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.

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.

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.

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。

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。

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

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

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。

经完全性手术切除的Ⅱ~ⅢA期EGFR野生型NSCLC术后辅助化疗中预防应用PEG-rhG-CSF的临床获益分析

目的探究经完全性手术切除的Ⅱ~ⅢA期表皮生长因子受体(EGFR)野生型非小细胞肺癌(NSCLC)术后辅助化疗中预防应用聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)的临床获益。方法前瞻性选取2019年2月至2021年2月广东医科大学附属医院经完全性手术切除的Ⅱ~ⅢA期EGFR野生型NSCLC术后辅助化疗患者90例作为研究对象,根据随机数字表法将患者分为观察组与对照组,每组各45例。对照组预防性应用重组人粒细胞(rhG-CSF),观察组预防性应用PEG-rhG-CSF。对患者随访3个月,比较两组治疗前及治疗1、3、5、10 d后的白细胞计数、中性粒细胞计数水平及白细胞减少症、中性粒细胞减少症发生情况,并记录患者随访期内化疗后的不良反应情况。结果两组患者在治疗前及治疗1、3、5 d后的白细胞计数水平比较,差异均无统计学意义(P>0.05);治疗10 d后,观察组患者的白细胞计数水平为(5.65±1.11)×10^(9)/L,高于对照组[(4.66±1.08)×10^(9)/L],差异有统计学意义(P<0.05)。两组患者在治疗前及治疗1、3、5 d后的中性粒细胞计数水平比较,差异均无统计学意义(P>0.05);治疗10 d后,观察组患者的中性粒细胞计数水平为(3.61±1.51)×10^(9)/L,高于对照组[(2.65±1.46)×10^(9)/L],差异有统计学意义(P<0.05)。观察组患者2、3级白细胞减少症和中性粒细胞减少症发生率分别为15.56%、11.11%,均低于对照组(35.56%、42.22%),差异均有统计学意义(P<0.05)。两组患者在骨骼肌疼痛、疲劳、感染、发热、胃肠反应等方面比较,差异均无统计学意义(P>0.05)。结论对经完全性手术切除后Ⅱ~ⅢA期EGFR野生型NSCLC患者,术后辅助化疗中预防应用PEG-rhG-CSF可以提高白细胞计数和中性粒细胞计数水平,并减少白细胞减少症和中性粒细胞减少症的发生,有助于改善患者的免疫功能和预后。

四君子汤联合rhG-CSF对卵巢癌患者术后化疗导致白细胞降低的临床效果

目的分析四君子汤联合重组人粒细胞刺激因子注射液(rhG-CSF)对卵巢癌患者术后化疗导致白细胞降低的临床效果。方法选取80例卵巢癌术后化疗导致白细胞降低患者,随机分为对照组(40例)和联合组(40例)。其中对照组给予rhG-CSF治疗,联合组给予四君子汤联合rhG-CSF治疗。比较2组Th1类细胞因子水平[肿瘤坏死因子α(TNF-α)、γ-干扰素(IFN-γ)、白细胞介素-2(IL-2)],Th2类细胞因子水平[白细胞介素-6(IL-6)、白细胞介素-4(IL-4)、白细胞介素-10(IL-10)],白细胞计数(WBC)、血小板计数(PLT)、中性粒细胞计数(NE),中医证候积分,临床疗效及不良反应发生情况。结果与治疗前比较,2组治疗后血清TNF-α、IL-6、IL-4、IL-10水平、神疲乏力、自汗盗汗、食少纳呆、腰膝酸软等中医证候积分均明显降低(P<0.05),且与对照组比较,观察组明显降低(P<0.05);2组血清IFN-γ、IL-2、WBC、PLT、NE水平明显升高(P<0.05),且与对照组比较,观察组明显升高(P<0.05);观察组总有效率(52.50%)明显高于对照组(30.00%)(P<0.05);观察组不良反应发生率(2.50%)明显低于对照组(20.00%)(P<0.05)。结论四君子汤联合rhG-CSF治疗卵巢癌术后化疗导致白细胞降低患者可有效改善临床症状,升高白细胞水平,提高免疫功能,安全有效。

