摘要
目的探索重组人粒细胞巨噬细胞集落刺激因子(rhGM—CSF)凝胶剂能否促进烧伤患者深Ⅱ度创面愈合。方法收集多中心研究中的其中两个单位资料,以深Ⅱ度烧伤患者作为试验对象,进行多中心随机双盲对照试验。试验组60例100cm^2创面使用100μg rhGM—CSF凝胶剂,对照组30例使用基质安慰剂。观察其创面愈合情况。结果试验组深Ⅱ度创面愈合时间为(14.71±0.48)d,较对照组(20.48±1.09)d明显缩短(P〈0.01)。试验组14,20,28d的创面愈合率分别为(84.55±25.20)%、(97.55±8.19)%和(100.00±0.00)%,也较对照组同期创面愈合率(44.44±35.90)%、(80.19±24.00)%和(96.67±12.09)%均明显提高(P均〈0.01)。未见与受试药物有关的不良反应。结论rhGM—CSF凝胶剂能促进烧伤患者深Ⅱ度创面愈合。且对100cm^2创面使用是安全的。
Objective To investigate whether recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) gel could accelerate deep Ⅱ° burn healing. Methods Data of 2 research centers were collected for a multiple center study. Ninety burn patients with deep Ⅱ° burn were randomly assigned into treatment group ( n - 60) and control group. 100 μg rhGM-CSF was used on 100 cm^2 wound daily in the treatment group and placebo gel used in the control group to observe the time and rate of wound healing as well as possible side effects. Results The wound healing time was (14.71 ± 0.48 ) days in the treatment group and (20.48 ± 1.09 ) days in the control group (P 〈 0.01 ). The wound healing rates at posthurn days 14, 20 and 28 in the treatment group were ( 84. 55 ± 25.20)%, (97.55 ± 8. 19)% and (100.00 ±0. 00)%, respectively, compared with (44.44 ± 35.90)%, (80. 19 ±24.00)% and (96.67 ±12.09)% in the control group, with statistically significant difference (P 〈 0.01 ). No side effect was observed. Conclusion rhGM-CSF gel can accelerate healing of deep Ⅱ° burn and the daily dose of 100 μg rhGM-CSF is safe for 100 cm^2 burn.
出处
《中华创伤杂志》
CAS
CSCD
北大核心
2008年第3期224-227,共4页
Chinese Journal of Trauma