Efficacy and safety of recombinant human granulocyte-macrophage colony-stimulating factor hydrogel in treating second- or third-degree burn wounds in children: a systematic review and meta-analysis.

Background: The efficacy and safety of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) hydrogel in adults with deep partial-thickness burns have been confirmed. However, the clinical safety and efficacy analysis of rhGM-CSF in pediatrics is lacking, and the results are questionable. Therefore, a meta-analysis was conducted to evaluate the efficacy and safety of rhGM-CSF hydrogel in children with second- or third-degree burn injury to provide evidence-based medicine for clinical application. Methods: Articles on rhGM-CSF hydrogel for the treatment of pediatric burn wounds were retrieved from PubMed, Embase, WOS, Cochrane Central Registry of Controlled Trials, Chinese Biomedical Literature Database (CBM), China Science and Technology Journal Database (CSTJ), China National Knowledge Infrastructure (CNKI) and Wanfang from the inception of the databases to March 2024. Two reviewers screened articles and extracted the following data: general characteristics, intervention and treatment course, outcome measure. The meta-analysis was conducted using Revman 5.4 software. Results: Eight reports (336 patients: experimental 175, control 161) were ultimately included in the meta-analysis, which showed that the experimental group (rhGM-CSF hydrogel ± other therapy) was superior to the control group (treatments without rhGM-CSF hydrogel) in terms of the wound healing rates at day 7 [mean difference (MD) =13.63, 95% confidence interval (CI): 7.25 to 20.00, P<0.001], day 14 (MD =15.59, 95% CI: 12.50 to 18.69, P<0.001), and day 21 (MD =7.47, 95% CI: 7.36 to 7.58, P<0.001), and the wound healing time (MD =-3.10, 95% CI: -3.50 to -2.71, P<0.001), and the differences were statistically significant. For the risks of bias, one study had a "high risk" in allocation sequence concealment, and the others were classified as "low risk" and "unclear risk". Conclusions: rhGM-CSF hydrogel is significantly effective in improving the wound healing rate and shortening the wound healing time in children with second- or third-degree burns.

Effects of Recombinant Human Granulocyte/Macrophage Colony-Stimulating Factor on Diabetic Lower Extremity Ulcers: Case Series of Nine Patients.

Background: Diabetic lower extremity ulcer, including diabetic foot ulcer (DFU) and leg ulcer, is one of the refractory complications of diabetes, the treatment of which is challenging, expensive, and lengthy. Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor (rhGM-CSF) is an immunomodulatory cytokine that has been mainly applied in the treatment of hematological diseases. Clinical evidence regarding GM-CSF in the treatment of diabetic lower extremity ulcers is limited. This study is the first case series that investigates the repurpose effects of rhGM-CSF on diabetic ulcer healing in real clinical practice. Methods: Nine patients diagnosed with diabetes and refractory lower extremity ulcer (ulcer duration ≥2 weeks) were included from September 2021 to February 2023 in the Division of Endocrinology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology. Patients with Wagner grade ≥4 and SINDAD ≥5 were excluded. The included subjects were treated with rhGM-CSF plus standard of care (SOC) including glycemic control, foot care education, debridement of necrotic tissues, topical wound dressings, offloading, and infection control when necessary. The observation endpoint was complete epithelialization. Their clinical manifestations, laboratory tests, and therapeutic effects were extracted and analyzed. Results: The case series included 9 cases aged from 29 to 80 years and all the patients were male. Seven of 9 patients presented neuropathic ulcer. Only one case showed non-infected ulcer from tissue samples and one case presented ankle brachial index (ABI) <0.9. It was observed that the ulcer areas among these 9 patients gradually declined throughout the whole treatment period with the average healing velocity 0.32 ± 013 cm2/day and the mean time to complete healing 16.0 ± 3.7 days. The relative area (percentage of initial ulcer area) decreased to 66.7 ± 13.0% on average after the first treatment. Ulcers in all the 9 patients achieved complete epithelialization after 4-8 times treatments. Conclusion: The case series suggests rhGM-CSF as a promising therapeutic strategy for the treatment of diabetic ulceration. More robust data from randomized controlled trials are required to further evaluate its clinical efficacy.

