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使用局部重组人酸性成纤维细胞生长因子治疗深Ⅱ度烧伤和皮肤移植供区的随机、多中心、双盲、安慰剂对照试验

Randomized, multicenter, double-blind, and placebo-controlled trial using topical recombinant human acidic fibroblast growth factor for deep partial-thickness burns and skin graft donor site.

作者信息

Ma Bing, Cheng Da-Sheng, Xia Zhao-Fan, Ben Dao-Feng, Lu Wei, Cao Zhi-Fang, Wang Qiang, He Jia, Chai Jia-Ke, Shen Chuan-An, Sun Yong-Hua, Zhang Guo-An, Hu Xiao-Hua

机构信息

Department of Burn Surgery, Changhai Hospital, the Second Military Medical University, Shanghai, China.

出版信息

Wound Repair Regen. 2007 Nov-Dec;15(6):795-9. doi: 10.1111/j.1524-475X.2007.00307.x.

Abstract

Wound healing is a dynamic and complex biologic process that could be accelerated by growth factors. To investigate the efficacy of topical recombinant human acidic fibroblast growth factor (rh-aFGF) treatment in deep partial-thickness burn or skin graft donor sites, we designed a randomized, multicenter, double-blind, and placebo-controlled clinical trial. The healing rate, fully healed rate, and healing time were evaluated to assess the efficacy of rh-aFGF application. Laboratory examinations and abnormal signs were used to assess the side and toxic effects. The results showed that the healing rate of burn wounds and skin graft donor sites treated by rh-aFGF was significantly higher than that by placebo, and the mean healed time of burn wounds and skin graft donor sites in the rh-aFGF group was significantly the shorter than that in the placebo group. In conclusion, topical administration of rh-aFGF can accelerate the wound healing process and shorten the healed time. It is a potential therapeutic application for promoting healing of deep partial-thickness burns or skin graft donor sites.

摘要

伤口愈合是一个动态且复杂的生物学过程,生长因子可加速这一过程。为研究局部应用重组人酸性成纤维细胞生长因子(rh-aFGF)治疗深Ⅱ度烧伤或皮肤移植供区的疗效,我们设计了一项随机、多中心、双盲、安慰剂对照的临床试验。通过评估愈合率、完全愈合率和愈合时间来评价rh-aFGF应用的疗效。采用实验室检查和异常体征来评估其副作用和毒性作用。结果显示,rh-aFGF治疗的烧伤创面和皮肤移植供区的愈合率显著高于安慰剂组,rh-aFGF组烧伤创面和皮肤移植供区的平均愈合时间明显短于安慰剂组。总之,局部应用rh-aFGF可加速伤口愈合过程并缩短愈合时间。它是促进深Ⅱ度烧伤或皮肤移植供区愈合的一种潜在治疗方法。

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