P. Kujath et al., COMPARATIVE-STUDY OF THE EFFICACY OF FLUCONAZOLE VERSUS AMPHOTERICIN B FLUCYTOSINE IN SURGICAL PATIENTS WITH SYSTEMIC MYCOSES/, Infection, 21(6), 1993, pp. 376-382
In an open, prospective, randomized study, the efficacy of fluconazole
was compared with that of the combination amphotericin B/flucytosine.
Forty surgical patients with deep-seated mycoses were included in the
study. Absolute inclusion criteria were histological finding of fungi
in a tissue sample taken during surgery from e. g. peritoneum, pancre
as, lungs or trachea, a positive blood culture or candida lesion of th
e eye. According to the random list 20 patients received up to 0.5 mg
amphotericin B per kg body weight in combination with 3x2.5 g flucytos
ine (5-FC) daily and 20 patients received fluconazole, 400 mg on the f
irst day and then 300 mg daily. The two therapy groups were comparable
in terms of age, sex and underlying diseases. Gastrointestinal perfor
ations (27 times) were the most frequent underlying diseases. Candida
albicans was the fungus most frequently detected microbiologically (34
times). The pathogens were eliminated from 12 patients in the flucona
zole group and 14 patients in the combination group. The median elimin
ation time was 8.5 days in the fluconazole group and 5.5 days in the a
mphotericin B/5-FC group. Six patients died in the fluconazole group,
whereas five patients died in the comparison group. Side effects which
necessitated switching of therapy occurred twice in the combination g
roup. In deep-seated candida mycoses, surgical patients receiving the
combination therapy with amphotericin B/5-FC showed an earlier elimina
tion than patients on monotherapy with fluconazole. With respect to cu
re rates there was no difference between these two regimens.