書誌事項
- タイトル別名
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- Open study of sitafloxacin in patients with respiratory tract infections
- 呼吸器感染症に対するsitafloxacinの一般臨床試験
- チシキ シホン シュギ ニ オケル ヒンコンカ ノ コウズ
- PK/PD study
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抄録
Sitafloxacin (STFX), a fluoroquinolone antimicrobial agent, has a broad spectrum ofactivity and a potent antimicrobial activity against Streptococcus pneumoniae which is a major pathogen in respiratory tract infections (RTI). This clinical study was conducted to confirm the clinical recommended dose of STFX as 50mg b.i.d. for RTI from PK/PD.<BR>Clinical efficacy was 92.3%(96/104) in the 50mg b.i.d. group and 93.1%(27/29) in the 100 mg bid. group. Bacteriological efficacy was 89.1%(57/64) in the 50mg b.i.d. group and 82.4%(14/17) in the 100mg bid. group. Eradication of major causative organisms was 91.7%(22/24) in S.pneumoniae and 100%(24/24) in Haemophilus influenzae.<BR>Steady state Cmax and AUC0-24h after repeated oral administration of STFX to patients with RTI were 0.57±0.21μg/mL and 9.38±4.24μg·h/mL in the 50mg b.i.d. group, and 1.17±0.45μg/mL and 17.16±6.52μg·h/mL in the 100 mg b.i.d. group.<BR>If Cmax/MIC was 5 or below, or AUC0-24h/MIC was 100 or below, eradication were 33.3%(3/9) or 40.0%(4/10).In contrast, if Cmax/MIC was over 5, it was 96.3%(79/82). If AUC0-24h/MIC wasover 100, it was 96.3%(78/81).MIC90 of STFX against the causative organisms in this study was 0.1μg/mL. Results suggest that 50mg b.i.d. of STFX can achieve Cmax/MIC 5 and AUC0-24h/MIC 100 against 90% of the causative organisms in RTI.<BR>Adverse drug reactions (ADR) occurred in 43.5%(50/115 patients) in the 50mg b.i.d. group and 42.4%(14/33 patients) in the 100mg b.i.d. group. The major ADR was diarrhoea (20/148, 13.5%). Cmax and AUC0-24h of patientsin whom diarrhoea or soft stool occurred tended to be higher than in patients free of these symptoms. No severe ADRs were observed in either groups.<BR>Results suggest that a dose of 50mg b.i.d. of STFX is optimal in the treatment of RTI.
収録刊行物
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- 日本化学療法学会雑誌
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日本化学療法学会雑誌 56 (Supplement1), 63-80, 2008
公益社団法人 日本化学療法学会
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詳細情報 詳細情報について
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- CRID
- 1390282681264794880
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- NII論文ID
- 110007007450
- 10021192816
- 130004102789
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- NII書誌ID
- AN10407566
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- ISSN
- 13417843
- 18845886
- 13407007
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- NDL書誌ID
- 10199452
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- 本文言語コード
- ja
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- データソース種別
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- JaLC
- IRDB
- NDL
- CiNii Articles
- KAKEN
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- 抄録ライセンスフラグ
- 使用不可