Randomized clinical study for two types of recombinant human granulocyte colony-stimulating factor mobilizing peripheral blood and bone marrow stem cells in patients receiving allogeneic hematopoietic stem cell transplantation

目的 比较两种重组人粒细胞集落刺激因子(rHuG-CSF)惠尔血和特尔津,对造血干细胞移植供者的动员疗效.方法 异基因造血干细胞移植(allo-HSCT)患者52例,人类白细胞抗原(HLA)配型全相合的同胞供者52例,随机采用两种rHuG-CSF特尔津和惠尔血分别进行供者造血干细胞动员,对供者千细胞动员参数及患者移植后造血重建等进行比较研究.结果 惠尔血组和特尔津组外周血白细胞计数高峰时间均为第4天(38.9±3.0)×109/L和(37.8±2.9)×109/L(P>0.05).惠尔血和特尔津两种动员剂对供者外周血造血干细胞参数的影响,其结果分别为采集物MNC计数(4.8±0.7)×108/kg vs(5.1±0.4)×108/kg;CD34+(1.6±0.3)×106/kg vs(1.9±0.7)×106/kg;惠尔血和特尔津两种动员剂对供者骨髓血造血干细胞参数有诸多方面的影响,其结果分别为采集物MNC计数(3.8±0.5)/L vs(3.9±0.7)/L;CD34+(1.3±0.7)×106/kg vs (1.5±0.4)×106/kg(均P>0.05).特尔津和惠尔血两种动员剂对造血干细胞移植后造血重建的影响,其结果分别为移植后中性粒细胞植活时间(14.6±0.9)d vs(15.2±1.6)d;血小板的植活时间(18.1±0.8)d vs(17.0±1.9)d(P>0.05);两种动员剂对造血干细胞移植供者不良反应无显著差异.结论 惠尔血和特尔津两种动员剂分别对供者外周血及骨髓的造血干细胞动员动力学,以及对患者造血重建影响均无显著性差异.特尔津能可靠用于造血干细胞供者的动员及患者移植后造血重建.To compare mobilization kinetics of CD34 + cells and MNC during mobilization with either recombinant human granulocyte colony-stimulating factor (rHuG-CSF) filgrastim (Huierxue) or topneuter (Teerjin) in allogeneic hematopoietic stem cells transplantation (allo-HSCT) donors.Two different agents of rHuG-CSF, Huierxue (filgrastim) and Teerjin (topneuter), were used for hematopoietic stem cells (HSC) mobilization. The HSCs mobilized by each agent were compared in mobilization efficacy, quality of stem cells, side effects in donors and influence of hematopoietic reconstitution in 52 subjects following allo-HSCT. Fifty-two HLA-matched sibling donors, receiving either (rHuG-CSF) topneuter (treatment group) or filgrastim (control group), were randomized in this study.The peak values of both groups, occurring at both Day 4, were (38.9 +/- 3.0) x 10(9)/L and (37.8 +/- 2.9) x 10(9)/L respectively (P > 0.05). Both agents had the following effects upon the HSC parameters: (4.8 +/- 0.7) x 10(8)/kg vs (5.1 +/- 0.4) x 10(8)/kg MNC, (1.6 +/- 0.3) x 10(6)/kg vs (1.9 +/- 0.7) x 10(6)/kg) CD34 + in peripheral blood of donors; (3.8 +/- 0.5)/L vs (3.9 +/- 0.7)/L MNC; (1.3 +/- 0.7) x 10(6)/kg vs (1.5 +/- 0.4) x 10(6)/kg CD34 + in bone marrow of donors (both P > 0.05). With regards to the effects upon hematopoietic reconstitution in subjects following allo-HSCT, both had rapid platelet count recovery (14.6 +/- 0.9) vs (15.2 +/-1.6) days (P > 0.05) and neutrophil count recovery (18.1 +/- 0.8) vs (17.0 +/- 1.9) days (P > 0.05). The adverse events were not significantly different in the HSC donors for these two mobilization agents.Filgrastim and topneuter demonstrate no statistically significant difference in either HSC mobilization kinetics of peripheral and bone marrow blood or hematopoietic reconstitution. Topneuter can be a reliable agent for donor HSC mobilization and recipient hematopoietic reconstitution following allo-HSCT.国家高技术研究发展计划(863计划); 国家自然科学基金; 教育部创新团队支持计划项目PubMed中文核心期刊要目总览(PKU)中国科技核心期刊(ISTIC)中国科学引文数据库(CSCD)0302116-21198