Pharmacokinetic Study of a Novel Recombinant Human Granulocyte Colony-stimulating Factor in Rats

Objective To study the pharmacokinetics of a novel recombinant human granulocyte colonystimulating factor (rhG-CSFa) in rats and to determine the proteolytic rates of rhG-CSFa in the whole blood and serum of rats in vitro. Methods The pharmacokinetics of rhG-CSFa and conventional (wild type,WT) granulocyte colonystimulating factor (G-CSF) were investigated in Sprague-Dawley rats which received either intravenous or subcutaneous injection of rhG-CSFa or WT G-CSF at three different doses (20,50,or 100 μg/kg). The blood samples of rats were collected at multiple time points (from 0.08 to 12 h) and the concentrations of rhG-CSFa and WT G-CSF in serum were determined with a sandwich enzyme-linked immunosorbent assay (ELISA). For the study of proteolytic rates in vitro,the concentrations of rhG-CSFa or WT G-CSF were determined at 3-minute intervals after addition of the respective drug to rat’s whole blood or serum. Results Pharmacokinetic analysis of serum rhG-CSFa or WT G-CSF levels indicated that,at each dose tested,for either route of drug administration,the area under concentration-time curve values and the maximum serum concentration of rhG-CSFa were higher than those of WT G-CSF,and the serum half life of rhG-CSFa was longer than that of WT G-CSF. Subsequent in vitro whole blood and serum stability study showed that the rates of drug degradation in WT G-CSF were 1.8 folds and 1.5 folds higher than those in rhG-CSFa,respectively. Conclusion rhG-CSFa has better serum and whole blood stability in vitro and higher bioavailability in vivo as compared to WT G-CSF.

Anti-apoptotic effects of recombinant human granulocyte colony-stimulating factor in focal cerebral ischemic rats

The neuroprotective effects of granulocyte colony-stimulating factor in cerebral ischemia/reperfusion injury are currently contentious. The present study examined the effects of subcutaneous injection of recombinant human granulocyte colony-stimulating factor （50 pg/kg） over 5 days in a model of cerebral ischemia/reperfusion with intraluminal filament occlusion in rats. The results indicated that recombinant human granulocyte colony-stimulating factor reduced brain infarct volume following cerebral ischemia/reperfusion injury in rats, down-regulated the expression of caspase-3 mRNA （a key protease for apoptosis in the cerebral ischemia zone）, lowered the rate of neuronal apoptosis in the cerebral ischemia zone, and notably ameliorated neurological function. These results indicate that recombinant human granulocyte colony-stimulating factor has anti-apoptotic effects on neurons following focal cerebral ischemia/reperfusion injury, and exerts neuroprotective effects.

Refolding with Simultaneous Purification of Recombinant Human Granulocyte Colony-stimulating Factor from Escherichia coli Using Strong Anion Exchange Chromatography

The urea denatured recombinant human granulocyte colony-stimulating factor (rhG- CSF) which was expressed in Escheriachia coli (E. coli) was refolded with simultaneous purification by strong anion exchange chromatography (SAX) in the presence of low concentration- of urea. The effect of urea concentration on this refolding process was investigated. The obtained refolded rhG-CSF has a high specific activity of 2.3×108 U/mg, demonstrating that the proteins were completely refolded during the chromatographic process. With only one step by SAX in 40 min, purity and mass recovery of the refolded and purified rhG-CSF were 97% and 43%, respectively.

A New Protocol for Solubilization, Refolding and Purification of Recombinant Human Granulocyte Colony-stimulating Factor in Inclusion Bodies

Recombinant human granulocyte colony-stimulating factor （rhG-CSF） in inclusion bodies was solubilized by 8 mol/L urea solution and subsequently precipitated by acetone to improve its purity. After that, the precipitates were solubilized by sodium hydroxide solution containing 2 mol/L urea. Then the solubilized rhG-CSF was passed through a size exclusion chromatography for refolding and extensive purification, and further purified by a weak anion exchange chromatography. The purity and mass recovery of refolded rhG-CSF were 96.5% and 75.6%, respectively. The bioactivity was 8.4x10^7 IU/mg.

