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.

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.

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.

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.

Application of pegylated recombinant human granulocyte colony-stimulating factor(PEG-rhG-CSF) for the prevention of neutropenia in triple negative breast cancer patients older than 65 years during adjuvant chemotherapy

Objective The aim of this study was to compare the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor(PEG-rhG-CSF)and recombinant human granulocyte colonystimulating factor(rhG-CSF)for the prevention of neutropenia in elderly breast cancer patients during adjuvant chemotherapy.Methods A total of 45 oncology inpatients with breast cancer,who received adjuvant chemotherapy and were older than 65 years from May 2017 to October 2018 in the General Hospital of the Northern Theater of the Chinese people’s Liberation Army,were included.Epirubivin Cyclophoshamide-Docetaxel(EC-T)sequential adjuvant chemotherapy was chosen.Forty-five patients were randomly divided into two groups;25 patients in the treatment group were treated with PEG-rhG-CSF and 20 patients in the control group were not treated with PEG-rhG-CSF,but only rhG-CSF.The experimental group was treated with the PEG-rhG-CSF at the end of chemotherapy for 24–48 h,with a 6 mg subcutaneous injection once per chemotherapy cycle.In the control group,rhG-CSF was administered after 48 h of chemotherapy,with a 100μg subcutaneous injection,1/d,d 1–7.The dosage could be increased step by step with the exacerbation of neutropenia.The primary aims of this study was to discover the incidence of leukopenia,neutropenia,neutrophilic fever,and adverse reactions in the two groups.Results The incidence of neutropenia,neutrophilic fever and adverse reactions decreased in the treatment group compared to the control group,but no significant difference existed between two groups(P>0.05).Patients in treatment group had a lower,but not statistically significant,incidence of adverse reactions(P>0.05).Conclusion Applying PEG-rhG-CSF could be effective in preventing neutropenia in elderly patients with postoperative adjuvant chemotherapy to treat breast cancer.It may effectively control the occurrence of neutropenia after chemotherapy and reduce the chance of infection.The incidence of side effects,such as fever and bone pain,was low.The adverse drug reactions were well tolerated by patients,which could ensure the smooth progress of chemotherapy.

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 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.

Clinical Study of Recombinant Human Granulocyte-Macrophage Colony-Stimulating Factor on Chemotherapy-Induced Leukopenia.

We have studied the efficacy and safery of recombinant human granulocyte-macrophate colony-stimulating factor

聚乙二醇化重组人粒细胞刺激因子预防急性淋巴细胞白血病患儿化疗后中性粒细胞减少的临床疗效观察

目的探讨聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)预防急性淋巴细胞白血病(ALL)患儿化疗后中性粒细胞减少的临床疗效。方法回顾性分析2020年7月至2023年7月在绵阳市中心医院就诊的60例急性ALL患儿的临床资料。根据治疗方法不同将患儿分为观察组和对照组,各30例。对照组采用重组人粒细胞刺激因子(rhG-CSF)进行干预,观察组采用PEG-rhG-CSF进行干预。比较两组患儿化疗前及化疗3周后绝对中性粒细胞计数(ANC)和白细胞计数(WBC)水平,化疗后3周的中性粒细胞减少的开始时间、持续时间和结束时间,比较两组患儿化疗3周后在白细胞降低发生率、中性粒细胞减少症(FN)发生率及不良反应发生率。结果化疗3周后,两组患者的ANC、WBC水平均较化疗前升高,且观察组患儿的ANC、WBC水平分别为(6.77±4.22)×10^(9)/L、(9.17±3.36)×10^(9)/L,均明显高于对照组[(6.34±2.34)×10^(9)/L、(8.91±3.56)×10^(9)/L],差异均有统计学意义(P<0.05)。两组患儿中性粒细胞减少的开始时间比较,差异无统计学意义(P>0.05);观察组患儿中性粒细胞减少的持续时间和结束时间分别为(8.99±3.31)、(4.79±1.18)d,均明显短于对照组[(15.56±4.91)、(6.97±3.32)d],差异均有统计学意义(P<0.05)。观察组患儿白细胞降低率、FN实际发生率、再住院率和抗生素使用率分别为30.00%、10.00%、3.33%、3.33%,均明显低于对照组(56.67%、40.00%、43.33%、36.67%),差异均有统计学意义(P<0.05)。观察组患儿的ANC减少、感染、骨骼肌肉酸痛、腹泻、恶心呕吐发生率分别为16.67%、6.67%、3.33%、6.67%、10.00%,均明显低于对照组(43.33%、30.00%、16.67%、26.67%、36.67%),差异均有统计学意义(P<0.05)。结论PEG-rhG-CSF能明显缩短急性ALL患儿化疗后中性粒细胞减少的持续时间和结束时间,且不良反应发生率低,在预防急性ALL患儿化疗后中性粒细胞减少方面疗效显著,安全性较高。

