1992 Volume 40 Issue 12 Pages 1451-1459
The efficacy of early miconazole (MCZ) use in infections associated with hematologic diseases was studied by the Tokai Infection Study Group on Hematological Disorders. Subjects consisted of 189 patients with hematologic disorders as underlying diseases, treated between July 1989 and December 1990. These subjects were suspected to have mycosis after a single course of antibiotic therapy had failed to relieve fever within 3 to 4 days. Subjects were randomized into the MCZ group or a control group using the envelope method. The MCZ group was given MCZ plus antibiotics, and the control group was given antibiotics alone. MCZ was administered at a dose of 400mg, two to three times daily, by intravenous drip infusion for a minimum period of 14 days. Selection of antibiotics for both groups was left to the attending physicians, and efficacy was evaluated by monitoring fever as well as by laboratory findings. To facilitate the diagnosis of mycosis, blood levels of β-D-glucan were measured, with 10μg/ml or more considered positive. Of the 189 patients studied, nine were ineligible, and 19 dropped out, leaving 84 patients in the MCZ group and 77 in the control group for efficacy evaluation. Among the patients in the MCZ group, excellent responses were observed in 27 and good responses in 24, a total of 60.7% (51/84). Among the control patients, excellent responses were observed in 29 and good responses in five, a total of 44.2% (31.77). Thus, significantly greater clinical responsiveness was observed in the MCZ group (p<0.05: x2 test). In addition, the rate of positivity for β-D-glucan was 30.8% (8/26) in the MCZ group and 38.1% (8/21) in controls. The response rate in β-glucanpositive patients was 66.7% (4/6) in the MCZ group and 37.5% (3/8) in controls. The above findings indicate that concomitant use of this antimycotic agent and antibiotics resulted in an increased therapeutic effect in patients who had failed to respond to an initial 3-to-4-day course of antibiotic therapy.
