A prospective randomly controlled clinical trial on azithromycin therapy for induction treatment of children with nephrotic syndrome

Abstract

A prospective study was designed to evaluate the efficacy of azithromycin (AZM) when combined with prednisone therapy compared with prednisone therapy alone in children with primary nephrotic syndrome (PNS) undergoing induction treatment. A prospective randomly controlled clinical trial was conducted. Randomization was performed to select the research subjects who were composed of children with PNS and treated with AZM combined with prednisone (the intervention group) and with prednisone alone (the control group). A total of 211 randomly selected patients with PNS received either AZM combined with prednisone (n = 106) or prednisone alone (n = 105) for 6 months. At three months in the follow-up period, 12 patients were lost to follow up (intervention group, 7; control group, 5), and 6 patients had a transient hypocomplementemia (intervention group, 4 ; control group, 2). AZM was administered at a dose of 10 mg/kg q.d (1 dose per day) for three consecutive days. The median duration before remission was 6 days in the intervention group and 9 days in the control group (p < 0.0001). Relapse rate differed among the groups at 3 months (11.6 vs. 21.4 %, p = 0.049). No difference in relapse rate was observed between the two groups within 4 to 6 months and at 6 months (p = 0.168, 0.052). After 4 weeks of treatment, steroid resistance occurred in 1 out of 95 (1.05 %) patients in the intervention group and in 10 out of 98 (10.2 %) patients in the control group (p = 0.006). After 8 weeks of treatment, no difference was found in steroid resistance between two groups (1/95 vs. 3/98, p = 0.327). During follow-up at 6 months, no difference was exhibited by the two groups on frequent relapse rates (p = 0.134). If a course of AZM is added to the glucocorticoid-induced treatment among children with PNS, then the sensitivity of prednisone increases. This increase consequently reduces duration to remission and decreases relapse. However, further studies are necessary to confirm these results.