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。

超声清创术+外用重组人粒细胞巨细胞刺激因子凝胶剂对糖尿病足WagnerⅡ、Ⅲ级溃疡治疗效果及愈合情况分析

目的探究超声清创术+外用重组人粒细胞巨细胞刺激因子凝胶剂在糖尿病足WagnerⅡ、Ⅲ级溃疡治疗中的应用效果。方法选取2023年2月—2024年2月江苏省靖江市人民医院内分泌科及烧伤整形科收治的70例糖尿病足WagnerⅡ、Ⅲ级溃疡患者为研究对象,以随机数表法分为参照组(35例,予以常规清创+胰岛素治疗)和研究组(35例,予以超声清创术+外用重组人粒细胞巨细胞刺激因子凝胶剂治疗)。比较两组溃疡面愈合率、炎症因子水平及治疗总有效率。结果治疗后2周,研究组溃疡创面愈合率略高于参照组,差异有统计学意义(P<0.05);治疗后1、2个月,研究组溃疡创面愈合率明显高于参照组,差异有统计学意义(P均<0.05)。治疗前,两组降钙素原、超敏C反应蛋白水平比较,差异无统计学意义(P均>0.05)。治疗后,两组降钙素原、超敏C反应蛋白水平均降低,且研究组显著低于参照组,差异有统计学意义(P均<0.05)。研究组WagnerⅡ、Ⅲ级溃疡治疗总有效率高于参照组,差异有统计学意义(P<0.05)。结论超声清创术联合外用重组人粒细胞巨细胞刺激因子凝胶剂可促进糖尿病足WagnerⅡ、Ⅲ级溃疡面愈合,控制血清炎症因子水平,整体疗效显著。

Granulocyte Colony-stimulating Factor-primed Bone Marrow： An Excellent Stem-cell Source for Transplantation in Acute Myelocytic Leukemia and Chronic Myelocytic Leukemia

Background：Steady-state bone marrow （SS-BM） and granulocyte colony-stimulating growth factor-primed BM/peripheral blood stem-cell （G-BM/G-PBSC） are the main stem-cell sources used in allogeneic hematopoietic stem-cell transplantation.Here,we evaluated the treatment effects of SS-BM and G-BM/G-PBSC in human leucocyte antigen （HLA）-identical sibling transplantation.Methods：A total of 226 patients （acute myelogenous leukemia-complete remission 1,chronic myelogenous leukemia-chronic phase 1） received SS-BM,G-BM,or G-PBSC from an HLA-identical sibling.Clinical outcomes （graft-versus-host disease [GVHD],overall survival,transplant-related mortality [TRM],and leukemia-free survival [LFS]） were analyzed.Results：When compared to SS-BM,G-BM gave faster recovery time to neutrophil or platelet （P 〈 0.05）.Incidence of grade Ⅲ-Ⅳ acute GVHD and extensive chronic GVHD （cGVHD） was lower than seen with SS-BM （P 〈 0.05） and similar to G-PBSC.Although the incidence of cGVHD in the G-BM group was similar to SS-BM,both were lower than G-PBSC （P 〈 0.05）.G-BM and G-PBSC exhibited similar survival,LFS,and TRM,but were significantly different from SS-BM （P 〈 0.05）.There were no significant differences in leukemia relapse rates among the groups （P 〉 0.05）.Conclusions：G-CSF-primed bone marrow shared the advantages of G-PBSC and SS-BM.We conclude that G-BM is an excellent stem-cell source that may be preferable to G-PBSC or SS-BM in patients receiving HLA-identical sibling hematopoietic stem-cell transplantation.

PEG-rhG-CSF与rhG-CSF预防肿瘤化疗相关中性粒细胞减少的有效性和安全性比较的系统评价和Meta分析

目的:比较聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)与重组人粒细胞集落刺激因子(rhG-CSF)预防肿瘤化疗相关中性粒细胞减少的有效性和安全性。方法:检索PubMed、Embase、the Cochrane Library、中国知网、万方数据库和维普数据库,纳入PEG-rhG-CSF与rhG-CSF预防肿瘤化疗相关中性粒细胞减少(CIN)的随机对照试验(干预措施为使用PEG-rhG-CSF;对照措施为使用rhG-CSF),检索时间截至2023年5月。文献筛选和信息提取由2名研究者独立完成,并进行偏倚风险评估。采用RevMan 5.3统计软件对提取的数据进行Meta分析。结果:共纳入41篇文献。Meta分析结果显示,与rhG-CSF比较,PEG-rhG-CSF可以显著降低化疗后中性粒细胞减少伴发热(FN)发生率(OR=0.64,95%CI=0.51~0.81,P=0.0002)和Ⅲ/Ⅳ度中性粒细胞减少发生率(OR=0.49,95%CI=0.35~0.69,P<0.0001),差异均有统计学意义,但Ⅲ/Ⅳ度中性粒细胞减少持续时间(MD=-0.33,95%CI=-0.68~0.01,P=0.06)、中性粒细胞减少恢复时间(MD=-0.11,95%CI=-0.32~0.09,P=0.27)、骨痛或骨骼肌肉痛发生率(OR=0.81,95%CI=0.66~1.00,P=0.05)的差异均无统计学意义。结论:PEG-rhG-CSF预防化疗后FN及Ⅲ/Ⅳ度中性粒细胞减少的有效性明显优于rhG-CSF,PEG-rhG-CSF作为一级预防具有可行性。

