Emerging Indications for Hyperbaric Oxygen Treatment: Registry Cohort Study.

IF 1.9 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Interactive Journal of Medical Research Pub Date : 2024-08-20 DOI:10.2196/53821
Hideaki L Tanaka, Judy R Rees, Ziyin Zhang, Judy A Ptak, Pamela M Hannigan, Elaine M Silverman, Janet L Peacock, Jay C Buckey
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Abstract

Background: Hyperbaric oxygen (HBO2) treatment is used across a range of medical specialties for a variety of applications, particularly where hypoxia and inflammation are important contributors. Because of its hypoxia-relieving and anti-inflammatory effects HBO2 may be useful for new indications not currently approved by the Undersea and Hyperbaric Medical Society. Identifying these new applications for HBO2 is difficult because individual centers may only treat a few cases and not track the outcomes consistently. The web-based International Multicenter Registry for Hyperbaric Oxygen Therapy captures prospective outcome data for patients treated with HBO2 therapy. These data can then be used to identify new potential applications for HBO2, which has relevance for a range of medical specialties.

Objective: Although hyperbaric medicine has established indications, new ones continue to emerge. One objective of this registry study was to identify cases where HBO2 has been used for conditions falling outside of current Undersea and Hyperbaric Medical Society-approved indications and present outcome data for them.

Methods: This descriptive study used data from a web-based, multicenter, international registry of patients treated with HBO2. Participating centers agree to collect data on all patients treated using standard outcome measures, and individual centers send deidentified data to the central registry. HBO2 treatment programs in the United States, the United Kingdom, and Australia participate. Demographic, outcome, complication, and treatment data, including pre- and posttreatment quality of life questionnaires (EQ-5D-5L) were collected for individuals referred for HBO2 treatment.

Results: Out of 9726 patient entries, 378 (3.89%) individuals were treated for 45 emerging indications. Post-COVID-19 condition (PCC; also known as postacute sequelae of COVID-19; 149/378, 39.4%), ulcerative colitis (47/378, 12.4%), and Crohn disease (40/378, 10.6%) accounted for 62.4% (n=236) of the total cases. Calciphylaxis (20/378, 5.3%), frostbite (18/378, 4.8%), and peripheral vascular disease-related wounds (12/378, 3.2%) accounted for a further 13.2% (n=50). Patients with PCC reported significant improvement on the Neurobehavioral Symptom Inventory (NSI score: pretreatment=30.6; posttreatment=14.4; P<.001). Patients with Crohn disease reported significantly improved quality of life (EQ-5D score: pretreatment=53.8; posttreatment=68.8), and 5 (13%) reported closing a fistula. Patients with ulcerative colitis and complete pre- and post-HBO2 data reported improved quality of life and lower scores on a bowel questionnaire examining frequency, blood, pain, and urgency. A subset of patients with calciphylaxis and arterial ulcers also reported improvement.

Conclusions: HBO2 is being used for a wide range of possible applications across various medical specialties for its hypoxia-relieving and anti-inflammatory effects. Results show statistically significant improvements in patient-reported outcomes for inflammatory bowel disease and PCC. HBO2 is also being used for frostbite, pyoderma gangrenosum, pterygium, hypospadias repair, and facial filler procedures. Other indications show evidence for improvement, and the case series for all indications is growing in the registry.

International registered report identifier (irrid): RR2-10.2196/18857.

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高压氧治疗的新适应症:登记队列研究
背景:高压氧(HBO2)治疗被广泛应用于各种医疗专科,尤其是缺氧和炎症是重要的致病因素。由于 HBO2 具有缓解缺氧和消炎的作用,它可能适用于目前尚未获得海底和高压氧医学会(UHMS)批准的新适应症。确定 HBO2 的这些新应用非常困难,因为单个中心可能只治疗少数病例,而且不能持续跟踪治疗结果。基于网络的国际多中心高压氧治疗注册中心收集了接受高压氧(HBO2)治疗患者的前瞻性疗效数据。这些数据可用于确定高压氧疗法新的潜在应用领域,这与一系列医学专科相关:目的:尽管高压氧治疗已确立了适应症,但新的适应症仍在不断涌现。这项登记研究的目的之一是确定 HBO2 用于当前 UHMS 批准的适应症之外的病症的病例,并提供这些病例的结果数据:这是一项基于网络的描述性研究,由多个中心对接受 HBO2 治疗的患者进行国际登记。各中心同意使用标准结果指标收集所有接受治疗患者的数据,并将各中心的去身份化数据发送至中央登记处。美国、英国和澳大利亚的 HBO2 治疗项目均参与其中。对转诊接受 HBO2 治疗的患者收集人口统计学、结果、并发症和治疗数据,包括治疗前后的生活质量问卷(EQ-5D-5L):结果:在 9726 名患者中,有 378 人接受了 45 种新适应症的治疗。COVID急性后遗症(PASC)(149/378,40%)、溃疡性结肠炎(47/378,12.4%)和克罗恩病(40/378,11%)占病例总数的62%。钙化症(20/378,占 5.3%)、冻伤(18/378,占 4.8%)和与外周血管疾病相关的伤口(12/378,占 3.2%)又占 13.2%。PASC患者的神经行为症状量表(NSI前值为30.6,NSI后值为14.4,p结论)显示,他们的病情得到了明显改善:HBO2 具有缓解缺氧和消炎的作用,目前正广泛应用于各医学专科。研究结果表明,HBO2 对炎症性肠病和 PASC 患者报告结果的改善具有统计学意义。HBO2 还可用于冻伤、脓疱疮、翼状胬肉、尿道下裂修复和面部填充手术。其他适应症也有改善的迹象,登记在册的所有适应症的系列病例也在不断增加:临床试验:Derr1-10.2196/18857.国际注册报告:临床试验:Derr1-10.2196/18857.国际注册报告:RR2-10.2196/18857。
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来源期刊
Interactive Journal of Medical Research
Interactive Journal of Medical Research MEDICINE, RESEARCH & EXPERIMENTAL-
自引率
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发文量
45
审稿时长
12 weeks
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