Darougheh A, Asilian A, Shariati F
Skin Diseases and Leishmaniasis Research Centre, and Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran.
Clin Exp Dermatol. 2009 Mar;34(2):219-23. doi: 10.1111/j.1365-2230.2007.02631.x. Epub 2008 Nov 6.
Keloids and hypertrophic scars are benign growths of dermal collagen that can cause physical and psychological (cosmetic) problems for patients.
In this 12-week, double-blind, clinical trial, 40 patients were randomized into two study groups. Patients in group 1 were given intralesional triamcinolone acetonide (TAC), and patients in group 2 were given a combination of TAC and 5-fluorouracil (5-FU); both groups received injections at weekly intervals for 8 weeks. Lesions were assessed for erythema, pruritus, pliability, height, length and width.
Four patients in group 1 and three patients in group 2 failed to complete the study. At the 8-week and 12-week follow-up visits, both groups showed an acceptable improvement in nearly all parameters, but these were more significant in the TAC + 5-FU group (P < 0.05 for all except pruritus and percentage of itch reduction). Good to excellent (> 50%) improvement were reported by 20% of the patients in group 1 and 55% of the patients in group 2, which was significantly different (P = 0.02). Good to excellent responses was reported by trained observers as 15% in group 1 and 40% in group 2. Their difference was not significant (P = 0.08).
The overall efficacy of TAC + 5-FU was comparable with TAC, but the TAC + 5-FU combination was more acceptable to patients and produced better results.
瘢痕疙瘩和增生性瘢痕是真皮胶原蛋白的良性增生,会给患者带来身体和心理(美容方面)的问题。
在这项为期12周的双盲临床试验中,40名患者被随机分为两个研究组。第1组患者接受病灶内注射曲安奈德(TAC),第2组患者接受TAC与5-氟尿嘧啶(5-FU)的联合治疗;两组均每周注射1次,共注射8周。对病灶的红斑、瘙痒、柔韧性、高度、长度和宽度进行评估。
第1组有4名患者和第2组有3名患者未完成研究。在8周和12周的随访中,两组几乎所有参数均有可接受的改善,但TAC + 5-FU组的改善更显著(除瘙痒和瘙痒减轻百分比外,所有参数P < 0.05)。第1组20%的患者和第2组55%的患者报告有良好至极佳(> 50%)的改善,差异有统计学意义(P = 0.02)。经培训的观察者报告第1组有良好至极佳反应的为15%,第2组为40%。两者差异无统计学意义(P = 0.08)。
TAC + 5-FU的总体疗效与TAC相当,但TAC + 5-FU联合治疗更易被患者接受,且效果更好。