A clinical study of fluconazole for the treatment of deep mycoses

Abstract

A multicenter clinical study of fluconazole was conducted at 41 hospital sites in Japan. Fluconazole was administered orally or intravenously at daily doses of 50 to 400 mg to 199 patients with deep-seated mycoses. Clinical efficacy was evaluable in 125 of these patients. Most cases were complicated with serious underlying diseases such as cancer, leukemia, or AIDS. Clinical cures were achieved in 56 (87.5%) of 64 cases of candidiasis, in 11 (68.8%) of 16 cases of cryptococcosis, in 19 (44.2%) of 43 cases of aspergillosis, and in one case each (100%) of mucormycosis and fungemia due to an unspecified yeast. Eradication rates of causative fungi were 87.9% in Candida spp., 62.5% in Cryptococcus neoformans, and 52.2% in Aspergillus spp. Side effects were observed in 13 cases, with an incidence rate of 6.5%. In most cases fluconazole was well tolerated. Changes in laboratory test values due to the drug were reported in 35 patients with an incidence rate of 17.6%. The changes were minor and transient; primarily increases in liver enzyme. Fluconazole is a useful antifungal agent for the treatment of systemic deep-seated mycoses.