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[Clinical study of fluconazole on deep-seated fungal infections]
H Ikemoto1, K Watanabe, T Mori
1Department of Internal Medicine, Juntendo University School of Medicine.
Abstract:
Fluconazole is a novel antifungal agent, available in oral and intravenous forms, which was developed by Pfizer Central Research. It is characterized by its long serum half-life (approximately 30 hours) to allow once-a-day dosing and favorable safety profile. Fluconazole was administered orally or intravenously to 166 patients with deep-seated mycosis and it was possible to evaluate clinical efficacies in 99 patients. Clinical cures were obtained in 41 (87.2%) out of 47 cases of candidiasis, in 10 (66.7%) out of 15 cases of cryptococcosis, in 17 (48.6%) out of 35 cases of aspergillosis and in 1 case each (100%) of mucormycosis and mycosis due to an unspecified yeast. Side effects were observed in 10 cases (rash 2, fever 2, abdominal discomfort 1, nausea 1, edema 1, edema/pleural effusion/oliguria 1, finger stiffness 1, hiccup 1) with incidence rate of 6.0%. Drug administrations were discontinued in 4 cases. In general, however, fluconazole was well tolerated. Abnormal changes in laboratory test values due to the drug were observed in 32 cases and incidence rate was 19.3%. These were, however, slight and temporary changes and most of them were in parameters of liver function. It is not clear if these changes were related to the fluconazole administration, because other drugs were concomitantly administered to these cases. These results indicate that fluconazole is an agent with very good potential for the treatment of the systemic deep-seated mycoses.
Insights
Fluconazole, a new antifungal medication, shows high efficacy in treating deep fungal infections like candidiasis and cryptococcosis. It is well-tolerated with a favorable safety profile, making it a promising option for systemic mycoses.
Area of Science:
- Mycology
- Pharmacology
- Infectious Diseases
Background:
- Deep-seated mycoses pose significant treatment challenges.
- Novel antifungal agents with improved safety and efficacy profiles are needed.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of fluconazole in patients with deep-seated mycoses.
- To assess fluconazole's potential as a treatment for systemic fungal infections.
Main Methods:
- Oral or intravenous fluconazole administered to 166 patients.
- Clinical efficacy evaluated in 99 patients across various mycosis types.
- Adverse events and laboratory test values monitored.
Main Results:
- High cure rates observed in candidiasis (87.2%) and cryptococcosis (66.7%).
- Moderate efficacy in aspergillosis (48.6%).
- Fluconazole generally well-tolerated with a 6.0% incidence of mild side effects.
Conclusions:
- Fluconazole demonstrates significant potential for treating systemic deep-seated mycoses.
- Its favorable safety profile and once-daily dosing support its clinical utility.
- Further research may be warranted to explore its full therapeutic scope.