title: Administration of recombinant human granulocyte colony-stimulating factor to normal donors: results of the Spanish National Donor Registry. Spanish Group of Allo-PBT.
abstract: A Spanish National PBPC Donor Registry has recently been established for short- and long-term safety data collection in normal donors receiving rhG-CSF. To date, 466 donors have been included in the Registry. Median (range) dose and duration of rhG-CSF administration was 10 microg/kg/day (4-20) and 5 days (4-8), respectively. Donors underwent a median of two aphereses (range, 1-5). Adverse effects consisted mainly of bone pain (90.2%), headache (16.9%) and fever (6. 1%), but no donor discontinued rhG-CSF prematurely due to toxicity. Side-effects were more frequent in donors receiving >10 microg/kg/day than in those with lower doses (82.8% vs 61.8%; P = 0. 004). A significant decrease between baseline and post-apheresis platelet counts was the most important analytical finding (229 x 10(9)/l vs 140 x 10(9)/l; P < 0.0001), with a progressive reduction in platelet count with each apheresis procedure. One donor developed pneumothorax that required hospitalization due to central venous line placement. The mean CD34+ cell dose collected was 6.9 x 10(6)/kg (range, 1.3-36), with only 14 donors (2.9%) not achieving a minimum target of CD34+ cells of 2 x 10(6)/kg. No definitive information about potential long-term side effects is yet available. However, we hope this National Registry will serve as a useful basis for better monitoring of the efficiency and side-effects of cytokine administration in healthy people.
authors.affiliation: Servicio de Hematología, Hospital Universitario La Fe, Valencia, Spain.
authors.forename: J
authors.initials: J
authors.lastname: de la Rubia
authors.forename: C
authors.initials: C
authors.lastname: Martínez
authors.forename: C
authors.initials: C
authors.lastname: Solano
authors.forename: S
authors.initials: S
authors.lastname: Brunet
authors.forename: P
authors.initials: P
authors.lastname: Cascón
authors.forename: R
authors.initials: R
authors.lastname: Arrieta
authors.forename: A
authors.initials: A
authors.lastname: Alegre
authors.forename: J
authors.initials: J
authors.lastname: Bargay
authors.forename: F
authors.initials: F
authors.lastname: de Arriba
authors.forename: C
authors.initials: C
authors.lastname: Cañizo
authors.forename: J
authors.initials: J
authors.lastname: López
authors.forename: D
authors.initials: D
authors.lastname: Serrano
authors.forename: A
authors.initials: A
authors.lastname: Verdeguer
authors.forename: M
authors.initials: M
authors.lastname: Torrabadella
authors.forename: M A
authors.initials: MA
authors.lastname: Díaz
authors.forename: A
authors.initials: A
authors.lastname: Insunza
authors.forename: J
authors.initials: J
authors.lastname: de la Serna
authors.forename: I
authors.initials: I
authors.lastname: Espigado
authors.forename: J
authors.initials: J
authors.lastname: Petit
authors.forename: M
authors.initials: M
authors.lastname: Martínez
authors.forename: L
authors.initials: L
authors.lastname: Benlloch
authors.forename: M
authors.initials: M
authors.lastname: Sanz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018952:Antigens, CD34 / Q000096:biosynthesis; D002648:Child; D002675:Child, Preschool; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D019650:Hematopoietic Stem Cell Mobilization; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007223:Infant; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012042:Registries; D012189:Retrospective Studies; D013030:Spain; D014019:Tissue Donors
chemical_list: D018952:Antigens, CD34; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor