Department of Nephrology, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Department of Nephrology, People's Hospital of Xinyu City, Xinyu, China.
Intern Med J. 2020 May;50(5):612-619. doi: 10.1111/imj.14446.
Guidelines recommend classical combined therapy of steroid and cyclophosphamide (CYC) for patients with idiopathic membranous nephropathy (IMN), while it is associated with severe adverse effects.
We conducted an observational and retrospective study to evaluate the effectiveness and safety of steroids plus tacrolimus (TAC) versus steroids plus CYC for IMN.
A total of 203 kidney-biopsy-proven IMN patients was enrolled in this study. One group (n = 142) received steroid combined with intravenous CYC (750 mg/m body surface) and the other group (n = 61) received steroid combined with oral TAC (target blood concentration of 4-8 ng/mL). The primary outcomes were achievement of remission. The secondary end-points included incidence of adverse events, relapse rates, 24 h urinary protein (UP), serum albumin, serum creatinine and estimated glomerular filtration rate.
Over the 18-month observation period, the study suggested that the remission rates at the first 3 months were significantly higher in TAC group than in CYC group (72.1% vs 54.9%, P < 0.05). Although the cumulative incidence of serious and non-serious adverse events was not different significantly between the two groups, the incidence after first 3 months was lower in TAC group. Levels of 24-h UP and serum albumin improved in the TAC group more than in the CYC group (P < 0.05) over the observed period.
Because of its short-term effectiveness and long-term safety profile, steroid plus TAC might be a better option for IMN.
指南推荐对特发性膜性肾病（IMN）患者采用类固醇和环磷酰胺（CYC）的经典联合疗法，但该疗法存在严重不良反应。
我们开展了一项观察性和回顾性研究，以评估类固醇联合他克莫司（TAC）与类固醇联合 CYC 治疗 IMN 的疗效和安全性。
共纳入 203 例经肾活检证实的 IMN 患者，其中一组（n=142）接受类固醇联合静脉注射 CYC（750 mg/m 体表面积），另一组（n=61）接受类固醇联合口服 TAC（目标血药浓度 4-8 ng/mL）。主要结局为缓解达标。次要终点包括不良事件发生率、复发率、24 小时尿蛋白（UP）、血清白蛋白、血清肌酐和估算肾小球滤过率。
在 18 个月的观察期内，研究提示 TAC 组在第 3 个月的缓解率明显高于 CYC 组（72.1% vs. 54.9%，P<0.05）。尽管两组严重和非严重不良事件的累积发生率无显著差异，但 TAC 组在第 3 个月后的发生率较低。TAC 组在观察期间的 24 小时 UP 和血清白蛋白水平改善优于 CYC 组（P<0.05）。
由于 TAC 联合类固醇具有短期疗效和长期安全性，可能是 IMN 的更佳选择。