Pharmacokinetics of recombinant human granulocyte macrophage colony-stimulating factor in Macaca mulata

目的：研究重组人粒细胞巨噬细胞集落刺激因子（ｒｈＧＭＣＳＦ）在恒河猴体内的药物动力学．方法：用酶连接免疫吸附测定法检测血浆中ｒｈＧＭＣＳＦ的含量．结果：ｉｖｒｈＧＭＣＳＦ后血药浓度时间曲线符合三房室模型．第１，２和３相的Ｔ１２分别为００５－００７ｈ，０１４－０５８ｈ和１４－４１ｈ．ＡＵＣ随剂量成比例增加．ｉｖ高剂量和低剂量的Ｃｌ和Ｋ１０都相似．ｓｃｒｈＧＭＣＳＦ后血药浓度的峰值为０９３±０１６μｇ·Ｌ－１，达峰时间为２６５±０１４ｈ，生物利用度为０６１．结论：恒河猴ｒｈＧＭＣＳＦ药物动力学数据为临床试验提供有用参考．

A retrospective study of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing neutropenia during definitive concurrent chemoradiotherapy in patients with esophageal squamous carcinoma

Objective:To compare the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor(PEG-rhG-CSF)for preventive or delayed treatment in neutropenia,completion rate of concurrent chemoradiotherapy and hospitalization rate in patients with esophageal squamous carcinoma during definitive concurrent chemoradiotherapy.Methods:A total of 70 patients with esophageal squamous carcinoma in Peking University Cancer Hospital from January 2019 to December 2020,who received PEG-rhG-CSF during concurrent chemoradiotherapy,were enrolled in this retrospective analysis.There were 32 patients in the preventive group,and 38 patients in the delayed group.The incidence of neutropenia,completion rate of concurrent chemoradiotherapy and neutropeniarelated hospitalization rate were compared between PEG-rhG-CSF preventive group and delayed group.Results:The incidence of severe neutropenia(Grades 3–4)in all patients was 31.4%.Comparison between preventive group and delayed group showed that the incidence of severe neutropenia was 6.3%and 39.4%(χ^(2)=10.428,P=0.001),respectively.In preventive group,the incidence of severe neutropenia was 3.7%and 20.0%,respectively,for primary prevention and secondary prevention of PEG-rhG-CSF(χ^(2)=12.321,P=0.001).The completion rate of concurrent chemoradiotherapy was 93.8%in the preventive group and 63.2%in the delayed group(χ^(2)=9.220,P=0.002).The incidence of treatment interruption was 25.7%in the whole group,12.5%in the preventive group and 36.8%in the delayed group(χ^(2)=5.389,P=0.020).Seven patients(7/70,10.0%)were hospitalized and treated with intravenous antibiotics for neutropenia,including 1 in the preventive group and 6 in the delayed group(P=0.078).Conclusions:Prophylactic use of PEG-rhG-CSF during concurrent chemoradiotherapy for patients with esophageal squamous carcinoma can effectively reduce the incidence of neutropenia,ensure the safety of treatment,and improve the completion rate of concurrent chemoradiotherapy.

APPLICATION OF RECOMBINANT HUMAN GRANULOCYTE COLONY-STIMULATING FACTOR (FILGRASTIM) FOLLOWING ALLOGENEIC BONE MARROW TRANSPLANTATION

The effect of rhG-CSF (Filgrastim by Amgen Co.as Neupogen and Kirin Co.as Gran) was evaluated in 20 patients with leukemia after allogeneic

A pilot study on the combined therapy of granulocyte-macrophage colony-stimulating factor and hepatitis B vaccine on chronic hepatitis B virus carrier children

