聚乙二醇化重组人粒细胞集落刺激因子预防化疗后中性粒细胞减少的临床观察

目的比较聚乙二醇化重组人粒细胞集落刺激因子（PEG-rhG-CSF）和重组人粒细胞集落刺激因子（rhG．CSF）预防化疗后中性粒细胞减少症的有效性和安全性。方法采用随机自身交叉对照,纳入42例初治恶性肿瘤患者,接受2个周期相同方案的化疗,其中试验周期给予PEG—rhG-CSF100μg／kg皮下注射1次,对照周期皮下注射rhG-CSF5阻异／（kg·d）直至外周血中性粒细胞绝对值（ANC）达低谷后连续2次检查≥5．0×10^9／L。结果42例患者,在40个试验周期和44个对照周期中,ANC〈2．0×10^9／L的发生率试验组和对照组分别为30％（12／40）和31.8％（14／44）,持续时间分别为（3±1．155）d和（4±1．225）d;受试药和对照药的不良反应均主要为骨骼肌肉疼痛、乏力、发热、头晕等,发生率与严重程度相似。结论PEG-rhG-CSF-次给药的疗效与与rhG-CSF多次给药相似,不良反应低。     

注射用聚乙二醇化重组人粒细胞集落刺激因子Ⅰ期临床药效学

目的初步观察我国自主研发的聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)预防化疗导致中性粒细胞减少症的效果。方法未经放化疗的非小细胞肺癌、乳腺癌患者接受2个周期相同剂量的紫杉醇/卡铂方案化疗,第1周期为对照周期,第2周期在化疗药物给药结束后48h给予PEG-rhG-CSF1次,初始剂量为30μg/kg,递增剂量依次为60、100和200μg/kg,每一剂量组4例受试患者,监测中性粒细胞变化。结果第1周期有7例患者因Ⅳ度中性粒细胞计数(ANC)减少应用了重组人粒细胞集落刺激因子(rhG-CSF),第2周期仅在第1剂量组出现Ⅳ度ANC减少1例。第1周期未使用rhG-CSF的9例患者ANC均值最低点为1·37×109/L。第2周期4个剂量组的ANC均值最低点依次为0·77×109/L、4·54×109/L、3·00×109/L和5·56×109/L。结论PEG-rhG-CSF可减少化疗期间Ⅳ度ANC减少的发生率,升高ANC最低值,60、100或200μg/kg每个化疗周期给药1次能较好地预防中性粒细胞减少症。     

rhG—CSF加速急性白血病化疗后中性粒细胞的恢复

目的观察rhG-CSF对急性白血病化疗后中性粒细胞恢复的效果.方法24例急性髓细胞白血病和21例急性淋巴细胞白血病联合化疗后,白细胞(WBC)计数＜1.0×109/L时起加用rhG-CSF300μg/d,皮下注射,直至中性粒细胞绝对值(ANC)＞1.5×109/L后停用.结果ANC＞1.5×109/L在用rhG-CSF组为(5.9±5.1)d明显短于对照组(14.8±5.0)d,用rhG-CSF组明显减少了感染的发生(20%∶80%).结论rhG-CSF能有效地加速急性白血病化疗后中性粒细胞的恢复.     

PEG-rhG-CSF注射液对乳腺癌术后化疗致中性粒细胞减少的防治效果

目的 探讨聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)注射液对乳腺癌术后化疗致中性粒细胞减少的防治作用.方法 法将89例术后接受化疗的乳腺癌患者分为观察组(PEG-rhG-CSF 100 μg/kg皮下注射1次)与对照组[rhG-CSF 5 μg·kg-1·d-1皮下注射,以外周血中性粒细胞绝对值(ANC)至最低点后连续2次其值大于或等于5.0×109/L为宜],比较两组患者疗效及安全性.结果 观察组第2个高峰ANC水平明显低于对照组(P＜0.05);两组患者4度中性粒细胞减少率、抗生素使用率、4度中性粒细胞减少持续时间及其他不良反应比较,差异无统计学意义(P＞0.05),观察组ANC由最低点上升至大于或等于2.0×109/L所需时间明显少于对照组(P＜0.05).结论 PEG-rhG-CSF 1次注射防治乳腺癌术后化疗致中性粒细胞减少效果与rhG-CSF多次注射相当,且未增加不良反应.     

