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Randomized controlled trial on immunomodulatory effects of azithromycin in children with steroid-dependent nephrotic syndrome

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Abstract

Background

Azithromycin (AZM) is a macrolide antibiotic with anti-inflammatory and immunomodulatory effects. Our aim was to compare the immunomodulatory effects of AZM combined with steroid therapy with that of steroid therapy alone in children with steroid-dependent nephrotic syndrome (SDNS).

Methods

We enrolled 57 patients with SDNS in a multicenter randomized control trial. Patients were classified into two groups: group A (intervention group, N = 29) and group B (control group, N = 28). After achievement of remission with full-dose daily prednisone, patients in group A received AZM in conjunction with steroids which was tapered gradually, while patients in group B received steroids alone. Urine protein creatinine ratio (uPCR) and TNF-α were measured at different points of follow-up throughout the study period (5 months after achieving remission).

Results

After achievement of remission by full-dose steroids, there were significant differences of TNF-α between the two groups after 1-, 3- and 5-month follow-up (p < 0.001, 0.003, and 0.001, respectively). Also, there was significant difference of TNF-α in both intervention and control groups after exclusion of the relapsed cases at 3- and 5-month follow-up (, p = 0.031 and p = 0.003, respectively). There was significant difference between both groups after 5-month follow-up as regards the number of relapsed patients (group A = 4, group B = 11, p = 0.015).

Conclusion

AZM was capable of reducing serum TNF-α which is one of the inflammatory cytokines implicated in the pathogenesis of NS.

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Correspondence to Happy Sawires.

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Sawires, H., Abdelaziz, H., Ahmed, H.M. et al. Randomized controlled trial on immunomodulatory effects of azithromycin in children with steroid-dependent nephrotic syndrome. Pediatr Nephrol 34, 1591–1597 (2019). https://doi.org/10.1007/s00467-019-04251-5

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  • DOI: https://doi.org/10.1007/s00467-019-04251-5

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