伴有运动诱导肺动脉压升高或肺动脉高压较轻的 COPD 患者的临床病程及波生坦干预的影响：前瞻性、单中心、随机、平行组研究。

Clinical course of COPD patients with exercise-induced elevation of pulmonary artery pressure or less severe pulmonary hypertension presenting with respiratory symptoms and the impact of bosentan intervention-prospective, single-center, randomized, parallel-group study.

机构信息

Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-Ku, Tokyo, 113-8603, Japan.

Department of Respiratory Medicine, Nippon Medical School, Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.

出版信息

BMC Pulm Med. 2024 Feb 17;24(1):90. doi: 10.1186/s12890-024-02895-0.

DOI:10.1186/s12890-024-02895-0

PMID:38368315

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10873998/

Abstract

BACKGROUND

The data on bosentan were lacking for the treatment of exercise-induced elevation of pulmonary artery pressure (eePAP) or less severe PH in COPD. This study was conducted to investigate long-term efficacy and safety of bosentan for the treatment of eePAP or less severe PH in COPD.

METHODS

COPD patients diagnosed at this hospital as having COPD (WHO functional class II, III or IV) with eePAP or less severe PH whose respiratory symptoms were stable but remained and gradually progressed even after COPD therapy were randomly assigned in a 1:1 ratio to receive either bosentan or no PH treatment for two years and assessed at baseline and every 6 months for respiratory failure, activities of daily living (ADL), lung and heart functions by right heart catheterization (RHC), and other parameters.

RESULTS

A total of 29 patients who underwent RHC for detail examination were enrolled in the current study between August 2010 and October 2018.No death occurred in drug-treated group (n = 14) for 2 years; 5 patients died in untreated group (n = 15). Significant differences were noted between the 2 group in hospital-free survival (686.00 ± 55.87 days vs. 499.94 ± 53.27 days; hazard ratio [HR], 0.18; P = 0.026) and overall survival (727 days vs. 516.36 ± 55.38 days; HR, 0.095; P = 0.030) in all causes of death analysis, but not in overall survival in analysis of respiratory-related death. Bosentan was not associated with increased adverse events including requiring O inhalation.

CONCLUSIONS

This study suggested that the prognosis for COPD patients with eePAP or less severe PH presenting with respiratory symptoms was very poor and that bosentan tended to improve their prognosis and suppress ADL deterioration without worsening respiratory failure.

TRIAL REGISTRATION

This study was registered with UMIN-CTR Clinical Trial as UMIN000004749 . First trial registration at 18/12/2010.

摘要

背景

博来霉素对肺动脉压升高（eePAP）或 COPD 较轻 PH 的治疗数据缺乏。本研究旨在探讨波生坦治疗 COPD 患者 eePAP 或较轻 PH 的长期疗效和安全性。

方法

本研究纳入了我院诊断为 COPD（WHO 功能分类 II、III 或 IV 级）且伴有 eePAP 或较轻 PH 的患者，这些患者的呼吸症状稳定，但在 COPD 治疗后仍持续存在并逐渐进展。这些患者被随机分为博来霉素治疗组和非 PH 治疗组，每组各 14 例，两组患者均接受为期两年的治疗，并在基线时和每 6 个月进行一次呼吸衰竭、日常生活活动（ADL）、肺和心脏功能的评估，评估方式为右心导管检查（RHC）。

结果

共有 29 例患者接受了 RHC 详细检查，其中 14 例（55.16%）患者接受了博来霉素治疗，15 例（44.84%）患者未接受 PH 治疗。在药物治疗组中，无患者在 2 年内死亡（n = 14），而在未治疗组中，有 5 例患者死亡（n = 15）。两组患者在无住院生存率（686.00 ± 55.87 天 vs. 499.94 ± 53.27 天；风险比 [HR]，0.18；P = 0.026）和全因死亡率分析中的总生存率（727 天 vs. 516.36 ± 55.38 天；HR，0.095；P = 0.030）方面存在显著差异，但在呼吸相关死亡分析中的总生存率方面无差异。博来霉素治疗并未增加包括需要吸氧在内的不良事件。