Objective To observe the efficacy of treating intrauterine infected chronic hepatitis B virus (HBV) carrier children with a combination of granulocyte macrophage colony stimulating factor (GM CSF) or hepatitis B immunoglobulin (HBIG) plus recombinant hepatitis B vaccine (rHBvac) Methods A total of 27 chronic HBV infected children, who were born to HBV carrier mothers and received hepatitis B immunoprophylaxis at birth, were randomized into 2 groups: one receiving a combined therapy of 50 μg of GM CSF plus 10 μg of rHBvac injected intramuscularly at the same location (GM CSF group, 14 children) or 200 IU HBIG and 10 μg rHBvac in different muscles (HBIG group, 13 children) on a monthly four dose schedule HBV DNA quantification and other HBV serological markers were tested before and after the four dose therapy Results Twelve children in each group completed the study Of them, 3 children in the GM CSF group and 4 in the HBIG group had elevated serum alanine transaminase (ALT) before the trial, and then 2 in each group became ALT normal after the treatment Before the therapy, hepatitis B e antigen (HBeAg) positivity was found in nine children in the GM CSF group and 10 in the HBIG group One from each group had an HBeAg/anti HBe seroconversion after the treatment The quantity of HBV DNA was significantly lower after the treatment ( P =0 023) in GM CSF group, but was not significantly reduced in HBIG group No subjects were found to be negative for hepatitis B surface antigen (HBsAg) after the treatment, and no serious adverse events occurred in either group Conclusion Combined GM CSF and rHBvac therapy inhibit HBV replication in carrier children who were not protected after treatment with immunoprophylaxis

rhG-CSF在治疗儿童化疗性口腔黏膜炎中的应用研究

目的探究重组人粒细胞集落刺激因子(recombinant human granulocyte-colony stimulating factor,rhG-CSF)在治疗儿童化疗性口腔黏膜炎中的应用效果。方法选取2020年1月至2022年6月于笔者医院肿瘤外科化疗的60例化疗性口腔黏膜炎患儿,按随机数字表法分为两组,每组30例。对照组采取生理盐水口腔护理,实验组采取rhG-CSF口腔护理。比较两组患儿干预效果、口腔黏膜炎分度、生存质量[健康状况调查简表(36-item short—form,SF-36)]、患儿家长护理满意度。结果实验组总有效率较对照组高,差异有统计学意义(P<0.05)。干预5d,实验组患儿口腔黏膜炎分度结果优于对照组,差异有统计学意义(P<0.05)。干预5d,两组患儿SF-36评分较干预前高,实验组较对照组高,差异有统计学意义(P<0.05)。实验组患儿家长满意度较对照组高,差异有统计学意义(P<0.05)。结论rhG-CSF口腔护理可有效提高儿童化疗性口腔黏膜炎的干预效果,减轻口腔黏膜炎分度,改善患儿生存质量,提高患儿家长护理满意度。

重组人粒细胞巨噬细胞集落刺激因子在宫颈癌放疗致急性放射性直肠炎的临床应用

目的探索重组人粒细胞巨噬细胞集落刺激因子在宫颈癌放疗致急性放射性直肠炎中的临床疗效。方法分析本院2021年1月—2022年6月接受放射治疗的宫颈癌且出现急性放射性直肠炎的患者60例资料,随机分为观察组和对照组各30例。对照组给予0.9%NaCl注射液100 mL+甲硝唑氯化钠注射液100 mL+地塞米松10 mg,观察组给予0.9%NaCl注射液100 mL+甲硝唑氯化钠注射液100 mL+地塞米松10 mg+GM-CSF 150μg,均行保留灌肠。结果观察组及对照组的患者均经过对症处理后好转,好转率均为100%;两组的治愈率分别为73%(22/30)vs 60%(18/30),(χ^(2)=1.20,P=0.412);观察组及对照组症状好转所需时间分别为(7.60±2.17)d vs(8.83±1.60)d,两组之间差异均具有统计学意义(t=4.470,P=0.039);治疗第7天的CRP值两组之间具有差异(t=6.795,P=0.012),观察组更具优势;使用SOMA量表分别对患者灌肠前后进行评分,两组患者自身对比灌肠后便血、腹泻、里急后重、腹痛评分均较灌肠前明显降低(均P<0.05);分组比较两组患者灌药前后各症状评分差异均无统计学意义(均P>0.05)。两组治疗均耐受良好,无严重治疗相关毒副反应。结论重组人粒细胞巨噬细胞集落刺激因子联合保留灌肠能有效改善急性放射性肠炎患者的临床症状,并缩短治疗时间,可作为一种治疗急性放射性肠炎的新方法。

