高压氧治疗 COVID-19 所致急性呼吸窘迫综合征：一项随机临床试验（COVID-19-HBO）的中期安全性报告
COVID-19-Induced Acute Respiratory Distress Syndrome Treated with Hyperbaric Oxygen: Interim Safety Report from a Randomized Clinical Trial (COVID-19-HBO).
作者信息
Kjellberg Anders, Douglas Johan, Hassler Adrian, Al-Ezerjawi Sarah, Boström Emil, Abdel-Halim Lina, Liwenborg Lovisa, Hetting Eric, Jonasdottir Njåstad Anna Dora, Kowalski Jan, Catrina Sergiu-Bogdan, Rodriguez-Wallberg Kenny A, Lindholm Peter
机构信息
Department of Physiology and Pharmacology, Karolinska Institutet, 171 77 Stockholm, Sweden.
Perioperative Medicine and Intensive Care Medicine, Karolinska University Hospital, 171 76 Stockholm, Sweden.
出版信息
J Clin Med. 2023 Jul 24;12(14):4850. doi: 10.3390/jcm12144850.
BACKGROUND
A few prospective trials and case series have suggested that hyperbaric oxygen therapy (HBOT) may be efficacious for the treatment of severe COVID-19, but safety is a concern for critically ill patients. We present an interim analysis of the safety of HBOT via a randomized controlled trial (COVID-19-HBO).
METHODS
A randomized controlled, open-label, clinical trial was conducted in compliance with good clinical practice to explore the safety and efficacy of HBOT for severe COVID-19 in critically ill patients with moderate acute respiratory distress syndrome (ARDS). Between 3 June 2020, and 17 May 2021, 31 patients with severe COVID-19 and moderate-to-severe ARDS, a ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO/FiO) < 26.7 kPa (200 mmHg), and at least two defined risk factors for intensive care unit (ICU) admission and/or mortality were enrolled in the trial and randomized 1:1 to best practice, or HBOT in addition to best practice. The subjects allocated to HBOT received a maximum of five treatments at 2.4 atmospheres absolute (ATA) for 80 min over seven days. The subjects were followed up for 30 days. The safety endpoints were analyzed.
RESULTS
Adverse events (AEs) were common. Hypoxia was the most common adverse event reported. There was no statistically significant difference between the groups. Numerically, serious adverse events (SAEs) and barotrauma were more frequent in the control group, and the differences between groups were in favor of the HBOT in PaO/FiO (PFI) and the national early warning score (NEWS); statistically, however, the differences were not significant at day 7, and no difference was observed for the total oxygen burden and cumulative pulmonary oxygen toxicity dose (CPTD).
CONCLUSION
HBOT appears to be safe as an intervention for critically ill patients with moderate-to-severe ARDS induced by COVID-19.
CLINICAL TRIAL REGISTRATION
NCT04327505 (31 March 2020) and EudraCT 2020-001349-37 (24 April 2020).
背景
一些前瞻性试验和病例系列研究表明，高压氧治疗（HBOT）可能对重症新型冠状病毒肺炎（COVID-19）有效，但对于危重症患者，安全性是一个令人担忧的问题。我们通过一项随机对照试验（COVID-19-HBO）对HBOT的安全性进行中期分析。
方法
开展一项符合良好临床实践的随机对照、开放标签临床试验，以探讨HBOT对中度急性呼吸窘迫综合征（ARDS）危重症患者的重症COVID-19的安全性和有效性。在2020年6月3日至2021年5月17日期间，31例重症COVID-19且伴有中重度ARDS（动脉血氧分压与吸入氧分数值之比（PaO/FiO）<26.7 kPa（200 mmHg））、至少有两个重症监护病房（ICU）入住和/或死亡的明确危险因素的患者被纳入试验，并按1:1随机分为接受最佳治疗组，或在最佳治疗基础上加用HBOT组。分配到HBOT组的受试者在7天内接受最多5次2.4绝对大气压（ATA）、每次80分钟的治疗。对受试者进行30天的随访。分析安全性终点。
结果
不良事件（AE）很常见。低氧是报告的最常见不良事件。两组之间无统计学显著差异。从数值上看，严重不良事件（SAE）和气压伤在对照组中更频繁，且两组之间在PaO/FiO（PFI）和国家早期预警评分（NEWS）方面的差异有利于HBOT组；然而，在第7天，统计学上差异不显著，且在总氧负荷和累积肺氧中毒剂量（CPTD）方面未观察到差异。
结论
对于由COVID-19引起的中重度ARDS危重症患者，HBOT作为一种干预措施似乎是安全的。
临床试验注册
NCT04327505（2020年3月31日）和EudraCT 2020-001349-37（2020年4月24日）。
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