Gøtzsche, P.C., & Johansen, H.K. (2014). Nystatin prophylaxis and treatment in severely immunodepressed patients. Cochrane Database of Systematic Reviews, 9, CD002033.

DOI Link

doi: 10.1002/14651858.CD002033.pub2

Purpose

STUDY PURPOSE: To determine if nystatin prophylaxis or treatment for fungal infection decreases morbidity and mortality in immunocompromised patients

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PubMed (1966–July 2014)

INCLUSION CRITERIA: All randomized trials, irrespective of language, that compared nystatin with placebo, an untreated control group; fluconazole or amphotericin B were eligible.

EXCLUSION CRITERIA: Excluded cases of oropharyngeal and vulvovaginal candidiasis, skin infections, Candida in the urine, and vaguely described infections

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 18

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The outcomes were meta-analyzed as relative risks with the Mantel-Haenszel technique. Because heterogeneity of the studies was expected because of various designs, diagnoses, drugs, doses, and routes of administration, and criteria for fungal invasion and colonization, a random-effects model was used. A fixed-effect model analysis was preferred, however, if the p value was greater than 0.1 for the test of heterogeneity. Ninety-five percent confidence intervals (CIs) were presented.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 14
TOTAL PATIENTS INCLUDED IN REVIEW = 1,569
KEY SAMPLE CHARACTERISTICS: Twelve of the 14 trials studied nystatin prophylaxis, and two studied nystatin treatment. Eleven trials included patients with acute leukemia, solid cancer, or bone marrow transplantation. One trial involved patients with liver transplantation, one trial involved patients who were critically ill from surgery and/or trauma, and one trial involved patients with AIDS.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

Nystatin was compared to placebo in three trials, with fluconazole in 10, and amphotericin B in one. The dose varied from 0.8 MIE to 72 MIE daily and was 2 mg/kg/d in a liposomal formulation. The effect of nystatin on fungal colonization was similar to that of placebo (relative risk [RR] = 0.85, 95% CI [0.65, 1.13]). No statistically significant difference existed between fluconazole and nystatin on mortality (RR = 0.75, 95% CI [0.54, 1.03]), whereas fluconazole was more effective in preventing invasive fungal infection (RR = 0.4, 95% CI [0.17, 0.93]) and colonization (RR = 0.5, 95% CI [0.36, 0.68]).

No proven fungal infections existed in a small trial that compared amphotericin B with liposomal nystatin. The results were very similar if the three studies not performed with patients with cancer were excluded.

Conclusions

Nystatin cannot be recommended for prophylaxis or the treatment of Candida infections in immunodepressed patients.

Nursing Implications

Nystatin is no more effective than placebo for the prevention or treatment of fungal infections in immunocompromised patients.

Legacy ID

6053