Schmitz N, Linch D C, Dreger P, Goldstone A H, Boogaerts M A, Ferrant A, Demuynck H M, Link H, Zander A, Barge A
Department of Internal Medicine II, Christian-Albrechts-Universität, Kiel, Germany.
Lancet. 1996 Feb 10;347(8998):353-7. doi: 10.1016/s0140-6736(96)90536-x.
A randomised trial comparing filgrastim-mobilised peripheral blood progenitor cell (PBPC) transplants with autologous bone marrow transplantation (ABMT) for haematopoietic stem cell support has not been done. We compared the effects of filgrastim-mobilised PBPC or autologous bone marrow reinfused to lymphoma patients after high-dose chemotherapy in a prospective randomised multicentre trial.
The trial was done at six centres in three European countries. After high-dose chemotherapy (carmustine, etoposide, cytarabine, and melphalan [BEAM protocol]) 58 patients with advanced Hodgkin's disease or high-grade non-Hodgkin lymphoma received either filgrastim-mobilised PBPC (n = 27) or bone marrow (n = 31) for haemopoietic reconstitution.
The median number of days with platelet transfusions after grafting was 6 in the PBPC transplantation group and 10 in the ABMT group (estimate of treatment difference 5 days, 95% CI 3-7 days). Time to platelet recovery above 20 x 10(9)/L was 16 days in the PBPC transplantation group and 23 days in the ABMT group (p = 0.02). Time to neutrophil recovery above 0.5 x 10(9)/L was also reduced in the PBPC transplantation group (11 vs 14 days, p = 0.005). Patients randomised to PBPC transplantation needed fewer red blood cell transfusions (two vs three, p = 0.002) and spent less time in hospital (17 vs 23 days, p = 0.002). Early post-transplant morbidity and mortality as well as overall survival (median follow-up 311 days) were similar in both groups. There was no notable toxicity ascribed to filgrastim administration or the leucapheresis procedures.
In patients with lymphoma treated with high-dose chemotherapy, reinfusing filgrastim-mobilised PBPC instead of autologous bone marrow significantly reduced the number of platelet transfusions, the time to platelet and neutrophil recovery, and led to earlier discharge from hospital.
尚未进行一项比较非格司亭动员的外周血祖细胞（PBPC）移植与自体骨髓移植（ABMT）用于造血干细胞支持的随机试验。我们在一项前瞻性随机多中心试验中比较了非格司亭动员的PBPC或自体骨髓回输给接受大剂量化疗后的淋巴瘤患者的效果。
该试验在三个欧洲国家的六个中心进行。58例晚期霍奇金病或高级别非霍奇金淋巴瘤患者在接受大剂量化疗（卡莫司汀、依托泊苷、阿糖胞苷和美法仑[BEAM方案]）后，接受非格司亭动员的PBPC（n = 27）或骨髓（n = 31）进行造血重建。
移植后接受血小板输注的天数中位数，PBPC移植组为6天，ABMT组为10天（治疗差异估计值为5天，95%CI为3 - 7天）。血小板恢复至高于20×10⁹/L的时间，PBPC移植组为16天，ABMT组为23天（p = 0.02）。PBPC移植组中性粒细胞恢复至高于0.5×10⁹/L的时间也缩短（11天对14天，p = 0.005）。随机分配至PBPC移植的患者需要的红细胞输注较少（2次对3次，p = 0.002），住院时间较短（17天对23天，p = 0.002）。两组移植后的早期发病率、死亡率以及总生存率（中位随访311天）相似。未发现非格司亭给药或白细胞分离术有明显毒性。
在接受大剂量化疗的淋巴瘤患者中，回输非格司亭动员的PBPC而非自体骨髓可显著减少血小板输注次数、缩短血小板和中性粒细胞恢复时间，并使患者更早出院。
