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高压氧治疗的新适应症:登记队列研究

Emerging Indications for Hyperbaric Oxygen Treatment: Registry Cohort Study.

作者信息

Tanaka Hideaki L, Rees Judy R, Zhang Ziyin, Ptak Judy A, Hannigan Pamela M, Silverman Elaine M, Peacock Janet L, Buckey Jay C

机构信息

Division of Undersea and Hyperbaric Medicine, Department of Emergency Medicine, University of California at San Diego, San Diego, CA, United States.

Geisel School of Medicine, Dartmouth College, Lebanon, NH, United States.

出版信息

Interact J Med Res. 2024 Aug 20;13:e53821. doi: 10.2196/53821.

Abstract

BACKGROUND

Hyperbaric oxygen (HBO) 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 HBO may be useful for new indications not currently approved by the Undersea and Hyperbaric Medical Society. Identifying these new applications for HBO 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 HBO therapy. These data can then be used to identify new potential applications for HBO, 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 HBO 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 HBO. Participating centers agree to collect data on all patients treated using standard outcome measures, and individual centers send deidentified data to the central registry. HBO 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 HBO 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-HBO 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

HBO 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. HBO 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.

摘要

背景

高压氧(HBO)治疗在一系列医学专科中有多种应用,特别是在缺氧和炎症起重要作用的情况下。由于其缓解缺氧和抗炎作用,HBO可能对目前未被水下和高压氧医学协会批准的新适应症有用。确定HBO的这些新应用很困难,因为各个中心可能只治疗少数病例,并且没有持续跟踪结果。基于网络的国际高压氧治疗多中心注册库收集了接受HBO治疗患者的前瞻性结果数据。这些数据随后可用于确定HBO的新潜在应用,这与一系列医学专科相关。

目的

尽管高压氧医学已有既定适应症,但新的适应症仍在不断出现。这项注册研究的一个目的是确定HBO用于当前水下和高压氧医学协会批准适应症以外情况的病例,并展示其结果数据。

方法

这项描述性研究使用了基于网络的多中心国际HBO治疗患者注册库的数据。参与中心同意使用标准结果测量方法收集所有接受治疗患者的数据,各个中心将去识别化数据发送到中央注册库。美国、英国和澳大利亚的HBO治疗项目参与其中。收集了接受HBO治疗患者的人口统计学、结果、并发症和治疗数据,包括治疗前和治疗后的生活质量问卷(EQ-5D-5L)。

结果

在9726条患者记录中,378名(3.89%)个体因45种新出现的适应症接受了治疗。新冠后状况(PCC;也称为新冠急性后遗症;149/378,39.4%)、溃疡性结肠炎(47/378,12.4%)和克罗恩病(40/378,10.6%)占总病例数目的62.4%(n = 236)。钙质沉着症(20/378,5.3%)、冻伤(18/378,4.8%)和外周血管疾病相关伤口(12/378,3.2%)又占13.2%(n = 50)。PCC患者在神经行为症状量表上报告有显著改善(NSI评分:治疗前 = 30.6;治疗后 = 14.4;P <.001)。克罗恩病患者报告生活质量显著改善(EQ-5D评分:治疗前 = 53.8;治疗后 = 68.8),5名(13%)患者报告瘘管闭合。有完整HBO治疗前后数据的溃疡性结肠炎患者报告生活质量改善,在一份关于排便频率、便血、疼痛和急迫性的肠道问卷上得分降低。一部分钙质沉着症和动脉溃疡患者也报告有改善。

结论

由于其缓解缺氧和抗炎作用,HBO正在被广泛用于各个医学专科的各种可能应用中。结果显示,炎症性肠病和PCC患者报告的结果有统计学上的显著改善。HBO还被用于冻伤、坏疽性脓皮病、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证据,并且注册库中所有适应症的病例系列都在增加。

国际注册报告识别码(IRRID):RR2-10.2196/18857

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd1e/11372337/a93a7389adcd/ijmr_v13i1e53821_fig1.jpg

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