Tom Wynnis L, Peng David H, Allaei Atabak, Hsu Daniel, Hata Tissa R
Division of Dermatology, Department of Medicine, University of California, San Diego, USA.
Arch Dermatol. 2005 Nov;141(11):1373-7. doi: 10.1001/archderm.141.11.1373.
To determine the efficacy and safety of short-contact administration of topical tretinoin on foot ulcers in patients with diabetes.
Randomized, double-blind, placebo-controlled trial.
Outpatient clinic at a Veterans Affairs medical center.
Twenty-four volunteers with diabetic foot ulcers but without evidence of peripheral arterial disease or infection.
Patients were randomized to 4 weeks of daily treatment with either topical 0.05% tretinoin solution (Retin-A) or placebo saline solution. Photographs and assessment of wound size and appearance were assessed every 2 weeks for a total of 16 weeks.
The proportion of ulcers that healed in each group and the degree of change in ulcer size.
Twenty-two patients, with a total of 24 foot ulcers, completed the study. At the end of 16 weeks, 2 (18%) of 11 ulcers in the control group and 6 (46%) of 13 ulcers in the tretinoin treatment group healed completely. Topical tretinoin therapy significantly decreased ulcer area and depth compared with placebo treatment over the 16 weeks of the study (P < .01 for surface area; P = .02 for depth). Adverse effects mainly consisted of mild pain at the ulcer site.
Short-contact application of topical tretinoin improved the healing of foot ulcers in patients with diabetes. The tretinoin therapy was generally well tolerated, without serious local or systemic adverse effects.
确定短期外用维甲酸治疗糖尿病患者足部溃疡的疗效和安全性。
随机、双盲、安慰剂对照试验。
一家退伍军人事务医疗中心的门诊诊所。
24名患有糖尿病足溃疡但无外周动脉疾病或感染证据的志愿者。
患者被随机分为两组，分别接受为期4周的每日外用0.05%维甲酸溶液（维甲酸）或安慰剂生理盐水溶液治疗。每2周对伤口大小和外观进行拍照和评估，共持续16周。
每组溃疡愈合的比例以及溃疡大小的变化程度。
22名患者（共24处足部溃疡）完成了研究。在16周结束时，对照组11处溃疡中有2处（18%）完全愈合，维甲酸治疗组13处溃疡中有6处（46%）完全愈合。在研究的16周内，与安慰剂治疗相比，外用维甲酸治疗显著减小了溃疡面积和深度（表面积P <.01；深度P =.02）。不良反应主要包括溃疡部位的轻度疼痛。
短期外用维甲酸可改善糖尿病患者足部溃疡的愈合情况。维甲酸治疗总体耐受性良好，无严重局部或全身不良反应。
