[Fluconazole versus ketoconazole in systemic fungal infection: a double-blind randomized study]

We carried out a multiple-center study, including a double-blined randomized clinical trial on fluconazole (Flu, group A) and ketoconazole (Keto, group B) and an open trial on Flu only for evaluating the efficacy and safety of Flu in treating deep and shallow fungal infection. 222 patients participated in the study and most of them had severe underlying diseases. The dosage and therapeutic duration were as follows: Flu 200-400 mg daily for 1-8 weeks in 34 patients with fungal infection and 150 mg as a single dose in 30 patients with fungal vaginitis; Keto 400 mg daily for 1-8 weeks in 30 patients with fungal diseases and for 5 days in 30 patients with fungal vaginitis. In the trial 124 patients were randomized to receive either Flu (64 patients) or Keto (60). The cure rate in group A and B was 81.3% (52/64) and 58.0% (35/60) respectively (P < 0.05). The fungal eradication rates of the two groups were 85.7% and 70.0% (P > 0.05) respectively. 98 patients entered the open trial. They included fungal infection of the respiratory tract and urinary tract, cryptococal meningitis, fungal sepesis and systemic dissemination of mycosis and fungal vaginitis. 84 (85.7%) were cured. The fungal eradication rate of this group was 92.9%. The side-effect rates of the three groups were 3.1% (2/64), 5.0% (3/60) and 6.1% (6/98) respectively. They were mild and transient vomiting, nausea, and anorexia. In group B and the open group however, there was one case of ALT elevation in each group (P > 0.05). This study suggests that Flu is a safe, effective and useful drug for the treatment of severe fungal infection.