BACKGROUND: Evidence regarding the optimal dose of tacrolimus (TAC) in treatment of idiopathic membranous nephropathy (IMN) remains inconclusive. The objective of this study was to evaluate the efficacy and safety of low-dose TAC combined with prednisone for patients with IMN. METHODS: We conducted a randomized prospective cohort study in IMN patients: 28 patients receivedoral TAC (target whole blood concentration of 2-4 ng/mL) plus prednisone for 12 months, and 28 patients received prednisone combined with intravenous cyclophosphamide (CYC) (750 mg/m2 body surface) once every 4 weeks for 24 weeks. RESULTS: Of the 56 patients who completed the 12-month treatment, complete remission (CR) occurred in 8 (28.6%) of the CYC group and 18 (64.3%) of the TAC group; partial remission (PR) occurred in 10 (35.7%) of the CYC group and 7 (25.0%) of the TAC group. The probability of remission (either CR or PR) was higher in the TAC group than in the CYC group (p = 0.0439, by log-rank test). Furthermore, a significantly greater improvement in proteinuria and serum albumin levels was observed in the TAC group compared with the CYC group. Patients treated with TAC can often show a rapid increase in their serum albumin levels before any obvious reduction of urinary protein excretion. Side effects were mild and transitory in both groups. CONCLUSION: The results demonstrated that the combined therapy of low-dose TAC and prednisone is an effective and safe therapeutic method for Chinese adults with IMN. Low-dose TAC accompanied by prednisone is enough to induce remission in the majority of patients with IMN.
RCT Entities:
BACKGROUND: Evidence regarding the optimal dose of tacrolimus (TAC) in treatment of idiopathic membranous nephropathy (IMN) remains inconclusive. The objective of this study was to evaluate the efficacy and safety of low-dose TAC combined with prednisone for patients with IMN. METHODS: We conducted a randomized prospective cohort study in IMN patients: 28 patients received oral TAC (target whole blood concentration of 2-4 ng/mL) plus prednisone for 12 months, and 28 patients received prednisone combined with intravenous cyclophosphamide (CYC) (750 mg/m2 body surface) once every 4 weeks for 24 weeks. RESULTS: Of the 56 patients who completed the 12-month treatment, complete remission (CR) occurred in 8 (28.6%) of the CYC group and 18 (64.3%) of the TAC group; partial remission (PR) occurred in 10 (35.7%) of the CYC group and 7 (25.0%) of the TAC group. The probability of remission (either CR or PR) was higher in the TAC group than in the CYC group (p = 0.0439, by log-rank test). Furthermore, a significantly greater improvement in proteinuria and serum albumin levels was observed in the TAC group compared with the CYC group. Patients treated with TAC can often show a rapid increase in their serum albumin levels before any obvious reduction of urinary protein excretion. Side effects were mild and transitory in both groups. CONCLUSION: The results demonstrated that the combined therapy of low-dose TAC and prednisone is an effective and safe therapeutic method for Chinese adults with IMN. Low-dose TAC accompanied by prednisone is enough to induce remission in the majority of patients with IMN.
Authors: Thilo C von Groote; Gabrielle Williams; Eric H Au; Yizhi Chen; Anna T Mathew; Elisabeth M Hodson; David J Tunnicliffe Journal: Cochrane Database Syst Rev Date: 2021-11-15
Authors: W Cui; X Lu; X Min; M Liu; S Guan; Y Wang; M Luo; W Li; Q Li; W Dong; L Miao; P Luo Journal: Braz J Med Biol Res Date: 2017-03-23 Impact factor: 2.590