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深在性真菌症患者におけるLiposomal Amphotericin B(L-AMB)の薬物動態および安全性の検討

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Title: 深在性真菌症患者におけるLiposomal Amphotericin B(L-AMB)の薬物動態および安全性の検討
Other Titles: Evaluation of pharmacokinetics and safety of liposomal amphotericin B (L-AMB) in patients with deep-seated fungal infection
Authors: 河野, 茂 / 小林, 宏行 / 正岡, 徹 / 浦部, 晶夫 / 金丸, 昭久 / 二木, 芳人 / 森, 健 / 原, 耕平 / 池本, 秀雄 / 馬庭, 貴司 / 中條, 英司 / 鈴木, 孝太 / 山口, 英世
Authors (alternative): Kohno, Shigeru / Kobayashi, Hiroyuki / Masaoka, Toru / Urabe, Akio / Kanamaru, Akihisa / Niki, Yoshihito / Mori, Takeshi / Hara, Kohei / Ikemoto, Hideo / Maniwa, Takashi / Nakajo, Eiji / Suzuki, Kota / Yamaguchi, Hideyo
Issue Date: Jul-2013
Publisher: 日本化学療法学会 / Japan Society of Chemotherapy
Citation: 日本化学療法学会雑誌, 61(4), pp.369-379, 2013
Abstract: 深在性真菌症罹患患者32名(23~73歳)を対象にLiposomal amphotericin B(L-AMB)を1.0 mg/kg/日,2.5 mg/kg/日または5.0 mg/kg/日の用量で原則7日間連日点滴静注し,薬物動態と安全性を検討した。L-AMB投与1日目の薬物動態ではCmax(平均値±標準偏差)は1.0 mg/kg/日,2.5 mg/kg/日,5.0 mg/kg/日の各用量でそれぞれ5.96±3.02 μg/mL,16.19±7.41 μg/mL,45.71±20.14 μg/mL,また,AUC0-24(平均値±標準偏差)では55.5±39.0 μg・hr/mL,138.5±56.5 μg・hr/mL,390.3±223.2 μg・hr/mLと用量が増すにつれ増加したが,投与量に対し非線形的な相関を示した。副作用は,用量が増すにつれ種類,頻度が増加する傾向にあった。1.0 mg/kg/日投与群で14例中10例(71.4%),2.5 mg/kg/日投与群で9例中8例(88.9%),5.0 mg/kg/日投与群で9例中9例(100%)であった。しかし,本剤の投与を制限する重篤な副作用は認められず,1.0 mg/kg/日~5.0 mg/kg/日を連日投与した場合の安全性と忍容性が確認された。 / The pharmacokinetics and safety of liposomal amphotericin B (L-AMB) were evaluated in 32 patients with deep-seated fungal infections (age, 23-73 years) after intravenous infusion at a dose of 1.0, 2.5, or 5.0 mg/kg/day for seven consecutive days. On Day 1 of treatment with L-AMB at doses of 1.0, 2.5, and 5.0 mg/kg/day, the Cmax (mean ± standard deviation [SD]) was 5.96 ± 3.02, 16.19 ± 7.41, and 45.71 ± 20.14 μg/mL, respectively, and the AUC0-24 (mean ± SD) was 55.5 ± 39.0, 138.5 ± 56.5, and 390.3 ± 223.2 μg·hr/mL, respectively. The Cmax and AUC0-24 increased with increasing doses, but not in a linear manner. The type and incidence of adverse drug reactions tended to increase with increasing doses. Adverse drug reactions were reported in 10 (71.4%) of the 14 subjects in the 1.0-mg/kg/day group, 8 (88.9%) of the 9 subjects in the 2.5-mg/kg/day group, and all (100%) of the 9 subjects in the 5.0-mg/kg/day group. However, no serious, dose-limiting adverse drug reactions occurred, demonstrating the safety and tolerability of daily treatment with L-AMB at doses of 1.0 to 5.0 mg/kg/day.
Keywords: Deep-seated fungal infection / Liposomal amphotericin B / Pharmacokinetics
URI: http://hdl.handle.net/10069/34113
ISSN: 13407007
Rights: © 日本化学療法学会 All rights reserved. / 利用は著作権の範囲内に限られる。
Type: Journal Article
Text Version: author
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/34113

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