摘要
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17d，低于对照组（20d。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、20d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。
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 μg/10 g/ 100 cm^2/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,28 th 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 safty.
出处
《中华烧伤杂志》
CAS
CSCD
北大核心
2008年第2期107-110,共4页
Chinese Journal of Burns
关键词
烧伤:粒细胞巨噬细胞集落刺激因子
重组
伤口愈合
多中心研究
Burns
Granulocyte macrophage colony-stimulating factors, recombinant
Wound healing
Muhicenter studies