粒细胞集落刺激因子对儿童急性粒细胞性白血病的疗效及安全性

目的探讨重组人粒细胞集落刺激因子(rhG-CSF)对儿童急性粒细胞性白血病(AML)的疗效及安全性。方法17例AML病儿化疗后中性粒细胞绝对值(ANC)<0.5×109/L者共67例次,其中治疗组42例次应用rhG-CSF,对照组25例次不用rhG-CSF。比较两组ANC升达1.5×109/L所需时间,感染的发生率,发热及抗生素应用与住院时间,成分输血量。并观察rhG-CSF治疗的不良反应。结果治疗组ANC升达1.5×109/L平均所需时间明显短于对照组;治疗组感染的发生率较对照组显著降低;治疗组的发热、抗生素应用与住院时间均短于对照组;而两组成分输血量比较无显著差异。rhG-CSF治疗过程中病儿无严重不良反应,治疗结束后复查骨髓无原始、幼稚细胞增多,未见其导致AML复发。结论应用rhG-CSF治疗儿童AML是安全而有效的。     

聚乙二醇化重组人粒细胞集落刺激因子用于卵巢癌及宫颈癌化疗的价值

目的观察聚乙二醇化重组人粒细胞集落刺激因子（PEG-rhG-CSF）用于卵巢癌、宫颈癌化疗预防中性粒细胞缺乏（粒缺）的价值。方法选取经病理或细胞学确诊的卵巢癌、宫颈癌患者共72例，随机分为实验组和对照组各36例，实验组在化疗后72h一次性皮下注射PEG-rhG-CSF6mg，体重45kg以下的患者减半；对照组在化疗后72h开始予以皮下注射rhG-CSF2~5滋g/kg，1次/d。观察两组患者的中性粒细胞数，3、4度粒缺和发热性粒缺的发生率及持续天数，不良反应发生情况及费用开支情况等并作比较。结果在使用PEG-rhG-CSF及rhG-CSF预防性治疗的周期中，实验组和对照组中性粒细胞水平比较差异均无统计学意义（均P＞0.05）。实验组和对照组3度粒缺发生率分别为11.1%和8.3%，差异无统计学意义（P＞0.05）。实验组与对照组各种不良反应发生率及严重程度均相似（2.8%~8.4%vs2.8%~11.2%），差异均无统计学意义（均P＞0.05）。实验组人均费用（3021.19元）和对照组（2773.18元）比较差异无统计学意义（P＞0.05）。结论PEG-rhG-CSF用于卵巢癌、宫颈癌化疗时，与rhG-CSF比较，不良反应及费用均相似，但使用相对方便，有利于改善患者的生存质量。     