Application of rhG-CSF in the treatment of chemotherapy-induced oral mucositis in children / 中国现代医生

@#Objective To explore the application effect of recombinant human granulocyte colony stimulating factor(rhG-CSF)in the treatment of chemotherapy-induced oral mucositis in children.Methods Totally 60 children with chemotherapy-induced oral mucositis who underwent chemotherapy in the tumor surgery of our hospital from January 2020 to June 2022 were randomly divided into two groups,30 cases each.The control group was given physiological saline oral care,and the experimental group was given rhG-CSF oral care.Compare the intervention effect,oral mucositis grading,quality of life[short form of health survey(SF-36)]and nursing satisfaction of parents of the two groups.Results The total effective rate of the experimental group was higher than that of the control group(P<0.05).After 5 days of intervention,the score of oral mucositis in the experimental group was better than that in the control group(P<0.05).After 5 days of intervention,the SF-36 score of children in the two groups was higher than that before intervention,and that in the experimental group was higher than that in the control group(P<0.05).The parents'satisfaction in the experimental group was higher than that in the control group(P<0.05).Conclusion rhG-CSF oral care can effectively improve the intervention effect of chemotherapy-induced oral mucositis in children,reduce the grade of oral mucositis,improve the quality of life of children,and improve the nursing satisfaction of parents of children.

Sargramostim in acute radiation syndrome.

INTRODUCTION: Since 1944, nearly 400 radiologic accidents/incidents have exposed about 3,000 people to substantial doses of ionizing radiation, with more than 125 deaths. Known are the Chernobyl and Fukushima nuclear power facility accidents, but the recent war in Ukraine has refocused attention on this issue. Therapy of acute, high-dose, whole-body exposures to ionizing radiation includes transfusions, antimicrobial drugs, molecularly cloned hematopoietic growth factors, and hematopoietic cell transplants (HCT). AREAS COVERED: We focus on approved therapies including recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF, sargramostim). Animal data indicate sargramostim accelerates marrow recovery and increases survival. In 2018, the United States Food and Drug Administration approved sargramostim for persons acutely exposed to myelosuppressive radiation doses based on two large nonhuman primate studies. In seven radiation accidents since 1986, 28 victims exposed to acute high-dose ionizing radiation received rhu GM-CSF alone or with other hematopoietic growth factors. Therapy appeared effective with few, if any, adverse events; 18 survived. EXPERT OPINION: This favorable benefit-to-risk ratio suggests giving sargramostim soon after exposure and is favored over HCT based on greater safety and fewer resource requirements, especially in the context of large-scale exposures which might occur after use of a tactical nuclear weapon or nuclear terrorism.

Therapeutic effect of subcutaneous injection of low dose recombinant human granulocyte-macrophage colony-stimulating factor on pulmonary alveolar proteinosis.

OBJECTIVE: To observe the efficacy of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) for pulmonary alveolar proteinosis (PAP). MATERIALS AND METHODS: A total of 55 patients with PAP were screened at Shanghai Pulmonary Hospital between May 2014 and May 2018. Among these, 42 were diagnosed with idiopathic PAP, 24 were included in this study, 20 were treated for 6 months, and 17 were followed up for additional 6 months. All patients received a subcutaneous injection of 75µg/d GM-CSF qd for 1 month. The therapeutic dose was adjusted according to the changes in the lesions of chest CT. If the lesions were absorbed, subcutaneous injections of 75µg/d GM- CSF qd and 75µg/d GM-CSF qod were given for 2 and 3 months, otherwise, the dose was increased to 150µg/d GM-CSF qd and 150µg/d qod for 2 and 3 months, respectively. All cases were treated once a day in the first 3 months and once every other day in the last 3 months. The total course of treatment was 6 months. After withdrawal, the patients were followed up for another 6 months. The deadline of follow up was September 30, 2019. RESULTS: Twenty patients completed the treatment and efficacy evaluation. One patient was completely cured, 16 cases improved, three cases were noneffective. After 1-month evaluation, 12 patients received an increased dose (150µg) from the second month of treatment. Seventeen patients completed the 12-month follow-up, among which fourteen improved. CT showed the lesions were slightly increased in three cases. Economic burden was the following: RMB 7324-15,190 Yuan were required for the 6-month treatment course, which is significantly lower compared to other treatment methods. CONCLUSION: Subcutaneous injection of rhGM-CSF at low dose (75µg-150µg /d) is effective treatment for patients with idiopathic PAP. TRIAL REGISTRATION: NCT01983657. Registered 16 April 2013.

