Abstract
Laboratory and clinical studies of ketoconazole were carried out and the results were as follows.
1. The drug concentrations in vaginal tissue, cervical tissue and vaginal fluid after a 300mg oral administration of ketoconazole were studied. Transfer of ketoconazole into these areas was proved.
2. The MICs of ketoconazole against Torulopsis glabrata were lower than those against Candida albicans. But clinical results were better in cases of C. albicans infection than in T. glabrata infection (initial cure rate: C. albicans-82.2%, T. glabrata-16.7%).
3. Ketoconazole was orally administered to 69 non-pregnant women with vulvovaginal mycosis. The patients were divided into 5 groups according to the dosage schedules. (Group 1: 100mg×1/day, Group 2: 200mg×1/day, Group 3: 100mg×2/day, Group 4: 300mg×1/day, Group 5: 100mg×3/day). All patients received the drug for 5 days. The overall initial cure rate was 73.9%. Among the 5 groups, Group 4 showed the best clinical and mycological results (initial cure rate: 84.2%).
4. No side effects were observed. And laboratory findings showed no significant changes.
Recurrences in vulvovaginal mycosis were mainly caused by the fungus which inhabit the rectum, urethra and the deep layer of the vaginal mucosal epithelium. There is a possibility that ketoconazole could be more useful in eradicating the fungus in above mentioned areas than conventional treatments.
