Fedorko Ludwik, Bowen James M, Jones Wilhelmine, Oreopoulos George, Goeree Ron, Hopkins Robert B, O'Reilly Daria J
Toronto General Hospital, University Health Network, Toronto, ON, Canada
Department of Clinical Epidemiology & Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada Programs for Assessment of Technology in Health, St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
Diabetes Care. 2016 Mar;39(3):392-9. doi: 10.2337/dc15-2001. Epub 2016 Jan 6.
Hyperbaric oxygen therapy (HBOT) is used for the treatment of chronic diabetic foot ulcers (DFUs). The controlled evidence for the efficacy of this treatment is limited. The goal of this study was to assess the efficacy of HBOT in reducing the need for major amputation and improving wound healing in patients with diabetes and chronic DFUs.
Patients with diabetes and foot lesions (Wagner grade 2-4) of at least 4 weeks' duration participated in this study. In addition to comprehensive wound care, participants were randomly assigned to receive 30 daily sessions of 90 min of HBOT (breathing oxygen at 244 kPa) or sham (breathing air at 125 kPa). Patients, physicians, and researchers were blinded to group assignment. At 12 weeks postrandomization, the primary outcome was freedom from meeting the criteria for amputation as assessed by a vascular surgeon. Secondary outcomes were measures of wound healing.
One hundred fifty-seven patients were assessed for eligibility, with 107 randomly assigned and 103 available for end point adjudication. Criteria for major amputation were met in 13 of 54 patients in the sham group and 11 of 49 in the HBOT group (odds ratio 0.91 [95% CI 0.37, 2.28], P = 0.846). Twelve (22%) patients in the sham group and 10 (20%) in the HBOT group were healed (0.90 [0.35, 2.31], P = 0.823). All other indices of wound healing were also not statistically significantly different between groups.
HBOT does not offer an additional advantage to comprehensive wound care in reducing the indication for amputation or facilitating wound healing in patients with chronic DFUs.
高压氧疗法（HBOT）用于治疗慢性糖尿病足溃疡（DFU）。该治疗效果的对照证据有限。本研究的目的是评估HBOT在减少糖尿病合并慢性DFU患者大截肢需求及促进伤口愈合方面的疗效。
患有糖尿病且足部病变（Wagner分级2 - 4级）持续至少4周的患者参与了本研究。除全面的伤口护理外，参与者被随机分配接受为期30天、每天90分钟的HBOT（在244 kPa下吸氧）或假治疗（在125 kPa下呼吸空气）。患者、医生和研究人员均对分组情况不知情。随机分组后12周，主要结局是血管外科医生评估的未达到截肢标准。次要结局是伤口愈合的指标。
157例患者接受了资格评估，107例被随机分组，103例可进行终点判定。假治疗组54例患者中有13例达到大截肢标准，HBOT组49例中有11例（优势比0.91 [95% CI 0.37, 2.28]，P = 0.846）。假治疗组12例（22%）患者伤口愈合，HBOT组10例（20%）患者伤口愈合（0.90 [0.35, 2.31]，P = 0.823）。两组间所有其他伤口愈合指标也无统计学显著差异。
在减少慢性DFU患者截肢指征或促进伤口愈合方面，HBOT相较于全面的伤口护理并无额外优势。
