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重组人粒细胞巨噬细胞集落刺激因子凝胶对中国东北地区三度冻伤创面的影响:一项随机对照试验

The Effects of Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor Gel on Third-Degree Frostbite Wounds in Northeastern China: A Randomized Controlled Trial.

作者信息

Zhang Xiu-Hang, Cui Chang-Lei, Zhu Hao-Yue, Wang Jian, Xue Yan, Zhang Nan, Sun Zhan-Ao, Gao Xin-Xin, Zhou Xin, Yu Jia-Ao, Chen Xin-Xin

机构信息

Department of Burn Surgery, The First Hospital of Jilin University, Changchun, China.

Department of Anesthesiology, The First Hospital of Jilin University, Changchun, China.

出版信息

J Burn Care Res. 2023 May 2;44(3):715-722. doi: 10.1093/jbcr/iraa019.

Abstract

The aim of the study was to investigate the effects of the rhGM-CSF gel on third-degree frostbite wounds. Sixty-two patients who had suffered third-degree frostbite on their hand or foot (91 wounds in total) were selected using a convenience sampling method and randomly allocated to two groups: the rhGM-CSF group(31patients,45 frostbite wounds) received the rhGM-CSF gel when wound dressing change daily; however, the control group (31patients, 46 frostbite wounds) received aloe glue. The wound healing time, the score of inflammation about the wound and the positive bacterial culture of wound secretions were used to measure outcomes, respectively. Data were analyzed using SPSS (25.0), Student's t test or Mann-Whitney U test and chi-square test or Fisher exact test were selected, as appropriate. The healing time of the rhGM-CSF group was (12.2 ± 5.0) days, which was significantly shorter than that of the control group (15.5 ± 4.7) days (P < .0001). The rhGM-CSF group's wound inflammation scores on the 7th and 14th day of treatment were (0.96 ± 0.21) and (1.88 ± 0.29), respectively, which were better than those of the control group (1.12 ± 0.24) and (1.38 ± 0.15) (both P < .0001). The positive bacterial culture of wound secretions in the rhGM-CSF group was also better than that in the control group on the 3rd, 7th, and 14th day after treatment (P = .027, .004, .030, respectively). According to the results, using rhGM-CSF gel considerably increases the speed of frostbite wounds healing, and have an effect on protecting third-degree frostbite wounds regarding the positive effects. Trial Registration: This trial was registered in the Chinese Clinical Trial Register, ChiCTR1900021299.

摘要

本研究的目的是探讨重组人粒细胞巨噬细胞集落刺激因子(rhGM-CSF)凝胶对三度冻伤创面的影响。采用方便抽样法选取62例手部或足部三度冻伤患者(共91处创面),随机分为两组:rhGM-CSF组(31例患者,45处冻伤创面)每天换药时使用rhGM-CSF凝胶;对照组(31例患者,46处冻伤创面)使用芦荟胶。分别采用创面愈合时间、创面炎症评分及创面分泌物细菌培养阳性情况来衡量疗效。数据采用SPSS(25.0)进行分析,根据情况选择Student's t检验或Mann-Whitney U检验以及卡方检验或Fisher确切检验。rhGM-CSF组的愈合时间为(12.2±5.0)天,显著短于对照组的(15.5±4.7)天(P<.0001)。rhGM-CSF组治疗第7天和第14天的创面炎症评分分别为(0.96±0.21)和(1.88±0.29),优于对照组的(1.12±0.24)和(1.38±0.15)(均P<.0001)。rhGM-CSF组治疗后第3天、第7天和第14天创面分泌物细菌培养阳性情况也优于对照组(P分别为.027、.004、.030)。根据结果,使用rhGM-CSF凝胶可显著提高冻伤创面的愈合速度,且在积极作用方面对三度冻伤创面有保护作用。试验注册:本试验在中国临床试验注册中心注册,注册号为ChiCTR1900021299。

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