PEG-rhG-CSF在血液肿瘤自体造血干细胞动员中的临床分析

目的:探讨无外周血CD34监测下聚乙二醇重组人粒细胞集落刺激因子(PEG-rhG-CSF)在血液肿瘤自体外周血干细胞动员中的采集时机及采集效果。方法:回顾性分析2017年8月至2022年1月福建医科大学附属第一医院收治的46例行自体外周血干细胞动员的血液恶性肿瘤患者。采用大剂量化疗联合PEG-rhG-CSF或重组人粒细胞集落刺激因子(G-CSF)动员方案,其中应用PEG-rhG-CSF动员的27例(PEG-rhG-CSF组),应用G-CSF动员的19例(G-CSF组),比较两组患者动员采集效果。结果:46例患者共采集86例次,PEG-rhG-CSF组与G-CSF组获得采集物的单个核细胞中位数分别为6.54(3.85-12.61)×10^(8)/kg和6.15(1.13-11.58)×10^(8)/kg(P>0.05),采集物CD34^(+)细胞数分别为11.44(1.33-65.02)×10^(6)/kg和4.95(0.30-24.02)×10^(6)/kg(P<0.05),采集时机分别为14(10-20)和14(4-22)d(P>0.05)。PEG-rhG-CSF组在外周血白细胞(WBC)≥10×10^(9)/L时单次所采集的产物CD34^(+)细胞数明显高于外周血WBC<10×10^(9)/L时采集的数量[19.04(2.85-65.02)×10^(6)/kg vs 6.22(0.81-34.86)×10^(6)/kg,(P<0.05)]。结论:采用PEG-rhG-CSF动员外周血干细胞单次采集足量CD34^(+)细胞成功率高,中位动员时间为14 d;在无外周血CD34监测情况下,外周血WBC≥10×10^(9)/L可以考虑作为单次采集足量干细胞的采集阈值。

基于加权TOPSIS法的PEG-rhG-CSF合理性评价

目的建立聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)合理性使用的评价标准,利用加权优劣解距离法(TOPSIS)对PEG-rhG-CSF进行评价,为临床合理使用提供参考依据。方法调取福州市第二医院2019年10月至2022年4月的出院病历,以PEG-rhG-CSF说明书为基础,参照相关指南、专家共识以及文献资料制订评价标准,采用加权TOPSIS法进行合理性评价。结果使用PEG-rhG-CSF的426份病历中,理想解相对接近度(C_(i))>80%共250例(占比58.69%),介于60%~80%的124例(占比29.11%),<60%的52例(占比12.21%)。主要不合理使用问题表现在适应证不适宜、给药时机不适宜、药物联用不适宜。结论基于TOPSIS法的合理性评价,综合考虑多个指标,可以反映药物使用过程中各个环节的使用情况,评价过程简便灵活,操作性强。评价结果显示福州市第二医院PEG-rhG-CSF的临床应用过程基本合理,但需要加大管理的力度,保证临床合理使用该类药物。

重组人粒细胞集落刺激因子联合阿司匹林对不明原因不孕症患者子宫内膜容受性的影响

目的探讨重组人粒细胞集落刺激因子(rhG-CSF)联合阿司匹林对不明原因不孕症患者子宫内膜容受性的影响。方法回顾性分析2020年10月至2022年10月河北燕达医院收治的97例不明原因不孕症患者的临床资料。根据治疗方式分为常规组(n=48,采用阿司匹林治疗)和联合组(n=49,采用rhG-CSF联合阿司匹林治疗)。比较两组治疗前后的子宫内膜厚度、子宫血流灌注指标[子宫动脉阻力指数(RI)、搏动指数(PI)、收缩期流速与舒张期流速比值(S/D)],比较两组的妊娠结局。结果治疗后,联合组子宫内膜厚度大于常规组,差异具有统计学意义(P<0.05)。治疗后,两组RI、PI及S/D值均降低,且联合组低于常规组,差异具有统计学意义(P<0.05)。治疗后,联合组生化妊娠率、临床妊娠率均高于常规组,差异具有统计学意义(P<0.05)。结论rhG-CSF联合阿司匹林治疗不明原因不孕症患者,可提高其的子宫内膜容受性,改善子宫血流灌注,有效提高妊娠率。