Tumor growth under rhGM-CSF application in an orthotopic rodent glioma model.

Regulation of the host immune response serves a pivotal role in the persistence and progression of malignant glioma. To date, cytotoxic cluster of differentiation (CD)-8+ T and natural killer cells are considered the main cellular components of host tumor control. The influence of macrophages in an orthotropic C6 tumor implantation model was investigated and the aim of the present study was to characterize the effects of systemic macrophage-activation on glioma growth by using the granulocyte macrophage colony stimulating factor (rhGM-CSF). A total of 20 male Sprague-Dawley rats were orthotopically implanted with C6 glioma spheroids and treated subcutaneously with 10 µg/kg rhGM-CSF every other day; 9 animals served as controls. Serial magnetic resonance imaging was performed on days 7, 14, 21, 28, 32 and 42 post-implantation to monitor tumor volume. Histological work-up included hematoxylin and eosin, CD68/ED-1 macrophage, CD8 T-cell and Ki-67 MIB1 proliferation staining in gliomas and spleen. Experimental C6-gliomas developed in 15/20 (75%) animals. In rhGM-CSF treated rats, tumors developed significantly later and reached a smaller size (median, 134 mm3) compared with the controls (median, 262 mm3). On day 14, solid tumors presented in 11/17 (65%) rhGM-CSF-treated animals; in control animals tumor growth was detected in 3/9 animals on day 7 and in all animals on day 14. The mean survival time was 35 days in the rhGM-CSF group and significantly longer when compared with the control group (24 days). Immunohistochemistry exhibited significantly more macrophages in tumors, particularly in the perivascular zone of the rhGM-CSF group when compared with untreated animals; intratumoral CD8+ counts were equal in both groups. A systemic stimulation of macrophages by rhGM-CSF resulted in significantly reduced and delayed tumor growth in the rodent C6 glioma model. The present data suggested a significant role of macrophages in host control of experimental gliomas on the innate immune response. Until now, the role of macrophages may have been underestimated in host glioma control.

Clinical analysis of recombinant human granulocyte macrophage colony-stimulating factor gel in the treatment of burn wounds / 中国生化药物杂志

Objective To analyze the clinical efficacy of recombinant human granulocyte macrophage colony stimulating factor gel in the treatment of burn wounds.Methods 80 cases of burn patients in our hospital from February 2016 to February 2017 received treatment, were randomly divided into control group and observation group, 40 cases in each group, the control group given routine treatment, and the observation group was treated with recombinant human granulocyte macrophage colony stimulating factor gel on the basis of the treatment of the control group.The clinical effects of the two groups were compared and analyzed, including the healing time, the total effective rate of wound healing, the healing rate of the wound, and the related adverse reactions.Results The patients in, the healing time, total wound healing efficiency,and wound healing rate of the control group were significantly better than those of the control group(P<0.05), and no adverse reactions occurred in the two groups.Conclusion Burns were treated with recombinant human granulocyte macrophage colony stimulating factor gel treatment can effectively improve the treatment of patients with total efficiency, shorten the healing time, and can improve the healing rate, the treatment has a very important meaning and value, worthy of promotion and application in clinical widely.

