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支气管内线圈再治疗重度肺气肿患者的安全性和可行性:一项试点研究。

The Safety and Feasibility of Re-treating Patients with Severe Emphysema with Endobronchial Coils: A Pilot Study.

作者信息

Hartman Jorine E, Klooster Karin, Ten Hacken Nick H T, Slebos Dirk-Jan

机构信息

a Department of Pulmonary diseases , University of Groningen, University Medical Center Groningen , Groningen , The Netherlands.

b Groningen Research Institute for Asthma and COPD , University of Groningen, University Medical Center Groningen , Groningen , The Netherlands.

出版信息

COPD. 2017 Jun;14(3):339-343. doi: 10.1080/15412555.2017.1318842. Epub 2017 May 12.

Abstract

Severe emphysema patients who have been treated with endobronchial coils have been shown to initially benefit, but slowly decline in the years thereafter. Re-treating a patient with endobronchial coils could potentially lead to new improvements and may again reduce the rate of further decline. To our knowledge, until now, no results are published about patients who are re-treated. The primary aim of this study is to investigate the safety and feasibility of re-treating severe emphysema patients with endobronchial coils, using the PneumRx coil system. Furthermore, as secondary aim, we will evaluate the efficacy of re-treating these patients. Patients who at least 2 years ago were treated with endobronchial coils and responded clinically meaningful to this treatment were included in the study and re-treated. Safety was evaluated by the number of reported adverse events. Efficacy was evaluated 6 months after re-treatment, and measured by the change in quality of life, exercise capacity and pulmonary function testing. Eight patients were re-treated at a median of 1382 days (range 849-1545) after initial coil treatment with a median additional of 12 (10-15) coils per patient. During treatment, and until 6 months of follow-up, no unexpected adverse events occurred. Quality of life, exercise capacity and lung function did not change significantly 6 months after re-treatment. The results of this pilot study suggest that re-treating patients with endobronchial coils is feasible and safe. However, larger studies are needed to confirm these results and to investigate the efficacy and thus the clinical relevance.

摘要

已证明,接受支气管内线圈治疗的重度肺气肿患者最初会受益,但此后几年病情会逐渐恶化。对患者再次进行支气管内线圈治疗可能会带来新的改善,并可能再次降低病情进一步恶化的速度。据我们所知,到目前为止,尚未发表关于再次治疗患者的结果。本研究的主要目的是使用PneumRx线圈系统,调查对重度肺气肿患者再次进行支气管内线圈治疗的安全性和可行性。此外,作为次要目的,我们将评估再次治疗这些患者的疗效。至少在2年前接受过支气管内线圈治疗且对该治疗有临床意义反应的患者被纳入研究并再次接受治疗。通过报告的不良事件数量评估安全性。在再次治疗6个月后评估疗效,通过生活质量、运动能力和肺功能测试的变化来衡量。8例患者在首次线圈治疗后的中位时间1382天(范围849 - 1545天)接受再次治疗,每位患者平均额外植入12(10 - 15)个线圈。在治疗期间以及随访的6个月内,未发生意外不良事件。再次治疗6个月后,生活质量、运动能力和肺功能没有显著变化。这项初步研究的结果表明,对患者再次进行支气管内线圈治疗是可行且安全的。然而,需要更大规模的研究来证实这些结果,并调查疗效以及临床相关性。

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