Nystatin prophylaxis and treatment in severely immunodepressed patients.
BACKGROUND
Nystatin is sometimes used prophylactically in patients with severe immunodeficiency or in the treatment of fungal infection in such patients, although the effect seems to be equivocal.


OBJECTIVE
To study whether nystatin decreases morbidity and mortality when given prophylactically or therapeutically to patients with severe immunodeficiency.


METHODS
MEDLINE and The Cochrane Library using a comprehensive search strategy, date of last search November 2001. Contacted industry and scanned reference lists.


METHODS
Randomised trials comparing nystatin with placebo, an untreated control group, fluconazole or amphotericin B.


METHODS
Data on mortality, invasive fungal infection and colonisation were extracted by both authors independently. A random effects model was used unless p>0.10 for the test of heterogeneity.


RESULTS
We included 12 trials (1,464 patients). The drugs were given prophylactically in ten trials and as treatment in two. Seven trials were in acute leukaemia, two in cancer, one in liver transplant patients, one in critically ill surgical and trauma patients, and one in AIDS patients. Nystatin had been compared with placebo in three trials and with fluconazole in nine; the dose varied from 1.5 MIE to 72 MIE daily. The effect of nystatin was similar to that of placebo on fungal colonisation (relative risk 0.85, 95% confidence interval 0.65 to 1.13). There was no statistically significant difference between fluconazole and nystatin on mortality (relative risk 0.76, 0.49 to 1.18) whereas fluconazole was more effective in preventing invasive fungal infection (relative risk 0.37, 0.15 to 0.91) and colonisation (relative risk 0.49, 0.34 to 0.70). The results were very similar if the three studies which were not performed in cancer patients were excluded.


CONCLUSIONS
Nystatin cannot be recommended for prophylaxis or treatment of Candida infections in immunodepressed patients.
Gøtzsche
P C
PC
The Nordic Cochrane Centre, Rigshospitalet, Dept. 7112, Blegdamsvej 9, Copenhagen Ø, Denmark, 2100. p.c.gotzsche@cochrane.dk
Johansen
H K
HK
D000666:Amphotericin B / Q000627:therapeutic use; D019072:Antibiotic Prophylaxis; D000935:Antifungal Agents / Q000627:therapeutic use*; D015725:Fluconazole / Q000627:therapeutic use; D006801:Humans; D016867:Immunocompromised Host; D009181:Mycoses / Q000401:mortality / Q000517:prevention & control*; D009761:Nystatin / Q000627:therapeutic use*; D009894:Opportunistic Infections / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic
D000935:Antifungal Agents; D009761:Nystatin; D000666:Amphotericin B; D015725:Fluconazole