Study of the use of recombinant human granulocyte-macrophage colony-stimulating factor hydrogel externally to treat residual wounds of extensive deep partial-thickness burn.

OBJECTIVE: The objective of this study was to observe the clinical effects of recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF) hydrogel in the treatment of residual wounds of extensive deep partial-thickness burn. METHODS: In this study, 21 subjects who sustained deep partial-thickness burns, which did not heal over 8 weeks, were observed. These were randomly assigned to two paired groups: the experimental group (using rhGM-CSF, n = 21) and the control group (using mupirocin ointment, n = 21). The wound dressings were changed once daily. Wound secretion, inflammation, granulation tissues, local and general side effects of the drug, wound healing time, and healing rate at different times were observed and compared between the two groups. The differences in the pathology of new vessels and fibroblasts between the two groups were observed, and their number in immunohistochemistry was detected. RESULTS: The wound healing time was 17.28 ± 6.70 days in the experimental group. It was significantly shorter than that of the control group (22.14 ± 7.38 days). The healing rates at 10 and 14 days in the experimental group were 54 ± 27% and 60 ± 36%, respectively. These healing rates were remarkably higher than those of the control group (43 ± 27% and 48 ± 30%). On the 3rd, 7th, 10th, and 14th day, the experimental group was obviously superior to the control group in wound inflammation, secretion, and granulation tissues. Furthermore, on the 7th, 10th, 14th, 21st, and 28th day, the bacterial clearance rates of the experimental group (42.85%, 52.38%, 90.47%, 95.24%, and 95.24%) were higher than those of the control group (4.76%, 4.76%, 38.10%, 76.19%, and 80.95%). On the 14th day, the average optical density of the vascular endothelial factor (VEGF) of the experimental group (0.21 ± 0.01) is bigger than that of the control group (0.18 ± 0.02) (P < 0.05), and the average optical density of the fibroblast growth factor (FGF) of the experimental group (0.25 ± 0.01) is also larger than that of the control group (0.18 ± 0.02) (P < 0.05). CONCLUSION: rhGM-CSF hydrogel effectively promotes the healing process of residual wounds of extensive deep partial-thickness burns. The hydrogel removed most of the bacteria or inhibited growth, and the local and general side reactions of the drug were mild during the study.

Evaluation of Therapeutic Effect of Recombinant Human Granulocyte-macrophage Colony-stimulating Factor Combined with SD-Ag Unguent on Deep Second Degree Burn / 医药导报

Objective To evaluate the therapeutic effect of recombinant human granulocyte-macrophage colony stimulating factor ( rhGM-CSF) combined with sulfadiazine silver ( SD-Ag) unguent on deep second degree burn. Methods Eighty-nine patients with deep second-degree burn (burns areas<10%) were enrolled.These patients were divided into two groups at random (Group A and Group B).The patients in Group A were treated with SD-Ag unguent only, and those in Group B were treated with rhGM-CSF and SD-Ag unguent.The therapeutic effects and the adverse drug reaction were recorded. Results The healing time in Group A [(19.79±1.47) days] was obviously shorter than that in Group B [(15.76±1.63) days].The total wound healing rates in Group B [on day 9:(76.41±3.24)%, day 13:(95.01±1.43)%, day 16:(99.54±0.88)%, and day 21 (100.00±0.00)%] were higher than those of Group A [on day 9: (67.24±2.33)%, day 13: (75.54±1.11)%, day 16:(88.33±1.32)%, day 21:(99.14±1.95)%].During the treatment, there was no obvious adverse reaction was observed in the two groups. Conclusion The application of rhGM-CSF combined with SD-Ag unguent can not only accelerate the healing rates of deep second-degree burn, but also has curative effect with safety.