归芪合剂联合聚乙二醇化重组人粒细胞集落刺激因子预防乳腺癌新辅助化疗后骨髓抑制的有效性及安全性

目的 探讨归芪合剂联合聚乙二醇化重组人粒细胞集落刺激因子(PEG-rh G-CSF)预防乳腺癌采用多西他赛+表柔比星+环磷酰胺(TEC)新辅助化疗后骨髓抑制的有效性及安全性。方法 本研究为回顾性研究,选取皖南医学院附属太和医院2021年5月至2024年5月收治的92例行TEC新辅助化疗的乳腺癌患者,经随机数字表法分为观察组和对照组,各46例。对照组患者在化疗48 h后给予PEG-rh G-CSF治疗,观察组在对照组的基础上采用归芪合剂联合治疗。比较两组患者骨髓抑制情况、白细胞计数(WBC)、中性粒细胞计数(NEU)、Karnofsky功能状态评分标准(KPS)评分、中医症候积分和不良反应发生情况。结果 观察组发生骨髓抑制Ⅰ级6例、Ⅱ级3例、Ⅲ级2例,总发生11例(23.91%),对照组发生骨髓抑制Ⅰ级16例、Ⅱ级13例、Ⅲ级6例、Ⅳ级1例,总发生36例(78.26%),观察组骨髓抑制发生率低于对照组(χ^(2)=27.187,P<0.05)。治疗后,观察组WBC、NEU[分别为(7.26±1.59)×10^(9)·L^(-1)、(5.07±0.92)×10^(9)·L^(-1)]均高于对照组[分别为(6.23±1.48)×10^(9)·L^(-1)、(4.63±0.87)×10^(9)·L^(-1)](t=3.216、2.356,均P<0.05)。治疗后,观察组KPS评分、中医症候积分[分别为(95.23±2.47)分、(14.23±1.26)分]改善程度均优于对照组[分别为(84.12±2.48)分、(17.35±1.24)分](t=21.528、11.970,均P<0.05)。观察组不良反应(30.43%,14/46)与对照组(36.96%,17/46)比较差异无统计学意义(χ^(2)=0.437,P>0.05)。结论 归芪合剂联合PEG-rhG-CSF能有效改善乳腺癌TEC新辅助化疗后骨髓抑制情况,改善健康状况,降低症候积分,安全性高。

PEG-rhG-CSF预防小细胞肺癌化疗后中性粒细胞减少症的效果分析

目的:探讨聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)预防小细胞肺癌化疗后中性粒细胞减少症的效果。方法:选取2020年1月—2023年3月北京市朝阳区桓兴肿瘤医院收治的小细胞肺癌化疗患者200例,按照信封法分为两组。对照组(n=98)化疗后应用重组人粒细胞刺激因子(rhGCSF),观察组(n=102)化疗后应用PEG-rhG-CSF。比较两组中性粒细胞减少症发生率、免疫功能、血清肿瘤标志物水平及不良反应发生情况。结果:观察组中性粒细胞减少症发生率低于对照组,差异有统计学意义(P<0.05)。治疗后,观察组CD3^(+)、CD4^(+)水平均高于对照组,CD8^(+)及细胞角质蛋白19片段(Cyfra21-1)、胃泌素释放肽前体(Pro-GRP)、神经元特异性烯醇化酶(NSE)水平均低于对照组,差异均有统计学意义(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:小细胞肺癌化疗后应用PEG-rhG-CSF能有效预防中性粒细胞减少症的发生,改善机体免疫功能,抑制血清肿瘤标志物水平,且安全性良好。

聚乙二醇化重组人粒细胞刺激因子在预防恶性肿瘤患者化疗后骨髓抑制中的疗效观察

目的探讨预防恶性肿瘤化疗后骨髓抑制的方法。方法将化疗后发生过骨髓抑制的110例恶性肿瘤患者随机分为观察组(60例)和对照组(50例),本次化疗结束48 h后,观察组单次皮下注射PEG-rhG-CSF,对照组不预防给药。观察两组中性粒细胞减少程度及不良反应情况。结果观察组中性粒细胞降低发生率为46.67%,高于对照组的80%(χ^(2)=12.84,P<0.01);两组不良反应发生率比较无统计学意义(χ^(2)=0.01,P=0.913)。结论恶性肿瘤患者化疗后应用PEG-rhG-CSF可减轻骨髓抑制,安全性高。

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。