PEG-rhG-CSF皮下注射与替吉奥联合调强放疗对晚期食管癌的疗效及生存质量的影响

目的探讨皮下注射聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)联合替吉奥在晚期食管癌调强放疗治疗中的价值。方法前瞻性选取2018年1月至2019年9月淮北矿工总医院收治的60例晚期食管癌患者作为研究对象,采用随机数字表法将患者分为观察组和对照组,各30例。对照组患者采用替吉奥+调强放疗措施治疗,观察组患者在对照组基础上同时给予PEG-rhG-CSF注射治疗。比较两组患者放疗近期效果、外周血T淋巴细胞亚群及NK细胞、生存质量评分、毒副反应发生率、生存率及生存时间差异。结果两组的治疗效果分布比较,差异无统计学意义(P>0.05)。治疗后,观察组患者的CD3^(+)、CD4^(+)、CD4^(+)/CD8^(+)、CD16^(+)CD56^(+)NK细胞占比分别为(62.50±4.80)%、(38.51±3.00)%、1.49±0.15、(22.63±2.24)%,均高于对照组[(58.83±5.28)%、(36.67±2.89)%、1.39±0.13、(21.55±1.87)%],差异均有统计学意义(P<0.05)。治疗后,观察组患者的乏力、恶心、食欲不振、失眠评分为(36.29±4.16)、(44.10±5.06)、(33.52±4.27)、(34.20±4.86)分,均低于对照组[(38.85±3.78)、(47.03±4.81)、(37.30±4.52)、(37.56±5.20)分],差异均有统计学意义(P<0.05)。治疗过程中,观察组患者的恶心、呕吐、放射性食管炎、放射性肺炎发生程度均低于对照组,差异有统计学意义(P<0.05)。随访2年,观察组生存率43.33%,对照组生存率33.33%,观察组的中位生存时间21个月,对照组20个月,两组差异无统计学意义(P>0.05)。结论PEG-rhG-CSF联合替吉奥在晚期食管癌调强放疗治疗中应用能缓解放化疗引起的细胞免疫功能受损、改善生存质量、降低毒副反应发生率。

PEG-rhG-CSF预防乳腺癌患者化疗致发热性中性粒细胞减少症效果分析

目的探讨聚乙二醇化重组人粒细胞刺激因子(pegylated recombinant human granulocyte colony-stimulating factor,PEG-rhG-CSF)预防乳腺癌患者化疗致发热性中性粒细胞减少症(febrile neutropenia,FN)的临床意义。方法回顾性分析宁夏医科大学总院2019年1月至2022年3月183例乳腺癌患者接受非密集型AC-T方案(吡柔比星70 mg+环磷酰胺0.8 g+多西他赛100 mg,21 d/周期)、剂量密集型ddAC-T方案(吡柔比星85 mg+环磷酰胺1.0 g+紫杉醇290 mg,14 d/周期)及其他化疗方案(铂类、吉西他滨等)化疗后的临床资料。分析不同化疗方案中性粒细胞减少症及第一周期与后续治疗周期FN的发生情况,采用Logistic回归分析FN发生的影响因素。结果183例乳腺癌患者化疗后预防性使用PEG-rhG-CSF后中性粒细胞减少症的发生率为67.21%(123/183),Ⅲ级及以上中性粒细胞绝对计数(absolute neutrophil count,ANC)减少在ddAC-T方案中的发生率较高。第一周期FN发生率为4.37%(8/183),后续治疗周期FN发生率为1.64%(3/183)。化疗方案(OR=0.139,95%CI:0.026~0.732,P=0.020)、既往化疗(OR=34.500,95%CI:6.360~187.145,P<0.001)和既往放疗(OR=11.067,95%CI:2.278~53.768,P=0.003)是FN发生的影响因素。不良事件发生率均较低,主要为肌肉关节酸疼。结论根据不同的化疗方案以及既往放化疗史,预防性使用PEG-rhG-CSF可有效减少化疗导致的中性粒细胞减少症和FN的发生率。

