University of California at San Diego, La Jolla, CA, USA. Dartmouth Hitchcock Medical Center, Lebanon, NH, USA. Mayo Clinic, Rochester, MN, USA. University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Am J Gastroenterol. 2018 Oct;113(10):1516-1523. doi: 10.1038/s41395-018-0005-z. Epub 2018 Feb 16.
Hyperbaric oxygen therapy (HBOT) markedly increases tissue oxygen delivery. Case series suggest it may have a potential therapeutic benefit in ulcerative colitis (UC). We investigated the therapeutic potential of HBOT as an adjunct to steroids for UC flares requiring hospitalization.
The study was terminated early due to poor recruitment with 18 of the planned 70 patients enrolled. UC patients hospitalized for moderate-severe flares (Mayo score ≥6, endoscopic sub-score ≥2) were block randomized to steroids + daily HBOT (n = 10) or steroids + daily sham hyperbaric air (n = 8). Patients were blinded to study assignment, and assessments were performed by a blinded gastroenterologist. Primary outcome was the clinical remission rate at study day 5 (partial Mayo score ≤2 with no sub-score >1). Key secondary outcomes were: clinical response (reduction in partial Mayo score ≥2, rectal bleeding sub-score of 0-1) and progression to second-line therapy (colectomy or biologic therapy) during the hospitalization.
A significantly higher proportion of HBOT-treated patients achieved clinical remission at study day 5 and 10 (50 vs. 0%, p = 0.04). HBOT-treated patients less often required progression to second-line therapy during the hospitalization (10 vs. 63%, p = 0.04). The proportion requiring in-hospital colectomy specifically as second-line therapy for medically refractory UC was lower in the HBOT group compared to sham (0 vs. 38%, p = 0.07). There were no serious adverse events.
In this small, proof-of-concept, phase 2A trial, the use of HBOT as an adjunctive therapy to steroids for UC patients hospitalized for moderate-severe flares resulted in higher rates of clinical remission, and a reduction in rates of progression to second-line therapy during the hospitalization. Larger well-powered trials are needed, however, to provided definitive evidence of therapeutic benefit.
高压氧治疗（HBOT）可显著增加组织的氧气输送。病例系列研究表明，它在溃疡性结肠炎（UC）中可能具有潜在的治疗益处。我们研究了 HBOT 作为辅助治疗药物对需要住院治疗的中重度 UC 发作的治疗潜力。
由于入组患者较少（计划入组 70 例，仅入组 18 例），该研究提前终止。因中重度发作而住院的 UC 患者（Mayo 评分≥6，内镜下评分≥2）采用区组随机化分组，分别接受类固醇治疗加每日 HBOT（n=10）或类固醇治疗加每日假高压空气治疗（n=8）。患者对研究分组不知情，评估由盲法胃肠病学家进行。主要终点为研究第 5 天的临床缓解率（部分 Mayo 评分≤2，无任何亚评分>1）。主要次要终点为：临床应答（部分 Mayo 评分降低≥2，直肠出血亚评分 0-1）和住院期间进展至二线治疗（结肠切除术或生物治疗）。
HBOT 治疗组在研究第 5 天和第 10 天达到临床缓解的比例显著更高（50% vs. 0%，p=0.04）。HBOT 治疗组在住院期间更不易进展至二线治疗（10% vs. 63%，p=0.04）。HBOT 组中因 UC 药物难治而需要进行结肠切除术的患者比例明显低于假高压空气组（0% vs. 38%，p=0.07）。两组均无严重不良事件。
在这项小型、概念验证性、2A 期试验中，HBOT 作为类固醇的辅助治疗药物用于治疗因中重度发作而住院的 UC 患者，可提高临床缓解率，并降低住院期间进展至二线治疗的比例。然而，需要更大规模、更有力的试验来提供治疗益处的确凿证据。
Zotero 插件