摘要
Background:Cyclosporine A and tacrolimus(TAC)are often used as a second-line treatment for children with refractory nephrotic syndrome(NS).This study was undertaken to investigate the efficacy and safety of Tacrobell®,a locally produced generic form of TAC.Methods:This study was a one-year prospective,open-label,single-arm,multicenter trial.Fourty-four children with steroid-dependent NS(SDNS)and 33 children with steroid-resistant NS(SRNS)were enrolled.The primary endpoints were defined as the remission rates,whereas the secondary endpoints were recognized as the duration of remission and adverse effects of TAC.Results:After one-year treatment,34(77.3%)of the 44 patients with SDNS were in complete remission,and 6(13.6%)were in partial remission.Nineteen(43.2%)patients did not relapse during the study;for those who did relapse,the mean duration of remission was 4.6±2.9 months.The number of relapse episodes during the study period(0.90 per patient-year)was significantly lower than that in the preceding year(2.8 per patientyear).After treatment for 3 and 6 months,12(36.4%)of the 33 patients with SRNS were in remission,and after treatment for 12 months,the number of patients had increased to 13(39.4%).The mean time to achieve remission was 4.0±3.2 months.After remission(duration,3.7±2.7 months),12(54.5%)of 22 patients relapsed.The fasting blood glucose and blood pressure levels during the therapy were similar to those at the time of study entry.Conclusions:Treatment with Tacrobell®was effective and safe for children with refractory NS.The efficacy of this generic form of TAC was better than that of the original TAC formula.
基金
supported by a grant from the Korean Health Technology R&D Project,Ministry of Health&Welfare,Republic of Korea(HI12C0014)
Basic Science Research Program through the National Research Foundation of Korea(NRF)funded by the Ministry of Education(NRF-2012R1A1A2006858)
Chong Kun Dang Pharmaceutical Corp.,Seoul,Korea
approved by the Institutional Review Board of Seoul National University Hospital(No.0911-027-300).
