Nemunaitis J, Rosenfeld C S, Ash R, Freedman M H, Deeg H J, Appelbaum F, Singer J W, Flomenberg N, Dalton W, Elfenbein G J
Texas Oncology, PA/Sammons Baylor, Dallas 75204, USA.
Bone Marrow Transplant. 1995 Jun;15(6):949-54.
Preliminary studies in allogeneic BMT suggest that recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) is well tolerated. This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial. Yeast-derived rhGM-CSF 250 micrograms/m2/day or placebo was administered by 4-hour i.v. infusion starting on the day of marrow infusion (day 0) to day 20. All patients received HLA-identical sibling marrow and cyclosporine and prednisone for GVHD prophylaxis. Fifty three patients received rhGM-CSF and 56 received placebo. Comparison of demographics revealed no differences. The time to achieve an absolute neutrophil count of > 0.5 x 10(9) cells/l was shortened in rhGM-CSF treated patients (day 13 vs. 17, P = 0.0001). The incidences of grade III-IV mucositis and infection were significantly reduced (P = 0.005, P = 0.001, respectively) and duration of hospitalization was modestly shortened by 1 day (P = 0.02) in rhGM-CSF treated patients. No differences in platelet recovery, erythrocyte recovery, incidence of veno-occlusive disease, GVHD severity, relapse or survival were observed. In conclusion, rhGM-CSF is well tolerated and reduces post-transplant morbidity in patients undergoing HLA-identical allogeneic BMT.
异基因骨髓移植的初步研究表明，重组人粒细胞巨噬细胞集落刺激因子（rhGM-CSF）耐受性良好。这是一项前瞻性、多中心、随机、双盲、安慰剂对照试验。从骨髓输注当天（第0天）至第20天，通过4小时静脉输注给予酵母衍生的rhGM-CSF 250微克/平方米/天或安慰剂。所有患者均接受 HLA 相同的同胞骨髓移植，并使用环孢素和泼尼松预防移植物抗宿主病（GVHD）。53例患者接受rhGM-CSF治疗，56例接受安慰剂治疗。人口统计学比较显示无差异。rhGM-CSF治疗的患者达到绝对中性粒细胞计数>0.5×10⁹/升的时间缩短（第13天对第17天，P = 0.0001）。rhGM-CSF治疗的患者中，III-IV级粘膜炎和感染的发生率显著降低（分别为P = 0.005，P = 0.001），住院时间适度缩短1天（P = 0.02）。在血小板恢复、红细胞恢复、静脉闭塞性疾病发生率、GVHD严重程度、复发或生存率方面未观察到差异。总之，rhGM-CSF耐受性良好，可降低接受 HLA 相同异基因骨髓移植患者的移植后发病率。
