title: Evaluation of the safety and efficacy of liposomal amphotericin B (L-AMB) in children.
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.
authors.affiliation: 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
authors.forename: Keisuke
authors.initials: K
authors.lastname: Sunakawa
authors.forename: Ichiro
authors.initials: I
authors.lastname: Tsukimoto
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Tsunematsu
authors.forename: Masatada
authors.initials: M
authors.lastname: Honda
authors.forename: Naoichi
authors.initials: N
authors.lastname: Iwai
authors.forename: Takashi
authors.initials: T
authors.lastname: Maniwa
authors.forename: Hisamatsu
authors.initials: H
authors.lastname: Haigo
authors.forename: Kota
authors.initials: K
authors.lastname: Suzuki
authors.forename: Takeshi
authors.initials: T
authors.lastname: Mori
mesh_terms: D000666:Amphotericin B / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003404:Creatinine / Q000097:blood; D005260:Female; D006801:Humans; D007008:Hypokalemia / Q000139:chemically induced / Q000382:microbiology; D008297:Male; D009181:Mycoses / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D009503:Neutropenia / Q000188:drug therapy / Q000382:microbiology
chemical_list: D000935:Antifungal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B; D003404:Creatinine