度高碳酸血症 AECOPD 患者时,与 NIV 相比,是否在治疗失败方面无差异。

方法

这是一项多中心、随机、非劣效性试验,纳入了 105 例 AECOPD 合并 II 型呼吸衰竭患者。参与者被随机分配接受 NHF 治疗或 NIV。主要终点是治疗失败的频率,定义为需要插管和有创机械通气或转为替代治疗组。次要终点包括呼吸参数、患者舒适度指标和并发症的发生变化。

结果

两组之间在主要结局上没有显著差异,NHF 组的治疗失败率为 19.6%(10/51),NIV 组为 14.8%(8/54)。有趣的是,NHF 使用者在多个随访点报告的呼吸困难和不适程度明显较低。尽管患者舒适度存在差异,但在整个研究期间,呼吸参数如呼吸频率、动脉血气和辅助呼吸肌的使用在两组之间没有显著差异。

结论

NHF 治疗在预防伴有高碳酸血症的 AECOPD 患者治疗失败方面与 NIV 相似,提供了一种更舒适的可行替代方法。

试验注册

该研究于 2018 年 3 月 15 日在 ClinicalTrials.gov(标识符:NCT03466385)前瞻性注册。

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