Thistlethwaite Kenneth R, Finlayson Kathleen J, Cooper P David, Brown Bebe, Bennett Michael H, Kay Graeme, O'Reilly Maria T, Edwards Helen E
Royal Brisbane & Women's Hospital, Hyperbaric Medicine Service, Herston, Australia.
School of Nursing, Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove, Australia.
Wound Repair Regen. 2018 Jul;26(4):324-331. doi: 10.1111/wrr.12657. Epub 2018 Oct 19.
Over 30% of venous leg ulcers do not heal despite evidence-based treatment. This study aimed to determine the effectiveness of Hyperbaric Oxygen Therapy (HBOT) as an adjunct treatment for nonhealing venous leg ulcers. A randomized, double-blind, parallel group, placebo-controlled trial was undertaken in three hyperbaric medicine units. Adults with a venous leg ulcer, Transcutaneous Oxygen Measurement indicative of a hypoxic wound responsive to oxygen challenge, and without contraindications for HBOT; were eligible. Of 84 eligible patients, 10 refused and 74 enrolled. 43 participants achieved over 50% ulcer Percent Area Reduction (PAR) after four weeks of evidence-based care and were thus excluded from the intervention phase. Thirty-one participants were randomized to either 30 HBOT treatments (100% oxygen at 2.4 atmospheres absolute (ATA) for 80 minutes), or 30 "placebo" treatments, receiving a validated "sham" air protocol, initially pressurized to 1.2ATA, then cycled between 1.05-1.2ATA for eight minutes before settling at 1.05ATA. The primary outcome was numbers in each group completely healed. Secondary outcomes were ulcer PAR, pain and quality of life, 12 weeks after commencing interventions. The participants' mean age was 70 years (standard deviation (SD) 12.9) and median ulcer duration at enrolment was 62 weeks (range 4-3120). At 12 weeks, there was no significant difference between groups in the numbers completely healed. The HBOT intervention group had a mean of 95 (SD 6.53) ulcer PAR, compared to 54 (SD 67.8) mean PAR for the placebo group (t = -2.24, p = 0.042, mean difference -40.8, SE 18.2) at 12 weeks. HBOT may improve refractory healing in venous leg ulcers, however patient selection is important. In this study, HBOT as an adjunct treatment for nonhealing patients returned indolent ulcers to a healing trajectory.
尽管采用了循证治疗，但超过30%的下肢静脉溃疡仍无法愈合。本研究旨在确定高压氧疗法（HBOT）作为不愈合下肢静脉溃疡辅助治疗的有效性。在三个高压医学单位进行了一项随机、双盲、平行组、安慰剂对照试验。纳入标准为患有下肢静脉溃疡、经皮氧测量显示伤口缺氧且对氧激发有反应、无HBOT治疗禁忌证的成年人。84名符合条件的患者中，10人拒绝参与，74人登记入组。43名参与者在接受四周循证护理后溃疡面积减少百分比（PAR）超过50%，因此被排除在干预阶段。31名参与者被随机分为两组，一组接受30次HBOT治疗（在2.4绝对大气压（ATA）下吸入100%氧气80分钟），另一组接受30次“安慰剂”治疗，采用经过验证的“假”空气方案，初始加压至1.2ATA，然后在1.05 - 1.2ATA之间循环8分钟，最后稳定在1.05ATA。主要结局是每组完全愈合的人数。次要结局是干预开始12周后的溃疡PAR、疼痛和生活质量。参与者的平均年龄为70岁（标准差（SD）12.9），入组时溃疡持续时间的中位数为62周（范围4 - 3120周）。在12周时，两组之间完全愈合的人数没有显著差异。在12周时，HBOT干预组的溃疡PAR平均为95（SD 6.53），而安慰剂组的平均PAR为54（SD 67.8）（t = -2.24，p = 0.042，平均差异 -40.8，标准误18.2）。HBOT可能会改善下肢静脉溃疡的难治性愈合，然而患者选择很重要。在本研究中，HBOT作为不愈合患者的辅助治疗使难治性溃疡走上了愈合轨道。
