A Randomized Trial Comparing Fluconazole with Amphotericin B for the Treatment of Candidemia in Patients without Neutropenia

作者：John H. Rex, John E. Bennett, Alan M. Sugar, Peter G. Pappas, Charles M. van der Horst, John Ernest Edwards, Ronald G. Washburn, W. Michael Scheld, Adolf W. Karchmer, A. Dine, Marcia J. Levenstein, Charles D. Webb · 发表于：New England Journal of Medicine · 年份：1994 · DOI：10.1056/nejm199411173312001 · 被引用次数：1049 · 研究领域：Antifungal resistance and susceptibility、Neutropenia and Cancer Infections、Blood disorders and treatments

BACKGROUND: Amphotericin B has long been the standard treatment for candidemia, but its use is complicated by its toxicity. More recently, fluconazole, a water-soluble triazole with activity against candida species and little toxicity, has become available. We conducted a multicenter randomized trial that compared amphotericin B with fluconazole as treatment for candidemia. METHODS: To be eligible, patients had to have a positive blood culture for candida species, a neutrophil count > or = 500 per cubic millimeter, and no major immunodeficiency. Patients were randomly assigned to receive either amphotericin B (0.5 to 0.6 mg per kilogram of body weight per day) or fluconazole (400 mg per day), each continued for at least 14 days after the last positive blood culture. Outcomes were assessed by a group of investigators blinded to treatment assignment. RESULTS: Of the 237 patients enrolled, 206 met all entry criteria. The most common diagnoses were renal failure, nonhematologic cancer, and gastrointestinal disease. There was no statistically significant difference in outcome: of the 103 patients treated with amphotericin B, 81 (79 percent) were judged to have been treated successfully, as were 72 of the 103 patients treated with fluconazole (70 percent P = 0.22; 95 percent confidence interval for the difference, -5 to 23 percent). The bloodstream infection failed to clear in 12 patients in the amphotericin group and 15 in the fluconazole group; the species most commonly associate...