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慢性高碳酸血症呼吸衰竭慢性阻塞性肺疾病患者家庭启动长期无创通气:一项随机对照试验。

Home initiation of chronic non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure: a randomised controlled trial.

作者信息

Duiverman Marieke L, Vonk Judith M, Bladder Gerrie, van Melle Joost P, Nieuwenhuis Jellie, Hazenberg Anda, Kerstjens Huib A M, van Boven Job F M, Wijkstra Peter J

机构信息

Department of Pulmonary Diseases/Home Mechanical Ventilation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands

Groningen Research Institute for Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

出版信息

Thorax. 2020 Mar;75(3):244-252. doi: 10.1136/thoraxjnl-2019-213303. Epub 2019 Sep 4.

Abstract

INTRODUCTION

Chronic non-invasive ventilation (NIV) has become evidence-based care for stable hypercapnic COPD patients. While the number of patients increases, home initiation of NIV would greatly alleviate the healthcare burden. We hypothesise that home initiation of NIV with the use of telemedicine in stable hypercapnic COPD is non-inferior to in-hospital NIV initiation.

METHODS

Sixty-seven stable hypercapnic COPD patients were randomised to initiation of NIV in the hospital or at home using telemedicine. Primary outcome was daytime arterial carbon dioxide pressure (PaCO) reduction after 6 months NIV, with a non-inferiority margin of 0.4 kPa. Secondary outcomes were health-related quality of life (HRQoL) and costs.

RESULTS

Home NIV initiation was non-inferior to in-hospital initiation (adjusted mean difference in PaCO change home vs in-hospital: 0.04 kPa (95% CI -0.31 to 0.38 kPa), with both groups showing a PaCO reduction at 6 months compared with baseline (home: from 7.3±0.9 to 6.4±0.8 kPa (p<0.001) and in-hospital: from 7.4±1.0 to 6.4±0.6 kPa (p<0.001)). In both groups, HRQoL improved without a difference in change between groups (Clinical COPD Questionnaire total score-adjusted mean difference 0.0 (95% CI -0.4 to 0.5)). Furthermore, home NIV initiation was significantly cheaper (home: median €3768 (IQR €3546-€4163) vs in-hospital: median €8537 (IQR €7540-€9175); p<0.001).

DISCUSSION

This is the first study showing that home initiation of chronic NIV in stable hypercapnic COPD patients, with the use of telemedicine, is non-inferior to in-hospital initiation, safe and reduces costs by over 50%.

TRIAL REGISTRATION NUMBER

NCT02652559.

摘要

引言

慢性无创通气(NIV)已成为稳定期高碳酸血症型慢性阻塞性肺疾病(COPD)患者的循证治疗方法。随着患者数量的增加,在家庭中启动NIV将极大地减轻医疗负担。我们假设,在稳定期高碳酸血症型COPD患者中,通过远程医疗在家庭中启动NIV并不比在医院启动NIV差。

方法

67例稳定期高碳酸血症型COPD患者被随机分为在医院或通过远程医疗在家庭中启动NIV。主要结局是NIV治疗6个月后日间动脉二氧化碳分压(PaCO)的降低,非劣效界值为0.4 kPa。次要结局是健康相关生活质量(HRQoL)和成本。

结果

家庭启动NIV并不比在医院启动差(家庭与医院PaCO变化的调整后平均差值:0.04 kPa(95%CI -0.31至0.38 kPa),两组在6个月时与基线相比PaCO均降低(家庭:从7.3±0.9降至6.4±0.8 kPa(p<0.001),医院:从7.4±1.0降至6.4±0.6 kPa(p<0.001))。两组的HRQoL均有所改善,组间变化无差异(慢性阻塞性肺疾病临床问卷总分调整后平均差值为0.0(95%CI -0.4至0.5))。此外,家庭启动NIV成本显著更低(家庭:中位数3768欧元(四分位间距3546 - 4163欧元),医院:中位数8537欧元(四分位间距7540 - 9175欧元);p<0.001)。

讨论

这是第一项表明在稳定期高碳酸血症型COPD患者中,通过远程医疗在家庭中启动慢性NIV并不比在医院启动差、安全且成本降低超过50%的研究。

试验注册号

NCT02652559。

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