A Randomized,Multi-center and Parallel Control Clinical Trial for Acidic Fibroblast Growth Factor in the Treatment of Deep Second Degree Burn / 中国药师

ABSTRACT

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-sionrh-aFGF shows better clinical efficacy than rh-bFGF in the treatment of deep second degree burn with the similar safety.