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Randomised trial of fluconazole versus lowdose amphotericin b in prophylaxis against fungal infections in patients undergoing hematopoietic cell transplantation

Publication ,  Journal Article
Koh, LP; Goh, YT; Yee, GM; Tan, P
Published in: Blood
2000

Background:Over the past decade, invasive fungal infections has become an increasingly important problem in patients undergoing hematopoietic cell transplantation(HCT). Effective prevention of invasive fungal infection has been unsatisfactory because of either inadequate anti-fungal spectrum or drug-associated toxicity.The optimal approach for prophylatic antifungal therapy has yet to be determined. Objectives:To resolve this issue, we performed a prospective randomised study to compare the efficacy of fluconazole (FL) vs low-dose amphotericin B (AmB) in preventing fungal infections during the first 100 days after HCT. Methods: Patients undergoing allogenic or autologous HCT were randomised to receive fluconazole 200mg/day p.o. or amphotericin B 0.2mg/kg/day i.v. beginning 1 day prior to commencement of conditioning regimen and continuing until engraftment, drugassociated toxicity was suspected, or a systemic fungal infection was suspected or proven. High dose amphotericin B (0.5-1.0 mg/kg/D)was started for patients with suspected or proven fungal infections. Results: From January 1993 to December 1998, a total of 186 patients were enrolled into the trial, with 100 receiving fluconazole and 86 receiving amphotericin B. There was no statistically significant difference among the 2 treatment arms for any of the demographic variable, duration of neutropenia, duration of prophylaxis, duration of fever, duration of therapeutic amphotericin B and total dose of therapeutic amphotericin B. 79(42.5%)patients were removed from prophylaxis for suspected fungal infections(FL 46 vs AmB 33, p0.05). The incidence of probable invasive fungal infections (FL 4% vs AmB 3.5%), superficial fungal infections (FL 1% vs AmB 3.5%) and fungal colonisation (FL 9% vs AmB 8.1%)did not show any significant difference. The survival at 100 days post transplant were similar between the 2 groups, although patients receiving fluconazole had a trend towards better survival compared to those receiving amphotericin B.(FL 78% vs AmB 70%, p=0.254) Death was attributed to fungal infections in 6 fluconazole recipients and 6 amphotericin B recipients (6% vs 7%, p0.05) Conclusions: We conclude that fluconazole is as effective as low-dose amphotericin B in prophylaxis against fungal infections in patients undergoing hematopoietic cell transplantation.

Duke Scholars

Published In

Blood

ISSN

0006-4971

Publication Date

2000

Volume

96

Issue

11 PART I

Start / End Page

189a

Related Subject Headings

  • Immunology
  • 1114 Paediatrics and Reproductive Medicine
  • 1103 Clinical Sciences
  • 1102 Cardiorespiratory Medicine and Haematology
 

Published In

Blood

ISSN

0006-4971

Publication Date

2000

Volume

96

Issue

11 PART I

Start / End Page

189a

Related Subject Headings

  • Immunology
  • 1114 Paediatrics and Reproductive Medicine
  • 1103 Clinical Sciences
  • 1102 Cardiorespiratory Medicine and Haematology