Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 1 de 1
Filter
Add more filters










Database
Language
Publication year range
1.
J Infect Chemother ; 18(4): 456-65, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22286407

ABSTRACT

A multicenter, uncontrolled clinical study has been conducted to evaluate the safety, efficacy, and pharmacokinetics of liposomal amphotericin B (L-AMB) in children. In this article, the safety and efficacy of L-AMB are discussed. Subjects were diagnosed with invasive fungal infection (definitely diagnosed cases), possible fungal infection (clinically diagnosed cases), and febrile neutropenia with suspected fungal infection (febrile neutropenia cases). Of the 39 subjects treated with L-AMB, 18 received a definite (11) or clinical (7) diagnosis of invasive fungal infection. In these subjects, excluding one unevaluable subject, L-AMB was effective in nine out of 17 subjects(52.9%). Of 12 febrile neutropenia cases, improvement in clinical symptoms, etc., was observed for six but these were excluded from the efficacy analysis because they concomitantly used medications that may have affected efficacy. The causative fungus was identified in four out of 39 subjects and confirmed to be eliminated by treatment with L-AMB in one subject. Adverse events possibly related to L-AMB (adverse drug reactions) were reported in 36 out of 39 subjects (92.3%). The most commonad verse drug reaction was decreased potassium in 20 out of 39 subjects (51.3%), but all these subjects recovered with appropriate treatment, for example potassium supplementation.In a Japanese Phase II clinical study of adult patients, the incidence of adverse drug reactions was 95.3%(82/86 subjects) and the efficacy was 63.6% (42/66). Taken together, these data indicate that the safety and efficacy of L-AMB are almost the same in pediatric and adult patients.


Subject(s)
Amphotericin B/adverse effects , Amphotericin B/therapeutic use , Antifungal Agents/adverse effects , Antifungal Agents/therapeutic use , Mycoses/drug therapy , Amphotericin B/pharmacokinetics , Antifungal Agents/pharmacokinetics , Child , Child, Preschool , Creatinine/blood , Female , Humans , Hypokalemia/chemically induced , Hypokalemia/microbiology , Male , Mycoses/blood , Mycoses/metabolism , Neutropenia/drug therapy , Neutropenia/microbiology
SELECTION OF CITATIONS
SEARCH DETAIL
...