aFGF与bFGF治疗Ⅲ度烧伤的多中心随机Ⅳ期双盲临床阳性药物对照试验

Ⅳ Multicenter Randomized Positive Drug Controlled Clinical Trial of aFGF and bFGF in the Treatment of Ⅲ Degree Burns

目的:比较重组人酸性成纤维细胞生长因子(rh-aFGF)与碱性成纤维细胞生长因子(bFGF)治疗Ⅲ度烧伤的临床疗效差异。方法:入选4个研究医院47例深重度烧伤患者,分为治疗组24例和对照组23例。入院72 h内均给予相应的削痂手术、皮片移植、抗感染及营养支持治疗。治疗组给予aFGF治疗(削痂术后冲洗,皮片处理,术后换药)。对照组给予bFGF治疗,给药方法同aFGF给药方法完全一致。两组连续治疗8周,观察创面愈合情况、皮瓣成活及不良反应发生情况。结果:治疗组患者完全愈合时间、30 d愈合率、皮片成活面积分别为(44.2±4.2)d、75.0%、(94.7±5.8)%;对照组分别为(48.8±4.6)d、43.5%、(87.4±6.4)%。另外治疗组1例(4.2%)发生脓毒血症,对照组发生5例(21.7%)。治疗过程两组均未发生明显的不良反应。结论:rh-aFGF促进愈合,提高皮瓣成活作用,改善重度烧伤患者预后优于bFGF。

Objective：To compare recombinant human acidic fibroblast growth factor （rh-aFGF） and basic differences in the clinical efficacy of a fibroblast growth factor （bFGF） treatment ofⅢdegree burns. Method：The study enrolled four hospital 47 cases of deep burns patients in both groups were given admission within 72 h corresponding tangential excision,skin graft,anti-infective and nutritional support. AFGF treatment group of 24 patients given treatment （tangential excision after washing,skin graft treatment,postoperative dressing）. BFGF control group of 23 patients received treatment with aFGF administration method of administration method exactly. Two continuous treatment 21 days,observe wound healing,skin flap survival and adverse events. Result：The complete healing time,30 d healing rate of skin graft survival area were （44.2±4.2）d,75.0%,（94.7±5.8）%,the control group were（48.8±4.6）d,43.5%,（87.4±6.4）%. 1 patient （4.2%） occurred sepsis in treatment group,the control group had five（21.7%）.There were no adverse reactions occur in treatment process. Conclusion：rh-aFGF to promote healing and improve skin flap survival role in improving patients with severe burns to heal than bFGF.