皮膚科領域におけるNM441の基礎的・臨床的検討

DOI 被引用文献2件 参考文献16件

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  • Basic and clinical evaluations of NM441, a prodrug new quinolone, in dermatology

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We studied NM441, the prodrug of active form NM394, and obtained the following results.<BR>1) Skin penetration of NM441 was examined using exudates from skin lesions and skin samples from skin surgery patients after informed consent was obtained. The concentration of NM394 in exudates (n=2) was <0.05μg/ml in one patient at 60 min after a single oral administration of 100mg with the corresponding serum concentration of 0.89μg/ml and 0.588μg/ml in the other patient at 60 min after a single oral administration of 200mg with the corresponding serum concentration of 0.56μg/ml. The concentration of NM394 in the skin (n=11) varied from 0.133 to 1.47μg/g (sampling time: 50-240 min) excluding 2 samples in which the concentration in the skin was below the limit of detection. The corresponding concentration in the serum ranged from 0.36 to 0.96μg/ml. The skin and serum concentration rate ranged from 0.26 to 1.79 (avg=0.91).<BR>2) NM441 was evaluated in a multicenter clinical trial in the treatment of skin and skin structure infections. Patients, older than 16 years, with skin and skin structure infections (folliculitis; furuncle, furunculosis, carbuncle; impetigo contagiosa; cellulitis, erysipelas, felon, acute paronychia; infected atheroma and miscellaneous abscesses; secondary skin infections) were enrolled after informed consent was obtained. The dosage was 100mg or 200mg twice a day in most patients. The patients were treated for 7 days except those with infected atheroma and miscellaneous abscesses treated for 10 days. The clinical efficacy rate was 93.3%. The bacteriological response rate was 92.4%. Adverse reactions were seen in 12 out of 214 patients (5.6%). Most of these were gastrointestinal. All were minor. Abnormal laboratory findings were observed in 8 out of 182 patients (4.4%). Liver enzyme elevation was the most frequent. All abnormalities were minor.<BR>These results suggest that NM441 will be an effective, safe, and useful drug in the treatment of skin and skin structure infections.

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