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1.
rhG-CSF预防恶性肿瘤化疗后粒细胞减少的Ⅱ期临床研究 总被引:5,自引:0,他引:5
目的:评价rhG-CSF(粒生素)对预防恶性肿瘤化疗后粒细胞减少的作用及不良反应。方法:人组总数63例,均为病理或细胞学证实的恶性肿瘤。采用自身交叉方法将患者随机分入AB和BA两组。A为治疗周期,即化疗用药结束48h开始,每日1次皮下注射rhG-CSF 5μg/kg,连续用药7~14d。B为空白对照周期。自化疗开始隔日查血常规1次,观察中性粒细胞(ANC)及白细胞(WBC)的变化。结果:治疗组于rhG-CSF注射24h后,WBC及ANC迅速上升,48h出现第1个高峰,第10天出现第2个高峰,而对照组化疗后,WBC和ANC逐渐下降,始终低于治疗组。WBC,ANC的最低值、WBC<4.0×109/L、ANC<2.0×109/L的持续时间,以及化疗后第21天WBC<4.0×109/L的病例数在治疗组和对照组间差异有显著性(P<0.05)。结论:rhG-CSF可以促进化疗患者WBC和ANC的恢复,耐受性良好,可以作为肿瘤化疗中提高剂量强度的有效辅助药。 相似文献
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基因重组人粒细胞/巨噬细胞集落刺激因子防治肿瘤化疗所致的白?… 总被引:5,自引:0,他引:5
目的 研究基因重组人粒细胞/巨噬细胞集落刺激因子(rhGM-CSF,生白能)防治实体瘤化疗所致白细胞(WBC)和中性粒细胞(ANC)减少的临床效果及不良反应。方法 采用多中心随机分组、自身交叉对照方法,对57例肿瘤化疗患者随机分成AB组和BA组。AB组第1周化疗加生白能治疗(治疗组),第2周期单用化疗(对照组);BA组第1周期单用化疗,第2周期化疗加白能治疗。有55例可做临床疗效分析。结果 生白能 相似文献
3.
基因重组人粒细胞/巨噬细胞集落刺激因子防治肿瘤化疗所致的白细胞减少 总被引:3,自引:0,他引:3
目的研究基因重组人粒细胞/巨噬细胞集落刺激因子(rhGM-CSF,生白能)防治实体瘤化疗所致白细胞(WBC)和中性粒细胞(ANC)减少的临床效果及不良反应。方法采用多中心随机分组、自身交叉对照方法,对57例肿瘤化疗患者随机分成AB组和BA组。AB组第1周期化疗加生白能治疗(治疗组),第2周期单用化疗(对照组);BA组第1周期单用化疗,第2周期化疗加生白能治疗。有55例可做临床疗效分析。结果生白能可明显减轻化疗所致WBC和ANC下降程度,缩短WBC和ANC降至正常值以下的持续时间,促进WBC和ANC早日恢复,有助于化疗按期进行。主要不良反应有轻、中度发热,注射部位疼痛,骨骼肌肉疼痛,乏力和皮疹,一般可以耐受。结论生白能是一种有价值的化疗辅助药物。 相似文献
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国产 rhG-CSF 预防肿瘤化疗所致白细胞减少的Ⅱ期临床研究 总被引:6,自引:0,他引:6
目的:考察国产重组人粒细胞集落刺激因子(rhG-CSF)对化疗患者的中性粒细胞的影响。方法:96例经病理检查证实的恶性肿瘤,包括肺癌、恶性淋巴瘤、乳癌、卵巢癌等四种肿瘤病例,分别使用同样方案和剂量的化疗并采用交叉自身配对对照的方法,对这些化疗病例同时加用或不加用重组人粒细胞集落刺激因子注射液(吉粒芬)作对照研究,比较两组病人中性粒细胞绝对数(ANC)的动态变化。结果:192个疗程不同化疗方案治疗几种肿瘤,并用国产rhG-CSF者,粒细胞减少症持续天数,ANC减少(<2.0×109/L)的发生率,化疗后ANC最低值以及因ANC过低致下一疗程化疗推迟的发生率,均优于空白对照组。注射国产rhG-CSF24小时后ANC迅速升高,多于第10~14天ANC恢复至正常或更高水平。本组观察国产rhG-CSF除轻微肾瘤、肌肉痛外未见明显毒副反应。结论:国产rhG-CSF可减轻化疗后ANC降低的程度,缩短粒细胞缺乏症的持续时间,促进ANC的恢复,无明显毒副反应,可作为肿瘤化疗中有价值的辅助药物。 相似文献
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目的观察不同剂量国产重组人粒细胞集落刺激因子(rhGCSF)对肺癌化疗患者中性粒细胞的影响以及对人体的毒副作用。方法81例经病理证实的肺癌患者,采用相应的方案进行化疗。并于化疗后24小时将患者分为3组采用低、中、高不同剂量的rhGCSF进行升白治疗,每组均为27例。rhGCSF用法为:低剂量组(T3)75μg/日,中剂量组(T2)150μg/日,高剂量组(T1)300μg/日,均为皮下注射,每日1次,直至ANC降至最低值后回升超过50×109/L2次以上或已用10天后停药;另高剂量组27例采用自身交叉对照法,即该组患者共进行2周期化疗,其中1周期于化疗后加用300μg者为高剂量组(T1),另1周期不加用者为对照组(C)。比较不同剂量组中性粒细胞绝对数(ANC)的动态变化。结果治疗组于化疗结束24h后并用rhGCSF能减轻粒细胞减少程度及缩短其持续时间。高剂量组效果最佳,中剂量组次之,即使低剂量组与对照组相比差异亦有显著性。本组观察国产rhGCSF除轻微骨痛、肌肉痛外未见其他明显毒副反应。结论国产rhGCSF可作为肿瘤化疗后预防ANC下降的有价值的辅助药物 相似文献
7.