Analysis of clinical effect of recombinant human granulocyte-macrophage colony-stimulating factor combined with recombinant bovine basic fibroblast growth factor in the treatment of oral ulcer caused by chemotherapy / 肿瘤研究与临床

Objective To investigate the effect of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) combined with recombinant bovine basic fibroblast growth factor (rb-bFGF) in the treatment of oral ulcer caused by chemotherapy.Methods 108 patients of oral ulcer caused by chemotherapy were randomly divided into two groups.54 cases in the control group were treated with cydiodine buccal tablets at first,then received the aerosol treatment which was prepared by mixing gentamicin,dexamethasone,2 ％ lidocaine and physiologic saline,three times per day.54 cases in the treatment group firstly received the gargle which was prepared by mixing rhGM-CSF,dexamethasone and physiologic saline,then were treated with rb-bFGF by spraying on the oral ulcer surface,three times per day.Results The effective rate of the treatment group was 96.30 ％ (52/54),which was significantly higher than that of the control group [64.81％ (35/54)],there was a significant difference between the two groups (x2 =17.08,P ＜ 0.05).Conclusion The effect of rhGM-CSF combined with rb-bFGF in the treatment of oral ulcer caused by chemotherapy is very significant.

Promotion effect of recombinant human granulocyte-macrophage colony stimulating factor on wound healing of gingiva in rabbits / 吉林大学学报(医学版)

Objective To investigate the effects of recombinant human granulocyte-macrophage colony stimulating factor (rhGM-CSF)on the gingival wound healing, and to lay a foundation for its application in the field of oral cavity.Methods 16 healthy rabbits were randomly divided into experiment and control groups(n=8).2 mm upper and lower incisors’labial gingivae were removed by scalpel. After operation, rhGM-CSF gel was applied to the surface of the wound gum in experiment group,while saline instead of drugs to the control group.2 rabbits were executed at 3,7,11,and 15 d after operation.HE staining was performed to observe the epithelium and epithelial connective tissue structure, distribution, and the changes of various cells of the rats;the number of positive epithelial cells and fibroblasts were observed by PCNA dyeing.Results On the 3rd day,the inflammatory cell infiltration was found in two groups, but a greater number of the cells were observed in experiment group;neovascularization was seen in both groups on the 7th day,and the fibroblasts and collagen fibers were observed too,but the extent of neovascularization in experiment group was more significant. On the 11th day, the fibroblasts proliferation was seen in two groups,but the extent in experiment group was more widely;on the 15th day,the trauma of gingivae of the rabbits in two groups returned to normal,there was no significant difference between two groups.Over time,the number of epithelial cells in proliferation was gradually increased,reached the peak on the 15th day.The number of fibroblasts began to increase from the 3rd day and reached the peak on the 11th day,and significantly reduced to the lowest value on the 15th day.The number of proliferative epithelial cells in experiment group was significantly higher (P0.05).Conclusion RhGM-CSF can promote the infiltration of inflammatory cells, angiogenesis,proliferation of epithelial cells and fibroblasts in gingivae. RhGM-CSF is beneficial with wound healing on gum tissue.

Effect of recombinant human granulocyte/macrophage colonystimulating factor combined with nano-silver for deep burn degreen Ⅱ about treatment / 实用医学杂志

Objective To observe the effect of recombinant human granulocyte/macrophage colonystimulating factor (rhGM-CSF) combined with nano-silver for deep burn degreen Ⅱ. Methods The burn model were done with Wistar rats. They were randomly divided into four groups , group A (n = 30): petrolatum treatment, group B(n = 30): nano-silver treatment, group C(n = 30): rhGM-CSF treatment, and group D(n =30): rhGM-CSF combined with nano-silver treatment. The healing rates of the four groups were observed on postburn day 1, 4, 7, 10, 14, 21. Meanwhile the levels of VEGF and EGF in serums were measured with ELISA. Results All groups started to heal on postburn day 10. Group A had inflammation obviously , and group D moderately. There were significant difference in the healing retes on postburn day 10 , 14, 21 between four groups (P < 0.05). The level of VEGF in group A peaked on postburn day 21 (25.76 ± 1.46)pg/mL, but the levels of VEGF in group B, group C and group D peaked on postburn day 14[(29.73 ± 1.58)pg/mL, (38.91 ± 2.38)pg/mL, (43.54 ± 1.28)pg/mL]. On postburn day 4, 7, 10, 14, 21, there were significant difference(P <0.05). The level of EGF peaked on postburn day 21 in all groups [(0.72 ± 0.14)ng/mL, (0.93 ± 0.13)ng/mL, (1.18 ± 0.16)ng/mL, (1.50 ± 0.15)ng/mL]. There were significant difference on postburn day 7, 10, 14, 21 between four groups (P < 0.05). Conclusions rhGM-CSF combined with nano-silver treatment could promote wound healing, and be better than rhGM-CSF and nano-silver singly.

