Clinical Study On Treating Deep Second Degree Burn Wounds With Recombinant Human Granulocyte-macrophage Colony-stimulating Factor Hydrogel

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is amultifunctional cytokine, found in lung-conditioned medium by Burgesset al. It was named as GM-CSF because its ability to stimulategranulocyte and macrophage colony formation, and GM-CSF was soonapplied to the various causes of low white blood cell experiments. Withthe development of the study of GM-CSF, recombinant human GM-CSF(recombinant human GM-CSF, of rhGM-CSF) has been widely used invarious fields of clinical treatment. As the most attractive cytokine ofresearch over the past decade, its effect in the treatment of wound healingin recent years has been the focus of attention.It is truly effective that GM-CSF can stimulate the proliferation anddifferentiation of bone marrow hematopoietic precursor cell,strengthening the antigen-presenting effects and activated white bloodcells and macrophages, relieving leucopenia and reduced immunity as aside effect of chemicotherapy. There is no conclusive evidence thatGM-CSF can directly stimulate vascular endothelial cell proliferation anddifferentiation. GM-CSF deficiency was found in a variety of refractorywounds, and it was found that wound repair mechanisms graduallyrecover after giving rhGM-CSF though relative effects of GM-CSF isstill unknown. Other effects such as inducing the migration ofinflammatory cells and endothelial cells, preventing their escape from thewound, inducing keratinocyte proliferation and differentiation, and lettingLangerhans cells into the dermis, thereby promoting wound repair, existmany circumstantial evidence, but is open to question with rhGM-CSF. Animal experiments showed that the topical application of GM-CSFcan promote wound healing in diabetic mice, immune suppression ordoxorubicin-treated rats, as well as other wounds. It is confirmed in manyclinical reports that topical application of rhGM-CSF is an effective andsafe treatment for acute and chronic wounds made by various reasons forit can promote wound healing. rhGM-CSF is limited to intramuscular,intravenous infusion and experiments because rhGM-CSF used to appliedas powder or mistura which cannot maintain the bioactivity ofrhGM-CSF for a long time and it is not economical. It is not widely ap-plied in wound healing until successful development in rhGM-CSF hy-drogel.Although many animal experiments and clinical studies havereported the efficacy and safety of the rhGM-CSF hydrogel used inwound healing, but there are also some studies have question in the effectwhether the rhGM-CSF can promote wound healing or not. Arandomized, double-blind, placebo-controlled study demonstrate thatrhGM-CSF didn’t accelerate wound healing in mouse abdomenexcisional model. Another animal experiment also found that GM-CSFdid not reduce the incidence of incisional hernias in rats. Someresearchers have pointed out that rhGM-CSF is less effective in theaspect of promoting wound healing than bFGF. There are a lot of studydemonstrate that rhGM-CSF promote refractory wound healing, but it isremains controversial.Based on the above unresolved dispute, this study focuses on theclinical trials for the treatment of burn wounds with topical rhGM-CSFhydrogel.Objective: To evaluate the efficacy and safety of topical applicationof rhGM-CSF hydrogel in the treatment of deep second degree burnwounds, and explore the underlying mechanism in order to find a newway for dealing with deep degree burn wounds, and provide theexperiment basis for the development of new drugs. Methods: A randomized, self-control study of100cases of deeppartial thickness burn wound wounds were randomly divided into groupA (n=50) and group B (n=50). The group A was treated withrhGM-CSF hydrogel [state drug approval document NO.: S20100601]treatment, the group B using traditional dilute povidone-iodine gauzebandage treatment, and the test period is28days. Local adverse reaction,wound healing time, wound healing rate and total efficiency7day,14day,20day,28day after treatment. Check liver and kidney function, blood,electrolytes and blood before and after treatment. The statistical analysiswas done with SPSS19statistical software. P <0.05was consideredstatistically significant.RESULTS: This study enrolled104cases with4cases lost, and thedata of100cases were analyzed.The median wound healing time was15d [95%confidence interval(15-18) d], which was significantly shorter than that in the group B19d[95%confidence interval (18-21) d](log-rank method χ~2=5.119, P<0.05). The total effective rate of group A was62.00%,96.67%,100%in8d,14d,20d, which was significantly higher than group B that30%,80%,88%(P<0.05); effectiveness of group A was superior (P <0.05). Noobvious discomfort after treatment, or any adverse reactions.Conclusion: rhGM-CSF hydrogel can quicken the healing processof deep partial thickness burn wound, and is of secure. Its underlyingmechanism may be in association with keeping wound moist, promotingcellular metabolism, enhancing capillaries regeneration, activating theimmune cells and raising cytokines secretion of keratin cell, macrophagesand neutrophils.