探讨低剂量格拉诺赛特(rhG-CSF)对淋巴瘤CHOPE化疗后白细胞和中性粒细胞减少的防治作用。采用随机分组、自身交叉对比的方法。患者随机分为A、B两组,A组第一周期化疗后加rhG-CSF,第二周期单用化疗;B组第一周期单用化疗,第二周期化疗后加rhG-CSF。rhG-CSF在化疗药物末次给药后48h起,50μg/日,皮下注射。结果表明,该剂量的rhG-CSF可以明显减轻化疗过程中的白细胞和中性粒细胞下降的程度,降低感染率,使化疗可以如期进行。低剂量的rhG-CSF疗效确切,副反应轻微,值得推广。 相似文献
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本文观察了46例中晚期肿瘤病人化疗、免疗(抗瘤iRNA及S-TF)及免疫化疗前后NK-IL-2-IFN-r系统及WBC等变化。结果发现:(1)肿瘤病人NK、IL-2及IFN-r活性均显著低于正常人;(2)化疗后除WBC明显降低外,其它指标化疗前后均无明显变化;(3)免疫及免疫化疗后各免疫指标均较治疗前显著增加;(4)免化组各免疫指标及WBC明显高于化疗组,其中IL-2及IFN-r活性还明显高于免疫组,但免疫组仅IL-2活性及WBC明显高于化疗组。本研究结果表明,抗瘤iRNA及S-TF不仅可恢复肿瘤宿主的免疫力,而且与化疗联用,还可能降低化疗的毒副反应,协调肿瘤病人NK-IL-2-IFN-r系统的抗癌功能。 相似文献
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基因重组人粒细胞/巨噬细胞集落刺激因子预防化疗所致白细胞减少症的临床疗效观察 总被引:13,自引:0,他引:13
作者采用随机分组、自身交叉对比的方法,观察了基因重组人粒细胞/巨噬细胞集落刺激因子(RecombinantHumanGranulocytsMacrophageColonyStimulatingFactor,rhGM-CSF,以下简称rhGM-CSF)对CE及CEA方案化疗所致白细胞和中性粒细胞减少的防治作用及毒副反应。全组共21例,其中A组8例、B组13例。结果表明,rhGM-CSF可以明显减轻化疗过程中白细胞和中性粒细胞下降的程度,降低其发生率,缩短白细胞和中性粒细胞降至正常值以下的持续时间,促进白细胞和中性粒细胞的早日恢复,但对血小板的变化影响不大。rhGM-CSP的副反应主要是发热(43%),此外还可见皮疹,感冒症状等。 相似文献
10.
本文观察了46例中晚期肿瘤病人化疗、免疗(抗瘤iRNA及S-TF)及免疫化疗前后NK-IL-2-IFN-r系统及WBC等变化。结果发现:(1)肿瘤病人NK、IL-2及IFN-r活性均显著低于正常人;(2)化疗后除WBC明显降低外,其它指标化疗前后均无明显变化;(3)免疫及免疫化疗后各免疫指标均较治疗前显著增加;(4)免化组各免疫指标及WBC明显高于化疗组,其中IL-2及IFN-r活性还明显高于免疫组,但免疫组仅IL-2活性及WBC明显高于化疗组。本研究结果表明,抗瘤iRNA及S-TF不仅可恢复肿瘤宿主的免疫力,而且与化疗联用,还可能降低化疗的毒副反应,协调肿瘤病人NK-IL-2-IFN-r系统的抗癌功能。 相似文献
11.