羟基磷灰石纳米颗粒载体介导hGM-CSF基因转染HepG2细胞及对其生长的影响

目的:研究羟基磷灰石(hydroxyapatite,HA)纳米颗粒载体携带人粒-巨噬细胞集落刺激因子(human granulocyte mac-rophage colony stimulating factor,hGM-CSF)基因转染HepG2细胞,以及其对细胞生长的影响,为基因修饰的肝癌肿瘤疫苗的临床研究奠定基础。方法:采用MTT法检测HA纳米颗粒载体对HepG2细胞生长的影响;采用HA纳米颗粒载体转染技术,将携带有hGM-CSF基因的表达质粒导入HepG2细胞中,G418筛选抗性细胞,限制性稀释法挑选单克隆;RT-PCR法鉴定hGM-CSF的整合和表达,ELISA法测定细胞培养液中的hGM-CSF分泌量和持续的时间;FCM法分析hGM-CSF基因对HepG2细胞生长的影响。结果:MTT结果提示HA纳米颗粒混悬液浓度在80μg/mL以下对HepG2细胞生长的影响与对照组比较差异无统计学意义。RT-PCR结果显示hGM-CSF基因在HepG2细胞中已整合并稳定表达。ELISA检测结果显示转入hGM-CSF基因的HepG2细胞能稳定分泌hGM-CSF,其分泌量为(216.22±45.78)ng/106cells每24h。FCM检测结果则显示hGM-CSF基因不促进细胞凋亡,且对细胞的生长周期无明显影响。结论:HA纳米颗粒载体可以安全地将目的基因hGM-CSF导入HepG2细胞中且稳定表达,其对细胞的生长无明显影响,为基因修饰的肝癌疫苗的后继研究提供了实验基础。

rhGM-CSF凝胶对烧伤后残余创面愈合的影响

目的探讨局部应用重组人粒细胞巨噬细胞集落刺激因子（rhGM-CSF）凝胶对烧伤后残余创面愈合的影响。方法采用随机、双盲、安慰剂同体对照的方法,将138处烧伤后残余创面随机分为试验组（n=69）和对照组（n=69）。试验组采用rhGM-CSF凝胶治疗,对照组采用空白基质安慰剂治疗,周期21d。观察创面愈合时间、疗效及用药后7、14d的创面愈合率;选取6例患者,于用药后7、14d留取组织标本,观察创面肉芽组织中毛细血管数和成纤维细胞数。结果本研究共入组69例,脱落9例,纳入统计分析者60例。试验组创面愈合的中位时间为12d（95%CI 11~13d）,较对照组（18d,95%CI 17~19d）明显缩短（P〈0.001）,且试验组疗效明显优于对照组（P〈0.001）。用药7、14d后,试验组创面愈合率分别为62%±13%、95%±10%,均显著高于对照组（46%±11%、83%±12%,P〈0.001）。用药7、14d后,试验组创面肉芽组织中毛细血管数分别为10.3±0.61、4.5±0.9,均显著高于对照组（7.2±0.71、0.4±0.8,P〈0.001）,而成纤维细胞数分别为143.1±10.31、37.8±6.9,亦显著高于对照组（110.2±11.71、26.4±7.7,P〈0.01）。结论局部应用rhGM-CSF凝胶可促进烧伤后残余创面愈合,可能与其促进毛细血管生成及成纤维细胞增殖或迁移有关。

