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Titolo:
Pharmacokinetics and adverse events following 5-day repeated administration of lenograstim, a recombinant human granulocyte colony-stimulating factor, in healthy subjects
Autore:
Akizuki, S; Mizorogi, F; Inoue, T; Sudo, K; Ohnishi, A;
Indirizzi:
Jikei Univ, Daisan Hosp, Sch Med, Dept Lab Med, Tokyo 2018601, Japan JikeiUniv Tokyo Japan 2018601 h Med, Dept Lab Med, Tokyo 2018601, Japan Jikei Univ, Daisan Hosp, Sch Med, Dept Internal Med, Tokyo 2018601, Japan Jikei Univ Tokyo Japan 2018601 , Dept Internal Med, Tokyo 2018601, Japan
Titolo Testata:
BONE MARROW TRANSPLANTATION
fascicolo: 9, volume: 26, anno: 2000,
pagine: 939 - 946
SICI:
0268-3369(200011)26:9<939:PAAEF5>2.0.ZU;2-L
Fonte:
ISI
Lingua:
ENG
Soggetto:
BLOOD PROGENITOR CELLS; FACTOR G-CSF; NORMAL VOLUNTEERS; STEM-CELLS; EXTRAMEDULLARY HEMATOPOIESIS; CANCER-PATIENTS; RHUG-CSF; TRANSPLANTATION; MOBILIZATION; DONORS;
Keywords:
granulocyte colony-stimulating factor; peripheral blood progenitor cell; allogenic transplantation; thrombocytopenia; pharmacokinetics;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
34
Recensione:
Indirizzi per estratti:
Indirizzo: Ohnishi, A Jikei Univ, Daisan Hosp, Sch Med, Dept Lab Med, 4-11-1 Izumihoncyo, Tokyo 2018601, Japan Jikei Univ 4-11-1 Izumihoncyo Tokyo Japan 2018601 18601, Japan
Citazione:
S. Akizuki et al., "Pharmacokinetics and adverse events following 5-day repeated administration of lenograstim, a recombinant human granulocyte colony-stimulating factor, in healthy subjects", BONE MAR TR, 26(9), 2000, pp. 939-946

Abstract

Recombinant human granulocyte colony-stimulating factor (rhG-CSF) (lenograstim) was administered to healthy subjects at doses of 2, 5 and 10 mug/kg/day for 5 days (twice a day subcutaneously) to examine the optimal dose and schedule of lenograstim in mobilizing peripheral blood progenitor cells (PBSC) for allogeneic transplantation. Lenograstim administration significantly increased CD34(+) cells in a dose-related manner. A significant correlation was observed between the maximal post-dosing counts and the pre-dosing baseline counts of CD34(+) cells. Peripheral neutrophils increased markedly by seven to 13 times from the baseline to a peak of approximately 40 000/mul on day 5 for the 5 and 10 mug/kg/day doses. After peak serum concentration (C-max) was attained 4 h following administration, serum G-CSF declined with time in a log-linear fashion. The C-max and 12 h area-under-the-curve increased dose dependently, but minimum drug level increased up to day 2 andthen decreased until day 5, Clearance decreased with increasing dosage at the first dose, and increased significantly at the last dose. We found a highly significant correlation between absolute neutrophil counts and clearance for each dose. Adverse events most frequently occurred on day 6, with increases of alkaline phosphatase and lactate dehydrogenase and onset of bonepain. Increases of aspartate aminotransferase and alanine aminotransferaseoccurred as delayed events. Platelet count gradually decreased after the end of drug administration to 57% of the pre-dosing count on day 10, but wasstill within the normal range, These preliminary results suggest that repeated doses of lenograstim induce mobilization of PBSC in a dose-dependent manner and the pre-dosing baseline count of PBSC may predict the post-dosingmaximal mobilization, The drug treatment may cause delayed-onset moderate thrombocytopenia and increased transaminase, and the drug clearance changesin a complex manner during repeated dosing.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 02/04/20 alle ore 02:49:23