rhGM-CSF预防肿瘤化疗所致白细胞减少的随机对照临床研究 总被引:1,自引:0,他引:1
观察rhGM-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。 相似文献
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L. Bergmann T. Karakas A. Knuth G. Lautenschlger P. S. Mitrou D. Hoelzer 《European journal of cancer (Oxford, England : 1990)》1995,31(13-14)
High-grade non-Hodgkin's lymphomas (NHL) can potentially be cured with combination chemotherapy, although the optimum schedules still have to be defined. Clinical trials with intensive chemotherapy are predominantly limited by myelosuppression. Here, haematopoetic growth factors open up the possibility of reducing chemotherapy-associated toxicities. In this randomised pilot study, we investigated the effects of a recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) following combined chemotherapy with vincristine, doxorubicin, cyclophosphamide, prednisone and etoposide (VACPE). A total of 35 patients with high-grade NHLs were randomised to receive either rhGM-CSF or placebo during the first two chemotherapy cycles and rhGM-CSF for all following cycles. rhGM-CSF was administered at a dosage of 5 μg/kg for 10 days or until neutrophils were > 1/nl following chemotherapy. The analyses revealed a significant reduction of neutropenia and duration of neutropenia in the rhGM-CSF group. Adverse events were rare and generally mild apart from one anaphylactoid reaction. No effects of rhGM-CSF were observed concerning the platelet nadir or duration of thrombocytopenia. The benefit of rhGM-CSF for response induction and survival via rhGM-CSF-supported dose intensification remains to be determined. 相似文献
14.
A D Ho F Del Valle M Engelhard W Hiddemann H Rückle G Schlimok R Haas E Thiel R Andreesen W Fiedler 《Cancer》1990,66(3):423-430
Previous study has shown that the combination of mitoxantrone (Novantrone, NO) and Ara-C (AC) (NOAC) was active in refractory non-Hodgkin's lymphoma (NHL) but myelosuppression was dose-limiting. In a pilot study, we investigated the effects of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) after NOAC chemotherapy in patients with refractory NHL. NO was applied at a dosage of 10 mg/m2/day on days 2 and 3 and AC at 3 g/m2/12h on days 1 and 2. RhGM-CSF was administered at 250 ug/m2/day as a continuous i.v. infusion from day 6 until the neutrophils were greater than 3.0/nl for 3 consecutive days. Twenty-three patients from five of the nine participating centers were treated with NOAC chemotherapy plus rhGM-CSF, whereas 14 patients from the other four centers received chemotherapy alone. With rhGM-CSF, the median duration of severe neutropenia (less than 0.5/nl) after NOAC was 8 days versus a median of 13 days without rhGM-CSF (P = 0.0058), and that of thrombocytopenia (less than 20.0/nl), 3 days versus 7 days (P greater than 0.4, NS). The rates of infections and stomatitis were 25% and 17%, respectively, for patients treated with rhGM-CSF as compared to 53% (P = 0.0547, NS) and 60% (P = 0.0078), respectively, without rhGM-CSF. The following side effects were associated with the administration of rhGM-CSF: pleural and/or pericardial effusions in five patients, thrombosis in two patients, bone pain in two patients, and respiratory distress syndrome in one patient. A complete remission was achieved in nine of the 23 patients treated with NOAC plus rhGM-CSF, and in two of the 14 patients treated with chemotherapy alone. The median survival of patients treated with rhGM-CSF was not reached at 400 days and seemed to be longer than that of patients treated with chemotherapy alone (median, 109 days; P = 0.036). RhGM-CSF after chemotherapy can be applied safely to patients with NHL, shorten the period of severe cytopenia, reduce the rates of stomatitis, and did not seem to cause adverse effects on response. 相似文献
15.
低剂量格拉诺赛特(rhG-CSF)防治肺癌CE方案化疗后中性粒细胞减少症的临床研究 总被引:1,自引:1,他引:1
作者采用随机分组、自身交叉对比的方法,观察了低剂量格拉诺赛特(Granocyte,rhG-CSF)对22例肺癌CE方案(卡铂+足叶乙甙)化疗后白细胞和中性粒细胞减少症的防治作用及毒副反应。患者随机分成A、B两组(各11例)。A组第一周期化疗后加用格拉诺赛特,第二周期单用化疗;B组第一周期单用化疗,第二周期化疗后加用格拉诺赛特。格拉诺赛特在化疗药物未次给药后48h起,50μg1次/日皮下注射。结果表明,该剂量的格拉诺赛特可以明显减轻化疗过程中白细胞和中性粒细胞下降的程度,降低中性粒细胞严重降低的发生率,缩短其在正常值以下的持续时间,促进早日恢复,缩短化疗周期的间隔时间,使化疗可以如期进行。低剂量的格拉诺赛特疗效确切,副反应轻微。 相似文献
16.
