氢气/氧气疗法治疗慢性阻塞性肺疾病急性加重：一项多中心、随机、双盲、平行对照临床试验的结果。
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.
机构信息
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.
Department of Respiratory and Critical Care Medicine, The First Hospital of Hebei Medical University, Shijiazhuang, China.
出版信息
Respir Res. 2021 May 13;22(1):149. doi: 10.1186/s12931-021-01740-w.
BACKGROUND
To 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).
METHODS
This 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.
RESULTS
Change 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.
CONCLUSIONS
The 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 .
背景
研究氢气/氧气混合物在改善慢性阻塞性肺疾病急性加重（AECOPD）患者症状方面是否优于氧气。
方法
这是一项在 10 个中心进行的前瞻性、随机、双盲、对照临床试验，纳入了 AECOPD 患者，其呼吸困难、咳嗽和咳痰量表（BCSS）评分至少为 6 分。符合条件的患者被随机分配（1:1 比例）接受氢气/氧气混合物或氧气治疗。主要终点是第 7 天 BCSS 评分与基线的变化。记录不良事件（AE）以评估安全性。
结果
氢气/氧气组的 BCSS 评分变化大于氧气组（-5.3 对-2.4 分；差值：-2.75[95%CI-3.27 至-2.22]，符合优势标准）。在第 2 天至第 6 天的其他时间点也观察到了类似的结果。与对照组相比，氢气/氧气组的咳嗽评估测试评分显著降低（-11.00 对-6.00，p<0.001）。两组之间的肺功能、动脉血气和无创血氧饱和度变化以及其他终点均无显著差异。氢气/氧气组有 34 例（63.0%）患者和氧气组有 42 例（77.8%）患者报告发生 AE。研究期间无死亡和设备缺陷报告。
结论
该试验表明，氢气/氧气治疗在 AECOPD 患者中优于氧气治疗，且具有可接受的安全性和耐受性。
试验注册
美国国立医学图书馆临床试验注册处名称：美国国立医学图书馆临床试验；试验注册号：NCT04000451；注册日期：2019 年 6 月 27 日-回顾性注册；试验注册处记录的网址：https://www.clinicaltrials.gov/ct2/show/study/NCT04000451?term=04000451&draw=2&rank=1。
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