This retrospective study aimed to explore the relative efficacy and safety of different tacrolimus (TAC) concentrations in the treatment of patients with idiopathic membranous nephropathy (IMN). A total of 260 IMN patients with nephrotic syndrome (NS) were recruited. Among these, 125 patients had TAC concentrations no greater than 5 ng/ml (C_TAC ≤ 5 ng/ml), and 135 patients had TAC concentrations greater than 5 ng/ml (C_TAC > 5 ng/ml). The primary outcomes included complete remission (CR) rates and overall (OR) response rates. The secondary outcomes included 24-h urinary protein (24-h UP), serum albumin and serum creatinine, and adverse events (AEs). During the 12-month follow-up, the overall response rates were significantly different between the C_TAC ≤ 5 ng/ml group and the C_TAC > 5 ng/ml group (P < 0.0001). However, there was no significant difference in the CR at 12 months between the two groups (chi-square, 62% vs 63%, P = 0.852). Compared with the C_TAC ≤ 5 ng/ml group, the C_TAC > 5 ng/ml group had improved levels of 24 h UP (P = 0.017) and serum albumin (P = 0.010). Moreover, the incidences of acute reversible nephrotoxicity (P < 0.001), hepatotoxicity (P = 0.036), new-onset diabetes mellitus (P = 0.036), and glucose intolerance (P = 0.005) were lower in the C_TAC ≤ 5 ng/ml group than in the C_TAC > 5 ng/ml group. The C_TAC > 5 ng/ml group was improved relative to the C_TAC ≤ 5 ng/ml group in terms of a PR and CR at 6 months, but there was no difference in the CR between the two groups at 12 months.

本回顾性研究旨在探讨不同浓度的他克莫司 (TAC) 治疗特发性膜性肾病 (IMN) 患者的相对疗效和安全性。共招募了 260 名患有肾病综合征 (NS) 的 IMN 患者。其中，125 名患者的 TAC 浓度不大于 5 ng/ml（C _TAC  ≤ 5 ng/ml），135 名患者的 TAC 浓度大于 5 ng/ml（C _TAC  > 5 ng/ml）。主要结果包括完全缓解 (CR) 率和总体 (OR) 反应率。次要结果包括 24 小时尿蛋白 (24 小时 UP)、血清白蛋白和血清肌酐以及不良事件 (AE)。在 12 个月的随访期间，C _TAC之间的总体反应率显着不同 ≤ 5 ng/ml 组和 C _TAC  > 5 ng/ml 组（P  < 0.0001）。然而，两组在 12 个月时的 CR 没有显着差异（卡方，62% vs 63%，P  = 0.852）。与 C _TAC  ≤ 5 ng/ml 组相比，C _TAC  > 5 ng/ml 组的 24 h UP（P  = 0.017）和血清白蛋白（P  = 0.010）水平有所提高。此外，急性可逆性肾毒性（P  < 0.001）、肝毒性（P  = 0.036）、新发糖尿病（P  = 0.036）和葡萄糖耐受不良（P  = 0.005）的发生率在 C _TAC中较低 ≤ 5 ng/ml 组高于 C _TAC  > 5 ng/ml 组。C _TAC  > 5 ng/ml 组 在 6 个月时的 PR 和 CR相对于 C _TAC ≤ 5 ng/ml 组有所改善，但两组在 12 个月时的 CR 没有差异。