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Title: 肺アスペルギルス症に対するmicafunginの臨床効果
Other Titles: Clinical efficacy and safety of micafungin, a novel echinocandin antifungal drug, in pulmonary aspergillosis in a postmarketing setting
Authors: 河野, 茂 / 二木, 芳人 / 網谷, 良一 / 小川, 賢二 / 倉島, 篤行 / 宮崎, 義継 / ミカファンギンCPA調査グループ
Authors (alternative): Kohno, Shigeru / Niki, Yoshihito / Amitani, Ryoichi / Ogawa, Kenji / Kurashima, Atsuyuki / Miyazaki, Yoshitsugu / Micafungin CPA Study Group
Issue Date: Mar-2010
Publisher: 日本化学療法学会 / Japanese Society of Chemotherapy
Citation: 日本化学療法学会雑誌, 58(2), pp.128-139; 2010
Abstract: 今回われわれは,呼吸器領域で実施された市販後調査の成績をもとに,慢性肺アスペルギルス症(chronic pulmonary aspergillosis:CPA)に対するmicafungin(MCFG)の有効性および安全性を検討した。 35施設から収集された109例のうち,CPAの診断が確認できなかった症例や併用薬の規定に違反した症例計18例を除く91例を有効性解析対象例とした。このうち,評価不能であった11例を除く80例の有効率は63.8%(51/80例)であった。診断名ごとの有効率は慢性壊死性肺アスペルギルス症(chronic necrotizing pulmonary aspergillosis:CNPA)62.0%(31/50例),アスペルギローマ66.7%(20/30例)であった。本薬剤以外の抗真菌薬併用の有無別の有効率は,本薬剤単独治療群(単独群)は57.1%(24/42例),他の抗真菌薬併用治療群(併用群)は71.1%(27/38例)であった。本薬剤の投与量別有効率は,軽症例は「150 mg以下」群69.8%(30/43例),「150 mg超」群68.4%(13/19例),重症例は,「150 mg以下」群28.6%(2/7例),「150 mg超」群54.5%(6/11例)であった。 安全性については,単独群61例のうち22例(36.1%)に35件の副作用が認められた。主な副作用は肝機能異常であったが,これらはいずれも重篤でなく,また本薬剤との因果関係においては確実とされたものはなかった。一方,35件の副作用のうち,腎機能障害1件のみが重篤で,本薬剤との因果関係も確実と判断された。副作用発現に影響を及ぼすと考えられる加齢や投与量の増加についても,副作用発現症例率との間に明らかな関係は認められなかった。 これらの成績から,MCFGはCPAに対する有用な治療薬と考えられた。 / Clinical efficacy and safety of micafungin(MCFG) in chronic pulmonary aspergillosis(CPA) were evaluated based on postmarketing survey data on 109 subjects from 35 medical institutions. Of these, 18 not diagnosed with CPA or violating specifications on concomitant drugs were excluded from clinical efficacy evaluation. Apart from 11 nonevaluable subjects, the overall efficacy in 80 was 63.8% (51/80). Overall efficacy by diagnosis was 62.0% (31/50) with chronic necrotizing pulmonary aspergillosis(CNPA) and 66.7% (20/30) with aspergilloma. Overall efficacy was 57.1% (24/42) in the MCFG monotherapy group and 71.1% (27/38) in the antifungal combination therapy group. No apparent differences were seen in overall efficacy by dose among those mildly ill, i.e., 69.8% (30/43) for doses of ?150 mg vs. 68.4% (13/19) for doses of >150 mg. Observed overall efficacy for doses of ?150 mg was moderately lower than that for doses of >150 mg among those who were very ill, i.e., 28.6% (2/7) vs. 54.5% (6/11). Total of 35 adverse drug reactions(ADRs) were observed in 22 of 61 subjects (36.1%) in the MCFG monotherapy group. The most common ADR was abnormal hepatic function, although none of the cases were serious or considered to have a definite causal relationship to MCFG. Of the 35 adverse drug reactions, only 1 case of renal impairment was serious and considered to have a definite causal relationship to MCFG. Aging and higher dosage did not affect ADR incidence. These results indicate that MCFG has favorable efficacy and safety profiles in the treatment of CPA in a postmarketing setting.
Keywords: micafungin / efficacy / safety / necrotizing pulmonary aspergillosis
URI: http://hdl.handle.net/10069/26675
ISSN: 13407007
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/26675

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