| Evaluation of the safety and efficacy of liposomal amphotericin B (L-AMB) in children. | |
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MedLine Citation:
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PMID: 22286407 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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 common adverse 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. |
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Authors:
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Keisuke Sunakawa; Ichiro Tsukimoto; Yukiko Tsunematsu; Masatada Honda; Naoichi Iwai; Takashi Maniwa; Hisamatsu Haigo; Kota Suzuki; Takeshi Mori |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-1-31 |
Journal Detail:
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Title: Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy Volume: - ISSN: 1437-7780 ISO Abbreviation: - Publication Date: 2012 Jan |
Date Detail:
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Created Date: 2012-1-30 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9608375 Medline TA: J Infect Chemother Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Kitasato Institute for Life Science, Department of Research Project Studies, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-0072, Japan, sunakawa@med.kitasato-u.ac.jp. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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