重组人粒细胞巨噬细胞集落刺激因子治疗烧伤后残余创面

Local treatment of residual burn wounds with recombinant human granulocyte-macrophage colony-stimulating factor

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21d。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12.6d(95%可信区间11.9～13.3d),较对照组(16.8d,95%可信区间16.1～17.5d)明显缩短(P<0.01)。用药6、12d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。

Objective To evaluate the efficacy and safety of recombinant human granulocyte-macrophage colony-stimulating factor （rbGM-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 rbGM-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.