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Titolo:
SAFETY, TOLERANCE, AND PHARMACOKINETICS OF A SMALL UNILAMELLAR LIPOSOMAL FORMULATION OF AMPHOTERICIN-B (AMBISOME) IN NEUTROPENIC PATIENTS
Autore:
WALSH TJ; YELDANDI V; MCEVOY M; GONZALEZ C; CHANOCK S; FREIFELD A; SEIBEL NI; WHITCOMB PO; JAROSINSKI P; BOSWELL G; BEKERSKY I; ALAK A; BUELL D; BARRET J; WILSON W;
Indirizzi:
NCI,POB,IHS,DEPT NURSING,BLDG 10,RM 13N-240 BETHESDA MD 20892 NCI,MED BRANCH BETHESDA MD 20892 NIH,WARREN GRANT MAGNUSON CLIN CTR,DEPT PHARM BETHESDA MD 20892 NHLBI,NIH BETHESDA MD 20892 LOYOLA UNIV,MED CTR CHICAGO IL 60611 CHILDRENS NATL MED CTR WASHINGTON DC 20010
Titolo Testata:
Antimicrobial agents and chemotherapy
fascicolo: 9, volume: 42, anno: 1998,
pagine: 2391 - 2398
SICI:
0066-4804(1998)42:9<2391:STAPOA>2.0.ZU;2-V
Fonte:
ISI
Lingua:
ENG
Soggetto:
INVASIVE FUNGAL-INFECTIONS; BONE-MARROW TRANSPLANT; RECENT PROGRESS; TOXICITY; INFUSION; EXPERIENCE; MORTALITY; EFFICACY; RABBITS; TRIAL;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
30
Recensione:
Indirizzi per estratti:
Citazione:
T.J. Walsh et al., "SAFETY, TOLERANCE, AND PHARMACOKINETICS OF A SMALL UNILAMELLAR LIPOSOMAL FORMULATION OF AMPHOTERICIN-B (AMBISOME) IN NEUTROPENIC PATIENTS", Antimicrobial agents and chemotherapy, 42(9), 1998, pp. 2391-2398

Abstract

The safety, tolerance, and pharmacokinetics of a small unilamellar liposomal formulation of amphotericin B (AmBisome) administered for empirical antifungal therapy were evaluated for 36 persistently febrile neutropenic adults receiving cancer chemotherapy and bone marrow transplantation. The protocol was an open-label, sequential-dose-escalation, multidose pharmacokinetic study which enrolled a total of 8 to 12 patients in each of the four dosage cohorts. Each cohort received daily doses of either 1.0, 2.5, 5.0, or 7.5 mg of amphotericin B in the form of AmBisome/kg of body weight. The study population consisted of patients between the ages of 13 and 80 years with neutropenia (absolute neutrophil count, <500/mm(3)) who were eligible to receive empirical antifungal therapy. Patients were monitored for safety and tolerance by frequent laboratory examinations and the monitoring of infusion-related reactions. Efficacy was assessed by monitoring for the development of invasive fungal infection. The pharmacokinetic parameters of AmBisome were measured as those of amphotericin B by high-performance liquid chromatography. Noncompartmental methods were used to calculate pharmacokinetic parameters. AmBisome administered as a l-h infusion in this population was well tolerated and was seldom associated with infusion-related toxicity. Infusion-related side effects occurred in 15 (5%) of all 331 infusions, and only two patients (5%) required premedication. Serum creatinine, potassium, and magnesium levels,were not significantlychanged from baseline in any of the dosage cohorts, and there was no net increase in serum transaminase levels. AmBisome followed a nonlinear dosage relationship that was consistent with reticuloendothelial uptake and redistribution. There were no breakthrough fungal infections during empirical therapy with AmBisome. AmBisome administered to febrile neutropenic patients in this study was well tolerated, was seldom associated,vith infusion-related toxicity, was characterized by nonlinear saturation kinetics, and was effective in preventing breakthrough fungal infections.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 06/07/20 alle ore 07:38:07