重组人粒细胞巨噬细胞集落刺激因子对深Ⅱ度烧伤创面的治疗作用

目的 了解重组人粒细胞巨噬细胞集落刺激因子(rhGM-CSF)凝胶剂治疗深Ⅱ度烧伤创面的有效性和安全性. 方法采用多中心、随机、双盲、安慰剂平行对照的研究方法,将深Ⅱ度烧伤创面作为目标创面,把321例烧伤患者(实际完成302例)分为用药组200例,创面涂rhGM-CSF凝胶;对照组102例,创面涂安慰剂.观察用药后两组患者的全身情况和不良反应,以及不同时相点创面愈合时间、愈合率、总有效率. 结果用药后两组患者生命体征,血、尿常规及肝、肾功能,创面分泌物、创缘反应比较,差异均无统计学意义(P>0.05),无不良反应.用药组创面愈合时间的中位数为17 d,低于对照组(20 d,P<0.01).用药第8、14、20、28天,用药组平均创面愈合率分别为24.5%、70.5%、95.3%、99.6%,均高于对照组(15.1%、51.4%、84.6%、97.1%,P<0.01).用药8、14、20 d用药组的总有效率显著高于对照组(P<0.01). 结论 rhGM-CSF凝胶剂能促进深Ⅱ度烧伤创面愈合,并且有一定的安全性.

Effect of recombinant human granulocyte-macrophage colony stimulating factor on wound healing in patients with deep partial thickness burn

OBJECTIVE: To evaluate the efficacy and safety of recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) hydrogel in wound healing in patients with deep partial thickness burn. METHODS: The study was a multicenter, randomized, double-blind, placebo-controlled parallel clinical trial. Three hundred and twenty-one patients (302 cases finally fulfilled the protocol) with deep partial thickness burn were divided into A group (n = 200, with treatment of rhGM-CSF hytrogel, 100 microg/10 g/100 cm2/d), C group (n = 102,with treatment of placebo). Side-effect, systemic condition, wound healing time, wound healing rate, and total effective rate at different time points were observed. RESULTS: There were no obvious differences in vital signs, wound secretion, wound edge reaction, blood and urine routine, liver and kidney function between two groups (P > 0.05). No side-effect was observed. The median wound healing time was 17 days in A group, which was obviously shorter than that in C group (20 days, P < 0.01). The mean wound healing rate in A group was 24.5%, 70.5%, 95.3%, 99.6% respectively on 8th, 14th, 20th, 28th day after treatment, which were obviously higher than that in C group (15.1%, 51.4%, 84.6%, 97.1%, respectively, P < 0.01). The total effective rates in A group on 8th, 14th, 20th day after treatment were also higher than that in C group (P < 0.01). CONCLUSION: rhGM-CSF hydrogel can significantly accelerate wound healing in patients with deep partial thickness burn with certain safety.