Azithromycin for Prevention of Graft-Versus-Host Disease: A Randomized Placebo-Controlled Trial

  • Maryam Barkhordar Hematology-Oncology and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran
  • Mehdi Mohammadi Department of Clinical Pharmacy, Faculty of Pharmacy, Alborz University of Medical Sciences, Karaj, Iran
  • Ahmad Reza Shamshiri Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
  • Molouk Hadjibabaie Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran
  • Ardeshir Ghavamzadeh Hematology-Oncology and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran
Keywords: Azithromycin, Graft-versus-host disease, Mucositis

Abstract

Background: Allogeneic hematopoietic stem cell transplantation has been used widely to treat various types of malignant and non-malignant disorders. Graft-versus-host disease is one of the main complications of this procedure which is associated with considerable mortality and affects quality of life. Despite careful selection of HLA-matched donors and implementing immunosuppressive therapy, the incidence rate of graft-versus-host disease remains high. Macrolide antibiotics are well-known immunomodulatory agents and have been effective as prophylaxis for graft-versus-host disease in preclinical studies.Materials and Methods: Ninety-six adult patients with acute leukemia were recruited into a double-blind, randomized, placebo-controlled trial. All patients were first-time transplant candidates for a full-matched related or unrelated donor. Patients were allocated to receive azithromycin 500 mg daily (n=48) or placebo (n=48) from day -6 to +12. All patients received high-dose chemotherapy, standard immunosuppressive regimen and supportive care according to institutional protocols.Results: The incidence of acute graft-versus-host disease grade III-IV and chronic graft-versus-host disease garde I-III was not significantly different between the two study arms. Oral mucositis grade 1-3 occurred in significantly lower number of patients in the azithromycin group compared with placebo.Conclusion: Based on the results of this study, protective effect of azithromycin on graft-versus-host disease could not be demonstrated.  

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Published
2018-04-05
How to Cite
1.
Barkhordar M, Mohammadi M, Shamshiri AR, Hadjibabaie M, Ghavamzadeh A. Azithromycin for Prevention of Graft-Versus-Host Disease: A Randomized Placebo-Controlled Trial. ijhoscr. 12(2):77-3.
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Original Article(s)