シプロフロキサシンの皮膚組織への移行性と皮膚科領域感染症におげる臨床効果の検討 [in Japanese] Permeability to Skin Tissue and Clinical Efficacy in Bacterial Skin Infections on Ciprofloxacin. [in Japanese]
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シプロキサン<SUP>®</SUP>錠 (ciprofloxacin, CPFX) の皮膚組織への移行性と臨床的有用性を検討した.移行性は10名の健常成人男女にCPFXを200mg投与し, 2時間後に血液と皮膚を採取してそのCPFX濃度を高速液体クリマトグラフィーを用いて測定した.その測定値は, 0.99±0.18μg/ml (血清中), 1.18±1.54μg/g (皮膚組織中) で, 組織移行率 (皮膚組織中濃度/血清中濃度) の平均は1.12と計算された.また, 対照薬として, tosufloxacin (TFLX) も150mgを, 同一人かつCPFX内服と同時に投与し, 同様の測定を行った.結果は, それぞれ, 0.49μg/ml, 0.34μg/g, 0.57であった.すなわち, CPFXにおける値は, いずれも, TFLXにおける値よりも統計学的有意差をもって高値であった.臨床試験では30名 (男女各15名, 平均46歳) の皮膚感染症患者に, おおむね, 600mg/dayのCPFXを7-14日間投与してその臨床効果を調べた.その結果は著効; 15例, 有効38例, やや有効; 3例, 無効; 1例, 判定不能; 3例であり, 有効率は85.2%であった. また, 試験開始時に採取した検体から12株の<I>S</I>.<I>aurens</I>株が分離され, CPFXのMICは12株中10株において0.2μg/ml以下であった.以上の成績から, CPFXは皮膚組織移行性においてTFLXよりも優れ, 皮膚科領域感染症にきわめて有用であることが示された.
Permeability to skin tissue in healthy volunteers and clinical efficacy of ciprofloxacin (CPFX) in bacterial skin infections were studied. Skin tissue and serum concentrations of CPFX at 2 hours after the oral single dose of 200mg of CPFX were determinated by high-performance liquid chromatography. The results were 0.99μg/ml in serum and 1.18μg/g in skin tissue, and the ratio of skin tissue and serum concentration was 1.12. One hundred and fifty mg of tosufloxacin (TFLX) was administered at the same time as the comparative drug and the results were 0.49μg/ml, 0.34μg/g and 0.57 respectively. Skin tissue and serum concentrations of CPFX were significantly higher than these of TFLX.<BR>Thirty patients were enrolled in this clinical trial to evaluate the efficacy of oral CPFX. These patients were suffering from various bacterial skin infections including infectious atheroma (7 cases), whitlow (4 cases), folliculitis (3 cases) and the others. Before the treatment, culture specimens from the lesions were obtained, and <I>Staphylococcus aureus</I> were isolated in 12 cases. The MICs of CPFX were 0.1-0.39μg/ml against these 12 <I>Staphylococcus aureus</I>strains. The dose of CPFX were 600mg/day in 29 patients and 800mg/day in a patient. The durations of administration were 5-14 days in 29 patients. Results obtained were following; marked improvement in 15 cases, moderate improvement in 8 cases, slight improvement in 3 cases and the efficacy rate was 85.2%. Any clinical adverse reactions were not seen in all patients.<BR>These findings of our studies support that CPFX is effective and safe for the treatment of bacterial skin infections.
- Skin research
Skin research 36(5), 670-682, 1994
Meeting of Osaka Dermatological Association