探究聚乙二醇化重组人粒细胞集落刺激因子对化疗相关性粒细胞减少骨髓抑制的预防效果

目的:通过与重组人粒细胞集落刺激因子(rh G-CSF)对比,探究新瑞白(PEG-rh G-CSF)对化疗相关性粒细胞减少的预防效果及安全性。方法:采用自身交叉对照研究方法,100例恶性肿瘤患者均接受两个周期化疗,方案相同。实验周期给予PEG-rh G-CSF 100μg/kg皮下注射,每周期1次,对照周期给予rh G-CSF 5μg/kg皮下注射,每日1次。于2次化疗周期的第3、5、7、9、11、13、17、21 d检测外周血象,记录中性粒细胞绝对计数(ANC)<1.5×109/L和ANC<0.5×109/L发生率,ANC<0.5×109/L持续时间,抗生素使用率和药物相关不良反应发生率。结果:在各化疗周期和总化疗中期中,PEG-rh G-CSF组与rh G-CSF组患者ANC<1.5×109/L发生率、ANC<0.5×109/L发生率、ANC<0.5×109/L持续时间、抗生素使用率方面差异无统计学意义(P>0.05);PEG-rh G-CSF组与rh G-CSF组治疗过程中ANC最低值均出现在化疗第7 d,分别为(6.8+2.4)×109/L和(7.3+3.5)×109/L,差异无统计学意义(t=2.42,P=0.109);PEG-rh G-CSF组与rh G-CSF组药物相关不良反应总发病率分别为26.0%和31.0%,差异无统计学意义(χ2=1.85,P=0.289)。结论:预防性用药时,新瑞白1剂给药与rh G-CSF连续给药效果相当,不良反应少,与rh G-CSF相比半衰期长,血药浓度稳定,是预防恶性肿瘤患者化疗后粒细胞减少的新选择,值得临床推广。     

肿瘤化疗前应用重组人粒细胞集落刺激因子预防白细胞减少临床研究

目的 观察重组人粒细胞集落刺激因子(rhG-CSF)预防化疗后中性粒细胞减少症的有效性和安全性.方法 采用随机对照,初治恶性肿瘤患者接受1个周期的化疗,其中治疗组化疗前给予rhG-CSF 150μg皮下注射1次,对照组不给予rhG-CSF.结果 入组60例肿瘤患者,治疗组和对照组各30例,WBC＜4.0 × 109/L的发生率分别为20.00%和56.67%(P＜0.05),Ⅰ度白细胞减少发生率分别为6.67%和20.00%,Ⅱ度白细胞减少发生率分别为10.00%和16.67%,Ⅲ度白细胞减少发生率分别为3.33%和10.00%,Ⅳ度白细胞减少发生率分别为0.00%和10.00%,持续时间分别为1.27天和4.04天(P＜0.05),抗生素使用率分别为7.69%和26.92%(P＜0.05),发热性中性粒细胞减少发生率分别为3.85%和26.92%(P＜0.05).结论 化疗前应用rhG-CSF能有效控制肿瘤化疗后白细胞减少的发生,降低肿瘤化疗后白细胞减少的程度.     

聚乙二醇化重组人粒细胞刺激因子在预防乳腺癌化疗后骨髓抑制中的作用

目的：评估聚乙二醇化重组人粒细胞刺激因子（PEG-rhG-CSF）在预防乳腺癌患者化疗后中性粒细胞减少的疗效与安全性。方法：45例乳腺癌患者采用EC-T/AT/TC/EC方案化疗,化疗后48h单次皮下注射聚乙二醇化重组人粒细胞刺激因子100μg/kg或6mg,化疗21d为1个周期。结果：出现IV度中性粒细胞减少22例（48.8%）,其中发热伴IV度中性粒细胞减少4例（8.9%）。化疗结束到中性粒细胞出现最低值的时间为（7.78±1.80）d,IV度中性粒细胞减少持续时间（1.2±0.8）d,中性粒细胞恢复>2.0×109/L的时间（2.5±1.1）d。23例（51.2％）在全程化疗中未出现粒细胞缺乏,并且治疗耐受性良好,提示PEG-rhG-CSF具有良好的预防中性粒细胞减少的效果和安全性。结论：乳腺癌患者化疗后应用聚乙二醇化重组人粒细胞刺激因子预防中性粒细胞减少疗效肯定,值得在临床中进一步推广。     

