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市中肺炎におけるlevofloxacin注射剤のceftriaxone sodiumを対照とした第III相比較試験


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Title: 市中肺炎におけるlevofloxacin注射剤のceftriaxone sodiumを対照とした第III相比較試験
Other Titles: Clinical phase III comparative study of intravenous levofloxacin and ceftriaxone in community-acquired pneumonia treatment
Authors: 河野, 茂 / 渡辺, 彰 / 青木, 信樹 / 二木, 芳人 / 門田, 淳一 / 藤田, 次郎 / 栁原, 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: May-2011
Publisher: 日本化学療法学会 / Japan Society of Chemotherapy
Citation: 日本化学療法学会雑誌, 59(S-1), pp.32-45; 2011
Abstract: 成人の非定型病原体を除く細菌性市中肺炎に対するlevofloxacin(LVFX)注射剤の有効性,安全性を検討する目的で,ceftriaxone(CTRX)注射剤を対照薬として,多施設共同,無作為化(中央登録方式), オープンラベル,非劣性検証試験を実施した。用法・用量および投与期間は,LVFX群は1回500 mg 1日1回,CTRX群は1回1 g 1日2回点滴静注,投与期間は7~14日間とした。 臨床効果:投与終了・中止時の有効率は,LVFX群で88.5%(92/104例),CTRX群で88.8%(79/89例),群間差は-0.3%(95%信頼区間:-9.3~8.7)であり,LVFXのCTRXに対する非劣性が検証された。 細菌学的効果:投与終了・中止時の陰性化率はLVFX群で96.7%(59/61例),CTRX群で97.8%(44/45例),群間差は-1.1%(95%信頼区間:-7.3~5.1)であった。 安全性:副作用発現率は,LVFX群で53.7%(73/136例),CTRX群で56.9%(70/123例)であり,群間差は-3.2%(95%信頼区間:-15.4~8.9)であった。 以上のことから,LVFX注射剤は,非定型病原体を除く細菌性市中肺炎に対して1回500 mg 1日1回投与でCTRX 1回1 g 1日2回投与と同様に十分な治療効果ならびに安全性の高い薬剤であることが確認された。 / To evaluate the efficacy and safety of intravenous levofloxacin(LVFX) in adults with community-acquired bacterial but not atypical organismic pneumonia, we conducted a multicenter randomized open-label noninferiority study using ceftriaxone(CTRX) as a comparator. Subjects were randomized through central registration to be administered LVFX 500 mg once daily or CTRX 1 g twice daily as an intravenous infusion for 7 to 14 days. Clinical efficacy: At the end of treatment, clinical response was 88.5% (92 104) in LVFX-treated and 88.8% (79 89) in CTRX-treated. The intergroup difference was -0.3% (95% confidence interval, -9.3 to 8.7) and non-inferiority of LVFX versus CTRX was established. Microbiologic efficacy: Eradication at the end of treatment was achieved in 96.7% (59 61) treated with LVFX and 97.8% (44 45) treated with CTRX. The intergroup difference was -1.1% (95% confidence interval, -7.3 to 5.1). Safety: Adverse drug reactions were reported in 53.7% (73 136) treated with LVFX and 56.9% (70 123) treated with CTRX. The intergroup difference was -3.2% (95% confidence interval, -15.4 to 8.9). Our results showed that intravenous LVFX 500 mg once daily is as effective and safe as CTRX 1 g twice daily in treating community-acquired bacterial pneumonia.
Keywords: Community-acquired pneumonia / Levofloxacin injection / Randomized-controlled trial
URI: http://hdl.handle.net/10069/25689
ISSN: 13407007
Relational Links: http://journal.chemotherapy.or.jp/abstract/059S10032_j.html
Rights: Copyright © 2011 日本化学療法学会
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/25689

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