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呼吸器感染症に対するlevofloxacin 500 mg 1日1回投与の臨床効果

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Title: 呼吸器感染症に対するlevofloxacin 500 mg 1日1回投与の臨床効果
Other Titles: Clinical response of levofloxacin 500 mg qd to respiratory tract infection
Authors: 河野, 茂 / 渡辺, 彰 / 青木, 信樹 / 二木, 芳人 / 門田, 淳一 / 藤田, 次郎 / 柳原, 克紀 / 賀来, 満夫 / 堀, 誠治
Authors (alternative): Kohno, Shigeru / Watanabe, Akira / Aoki, Nobuki / Niki, Yoshihito / Kadota, Junichi / Fujita, Jiro / Yanagihara, Katsunori / Kaku, Mitsuo / Hori, Seiji
Issue Date: Jul-2009
Publisher: 日本化学療法学会 / Japanese Society of Chemotherapy
Citation: 日本化学療法学会雑誌, 57(S2), pp.20-33; 2009
Abstract: 日本人呼吸器感染症患者152例を対象にlevofloxacin(LVFX)500 mgを1日1回7日間投与し,有効性および安全性を非盲検非対照試験にて検討した。また,各患者の血漿中薬物濃度を測定し,ベイズ推定により患者ごとの薬物動態パラメータを算出し,有害事象および副作用発現との相関を検討した。 臨床効果の有効率は95.1%(136/143例),微生物学的効果(陰性化)の陰性化率は100%(45/45例)であった。主な原因菌はStreptococcus pneumoniae,Haemophilus influenzae,Moraxella (Branhamella) catarrhalis,Staphylococcus aureusおよびKlebsiella pneumoniaeであり,これらを含めて微生物学的効果(消失)判定が可能であった原因菌50株はすべて消失した。 副作用発現率は39.5%(60/152例)であり,重篤な副作用として1例に肝障害がみられたがLVFXの投与を中止し,入院加療により回復した。重度の副作用はなく,いずれの副作用もLVFXの副作用として従来報告されている事象であった。本試験の血漿中薬物濃度の範囲では,LVFXの曝露量の増加に伴い有害事象または副作用の発現率に上昇傾向は認められなかった。 以上のとおり,LVFXの500 mg 1日1回投与は呼吸器感染症に対して100 mg 1日3回投与と同等以上の十分な効果が期待され,その安全性に重大な問題はないと考えられた。 / We evaluated the efficacy and safety of LVFX 500 mg qd administered for 7 days to 152 Japanese patients with respiratory tract infection in an open uncontrolled clinical study. We also studied the possible correlation of the incidence of adverse event and adverse drug reactions(ADRs) with individual pharmacokinetic (PK) parameters estimated by the Bayesian method. Clinical efficacy was 95.1% (136/143 patients), and bacteriological efficacy 100% (45/45 patients). All causative organisms (50 strains), including those commonly separated, i.e., Streptococcus pneumoniae, Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Staphylococcus aureus, and Klebsiella pneumoniae, were eradicated with treatment in patients eligible for bacteriological efficacy assessment. ADRs were reported in 60 patients at an incidence of 39.5%. A liver disorder was reported as a serious adverse drug reaction in a patient administered LVFX. The patient discontinued taking LVFX and recovered through hospitalization and medical treatment. No ADRs were severe and all had already been reported as LVFX ADRs. Neither the incidence of adverse events nor ADRs was exposure-dependent in the LVFX plasma concentration range observed in this study. In conclusion, LVFX 500 mg qd appears to have efficacy comparable or superior to that of the current standard dosage and presents no significant safety problem.
Keywords: levofloxacin / respiratory tract infection / PK-PD / clinical study / once-a-day
URI: http://hdl.handle.net/10069/26674
ISSN: 13407007
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/26674

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