[Effects of recombinant human granulocyte macrophage colony stimulating factor gel on treatment of full-thickness frostbite wounds on foot and hand]

Zhonghua Shao Shang Za Zhi. 2020 Feb 20;36(2):117-121. doi: 10.3760/cma.j.issn.1009-2587.2020.02.007.
[Article in Chinese]

Abstract

Objective: To explore the effects of recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF) gel on treatment of thefull-thickness frostbite wounds on foot and hand. Methods: From November 2013 to April 2017, a total of 45 patients of 71 full-thickness frostbite wounds on foot and hand meeting the inclusion criteria were admitted to the First Hospital of Jilin University and the prospective randomized controlled study was done. The patients were divided into rhGM-CSF group of 24 patients with 35 wounds and control group of 21 patients with 36 wounds according to the random number table. There were 20 males and 4 females, aged (38±13) years among patients in rhGM-CSF group, and there were 19 males and 2 females, aged (36±14) years among patients in control group. Patients in 2 groups were performed with the same systemic treatment of rewarming, anti-inflammation, pain relief, anti-infection, anti-coagulation, and thrombolysis. Wounds of patients in rhGM-CSF group and control group were respectively treated with rhGM-CSF gel and aloe vera gel for external usage with 10 mg for every square centimeter and dressing change once every 24 hours, until wounds healed completely. The wound inflammatory response was scored on treatment day (TD) 1, 3, 7, 14, wound secretion was collected for bacteria culture and positive bacteria detection rate was calculated before treatment and on TD 6 and 12, adverse drug reaction after drug use was observed, and the complete wound healing time was recorded. Data were processed with Fisher's exact probability test, analysis of variance for repeated measurement, t test, and Bonferroni correction. Results: The scores of wound inflammatory response of patients in 2 groups on TD 1 and 3 were close (t=0.37, 2.93, P>0.05). The scores of wound inflammatory response of patients on TD 7 and 14 in rhGM-CSF group were significantly higher than those in control group (t=5.77, 5.83, P<0.01). The results of bacteria culture of wound secretion of patients in 2 groups before treatment were negative. The positive bacteria detection rates of wound secretion of patients in rhGM-CSF group on TD 6 and 12 were 5.71% (2/35) and 22.86% (8/35), which were slightly lower than 13.89% (5/36) and 30.56%(11/36) in control group respectively, but there was no significantly statistical difference (P>0.05). No adverse drug response occurred in patients in rhGM-CSF group, while 1 patient in control group had adverse drug response, with symptoms of redness and swelling of wounds and patchy erythema on skin around wounds, which were alleviated by irrigating with normal saline. The complete wound healing time of patients in rhGM-CSF was (12.3±0.5) d, which was significantly shorter than (16.5±0.8) d in control group (t=24.89, P<0.05). Conclusions: The topical rhGM-CSF gel has effects of shortening time of wound healing and reducing inflammatory response of wound on treatment of full-thickness frostbite wounds on foot and hand, which is safe in clinical application.

目的: 探讨重组人粒细胞巨噬细胞集落刺激因子(rhGM-CSF)凝胶对手足部Ⅲ度冻伤创面的治疗效果。 方法: 2013年11月—2017年4月,吉林大学第一医院收治45例(共71个创面)符合入选标准的手足部Ⅲ度冻伤患者,对其进行前瞻性随机对照研究。按随机数字表法将患者分为rhGM-CSF组24例(35个创面)和对照组21例(36个创面)。rhGM-CSF组患者中男20例、女4例,年龄(38±13)岁;对照组患者中男19例、女2例,年龄(36±14)岁。2组患者均进行复温、抗炎止痛、抗感染、抗凝、溶栓等全身治疗,rhGM-CSF组患者和对照组患者创面分别外涂rhGM-CSF凝胶和芦荟抑菌胶,每平方厘米创面外涂10 mg,每24小时换药1次,直至创面完全愈合。治疗1、3、7、14 d,对创面炎症反应进行评分;治疗前及治疗6、12 d,取创面分泌物行细菌培养并计算细菌阳性检出率;观察用药后的药物不良反应;记录创面完全愈合时间。对数据行Fisher确切概率法检验、重复测量方差分析、t检验及Bonferroni校正。 结果: 治疗1、3 d,2组患者创面炎症反应评分相近(t=0.37、2.93,P>0.05);治疗7、14 d,rhGM-CSF组患者创面炎症反应评分明显高于对照组(t=5.77、5.83,P<0.01)。治疗前,2组患者创面分泌物细菌培养结果均为阴性。治疗6、12 d,rhGM-CSF组患者创面分泌物细菌阳性检出率分别为5.71%(2/35)、22.86%(8/35),略低于对照组的13.89%(5/36)、30.56%(11/36),差异无统计学意义(P>0.05)。rhGM-CSF组患者未出现药物不良反应。对照组患者中1例出现药物不良反应,表现为创面红肿,创周皮肤片状红斑,经生理盐水冲洗后缓解。rhGM-CSF组患者创面完全愈合时间为(12.3±0.5)d,明显短于对照组的(16.5±0.8)d(t=24.89,P<0.05)。 结论: 外用rhGM-CSF凝胶治疗手足部Ⅲ度冻伤创面可缩短创面愈合时间、减少创面炎症反应,临床应用安全。.

Keywords: Foot; Frostbite; Granulocyte macrophage colony-stimulating factors, recombinant; Hand; Wound healing.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Bacteria
  • Female
  • Frostbite / drug therapy*
  • Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Recombinant Proteins
  • Wound Healing
  • Young Adult

Substances

  • Recombinant Proteins
  • Granulocyte-Macrophage Colony-Stimulating Factor