A phase 2B randomised trial of hyperbaric oxygen therapy for ulcerative colitis patients hospitalised for moderate to severe flares.

Autor: Dulai PS; University of California San Diego, La Jolla, CA, USA., Raffals LE; Mayo Clinic, Rochester, MN, USA., Hudesman D; NYU Langone Health, New York, NY, USA., Chiorean M; Virginia Mason, Seattle, WA, USA., Cross R; University of Maryland, Baltimore, MD, USA., Ahmed T; University of Texas Southwestern Medical Center, Dallas, TX, USA., Winter M; Dartmouth Hitchcock Medical Center, Lebanon, NH, USA., Chang S; NYU Langone Health, New York, NY, USA., Fudman D; University of Texas Southwestern Medical Center, Dallas, TX, USA., Sadler C; University of California San Diego, La Jolla, CA, USA., Chiu EL; NYU Langone Health, New York, NY, USA., Ross FL; NYU Langone Health, New York, NY, USA., Toups G; Mayo Clinic, Rochester, MN, USA., Murad MH; Mayo Clinic, Rochester, MN, USA., Sethuraman K; University of Maryland, Baltimore, MD, USA., Holm JR; Virginia Mason, Seattle, WA, USA., Guilliod R; University of Texas Southwestern Medical Center, Dallas, TX, USA., Levine B; University of Texas Southwestern Medical Center, Dallas, TX, USA., Buckey JC Jr; Dartmouth Hitchcock Medical Center, Lebanon, NH, USA., Siegel CA; Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.
Jazyk: angličtina
Zdroj: Alimentary pharmacology & therapeutics [Aliment Pharmacol Ther] 2020 Sep; Vol. 52 (6), pp. 955-963. Date of Electronic Publication: 2020 Aug 03.
DOI: 10.1111/apt.15984
Abstrakt: Background: Hyperbaric oxygen has been reported to improve disease activity in hospitalised ulcerative colitis (UC) patients.
Aim: To evaluate dosing strategies with hyperbaric oxygen for hospitalised UC patients.
Methods: We enrolled UC patients hospitalised for acute flares (Mayo score 6-12). Initially, all patients received 3 days of hyperbaric oxygen at 2.4 atmospheres (90 minutes with two air breaks) in addition to intravenous steroids. Day 3 responders (reduction of partial Mayo score ≥ 2 points and rectal bleeding score ≥ 1 point) were randomised to receive a total of 5 days vs 3 days of hyperbaric oxygen.
Results: We treated 20 patients with hyperbaric oxygen (75% prior biologic failure). Day 3 response was achieved in 55% (n = 11/20), with significant reductions in stool frequency, rectal bleeding and CRP (P < 0.01). A more significant reduction in disease activity was observed with 5 days vs 3 days of hyperbaric oxygen (P = 0.03). Infliximab or colectomy was required in only three patients (15%) despite a predicted probability of 80% for second-line therapy. Day 3 hyperbaric oxygen responders were less likely to require re-hospitalisation or colectomy by 3 months vs non-responders (0% vs 66%, P = 0.002). No treatment-related adverse events were observed.
Conclusion: Hyperbaric oxygen appears to be effective for optimising response to intravenous steroids in UC patients hospitalised for acute flares, with low rates of re-hospitalisation or colectomy at 3 months. An optimal clinical response is achieved with 5 days of hyperbaric oxygen. Larger phase 3 trials are needed to confirm efficacy and obtain labelled approval.
(© 2020 John Wiley & Sons Ltd.)
Databáze: MEDLINE
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