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发光二极管-红光治疗减少术后瘢痕:一项剂量范围、分割面部、随机对照试验的结果。

Light emitting diode-red light for reduction of post-surgical scarring: Results from a dose-ranging, split-face, randomized controlled trial.

机构信息

Rutgers Robert Wood Johnson Medical School, Piscataway, New Jersey, USA.

Dermatology Service, VA New York Harbor Healthcare System, Brooklyn, New York, USA.

出版信息

J Biophotonics. 2021 Jul;14(7):e202100073. doi: 10.1002/jbio.202100073. Epub 2021 May 4.

Abstract

Scarring has significant esthetic and functional consequences for patients. A need exists for anti-scarring therapeutics. Light emitting diode-red light (LED-RL) has been shown to modulate skin fibrosis. The aim of this study is to evaluate the safety and efficacy of LED-RL to reduce post-operative scarring. Cutaneous Understanding of Red-light Efficacy on Scarring was a randomized, mock-controlled, single-blind, dose-ranging, split-face phase II clinical trial. Starting 1 week post-surgery, patients received LED-RL irradiation and temperature-controlled mock therapy to incision sites at fluences of 160, 320 or 480 J/cm , triweekly for 3 weeks. Efficacy was assessed at 1, 3 and 6-12 months. The primary endpoint was difference in scar pliability between LED-RL-treated and control sites. Secondary outcomes included Patient and Observer Scar Assessment Scale, collagen and water concentration, and adverse events. There were no significant differences in scar pliability between treated and control scars. At certain fluences, treated scars showed greater improvements in observer rating and scar pliability, reflected by greater reductions in induration, from baseline to 6 months compared to control scars. Treatment-site adverse events included blistering (n = 2) and swelling (n = 1), which were mild and resolved without sequelae. LED-RL phototherapy is safe in the early postoperative period and may reduce scarring.

摘要

瘢痕形成会对患者的美观和功能造成重大影响。因此需要开发抗瘢痕疗法。已有研究表明发光二极管-红光(LED-RL)可调节皮肤纤维化。本研究旨在评估 LED-RL 减少术后瘢痕形成的安全性和有效性。光疗理解红光在瘢痕治疗中的疗效为一项随机、模拟对照、单盲、剂量范围、分割面部的 II 期临床试验。术后 1 周开始,患者接受 LED-RL 辐照和温度控制模拟治疗,剂量分别为 160、320 或 480 J/cm ,每周 3 次,共 3 周。在 1、3 和 6-12 个月评估疗效。主要终点是 LED-RL 治疗区和对照区之间的瘢痕柔韧性差异。次要终点包括患者和观察者瘢痕评估量表、胶原蛋白和水分浓度以及不良事件。治疗区和对照区的瘢痕柔韧性无显著差异。在某些剂量下,与对照瘢痕相比,治疗后瘢痕的观察者评分和瘢痕柔韧性有更大的改善,表现在从基线到 6 个月时硬结程度的降低。治疗部位的不良事件包括水疱(n=2)和肿胀(n=1),均为轻度,且无后遗症。LED-RL 光疗在术后早期是安全的,可能减少瘢痕形成。

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