[两种重组人粒细胞集落刺激因子动员接受异基因造血干细胞移植患者外周血和骨髓干细胞的随机临床研究]

[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].

作者信息

Zhang Xiao-Hui, Huang Xiao-Jun, Liu Dai-Hong, Liu Kai-Yan, Han Wei, Chen Huan, Wang Feng-Rong, Chen Yu-Hong, Wang Jing-Zhi, Zhao Ting, Wang Yu, Xu Lan-Ping

机构信息

Institute of Hematology, Peking University People's Hospital, Beijing 100044, China.

出版信息

Zhonghua Yi Xue Za Zhi. 2009 Aug 11;89(30):2116-9.

PMID:20058615

Abstract

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

目的

比较重组人粒细胞集落刺激因子（rHuG-CSF）非格司亭（惠尔血）或特尔津（天津）动员异基因造血干细胞移植（allo-HSCT）供者时CD34+细胞和单个核细胞（MNC）的动员动力学。

方法

使用两种不同的rHuG-CSF制剂，惠尔血（非格司亭）和特尔津，进行造血干细胞（HSC）动员。比较每种制剂动员的HSC在52例allo-HSCT受试者中的动员效果、干细胞质量、对供者的副作用以及对造血重建的影响。52例HLA匹配的同胞供者，随机接受特尔津（治疗组）或非格司亭（对照组）治疗。

结果

两组的峰值均出现在第4天，分别为（38.9±3.0）×10⁹/L和（37.8±2.9）×10⁹/L（P>0.05）。两种制剂对HSC参数的影响如下：供者外周血中MNC为（4.8±0.7）×10⁸/kg vs（5.1±0.4）×10⁸/kg，CD34+为（1.6±0.3）×10⁶/kg vs（1.9±0.7）×10⁶/kg；供者骨髓中MNC为（3.8±0.5）/L vs（3.9±0.7）/L，CD34+为（1.3±0.7）×10⁶/kg vs（1.5±0.4）×10⁶/kg（均P>0.05）。关于对allo-HSCT受试者造血重建的影响，两者的血小板计数恢复均较快（14.6±0.9）天vs（15.2±1.6）天（P>0.05），中性粒细胞计数恢复为（18.1±0.8）天vs（17.0±1.9）天（P>0.05）。这两种动员制剂在HSC供者中的不良事件无显著差异。