PEG-rhG-CSF治疗乳腺癌化疗后白细胞减少症的有效性及安全性研究

目的:分析聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)治疗乳腺癌化疗后白细胞减少症的有效性和安全性。方法:回顾性分析80例接受化疗的乳腺癌患者,将他们分为对照组[n=40,采用重组人粒细胞刺激因子(rhG-CSF)治疗]和观察组(n=40,采用PEG-rhG-CSF治疗),比较两组白细胞计数(WBC)、绝对中性粒细胞计数(ANC)和其动态变化情况、药物费用及不良反应发生情况。结果:观察组治疗后3 d的WBC和治疗21 d内的ANC和药物费用均高于对照组(P<0.05);两组不良反应发生情况比较差异无统计学意义(P>0.05)。结论:PEG-rhG-CSF可提高乳腺癌化疗后白细胞减少症治疗的有效性,安全性尚可。

rhG-CSF联合PEG-rhG-CSF治疗小鼠中性粒细胞减少症的研究

目的探讨重组人粒细胞集落刺激因子(rhG-CSF)联合聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)对小鼠中性粒细胞减少症(NP)的治疗作用。方法将24只Balb/c小鼠平均分为CTL组、Model组、PEG-rhG-CSF组和rhG-CSF+PEG-rhG-CSF组。用环磷酰胺诱导小鼠建立NP模型,给药后观察各组小鼠脾脏重量、脾表面造血灶(CFU-S)数量及骨髓有核细胞(BMNCs)数量变化;血常规检测3~9 d小鼠外周血中性粒细胞的数量;流式分析仪检测小鼠外周血中CD11b^(+)Ly6G^(+)细胞群含量及骨髓中CXCR4^(+)的表达。结果与Model组比较,PEG-rhG-CSF组和rhG-CSF+PEG-rhG-CSF组小鼠脾脏重量、CFU-S数量、BMNCs数量、外周血中CD11b^(+)Ly6G^(+)细胞群及骨髓中CXCR4^(+)的表达增加,差异有统计学意义(P<0.05);与PEG-rhG-CSF组比较,rhG-CSF+PEG-rhG-CSF组小鼠CFU-S数量、BMNCs数量、外周血CD11b^(+)Ly6G^(+)细胞群及骨髓CXCR4^(+)的表达增加更显著,差异有统计学意义(P<0.05)。结论rhG-CSF联合PEG-rhG-CSF可通过提高NP小鼠骨髓CXCR4+及外周血中性粒细胞CD11b^(+)Ly6G^(+)含量来维持体内中性粒细胞的平衡。

关于PEG-rhG-CSF在预防结直肠癌化疗中性粒细胞减少的对比研究

目的 在接受mFOLFOX6方案进行结直肠癌化疗的过程中分别使用PEG-rhG-CSF与rhG-CSF,对比两者预防效果及安全性。方法 对本院收治的113例接受mFOLFOX6方案化疗的结直肠癌患者进行两个周期的化疗。2组患者化疗结束后分别给予PEG-rhG-CSF 100μg/kg和rhG-CSF 5μg/kg对比研究。化疗后定期检测患者的血常规,记录中性粒细胞绝对计数明显降低的发生率及药物不良反应等数据。结果 在各个化疗周期和总化疗过程中,2组患者中性粒细胞降低的发生率及其持续时间差异无统计学意义(P>0.05),药物不良反应发生率差异无统计学意义(χ2=1.75,P=0.269);中性粒细胞最低值均出现时间差异无统计学意义(t=2.36,P=0.113)。结论 预防性用药时,PEG-rhG-CSF每化疗周期给药一次与rhG-CSF连续给药相比,治疗效果、药物不良反应类似,但其半衰期更长,血药浓度更稳定。