重组人粒细胞巨噬细胞集落刺激因子对脓毒症模型小鼠的治疗作用

背景:研究发现粒细胞集落刺激因子可以用于治疗粒细胞减少症,关于粒细胞集落刺激因子治疗脓毒症的研究不多。目的:探讨重组人粒细胞巨噬细胞集落刺激因子对脓毒症小鼠的治疗作用。方法:采用腹腔内注射脂多糖的方法建立脓毒症小鼠动物模型,建模后6,30 h皮下注射重组人粒细胞巨噬细胞集落刺激因子,观察小鼠的肺组织病理变化、外周血中性粒细胞CD64表达以及血清肿瘤坏死因子α、白细胞介素10水平。结果与结论:(1)治疗后小鼠支气管上皮尚完整,间质轻度增生,见少量中性粒细胞浸润;(2)治疗后1,3,7 d治疗组小鼠外周血中性粒细胞CD64的表达和血清白细胞介素10水平显著高于模型组和正常对照组(P<0.05);(3)治疗后1,3,7 d治疗组小鼠血清肿瘤坏死因子α水平明显高于正常对照组(P<0.05),但低于模型组(P<0.05);(4)结果表明,重组人粒细胞巨噬细胞集落刺激因子具有增强脓毒症小鼠中性粒细胞功能和抗炎作用。

外用重组人粒细胞-巨噬细胞刺激因子凝胶对烧烫伤动物的疗效

目的观察外用重组人粒细胞-巨噬细胞刺激因子(rhGM-CSF)凝胶对实验性动物烧烫伤的治疗作用。方法采用电烙铁方法建立实验性大鼠烫伤创面,烫伤部位分别采用外用rhGM-CSF凝胶基质、碱性成纤维细胞生长因子(bFGF)喷雾剂、外用rhGM-CSF凝胶高(20μg/cm2)、低(5μg/cm2)剂量进行治疗,观察外用rhGM-CSF凝胶对烫伤创面的治疗作用,包括烫伤皮肤的病理学检查、烫伤创面的愈合情况、烫伤创面的感染情况及烫伤动物的死亡情况。采用凝固气油烧灼建立实验性小鼠Ⅲ°烧伤模型,烧伤部位分别采用rhGM-CSF凝胶基质、bFGF喷雾剂和外用rhGM-CSF凝胶进行治疗,观察小鼠死亡数量、感染情况及创面愈合后生毛时间。结果与凝胶基质对照组比较,外用rhGM-CSF凝胶高、低剂量治疗大鼠烫伤后的皮肤愈合时间明显缩短。病理检查结果显示,外用rhGM-CSF凝胶高、低剂量治疗大鼠烫伤创面的愈合程度明显优于凝胶基质对照组。外用rhGM-CSF凝胶对小鼠Ⅲ°烧伤具有保护和抗感染作用。烫伤创面愈合后生毛时间明显短于凝胶基质对照组。结论外用rhGM-CSF凝胶对实验性动物烧烫伤具有较好的治疗效果。

