PDF(Pubmed)
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 O2 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.
BACKGROUND: This study was registered with UMIN-CTR Clinical Trial as UMIN000004749 . First trial registration at 18/12/2010.
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 O2 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.
BACKGROUND: This study was registered with UMIN-CTR Clinical Trial as UMIN000004749 . First trial registration at 18/12/2010.
摘要：
背景：关于波生坦的数据缺乏用于治疗COPD中运动诱发的肺动脉压升高（eePAP）或较不严重的PH。这项研究旨在研究波生坦治疗COPD中ePAP或较不严重的PH的长期疗效和安全性。
方法：在该医院诊断为患有COPD的COPD患者（WHO功能II级，III或IV）患有ePAP或较不严重的PH，其呼吸道症状稳定但即使在COPD治疗后仍保持并逐渐发展，以1：1的比例随机分配接受波生坦或不接受PH治疗两年，并在基线和每6个月评估一次呼吸衰竭，日常生活活动（ADL），通过右心导管插入术（RHC），肺和心脏功能，和其他参数。
结果：2010年8月至2018年10月，本研究共纳入29例接受RHC进行详细检查的患者。药物治疗组（n=14）2年无死亡；未治疗组5例患者死亡（n=15）。两组之间的无医院生存率存在显着差异（686.00±55.87天vs.499.94±53.27天；危险比[HR]，0.18；P=0.026）和总生存期（727天vs.516.36±55.38天；HR，0.095；P=0.030）在所有死亡原因分析中，但在呼吸相关死亡的分析中没有总生存期。波生坦与包括需要吸入O2在内的不良事件增加无关。
结论：这项研究表明，合并有呼吸症状的ePAP或不太严重的PH的COPD患者的预后非常差，波生坦倾向于改善其预后并抑制ADL恶化而不加重呼吸衰竭。
背景：本研究在UMIN-CTR临床试验中注册为UMIN000004749。第一次审判登记在18/12/2010。
方法：在该医院诊断为患有COPD的COPD患者（WHO功能II级，III或IV）患有ePAP或较不严重的PH，其呼吸道症状稳定但即使在COPD治疗后仍保持并逐渐发展，以1：1的比例随机分配接受波生坦或不接受PH治疗两年，并在基线和每6个月评估一次呼吸衰竭，日常生活活动（ADL），通过右心导管插入术（RHC），肺和心脏功能，和其他参数。
结果：2010年8月至2018年10月，本研究共纳入29例接受RHC进行详细检查的患者。药物治疗组（n=14）2年无死亡；未治疗组5例患者死亡（n=15）。两组之间的无医院生存率存在显着差异（686.00±55.87天vs.499.94±53.27天；危险比[HR]，0.18；P=0.026）和总生存期（727天vs.516.36±55.38天；HR，0.095；P=0.030）在所有死亡原因分析中，但在呼吸相关死亡的分析中没有总生存期。波生坦与包括需要吸入O2在内的不良事件增加无关。
结论：这项研究表明，合并有呼吸症状的ePAP或不太严重的PH的COPD患者的预后非常差，波生坦倾向于改善其预后并抑制ADL恶化而不加重呼吸衰竭。
背景：本研究在UMIN-CTR临床试验中注册为UMIN000004749。第一次审判登记在18/12/2010。
