浅在性化膿性疾患に対するgrepafloxacinの臨床的検討

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  • Skin penetration of grepafloxacin and its clinical use in the treatment of skin and skin structure infections

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In a multicenter clinical trial, grepafloxacin (GPFX), a new fluoroquinolone, was examined in terms of its skin penetration and its clinical efficacy in the treatment of skin and skin structure infections. Patients were enrolled in the trial, after informed consent was obtained.<BR>Skin samples were obtained from the normal portions of excised materials in 22 skin surgery patients who received a single oral dose of 200mg of GPFX. The excision was done 51 to 266 min after drug administration in 20 patients and 24 h after drug administration in two patients. The blood samples were drawn about the same time as the skin excisions. The skin and blood levels were 0.12 to 2.35.μg/g and 0.06 to 1.07.μg/ml, respectively, where levels lower than the detectable limits (3 cases for skin and one for serum) were omitted. The skin concentration and serum concentration ratios varied from 14.6% to 343.3%. The skin and serum levels in two patients after 24 h were (0.72, 0.72.μg/g) and (0.10, 0.18.μg/ml), respectively. The skin concentration and serum concentration ratios were 720% and 400%. Minimum inhibitory concentrations (MICs) of GPFX against 63 clinical isolates of Staphylococcus aureus ranged from 0.024 to 12.5.μg/ml, with MIC inhibiting 50% of the strains at 0.05.μg/ml and MIC inhibiting 90% of the strains at 0.2.μg/ml.<BR>GPFX was administered to 179 patients. Clinical efficacy was evaluated in 169 patients. The daily dosages were 100 mg once a day in 43 patients, 200mg once a day in 39 patients, and 100mg twice a day in 87 patients. Clinical evaluation was done in less than 9 days except for infected atheroma and miscellaneous abscesses in which evaluation was done in less than 12 days. The overall clinical efficacy rate was 89.3%(151/169). The rates were 83.7%(36/43) in the group given 100mg once a day, 92.3%(36/39) in the group given 200mg once a day, and 90.8%(79/87) in the group given 100mg twice a day. The bacteriologic response rate was 81.1%(82.1% for S.aureus). Adverse reactions were seen in 4 out of 175 patients. Skin eruption was seen in 2 patients, but phototoxicity was not observed. Minor abnormalities of laboratory findings were seen in 7 out of 146 patients.<BR>We concluded that GPFX is worthy of further investigation in the dermatological field and that the dose of 200mg once a day will be useful in terms of compliance. Phototoxicity should be carefully monitored.

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