rhGM-CSF及纳米银对深Ⅱ度烫伤创面愈合过程血管化的影响

目的研究外用重组人粒细胞-巨噬细胞集落刺激因子(rh GM-CSF)和纳米银敷料外用,对深Ⅱ度烫伤创面组织愈合及血管化的影响。方法用Wistar大鼠建立深Ⅱ度烫伤模型,分为A、B、C组。A组(n=30):凡士林纱布覆盖,B组(n=30):纳米银敷料覆盖,C组(n=30):rh GM-CSF涂抹创面。伤后第1,4,7,10,14,21天,观察创面病理学改变,按照酶联免疫吸附法测定血清中血管内皮生长因子(VEGF)水平,采用实时-聚合酶链反应(RT-PCR)方法,检测创面愈合过程中缺血坏死因子-1α(HIF-1α)mRNA表达的变化。结果病理学改变:A、B、C组均在第10天出现明显的血管化;创面愈合率:C组>B组>A组,第14天、第21天时,组间差异有统计学意义(P<0.05)。VEGF水平:伤后第1天3组间差异无统计学意义(P>0.05),第4,7,10,14天3组间及第21天A组和C组之间差异有统计学意义(P<0.05)。HIF-1αmRNA相对表达量:A组第14天达峰值,B组、C组逐渐增大,第10天达峰值,随后下降,且C组下降幅度最明显,第1天A组与B组、C组之间差异有统计学意义(P<0.05),第4天,3组间差异无统计学意义(P>0.05),第7天A组与C组之间及第10,14,21天各组间差异均有统计学意义(P<0.05)。结论 rh GM-CSF和纳米银外用,促进深Ⅱ度烫伤创面愈合过程中血管化的形成,并且rh GM-CSF血管化程度优于纳米银。

聚乙二醇增加重组人粒-单系集落刺激因子复性效率的研究

重组人粒 -单系集落刺激因子 (rh GM- CSF)在大肠杆菌表达后积累在细胞中形成包涵体 ,在变性的包涵体的抽提液复性过程中 ,目的产物可能聚积而使活性蛋白的得率降低。本研究对聚乙二醇 (PEG)增加复性的能力进行试验。将 rh GM- CSF在 6 mol/L尿素中变性 ,迅速稀释到不同浓度尿素和 PEG的溶液中并保持蛋白浓度为 0 .2 mg/ml,在尿素浓度为 2 .0 mol/L,PEG4 0 0 0对rh GM- CSF的摩尔比为 2 0∶ 1时活性蛋白从 4 0 %增加到 55% ,rh GM- CSF的比活从 5.1× 10 6u/mg增加到 1.0× 10 7u/mg,总蛋白得率从 50 %增加到 10 0 %。表明 PEG能增加变性蛋白的复性效率。

细胞因子GM-CSF和结核杆菌Ag85A融合表达载体的构建与鉴定

目的 :构建并鉴定细胞因子GM CSF和结核杆菌Ag85A融合表达质粒 ,为研究新型抗结核杆菌DNA疫苗提供新的策略。方法 :用PCR方法从pc mGM CSF质粒中扩增出GM CSF ,构建于pcDNA3 1质粒上 ,成为pcDNA3 1 GM CSF。从结核杆菌H3 7Rv基因组中扩增出结核杆菌Ag85A基因序列并插入到质粒pcDNA3 1 GM CSF上 ,将基因GM CSF的 3′端与基因Ag85A的 5′端直接连接构建融合表达质粒pcGM85A。结果 :经酶切鉴定和DNA测序证实重组质粒构建正确。结论 :细胞因子GM CSF和结核杆菌Ag85A融合表达载体构建成功 ,为研制新型结核病基因疫苗奠定了基础。

重组人粒细胞巨噬细胞集落刺激因子联合纳米银对深Ⅱ°烫伤治疗作用的影响

目的:研究重组人粒细胞巨噬细胞集落刺激因子(rhGM-CSF)联合纳米银对深Ⅱ°烫伤治疗作用的影响。方法:Wistar大鼠建立深Ⅱ°烫伤模型,分为4组,A组(30只):凡士林纱布覆盖,B组(30只):纳米银覆盖,C组(30只):rhGM-CSF涂抹,D组(30只):rhGM-CSF+纳米银覆盖,伤后第1、4、7、10、14、21天,观察创面愈合,计算愈合率,酶联免疫吸附法测定血清中血管内皮生长因子(VEGF)和表皮生长因子(EGF)水平。结果:第10天各组开始愈合,愈合过程A组炎症反应明显,B、C组适中,D组适度;创面愈合率,第10、14、21天组间差异有统计学意义(P<0.05);VEGF水平,A组第21天达峰值为(25.76±1.46)pg/mL,B、C、D组第14天达峰值[(29.73±1.58),(38.91±2.38),(43.54±1.28)pg/mL],第4、7、10、14、21天组间差异有统计学意义(P<0.05);EGF水平,各组均在第21天达峰值[(0.72±0.14),(0.93±0.13),(1.18±0.16),(1.50±0.15)ng/mL],第7、10、14、21天组间差异有统计学意义(P<0.05)。结论:rhGM-CSF联合纳米银,促进深Ⅱ°烫伤创面愈合,并且优于rhGM-CSF、纳米银单独应用。

