Switch to
Predicate | Object |
---|---|
rdf:type | |
lifeskim:mentions | |
pubmed:issue |
4
|
pubmed:dateCreated |
1996-10-16
|
pubmed:abstractText |
To evaluate the safety, tolerance and pharmacokinetics of a new formulation of amphotericin B (AmB; CAS 1397-89-3) 18 AIDS patients treated for different kinds of mycoses were studied: oropharingeal and/or esophageal azole-resistant candidiasis (9), CNS cryptococcosis (7) or aspergillosis (2). Amphotericin B daily dose was infused in 100 ml of a lipid emulsion. The patients aged from 26 to 54 years with body weight ranging from 42 to 89 kg. Blood samples were collected at fixed intervals and plasma stored at -20 degrees C until tested by a specific HPLC assay. The individual kinetic analysis of plasma drug levels was performed by a two-compartment open model. The data were analyzed using P-Pharm, a computer program designed for population pharmacokinetic analysis that allows pooling of data. The effect of a variety of demographic factors on clearance and volume of distribution was investigated. The clearance and the apparent volume of distribution were, respectively, (mean +/- SD): 0.037 +/- 0.015 l/h/kg and 0.45 +/- 0.32 l/kg. The interindividual variability in AmB clearance and volume of distribution was modelled with proportional error with an estimated coefficient of variation of 40.6% and 70.9%, respectively. Clinical and biological tolerance was very good and no patient experience infusion-related adverse effects or hematologic and hepatic toxicity; a moderate renal failure occurred in only one patient.
|
pubmed:language |
eng
|
pubmed:journal | |
pubmed:citationSubset |
IM
|
pubmed:chemical | |
pubmed:status |
MEDLINE
|
pubmed:month |
Apr
|
pubmed:issn |
0004-4172
|
pubmed:author | |
pubmed:issnType |
Print
|
pubmed:volume |
46
|
pubmed:owner |
NLM
|
pubmed:authorsComplete |
Y
|
pubmed:pagination |
445-9
|
pubmed:dateRevised |
2009-11-19
|
pubmed:meshHeading |
pubmed-meshheading:8740098-Acquired Immunodeficiency Syndrome,
pubmed-meshheading:8740098-Adult,
pubmed-meshheading:8740098-Amphotericin B,
pubmed-meshheading:8740098-Antifungal Agents,
pubmed-meshheading:8740098-Chromatography, High Pressure Liquid,
pubmed-meshheading:8740098-Drug Delivery Systems,
pubmed-meshheading:8740098-Female,
pubmed-meshheading:8740098-Humans,
pubmed-meshheading:8740098-Infusions, Intravenous,
pubmed-meshheading:8740098-Lipids,
pubmed-meshheading:8740098-Male,
pubmed-meshheading:8740098-Middle Aged,
pubmed-meshheading:8740098-Mycoses
|
pubmed:year |
1996
|
pubmed:articleTitle |
Clinical and pharmacokinetic evaluation of a new lipid-based delivery system of amphotericin B in AIDS patients.
|
pubmed:affiliation |
Pharmacology Department, S. Matteo Hospital, Pavia, Italy.
|
pubmed:publicationType |
Journal Article,
Clinical Trial
|