聚乙二醇化重组人粒细胞刺激因子二级预防卵巢癌化疗后中性粒细胞减少的疗效分析

目的 探析聚乙二醇化重组人粒细胞刺激因子(Pegylatedrecombinanthumangranulocytecolonystimulating factor, PEG-rhG-CSF)二级预防卵巢癌化疗后中性粒细胞减少的临床疗效。方法 方便选取2019年1月—2021年10月盐城市第三人民医院收治的采取“紫杉醇+顺铂/卡铂”方案化疗且上一周期出现Ⅲ～Ⅳ度中性粒细胞减少的卵巢癌患者44例,随机分为观察组和对照组,各22例。观察组在化疗结束24 h后给予PEG-rhG-CSF单次皮下注射,对照组在化疗结束24 h后给予重组人粒细胞刺激因子(recombinant human granulocytestimulating factor, rhG-CSF)每日皮下注射。统计两组患者中性粒细胞绝对值减少发生率、中性粒细胞减少性发热发生率、不良反应发生率及生活质量。结果 观察组Ⅲ～Ⅳ度ANC减少发生率(27.27%)低于对照组(36.36%),但差异无统计学意义(χ²=0.419,P>0.05)。两组中性粒细胞减少性发热及不良反应发生率比较,差异无统计学意义(P&...     

阿糖胞苷联合粒细胞集落刺激因子动员自体外周血干细胞效果的研究

目的　观察阿糖胞苷 (Ara C)联合重组人粒细胞集落刺激因子 (rhG CSF)对恶性淋巴瘤患者自体外周血造血干细胞 (APBSC)的动员效果 ,并寻找Ara C合适的给药剂量。方法　按照入组的先后顺序 ,将患者分成两组 ,A组Ara C的给药剂量为 6g/m2 静滴 (分 2次 ,间隔 2 4h) ,B组Ara C的给药剂量为 10g/m2 静滴 (分 4次 ,间隔 12h) ,白细胞 (WBC)降至最低点时开始皮下注射rhG CSF 30 0 μg·人 -1·d-1,直至采集结束前 1d ,白细胞恢复到 5 .0× 10 9/L以上时开始连日采集APBSC ,当累计采集的单个核细胞≥ 5× 10 8/kg或CD34+ 细胞≥ 2× 10 6/kg时停止采集。结果　 2 2例患者进入本研究 ,A、B两组各有 11例患者。Ara C给药后 ,患者外周血中白细胞和中性粒细胞绝对值 (ANC)的最低值 ,B组明显低于A组 ,出现的时间B组也明显晚于A组。A、B两组rhG CSF给药的开始时间和持续时间、APBSC采集的开始时间和持续时间均无显著差异 ,在APBSC采集时的循环血量、血流速和采集时间相同的情况下 ,APBSC的采集次数、每次采集的细胞数量和总量亦差异无显著意义 ,B组Ara C引起的某些毒副反应略重于A组 ,但两组间差异无显著意义。结论　Ara C联合rhG CSF是一种安全、高效的APBSC的动员方法 ,6g/m2 的Ara C即可得到满意的动员效果。     

PERIPHERAL BLOOD CD34^＋ CELL MOBILIZATION IN 42 PATIENTS WITH SEVERE AUTOIMMUNE DISEASE

Objective To evaluate the feasibility and safety of peripheral CD34 cell mobilization in patients with severe autoimmune disease. Methods Forty-two patients underwent a total of 46 mobilizations by the regimen of cyclophosphamide 2-3 g/m2 recombinant human granulocyte colony stimulating factor (rhG-CSF) 5 μg·kg-1·d-1. The positive selection of CD34 cell was performed through the CliniMACS. Results In 8.1±2.3 days after administration of cyclophosphamide, the peripheral white blood cell and mononuclear cell (MNC) decreased to the lowest level. In 3.7±1.6 days after injection of rhG-CSF, the peripheral absolute MNC and CD34 cell counts were 0.95×109/L and 0.035×109/L, respectively. After 2.4±0.6 times of leukapheresis, there gained 4.46×108/kg of MNC and 5.26×106/kg of CD34 , respectively. After mobilization, the underlying diseases were ameliorated more or less. In systemic lupus erythematosus (SLE) patients, SLE Disease Activity Index (SLEDAI) decreased from a median of 17 to 3 (P<0.01). In rheumatic arthritis patients, an American College of Rheumatology criteria for 20%(ACR20) response was achieved in all five patients. Totally, 17.4% of patients whose absolute neutrophil count <0.5×109/L suffered infection, and 31.0% of patients had bone pain after the injection of rhG-CSF. Two patients suffered severe complications, one with acute renal failure and recovered by hemodialysis, the other died of thrombotic thrombocytopenic purpura. Failed mobilization occurred in three patients. Conclusions Sufficient CD34 cells can be mobilized by low dose of cyclophosphamide and rhG-CSF. CD34 cell mobilization for treatment of severe autoimmune disease not only is appropriate in both effectiveness and safety but ameliorates disease also.     

