酸性成纤维细胞生长因子治疗深Ⅱ度烧伤的多中心随机对照临床试验

摘要

Objective:To evaluate the efficacy and safety of recombinant human acidic fibroblast growth factor( rh-aFGF)and re-combinant human basic fibroblast growth factor( rh-bFGF)in the treatment of deep second degree burn. Methods:A multicenter,pro-spective,randomized and double-blind clinical trial was conducted. Totally 216 cases of deep second degree burn were selected from five research centers and given appropriate antibiotics and nutritional supplement therapy. The wound of 108 cases in the observation group were rinsing with rh-aFGF(one bottle / 5cm2)according to the wound area at the time of admission followed by rh-aFGF daily spraying,3-4 press/cm2 ,6-8 times a day. The 108 patients in the control group were treated with rh-bFGF with the same regimen as the observation group. After the 30-day follow-up,the wound healing was evaluated in the two groups. Results:The complete healing time,debridement time,complete healing rate in 12 days and 15 days in the observation group were all better than those in the control group(P<0. 05). After the 7-day treatment,the level of leukocyte and seepage score of the observation group were both lower than those of the control group(P<0. 01). The moderate rate showed significant difference between the two groups(P<0. 05). Conclu-sion:rh-aFGF shows better clinical efficacy than rh-bFGF in the treatment of deep second degree burn with the similar safety.%目的：评价重组人酸性成纤维细胞生长因子（ rh-aFGF）与重组人碱性成纤维细胞生长因子（ rh-bFGF）治疗深Ⅱ度烧伤的临床疗效与安全性。方法：采用多中心、随机、平行对照临床试验方法，入选5个研究中心216例深Ⅱ度烧伤患者，两组患者均给予相应抗感染、营养补充治疗。观察组（108例）入院时首先根据创面大小给予rh-aFGF1瓶/5 cm2进行冲洗，然后每日3~4喷/cm2喷雾治疗，6~8次/d，对照组（108例）给予rh-bFGF治疗，给药方法同观察组。随访30 d后，评价两组患者创面愈合情况。结果：观察组完全愈合时间、溶痂时间、12 d 完全愈合率、15 d 完全愈合率等指标均明显优于对照组（ P <0.05）。治疗7 d后，观察组白细胞水平、渗出评分均明显低于对照组（ P<0.01）。两组总评分中度构成比比较，差异有统计学意义（ P<0.05）。结论：rh-aFGF治疗深Ⅱ度烧伤创面临床疗效优于rh-bFGF，安全性相似。