Effect of Recombinant Human Granulocyte∕macrophage Colony_stimulating Factor and Nano_silver on Neovascularization in Healing Process of Skin with Deep II Degree Burn / 医药导报

Objective To obserVe the effect of recombinant human granulocyte∕macroPhage colony stimulating factor ( rhGM_CSF) and nano_silVer as treatment for skin with deeP II degree burn. Methods DeeP II degree burn Wistar rat model was established. The rats were randomly diVided into three grouPs,Petrolatum treatment grouP (grouP A,n=30),nano_silVer treatment grouP (grouP B,n=30),and rhGM_CSF treatment grouP (grouP C,n=30). The Pathological changes of wound of the three grouPs were obserVed 1,4,7,10,14 and 21 days after the treatment. The concentration of VEGF in serums was measured with ELISA. The leVels of HIF_1α mRNA exPression were detected by RT_PCR. Results On day 10, neoVascularization deVeloPed in grouPs A, B and C. Healing rate of the wound was the highest in grouP C, lowest in grouP A, with significant differences among the three grouPs on day 14 and day 21 (P<0. 05). VEGF leVel Peaked on day 14 in grouP A,and on day 10 in grouPs B and C. There were significant differences in VEGF leVel on day 1 between grouP A and grouPs B,C,on day 7 between grouP A and grouP C,on day 10,14 and 21 among the three grouPs (P<0. 05),but no significant differences on day 4 among the three grouPs. Conclusion rhGM_CSF and nano_silVer treatment can accelerate neoVascularization of wound,and rhGM_CSF is better than nano_silVer.

Efficacy of rhGM-CSF in treatment of radiation-induced oral mucositis: A prospective randomized controlled trial / 肿瘤

Objective: The aim of this study was to evaluate the efficacy and safety of recombinant human granulocyte macrophage colony-stimulating factor (rhGM-CSF) in treatment of nasopharyngeal cancer with radiation-induced oral mucositis. Methods: Sixty patients with nasopharyngeal cancer who received radiation (70 Gy) and chemotherapy were randomly divided into two groups: the patients (n = 30) in the experiment group rinsed their mouths with 25 mL of rhGM-CSF solution (1 μg/mL) for 3 minutes a time and four times daily from the occurrence of oral mucositis until the healing in the oral mucosa or completing 14 days of mouth rinse; the patients (n = 30) in the control group received chlorhexidine with the same dosage and administration. The serverities of mucosal damage and oral pain, the swallowing functions, time to treatment discontinuation and adverse reactions were recorded. Results: As compared with the control group, the degree of mucosal damage in the experiment group was significantly reduced with a lower score (2.04±0.96 vs 1.36±1.29, P = 0.034) after 7 days of rhGM-CSF administration. The numbers of patients with complete oral mucosal healing in the experiment group and the control group were 11 (44.0%) and 4 (14.3%), respectively (P = 0.017); the rates of oral mucosal healing were 72.0% (18/25) and 28.6% (8/28), respectively (P = 0.002) after 14 days of administration. The degrees of mucosal damage and oral pain were obviously reduced and the swallowing functions in the experiment group were significantly improved as compared with those in the control group (P < 0.001). Conclusion: rhGM-CSF can significantly improve the rate of oral mucosal healing, reduce the severities of mucosal damage and oral pain, and improve the swallowing functions, which can ensure the completion of chemotherapy and radiation therapy for nasopharyngeal cancer. Copyright© 2014 by TUMOR.

