Fluconazole Prophylaxis of Fungal Infections in Patients with Acute Leukemia: Results of a Randomized Placebo-Controlled, Double-Blind, Multicenter Trial

作者：Drew J. Winston, Pranatharthi Haran Chandrasekar, Hillard Michael Lazarus, Jesse L. Goodman, Jeffrey L. Silber, Harold W. Horowitz, Richard K. Shadduck, Craig S. Rosenfeld, Winston G. Ho, Muhammed Z. Islam, Donald N. Buell · 发表于：Annals of Internal Medicine · 年份：1993 · DOI：10.7326/0003-4819-118-7-199304010-00003 · 被引用次数：379 · 研究领域：Antifungal resistance and susceptibility、Fungal Infections and Studies、Neutropenia and Cancer Infections

OBJECTIVE: To evaluate the efficacy and safety of fluconazole for prevention of fungal infections. DESIGN: A randomized, placebo-controlled, double-blind, multicenter trial. PATIENTS: Adults (257) undergoing chemotherapy for acute leukemia. INTERVENTION: Patients were randomly assigned to receive either fluconazole (400 mg orally once daily or 200 mg intravenously every 12 hours) or placebo. The study drug was started at initiation of chemotherapy and continued until recovery of neutrophil count, development of proven or suspected invasive fungal infection, or the occurrence of a drug-related toxicity. MEASUREMENTS: Fungal colonization, proven superficial or invasive fungal infection, empiric antifungal therapy with amphotericin B, drug-related side effects, and mortality. MAIN RESULTS: Fluconazole decreased fungal colonization (83 of 122 [68%] placebo patients compared with 34 of 119 [29%] fluconazole patients colonized at end of prophylaxis, P < 0.001) and proven fungal infections (27 of 132 [21%] placebo patients compared with 11 of 123 [9%] fluconazole patients infected, P = 0.02). Superficial fungal infections occurred in 20 of 132 (15%) placebo patients but in only 7 of 123 (6%) fluconazole patients (P = 0.01), whereas invasive fungal infections developed in 10 of 132 (8%) placebo patients and in 5 of 123 (4%) fluconazole patients (P = 0.3). Fluconazole was especially effective in eliminating colonization and infection by Candida species other than Candida krusei (66 of...