Department of Dermatology, Kyushu University Hospital, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan.
Eur J Dermatol. 2009 Sep-Oct;19(5):461-8. doi: 10.1684/ejd.2009.0750. Epub 2009 Jul 29.
Basic fibroblast growth factor (bFGF) has been shown to promote wound healing. The present trial evaluated the clinical efficacy of bFGF for diabetic ulcer, a type of refractory skin ulcer, and the dose-response relationship. This was designed as a randomized, double-blind, dose-ranging, placebo-controlled trial. A total of 150 patients with non-ischaemic diabetic ulcers measuring 900 mm2 or less were randomized into a placebo group (n = 51), a 0.001% bFGF group (n = 49) and a 0.01% bFGF group (n = 50), and 148 of these patients received treatment for 8 weeks or less. The efficacy evaluation was carried out on 139 patients who met the protocol in this trial. The primary outcome was the percentage of patients showing 75% or greater reductions in the area of ulcer. The area of ulcer decreased by 75% or more in 57.5% (27/47), 72.3% (34/47), and 82.2% (37/45) in the placebo, 0.001% bFGF and 0.01% bFGF groups, respectively, and differences were significant between the 0.01% bFGF and placebo groups (p = 0.025). The cure rate was 46.8% (22/47), 57.4% (27/47), and 66.7% (30/45) in the placebo, 0.001% bFGF and 0.01% bFGF groups, respectively. The findings obtained in this trial showed wound healing accelerating effects of bFGF on diabetic ulcers.
碱性成纤维细胞生长因子（bFGF）已被证明可促进伤口愈合。本试验评估了 bFGF 治疗糖尿病溃疡（一种难治性皮肤溃疡）的临床疗效及其剂量反应关系。这是一项随机、双盲、剂量范围、安慰剂对照试验。共有 150 名非缺血性糖尿病溃疡患者（面积<900mm2）随机分为安慰剂组（n=51）、0.001%bFGF 组（n=49）和 0.01%bFGF 组（n=50），其中 148 名患者接受治疗<8 周。对符合本试验方案的 139 名患者进行疗效评估。主要疗效指标为溃疡面积减少 75%以上的患者比例。安慰剂、0.001%bFGF 和 0.01%bFGF 组的溃疡面积分别减少 75%或更多的患者比例为 57.5%（27/47）、72.3%（34/47）和 82.2%（37/45），0.01%bFGF 组与安慰剂组之间差异有统计学意义（p=0.025）。安慰剂、0.001%bFGF 和 0.01%bFGF 组的治愈率分别为 46.8%（22/47）、57.4%（27/47）和 66.7%（30/45）。本试验结果表明 bFGF 对糖尿病溃疡有促进愈合作用。
