Institution of Clinical Sciences in Lund, Lund University, Lund, Sweden.
Department of Endocrinology, Skåne University Hospital, Lund, Sweden.
Undersea Hyperb Med. 2020 Third Quarter;47(3):423-430. doi: 10.22462/03.07.2020.3.
Hyperbaric oxygen (HBO2) therapy is an adjunct treatment for diabetic foot ulcers. Since plausible mechanisms of action for this treatment include increased angiogenesis and high tissue oxygen concentrations, concerns about deterioration of retinopathy have been raised. The aim of this study was to evaluate the effects of HBO2 on visual acuity (VA) and retinopathy in patients with chronic diabetic foot ulcers during a two-year follow-up period. This is a randomized, single-center, double-blinded and placebo-controlled clinical trial evaluating the effects of HBO2 in patients with diabetes mellitus and chronic foot ulcers. All study participants underwent an ophthalmological examination before the first study treatment and then at three, six, 12 and 24 months. Fifty patients with a median age of 67 years were included. Visual acuity was similar between groups and did not change during the two-year observation period. No differences in retinopathy were seen between groups; neither were any differences found in numbers or areas of bleedings, hard exudates, microaneurysms or edemas, nor between groups or visits. New clinically significant macular edema was identified in four eyes in the HBO2 group and in three eyes in the placebo group. In this population of diabetic foot ulcer patients HBO2 seems to be neutral in an ophthalmological perspective. From a retinal point of view, we could not identify any indication of harmful effects of HBO2 on the microvascular bed in the placebo group.
高压氧（HBO2）治疗是糖尿病足溃疡的辅助治疗方法。由于这种治疗的合理作用机制包括增加血管生成和组织中的高氧浓度，因此人们对视网膜病变恶化的问题表示担忧。本研究的目的是在两年的随访期间评估 HBO2 对慢性糖尿病足溃疡患者的视力（VA）和视网膜病变的影响。这是一项随机、单中心、双盲、安慰剂对照的临床试验，评估 HBO2 对糖尿病和慢性足部溃疡患者的影响。所有研究参与者在第一次研究治疗前和随后的 3、6、12 和 24 个月进行眼科检查。共纳入 50 名年龄中位数为 67 岁的患者。两组之间的视力相似，在两年的观察期间没有变化。两组之间在视网膜病变方面没有差异；在出血、硬性渗出物、微动脉瘤或水肿的数量或面积方面，以及在组间或随访时也没有差异。在 HBO2 组的 4 只眼中和安慰剂组的 3 只眼中发现了新的临床显著的黄斑水肿。在糖尿病足溃疡患者人群中，HBO2 似乎在眼科方面没有影响。从视网膜的角度来看，我们无法确定 HBO2 对安慰剂组微血管床的有害影响的任何迹象。
