Gar. Young et al., A double-blind comparison of fluconazole and nystatin in the prevention ofcandidiasis in patients with leukaemia, EUR J CANC, 35(8), 1999, pp. 1208-1213
In this multicentre, randomised, double-blind study, the safety and efficac
y of oral fluconazole (200 mu g/day) and nystatin suspension (6 000 000 IU/
day) for the prevention of fungal infections were compared in patients with
leukaemia undergoing remission induction chemotherapy. Antifungal prophyla
xis was initiated at the time chemotherapy was started and continued throug
hout the hospital stay or the period of neutropenia to a maximum of 42 days
. Prophylaxis was successful (no evidence of fungal infection or fever of u
nknown origin unresponsive to antibiotics) in 38 of 56 (68%) fluconazole-tr
eated and 25 of 53 (47%) nystatin-treated patients (P= 0.03). 2 patients (4
%) in the fluconazole group and 6 (11%) patients in the nystatin group deve
loped systemic fungal infections (P= 0.15). The overall frequency of advers
e events was similar among fluconazole-treated (29%) and nystatin-treated (
32%); most events in both treatment groups involved the gastrointestinal tr
act. These results indicated fluconazole was more effective than nystatin i
n preventing Candida infections in patients with leukaemia; fluconazole was
well tolerated. (C) 1999 Elsevier Science Ltd. All rights reserved.