HX—97方案对外周血造血干细胞动员,采集和移植后造血重建的 …

为提高外周血造血干细胞动员、采集、和移植后造血重建的效率,作者从１９９７年４月至１９９年６月;进行了２２例异基因或自体外周血造血干细胞移植,对外周血造血干细胞动员、采集和移植后造血重建方案（ＨＸ－９７方案）作了系统观察。ＨＸ－９７方案的主要内容是：①外周血造血干细胞动员,采用ｒｈＧ－ＣＳＦ３００μｇ／天,皮下注射,共６天,第６剂在干细胞采集有９０分钟用;②自体外周血造血干细胞动员采用大剂量化疗加造     

Effect of Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) For the Treatment of Neonates in Presumed Sepsis with Neutropenia

Bacterial sepsis continues to be an important cause of morbidity and mortality in neonates. In newborn with presumed sepsis, short-term treatment with rhG-CSF increased the neutrophil count and more importantly improved survival. The objective of the study was to evaluate the effect of rhG-CSF for the treatment of neonates in presumed sepsis with neutropenia. This interventional study was conducted in the Department of Neonatology, BSMMU, Dhaka during July 2009 to May 2010. Total 30 neonates of presumed sepsis with absolute neutrophil count ≤5000/cumm, age<28days and birth weight 1000-2000g were included in the study. A subcutaneous injection of rhG-CSF (10μgm/kg/day) was administered to 15 neonates for 5 consecutive days (study group) and 15 neonates did not receive it (control group) in addition to standard antibiotic protocol for neonatal sepsis. Baseline characteristics of 30 neonates shows male/female ratio, weight on admission, gestational age were similar in both groups. Among 30 neonates of clinically presumed sepsis 7(23%) were culture proven. E. coli was the most common organism. After 24 hours of treatment mean ANC was increased more in study group (p<0.05) compared to control group. Mean ANC after 72 hours of treatment was increased significantly in study group than control group: 5940.00 versus 5706.00 (p=0.01). At the end of treatment, the mean ANC was higher than that of control (p=0.001). Twelve neonates in study group and ten neonates in control group survived to hospital discharge. The mortality rate in the study group 3/15(20%) and in control group 5/15(33%) were not significant. Duration of hospital stay was less in study group but not significant. The study concluded that before routine use of rhG-CSF in neonatal sepsis with neutropenia further large scale, multi-centre, randomized, placebo controlled trial are needed to validate the beneficial effect.     

Autogeneic peripheral blood hemopoietic stem cell transplantation for chronic myeloid leukemia with imatinib mesylate-induced negative Philadelphia chromosome]

