Nephrology Department, Second Xiangya Hospital, Central South University, Key Lab of Kidney Disease and Blood Purification in Hunan, Changsha, Hunan, PR China.
J Nephrol. 2013 May-Jun;26(3):564-71. doi: 10.5301/jn.5000199. Epub 2012 Sep 4.
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.
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.
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.
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.
关于他克莫司（TAC）治疗特发性膜性肾病（IMN）的最佳剂量的证据仍不明确。本研究旨在评估低剂量 TAC 联合泼尼松治疗 IMN 患者的疗效和安全性。
我们对 IMN 患者进行了一项随机前瞻性队列研究：28 例患者接受口服 TAC（目标全血浓度 2-4ng/ml）加泼尼松治疗 12 个月，28 例患者接受静脉环磷酰胺（CYC）（750mg/m2 体表面积）治疗，每 4 周 1 次，共 24 周。
在完成 12 个月治疗的 56 例患者中，CYC 组完全缓解（CR）8 例（28.6%），TAC 组 18 例（64.3%）；部分缓解（PR）CYC 组 10 例（35.7%），TAC 组 7 例（25.0%）。TAC 组的缓解率（CR 或 PR）高于 CYC 组（p=0.0439，对数秩检验）。此外，TAC 组蛋白尿和血清白蛋白水平的改善明显优于 CYC 组。与 CYC 组相比，TAC 组患者的血清白蛋白水平在尿蛋白排泄量明显减少之前通常会迅速升高。两组患者的副作用均较轻且短暂。
结果表明，低剂量 TAC 联合泼尼松治疗是中国成人 IMN 的有效且安全的治疗方法。低剂量 TAC 联合泼尼松足以诱导大多数 IMN 患者缓解。
