title: [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].
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute of Hematology, Peking University People's Hospital, Beijing 100044, China.
authors.forename: Xiao-Hui
authors.initials: XH
authors.lastname: Zhang
authors.forename: Xiao-Jun
authors.initials: XJ
authors.lastname: Huang
authors.forename: Dai-Hong
authors.initials: DH
authors.lastname: Liu
authors.forename: Kai-Yan
authors.initials: KY
authors.lastname: Liu
authors.forename: Wei
authors.initials: W
authors.lastname: Han
authors.forename: Huan
authors.initials: H
authors.lastname: Chen
authors.forename: Feng-Rong
authors.initials: FR
authors.lastname: Wang
authors.forename: Yu-Hong
authors.initials: YH
authors.lastname: Chen
authors.forename: Jing-Zhi
authors.initials: JZ
authors.lastname: Wang
authors.forename: Ting
authors.initials: T
authors.lastname: Zhao
authors.forename: Yu
authors.initials: Y
authors.lastname: Wang
authors.forename: Lan-Ping
authors.initials: LP
authors.lastname: Xu
mesh_terms: D000293:Adolescent; D000328:Adult; D001854:Bone Marrow Cells / Q000187:drug effects; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006412:Hematopoietic Stem Cells / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D014019:Tissue Donors; D055815:Young Adult
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim