Hydrogen/oxygen therapy for the treatment of an acute exacerbation of chronic obstructive pulmonary disease: results of a multicenter, randomized, double-blind, parallel-group controlled trial

Respiratory Research

Hui Zhao¹  Zhong-Liang Guo²  Jin-Fu Xu³  Chang-Hui Wang⁴  Zhi-Jun Jie⁵  Jing Wang⁶  Wu-Zhuang Sun⁷  Jie Cao⁸  Yuan-Lin Song⁹  Jie-Ying Hu^1,10  Nan-Shan Zhong^1,10  Ze-Guang Zheng^1,10 

[1] Department of Respiratory and Critical Care Medicine, Second Hospital of Shanxi Medical University, Taiyuan, China;Department of Respiratory and Critical Care Medicine, Shanghai East Hospital of Tongji University, Shanghai, China;Department of Respiratory and Critical Care Medicine, Shanghai Pulmonary Hospital, Shanghai, China;Department of Respiratory and Critical Care Medicine, Shanghai Tenth People’s Hospital, Shanghai, China;Department of Respiratory and Critical Care Medicine, The Fifth People’s Hospital of Shanghai, Shanghai, China;Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China;Department of Respiratory and Critical Care Medicine, The First Hospital of Hebei Medical University, Shijiazhuang, China;Department of Respiratory and Critical Care Medicine, Tianjin Medical University General Hospital, Tianjin, China;Department of Respiratory and Critical Care Medicine, Zhongshan Hospital, Fudan University, Shanghai, China;State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Guangzhou Medical University, 151 Yanjiang Road, Guangdong, China;

关键词: Chronic obstructive pulmonary disease;    Acute exacerbation;    Hydrogen;    Oxygen;    Outcome;   

DOI  :  10.1186/s12931-021-01740-w

来源: Springer

【 摘 要 】

BackgroundTo investigate whether the administration of hydrogen/oxygen mixture was superior to oxygen in improving symptoms in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD).MethodsThis prospective, randomized, double-blind, controlled clinical trial in 10 centres enrolled patient with AECOPD and a Breathlessness, Cough, and Sputum Scale (BCSS) score of at least 6 points. Eligible patients were randomly assigned (in a 1:1 ratio) to receive either hydrogen/oxygen mixture or oxygen therapy. Primary endpoint was the change from baseline in BCSS score at day 7. Adverse events (AEs) were recorded to evaluate safety.ResultsChange of BCSS score in Hydrogen/oxygen group was larger than that in Oxygen group (− 5.3 vs. − 2.4 point; difference: − 2.75 [95% CI − 3.27 to − 2.22], meeting criteria for superiority). Similar results were observed in other time points from day 2 through day 6. There was a significant reduction of Cough Assessment Test score in Hydrogen/oxygen group compared to control (− 11.00 vs. − 6.00, p < 0.001). Changes in pulmonary function, arterial blood gas and noninvasive oxygen saturation did not differ significantly between groups as well as other endpoints. AEs were reported in 34 (63.0%) patients in Hydrogen/oxygen group and 42 (77.8%) in Oxygen group. No death and equipment defects were reported during study period.ConclusionsThe trial demonstrated that hydrogen/oxygen therapy is superior to oxygen therapy in patient with AECOPD with acceptable safety and tolerability profile. Trial registration: Name of the registry: U.S National Library of Medicine Clinical Trials; Trial registration number: NCT04000451; Date of registration: June 27, 2019-Retrospectively registered; URL of trial registry record: https://www.clinicaltrials.gov/ct2/show/study/NCT04000451?term=04000451&draw=2&rank=1.

【 授权许可】

CC BY