GM-CSF Priming of U937 Monocytic Cells Accelerates, But Does Not Increase, Tissue Factor (TF) Expression or Procoagulant Activity (PCA) After Stimulation with Endotoxin (LPS).

The monocytic U937 cell line, though immature, has many properties in common with mature monocytes. We have studied the antigenic expression and activity of tissue factor (TF) in the cytosol and on the surface of U937 cells after exposure to GM-CSF and endotoxin (LPS). Following exposure to LPS, both TF phenotype and procoagulant activity (PCA) increased linearly, with peak expression and activity after 18 hours of stimulation. Total PCA (tPCA) increased as early as 6 hours, unlike surface PCA (sPCA) which peaked at 18 hours. A linear correlation was observed between surface TF and both sPCA and tPCA. Incubation of cells with rHuGM-CSF did not effect phenotypic markers of monocyte maturation and had no significant effect on TF expression or PCA. However, cells activated with LPS after rHuGM-CSF priming, demonstrated accelerated expression of TF and PCA, with TF expression peaking at 6 hours and PCA at 2 hours. No increase in the absolute levels of TF were seen after priming with GM-CSF. We conclude that GM-CSF accelerates, but does not increase the magnitude of, the procoagulant response of monocytic cells to endotoxin. We propose that the initial accelerated PCA induction by LPS after rHu-GM-CSF priming, was due to conformational changes in TF and was not due to de novo synthesis of TF protein.

A Randomized and Controlled Study of rhGM-CSF on Leucopenia Induced by Chemotherapy on Cancer Patients / 中国肿瘤生物治疗杂志

Objective: To evaluate the efficacy and tolerability of rhGM-CSF in prevention of neutropenia caused by chemothera- py of cancer patients. Methods: A muticenter, randomized,match and crossover clinical study was conducted. 64 enrolled patients were randomized into AB and BA groups and each patient received two cycles of combination chemotherapy.Results:59 patients were evaluted for clinical efficacy.rhGM-CSF significantly increased the number of WBC and ANC at the stage of nadir. The period when the patients, rhGM-CSF also resulted in a hastening recovery from leucopenia and neutropenia.Conclusion: The administraton of rhTM-CSF ensures the implement of sheduled combination chemotherapy. The main side effects such as fever, osteomyalgia,skin rash were generally tolerable.

Effect of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) on Neutropenia Occuring during Radiotherapy / 대한치료방사선과학회지

PURPOSE: To assess the efficacy of recombinant human granulocyte-macrophage colony-stimulatin g factor(GM-CSF) in the neutropenia by radiotherapy. MATERIALS AND METHODS: Eleven patients with various solid tumor were treated with a daily subcutaneous dose of GM-CSF(3-7 microgram/kg) for 5 days during the radiotherapy. Before and during the course of the study all the patients were monitored by the recording of physical examination, the complete blood count with differential and reticulocyte count and liver function test. Eight patients received patients received prior or concurrent chemotherapy. RESULTS: In 10 patients, the neutrophilic nadir was significantly elevated and the length of time that patients had a neutrophil count below 103/mm3, a threshold known to be critical to acquiring infective complications was shortened following GM-CSF injection. A significant rise (two fold or greater) of neutrophil count was seen in 10 of 11 patients. In most patients, discountinuation of GM-CSF resulted in a prompt return of granulocyte counts toward baseline. However the neutrophil count remained elevated over 103/mm3 during radiation therapy, and radiotherapy delays were avoided. Other peripheral blood components including monocytes and platelets also increased after GM-CSF treatment. No siginificant toxicity was encountered with subcutaneous GM-CSF treatment. CONCLUSION: GM-CSF was well tolerated by subcutaneous route and induced improvement in the neutropenia caused by radiotherapy.