Objective To evaluate the efficacy and safety of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) hydrogel for the local treatment of residual burn wounds. Methods The study was a randomized, double-blind, placebo-controlled and self-controlled clinical trial. One hundred and twenty residual burn wounds were divided into group A (n = 60, with treatment of rhGM-CSF hydrogel ) and group C (n= 60, with treatment of placebo), and were treated for 21 days totally. Side-effect, wound healing time,wound healing rate and total effective rate at different time points were observed. Results Slight side-effect was observed after treatment. The mean wound healing time was 12.6 (95％ CI was 11.9 to 13.3 ) days in group A,which was obviously shorter than that in group C [ 16.8 (95％ CI was 16.1 to 17.5) days, P ＜ 0.01 ]. The wound healing rate in group A was (53± 13)％ and (91± 12)％ respectively on the 6th and 12th day after treatment,which were obviously higher than those in group C [ (36 ± 11 )％ and (73 ± 14)％, P ＜ 0.01 ]. The total effective rates in group A (13.00％ and 91.67％) were also higher than those in group C (1.67％ and 53.33％) (P ＜0.05). The therapeutic efficacy of group A was obviously better than that of group C (P ＜ 0.01 ). Conclusions Local treatment of rhGM-CSF hydrogel can accelerate wound healing in patients with residual burn wounds with superior safety.%目的:探讨局部应用重组人粒细胞巨噬细胞集落刺激因子(rhGM-CSF)凝胶治疗烧伤后残余创面的安全性和有效性.方法:采用随机、双盲、安慰剂同体对照的研究方法,将120处烧伤后残余创面,随机分为试验组(n ＝ 60)和对照组(n ＝ 60).试验组采用rhGM-CSF凝胶治疗,对照组采用空白基质安慰剂治疗,试验周期为21 d.观察用药后不良反应和创面愈合时间,以及不同时相点的创面愈合率、总有效率.结果:用药后不良反应轻微.试验组创面平均愈合时间为12.6 d (95%可信区间 11.9 ～ 13.3 d),较对照组(16.8 d,95%可信区间16.1 ～ 17.5 d)明显缩短(P ＜ 0.01).用药6、12 d后,试验组创面愈合率分别为(53 ± 13)%、(91 ± 12)%,均显著高于对照组[(36 ± 11)%、(73 ± 14)%,P ＜ 0.01];试验组总有效率(13.00%、91.67%)均显著高于对照组(1.67%、53.33%,P ＜ 0.05);试验组疗效明显优于对照组(P ＜ 0.01).结论:局部应用rhGM-CSF凝胶能促进烧伤后残余创面愈合,并且具有较好的安全性.
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