呼吸器感染症を対象としたgarenoxacinの臨床第II相試験
書誌事項
- タイトル別名
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- Clinical phase II study of garenoxacin in patients with respiratory tract infections
- Open-label, multi-center, non-comparatlve
- 非盲検・非対照・多施設試験
抄録
The efficacy and safety of garenoxacin mesilate hydrate (GRNX), a des-F (6)-quinolone antibiotic, with 200 mg and 400mg administered once daily were evaluated in patients with respiratory tract infections. Plasma concentrations of garenoxacin were determined preliminarily.<BR>1. Clinical assessment: The efficacy rates were 96.0%(24/25) in 200mg group and 87.5%(21/24) in 400 mg group at the end of treatment. The efficacy rates at the 7th day of post-treatment were 100%(19/19) in 200mg group and 94.7%(18/19) in 400mg group.<BR>2. Bacteriological efficacy: The eradication rates were 100%(16/16) in 200mg group and 70.0%(7/10) in 400mg group at the end of treatment. The eradication rates at the 7th day of post-treatment were 100%(11/11) in 200mg group and 6/8 in 400mg group.<BR>3. Safety: The incidence of drug-related adverse events was 9.7%(3/31) in 200mg group and 6.5%(2/31) in 400mg group. The incidence of drug-related laboratory abnormality was 26.7%(8/30) in 200mg group and 19.4%(6/31) in 400mg group.<BR>4. Plasma concentration: The trough concentration of garenoxacin was 0.89±0.42μg/mL in 200mg group and 1.71±0.46μg/mL in 400mg group.<BR>Results indicate that a 400mg daily dose of GRNX gives a favorable prognosis in treatment for patients with respiratory tract infections.
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 55 (Supplement1), 116-126, 2007
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
- 1390001206288042368
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- NII論文ID
- 130004298334
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- ISSN
- 18845886
- 13407007
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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
- CiNii Articles
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- 抄録ライセンスフラグ
- 使用不可