外用重组牛碱性成纤维细胞生长因子治疗二度烧伤的随机安慰剂对照试验

Randomised placebo-controlled trial of use of topical recombinant bovine basic fibroblast growth factor for second-degree burns.

作者信息

Fu X, Shen Z, Chen Y, Xie J, Guo Z, Zhang M, Sheng Z

机构信息

304th Hospital, Trauma Center of Postgraduate Medical College, Beijing, PR China.

出版信息

Lancet. 1998 Nov 21;352(9141):1661-4. doi: 10.1016/S0140-6736(98)01260-4.

DOI:10.1016/S0140-6736(98)01260-4

PMID:9853438

Abstract

BACKGROUND

Wound healing is a dynamic process that could be accelerated by growth factors. We investigated the effect of recombinant bovine basic fibroblast growth factor (rbFGF) on burn healing in a randomised placebo-controlled trial.

METHODS

We recruited 600 patients with superficial or deep second-degree burns. Patients received 150 AU/cm2 daily topical rbFGF (n=300) or placebo (n=300) plus vehicle. We assessed healing by photography, punch-biopsy, and clinical examination.

FINDINGS

All patients treated with rbFGF had faster granulation tissue formation and epidermal regeneration than those in the placebo group. Superficial and deep second-degree burns treated with rbFGF healed in a mean of 9.9 (SD 2.5) days and 17.0 (4.6) days, respectively, compared with 12.4 (2.7) and 21.2 (4.9) days (p=0.0008 and p=0.0003, respectively). No adverse effects were seen locally or systemically with rbFGF.

INTERPRETATION

rbFGF effectively decreased healing time and improved healing quality. Clinical benefits would be shorter hospital stays and the patient's skin quickly becoming available for harvesting and grafting.

摘要

背景

伤口愈合是一个动态过程，生长因子可加速这一过程。我们在一项随机安慰剂对照试验中研究了重组牛碱性成纤维细胞生长因子（rbFGF）对烧伤愈合的影响。

方法

我们招募了600例浅Ⅱ度或深Ⅱ度烧伤患者。患者每天接受150 AU/cm²的局部rbFGF治疗（n = 300）或安慰剂治疗（n = 300）加赋形剂。我们通过摄影、打孔活检和临床检查评估愈合情况。

结果

所有接受rbFGF治疗的患者与安慰剂组相比，肉芽组织形成和表皮再生更快。用rbFGF治疗的浅Ⅱ度和深Ⅱ度烧伤分别平均在9.9（标准差2.5）天和17.0（4.6）天愈合，而安慰剂组分别为12.4（2.7）天和21.2（4.9）天（p分别为0.0008和0.0003）。rbFGF在局部或全身均未观察到不良反应。