一项关于自体干细胞移植后第1天与第7天开始使用粒细胞集落刺激因子(惠尔血)的随机试验。

A randomized trial of granulocyte colony-stimulating factor (Neupogen) starting day 1 vs day 7 post-autologous stem cell transplantation.

作者信息

Bence-Bruckler I, Bredeson C, Atkins H, McDiarmid S, Hamelin L, Hopkins H, Perry G, Genest P, Huebsch L

机构信息

Ottawa General Hospital Blood and Marrow Transplantation Programme, University of Ottawa, Ontario, Canada.

出版信息

Bone Marrow Transplant. 1998 Nov;22(10):965-9. doi: 10.1038/sj.bmt.1701469.

Abstract

The purpose of the study was to evaluate the effect of delayed granulocyte colony-stimulating factor (G-CSF) use on hematopoietic recovery post-autologous peripheral blood progenitor cell (PBPC) transplantation. Patients were randomized to begin G-CSF on day +1 or day +7 post transplantation. Thirty-seven patients with lymphoma or myeloma undergoing high-dose therapy and autologous PBPC rescue were randomized to daily subcutaneous G-CSF beginning on day +1 or day +7 post-transplant. Patients < or =70 kg received 300 microg/day and >70 kg 480 microg/day. All patients were reinfused with PBPCs with a CD34+ cell count >2.0 x 10(6)/kg. Baseline characteristics of age, sex and CD34+ cell count were similar between the two arms, the median CD34+ cell count being 5.87 x 10(6)/kg in the day +1 group and 7.70 x 10(6)/kg in the day +7 group (P=0.7). The median time to reach a neutrophil count of >0.5 x 10(9)/l was 9 days in the day +1 arm and 10 days in the day +7 arm, a difference which was not statistically significant (P=0.68). Similarly, there was no difference in median days to platelet recovery >20000 x 10(9)/l, which was 10 days in the day +1 arm and 11 days in the day +7 arm (P=0.83). There was also no significant difference in the median duration of febrile neutropenia (4 vs 6 days; P=0.7), intravenous antibiotic use (7 vs 8 days; P=0.54) or median number of red blood cell transfusions (4 vs 7 units; P=0.82) between the two arms. Median length of hospital stay was 11 days post-PBPC reinfusion in both groups. The median number of G-CSF injections used was 8 in the day +1 group and 3 in the day +7 group (P < 0.0001). There is no significant difference in time to neutrophil or platelet recovery when G-CSF is initiated on day +7 compared to day +1 post-autologous PBPC transplantation. There is also no difference in number of febrile neutropenic or antibiotic days, number of red blood cell transfusions or length of hospital stay. The number of doses of G-CSF used per transplant is significantly reduced with delayed initiation, resulting in a significant reduction in drug costs. For patients with an adequately mobilized PBPC graft, the initiation of G-CSF can be delayed until day +7 post-PBPC reinfusion.

摘要

本研究的目的是评估延迟使用粒细胞集落刺激因子(G-CSF)对自体外周血祖细胞(PBPC)移植后造血恢复的影响。患者被随机分为在移植后第+1天或第+7天开始使用G-CSF。37例接受高剂量治疗及自体PBPC挽救的淋巴瘤或骨髓瘤患者被随机分为在移植后第+1天或第+7天开始每日皮下注射G-CSF。体重≤70 kg的患者每日剂量为300 μg,体重>70 kg的患者每日剂量为480 μg。所有患者回输的PBPC中CD34+细胞计数>2.0×10⁶/kg。两组患者的年龄、性别和CD34+细胞计数等基线特征相似,第+1天组的CD34+细胞计数中位数为5.87×10⁶/kg,第+7天组为7.70×10⁶/kg(P = 0.7)。第+1天组达到中性粒细胞计数>0.5×10⁹/L的中位时间为9天,第+7天组为10天,差异无统计学意义(P = 0.68)。同样,血小板恢复至>20000×10⁹/L的中位天数在两组间也无差异,第+1天组为10天,第+7天组为11天(P = 0.83)。两组间发热性中性粒细胞减少的中位持续时间(4天对6天;P = 0.7)、静脉使用抗生素的时间(7天对8天;P = 0.54)或红细胞输注的中位数(4单位对7单位;P = 0.82)也均无显著差异。两组PBPC回输后的中位住院时间均为11天。第+1天组使用G-CSF注射的中位数为8次,第+7天组为3次(P<0.0001)。与自体PBPC移植后第+1天开始使用G-CSF相比,第+7天开始使用时,中性粒细胞或血小板恢复时间无显著差异。发热性中性粒细胞减少天数或使用抗生素天数、红细胞输注次数或住院时间也无差异。延迟开始使用G-CSF可显著减少每次移植使用的G-CSF剂量,从而显著降低药物成本。对于PBPC移植物充分动员的患者,G-CSF的使用可延迟至PBPC回输后第+7天。

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