OBJECTIVE: To study the possibility of curing chronic myeloid leukemia with autogeneic hemopoietic stem cell transplantation in patients with negative Philadelphia (Ph) chromosome induced by imatinib mesylate (STI 571) treatment. METHODS: Two patients with chronic myeloid leukemia in chronic phase, who had 90% Ph chromosome-positive cells and bcr/abl fusion gene-positive cells as shown by interphase fluorescence in situ hybridization (I-FISH), failed to respond favorably to interferon-alpha therapy in the treatment courses of 7 and 8 months, respectively. Treatment with STI 571 at a daily dose of 300 to 400 mg for 5 months to 8 months was subsequently implemented, after which the Ph chromosome and bcr/abl fusion genes became normal in detection for 3 times. Peripheral blood haemopoietic stem cell mobilization was then initiated by intravenous injection of cytarabine (2.0 g/d) for 3 days, etoposide (0.2 g/d) for 3 d and cyclophosphamide (1.0 g/d) for one day. When the white blood cell was below 1.0x10(9)/L, the G-CSF (300 microg/d) was administered subcutaneously for 5 or 6 d, and the peripheral blood mononuclear cells were collected by CS3000 Plus blood cell separator. The percentage of bcr/abl fusion gene-positive cells among CD34(9) cells enriched by MiniMAC ranged from 11% to 14%. After 3 or 4 weeks, the patients received total body irradiation at 9 Gy given in 2 fractions, with intravenous injection of cyclophosphamide (60 mg/kg daily) and etoposide (300 mg/d) for 2 d. On the day of transplantation, the collected mononuclear cells were 4.17x10(8)/kg and 3.9x10(8)/kg, with CD34(+)/ cells reaching 4.89x10(6)/kg.b.w and 4.89x10(6)/kg. CsA was also used since day -1 to day +13 of the transplantation for prevention of graft-versus-host disease. G-CSF was administrated daily at the dose of 300 microg subcutaneously from day +3 to +12. RESULTS: After the transplantation, the absolute neutrophil count (ANC) took a mean of 11 d to exceed 0.5x10(9)/L in these two patients, and 19 and 21 d, respectively, were needed for the platelet count to exceed 20x10(9)/L. The two patients showed cytogenetic relapse at 120 and 300 d after the transplantation, respectively. CONCLUSION: Autogeneic peripheral blood stem cells transplantation after Ph chromosome is negative in patients with chronic myeloid leukemia, who receive STI 571 treatment, may also relapse, and more radical elimination of Ph chromosome-positive cells is needed.     

聚乙二醇化重组人粒细胞集落刺激因子的药代动力学与组织分布研究

目的 研究聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)在动物体内的药代动力学与组织分布.方法 猕猴给予不同剂量(30、100和300μg/kg)的PEG-rhG-CSF,酶联免疫吸附法(ELISA)测定猕猴血浆中PEG-rhG-CSF浓度;[(125)I]标记示踪法结合分子排阻色潜法观察PEG-rhG-...     

PEG-rhG-CSF对80例小细胞肺癌同步放化疗预防中性粒细胞减少的临床观察

目的 探讨聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)在小细胞肺癌患者同步放化疗中中性粒细胞减少的预防效果。 方法 回顾性分析在山东省肿瘤医院行同步放化疗、且预防使用PEG-rhG-CSF的小细胞肺癌病例80例(观察组),根据年龄、性别等因素1∶1匹配了未使用PEG-rhG-CSF的对照组80例。 观察比较两组的中性粒细胞减少情况。 结果 同步放化疗后,观察组和对照组的白细胞均减少,但前者(3.15±0.76)×10⁹个/L高于后者(1.82±0.77)×10⁹个/L,差异有统计学意义(Z=-8.467,P<0.001);观察组与对照组同步放化疗前,两组中性粒细胞绝对值差异无统计学意义(Z=-1.543,P=0.123),同步放化疗后观察组中性粒细胞减至(1.89±0.52)×10⁹个/L,对照组减至(0.77±0.44)×10⁹个/L,观察组绝对值减少幅度低于对照组,差异有统计学意义(Z=-10.034,P<0.001)。 结论 使用PEG-rhG-CSF对预防白细胞、中性粒细胞绝对值的降低有作用,可改善中性粒细胞减少,但尚待大样本验证。