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深在性真菌症に対するLiposomal Amphotericin B(L-AMB)の有効性および安全性の検討

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Title: 深在性真菌症に対するLiposomal Amphotericin B(L-AMB)の有効性および安全性の検討
Other Titles: Evaluation of efficacy and safety of liposomal amphotericin B (L-AMB) in 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.347-368; 2013
Abstract: 深在性真菌症を対象としたLiposomal amphotericin B(L-AMB)の多施設共同,非対照試験を実施した。対象は真菌感染症と確定診断された患者または真菌感染症が疑われる患者とし,L-AMBの1日1回点滴静脈内投与における有効性,安全性および薬物動態を検討した。投与量は初回を2.5 mg/kgとし,5.0 mg/kgへの増量または1.0 mg/kgへの減量を可能とした。投与症例88例のうち安全性評価対象は86例,有効性評価対象は66例であった。  全体の有効性(主要評価項目:総合効果)は63.6%(42/66)であり,原因真菌別の有効性ではカンジダ症66.7%(8/12),アスペルギルス症51.4%(18/35),クリプトコックス症(1/1),混合真菌症(0/2)および真菌症疑い例93.8%(15/16)であった。また,他の抗真菌薬無効例では62.3%(33/53),造血器悪性腫瘍合併症例では70.5%(31/44)の有効率であった。  原因真菌が分離できた19例の真菌の消失率は63.2%(12/19)であり,内訳はカンジダ症100%(7/7),アスペルギルス症41.7%(5/12)であった。また,臨床分離株に対するL-AMBのMICはカンジダ属で0.5~4 μg/mL,アスペルギルス属で≦0.12~1 μg/mLであった。  因果関係が否定できない有害事象(副作用)は86例中82例(95.3%),664件が認められた。発現率が10%以上であった主な副作用は悪心,発熱,血清中クレアチニン増加,BUN増加,血清中カリウム減少などで,そのほとんどが軽度ならびに中等度の副作用であった。  血清中のトラフ濃度を78例で測定し,8例にトラフ濃度値の上昇が認められた。また,血漿中におけるAmphotericin Bの存在形態としては89.1%がリポソーム体であった。  以上よりL-AMBの深在性真菌症患者における有効性と安全性および薬物動態が確認できた。これらの結果から,深在性真菌症治療に対するL-AMBの臨床的有用性が確認できたと考えられた。 / A multicenter, uncontrolled study of liposomal amphotericin B(L-AMB) was conducted in patients with deep-seated fungal infection. Patients with a suspected or confirmed diagnosis of fungal infection were included in the study, and the efficacy, safety, and pharmacokinetics of once-daily intravenous infusion of L-AMB were evaluated. After treatment was started at a dose of 2.5 mg/kg, the dose could be increased to 5.0 mg/kg or reduced to 1.0 mg/kg. Of 88 subjects treated, 86 subjects were included in the safety analysis population, and 66 subjects were included in the efficacy analysis population. The efficacy rate (primary endpoint: overall efficacy) was 63.6% (42/66) in the entire population. The efficacy rate in patients grouped by fungal disease was 66.7% for candidiasis (8/12), 51.4% (18/35) for aspergillosis, 100% (1/1) for cryptococcosis, 0% (0/2) for mixed mycosis, and 93.8% (15/16) for suspected mycosis. The efficacy rate was 62.3% (33/53) in subjects unresponsive to other antifungal agents and 70.5% (31/44) in subjects with concomitant hematopoietic malignancy. In 19 subjects from whom the causative fungus was isolated, the fungal elimination rate was 63.2% (12/19): 100% (7/7) in patients with candidiasis and 41.7% (5/12) in patients with aspergillosis. The MIC of L-AMB in clinical isolates of Candida spp. and Aspergillus spp. (in μg/mL) was 0.5-4 and ≤0.12-1, respectively. A total of 664 adverse events possibly related to L-AMB (adverse drug reactions) were reported in 82 (95.3%) of 86 subjects. The most common adverse drug reactions with an incidence of ≥10% included nausea, pyrexia, increased serum creatinine, increased BUN, and decreased serum potassium. Most of these adverse drug reactions were mild or moderate in severity. Serum trough concentrations were measured in 78 subjects and increased in 8 of these subjects. In plasma, 89.1% of amphotericin B was found in the liposomal form. By demonstrating the efficacy, safety, and pharmacokinetics of L-AMB in patients with deep-seated fungal infection, these results indicate the clinical usefulness of L-AMB in the treatment of deep-seated fungal infection.
Keywords: deep-seated fungal infection / Liposomal amphotericin B
URI: http://hdl.handle.net/10069/34112
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/10069/34112

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