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. 2018 Apr 1;12(2):77-83.

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

Maryam Barkhordar  1 , Mehdi Mohammadi  2 , Molouk Hadjibabaie  3   4 , Ardeshir Ghavamzadeh  1
Affiliations

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

Maryam Barkhordar et al. Int J Hematol Oncol Stem Cell Res. .

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.

Keywords: Azithromycin; Graft-versus-host disease; Mucositis.

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Figures

Figure 1
Figure 1
The Consort flow diagram of study
Figure 2
Figure 2
Frequency of OM ( oral Mucositis) according to WHO to WHO oral toxicity scale
Figure 3
Figure 3
The Kaplan-Meier plots for overall survival and relapse-free survival
See this image and copyright information in PMC

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