Font A Moyano AJ Puerto JM Tres A Garcia-Giron C Barneto I Anton A Sanchez JJ Salvador A Rosell R 《Cancer》1999,85(4):855-863
BACKGROUND: The authors designed this randomized, controlled trial to assess whether dose intensification of a cisplatin-etoposide combination (PE), achieved by shortening the interval between chemotherapy cycles, would improve response rate and survival. The maximum tolerated dose of PE was administered in either 3- or 4-week cycles to patients with advanced nonsmall cell lung carcinoma (NSCLC). METHODS: One hundred twenty-three patients were randomized into two groups. The dose-intense arm received cisplatin 35 mg/m2 and etoposide 200 mg/m2 on Days 1-3 every 4 weeks. The dose-dense arm received the same schedule every 3 weeks along with 5 microg/kg of recombinant human granulocyte macrophage-colony stimulating factor (rhGM-CSF) administered subcutaneously on Days 4-13. RESULTS: Patient characteristics were well balanced in both treatment arms. Fifty-four percent of patients were classified as Stage IIIB. A 32% increase in relative dose intensity was achieved in the dose-dense arm compared with the dose-intense arm. The response rates were 32% in the dose-intense arm and 27% in the dose-dense arm (P = 0.9). The median overall survival was higher in the dose-dense arm, 9 versus 7.2 months (P = 0.2). The main toxicity was myelosuppression, although the administration of GM-CSF significantly reduced the percentage of patients with Grade 4 granulocytopenia (53% vs. 78%). Fifty-four percent of the patients in the dose-intense arm and 35% of those in the dose-dense arm developed febrile neutropenia (P = 0.07). There were ten (8%) treatment-related deaths, three (4%) in the dose-intense arm and seven (12%) in the dose-dense arm (P = 0.3); three deaths in each arm were due to febrile neutropenia. CONCLUSIONS: The dose-intensification achieved in the dose-dense PE regimen did not correlate with significant improvements in response rate or survival and cannot be recommended in the light of the diversity of new drug combinations available today. However, the use of rhGM-CSF significantly reduced the incidence of severe granulocytopenia. 相似文献
17.
Glaspy JA 《Oncology (Williston Park, N.Y.)》2003,17(11):1593-1603
Hematopoietic growth factors have transformed the practice of oncology. The two major factors in clinical use are recombinant human (rh) granulocyte colony-stimulating factor (G-CSF, filgrastin [Neupogen]) and granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim [Leukine]). These factors differ significantly in their role in hematopoiesis and the regulation of mature effector cell function. G-CSF regulates both basal and neutrophil production and increased production and release of neutrophils from the marrow in response to infection. GM-CSF mediates its effects on the neutrophil lineage through its effects on phagocytic accessory cells and its synergy with G-CSF, but it does not appear to have a role in basal hematopoiesis. Part 1 of this two-part series focuses on the use of the myeloid growth factors rhG-CSF and rhGM-CSF to shorten the duration of chemotherapy-induced neutropenia and thus prevent infection in cancer patients. In randomized trials, rhG-CSF has consistently decreased the duration of neutropenia during all cycles of chemotherapy and reduced the risk of infection by 50% or more. Trials of rhGM-CSF have not reported consistent results. 相似文献
18.
R. Rampling W. Steward J. Paul M. A. Macham E. Harvey D. Eckley 《British journal of cancer》1994,69(3):541-545
Nitrosoureas are the drugs most effective in the treatment of patients with intracerebral malignant glioma. Their limiting toxicity is delayed myelosuppression. A prospective, randomised crossover study of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) was performed in patients receiving BCNU for relapsed glioblastoma, to investigate whether the resulting haematological toxicity profile could be modified by rhGM-CSF. Adequate data for analysis were obtained in 13 patients. Following BCNU, the nadir neutrophil count was higher in 12 out of 13 patients during the rhGM-CSF-protected cycles compared with the unprotected cycles. The median nadir was also significantly higher (1.79, CI 0.76-3.52, P < 0.005). Five episodes of neutropenia (< 2 x 10(9) l-1) occurred during the unprotected cycles compared with none in the rhGM-CSF-protected cycles (P = 0.076). There was no evidence of any effect on platelets. This result shows that the haematological toxicity profile following therapeutic doses of BCNU can be modified. It suggests that rhGM-CSF and other growth factors should be investigated for clinical efficacy in chemotherapy using nitrosoureas. 相似文献