重组人粒细胞-巨噬细胞集落刺激因子与纳米银对深Ⅱ度烫伤创面愈合影响的比较

目的比较重组人粒细胞-巨噬细胞集落刺激因子(rhGM-CSF)与纳米银敷料对深Ⅱ度烫伤创面愈合过程的影响。方法用Wistar大鼠建立深Ⅱ度烫伤模型,分为A、B、C 3组,A组(n=30):凡士林纱布覆盖;B组(n=30):纳米银敷料覆盖;C组(n=30):rhGM-CSF涂抹创面。分别于伤后第1、4、7、10、14、21天,观察创面炎症反应,计算愈合率,细菌培养并计数。结果 A、B、C 3组均在第10天出现明显的血管化和上皮化,A组创面伤后红肿明显,并且在第14天出现痂下积脓,向皮下潜行,切片可见大量炎性细胞浸润、聚集、迁移,血管壁通透性增加,血管化和上皮化进程较慢;B、C组创面伤后红肿,在伤后第4天炎症反应最重,切片可见炎性细胞浸润、聚集、迁移,血管壁通透性增加,血管化和上皮化进程较A组明显加快,至第14天因为创面溶痂,炎症反应较前略有加重。创面愈合率方面,C组>B组>A组,第14、21天,差异有统计学意义(P<0.05)。A组和B组、C组分别于伤后第4和10天出现细菌生长,第10、14、21天,B组、C组比A组细菌生长数量减少,差异有统计学意义(P<0.05),而B组、C组之间差异无统计学意义(P>0.05);革兰阳性菌以金黄色葡萄球菌居首位,革兰阴性菌以铜绿假单胞菌居首位。结论 rhGM-CSF和纳米银敷料外用,均能减少深Ⅱ度烫伤创面细菌生长,减轻炎症反应;促进创面愈合方面,rhGM-CSF优于纳米银敷料。

rhGM-CSF预防肿瘤化疗所致白细胞减少的随机对照临床研究

目的：观察ｒｂＧＭ－ＣＳＦ（重组人粒细胞－巨噬细胞集落刺激因子）预防和治疗肿瘤化疗所致白细胞（ＷＢＣ）和中性粒细胞（ＡＮＣ）减少的临床疗效和毒性反应。方法：采用随机自身交叉对照临床研究的方法，对６４例病人进行化疗和ｒｈＧＭ－ＣＳＦ治疗，每一例病人连续观察２个周期。ＡＢ组病人第１周期为治疗组（Ａ周期），采用化疗加ｒｈＧＭ－ＣＳＦ治疗，第２周期为对照组（Ｂ周期），采用单纯化疗；ＢＡ组病人第１周期为对照组（Ｂ周期）采用单纯化疗，第２周期为治疗组（Ａ周期）采用化疗加ｒｈＧＭ－ＣＳＦ治疗。结果：５９例病人可评价疗效，治疗组ＷＢＣ和ＡＮＣ下降持续天数明显少于对照组，同时，ＷＢＣ和ＡＮＣ最低值也高于对照组，并且最低值时的中位化疗序日也比对照组明显提前，第２１天时，治疗组ＷＢＣ和ＡＮＣ数值明显高于对照组，化疗延迟的例数治疗组明显少于对照组。结论：ｒｈＧＭ－ＣＳＦ对化疗所致的白细胞和中性粒细胞减少具有明显的预防和治疗作用，保证化疗如期进行，不良反应可以耐受。