Abstract：
BACKGROUND: The modified Ponticelli regimen (mPR) is a first-line therapy in patients with idiopathic membranous nephropathy (IMN); however, it has a less favorable safety profile. Though mycophenolate mofetil (MMF) + steroid (S) is not recommended by Kidney Disease Improving Global Outcomes guidelines, it can be used as an alternative to mPR due to higher tolerability and steroid-sparing effect. Thus, we compared the safety and effectiveness of MMF + S and mPR regimens in patients with IMN.
METHODS: This randomized, open-label study enrolled patients with adult-onset nephrotic syndrome (NS) and biopsy-proven IMN. Forty-two patients were allocated to MMF + S group (MMF 1 gm twice daily + oral prednisolone 0.5 mg/kg/day; n = 21) and mPR group [methylprednisolone (1 gm intravenous) for 3 days followed by alternating monthly cycles of oral prednisolone (0.5 mg/kg/day) for the next 27 days and cyclophosphamide (2 mg/kg/day) for 6 months; n = 21]. The primary outcome measure was change in urinary protein creatinine ratio (UPCR).
RESULTS: At 6 months, both groups demonstrated a significant increase in serum albumin levels and estimated glomerular filtration rate (eGFR) (both p-values <0.0001) as well as a decrease in 24-hour proteinuria (MMF + S group: p-value = 0.003, and mPR group: p-value <0.0001) and UPCR (both p-values <0.0001). However, the groups did not differ in any of these parameters at any of the monthly follow-up visits. Moreover, the groups did not differ significantly in terms of the composite remission rates (61.91% for MMF + S group and 71.43% for mPR group).
CONCLUSIONS: MMF + S and mPR had comparable tolerability and effectiveness, with MMF-associated advantage of reduced steroid exposure.
METHODS: This randomized, open-label study enrolled patients with adult-onset nephrotic syndrome (NS) and biopsy-proven IMN. Forty-two patients were allocated to MMF + S group (MMF 1 gm twice daily + oral prednisolone 0.5 mg/kg/day; n = 21) and mPR group [methylprednisolone (1 gm intravenous) for 3 days followed by alternating monthly cycles of oral prednisolone (0.5 mg/kg/day) for the next 27 days and cyclophosphamide (2 mg/kg/day) for 6 months; n = 21]. The primary outcome measure was change in urinary protein creatinine ratio (UPCR).
RESULTS: At 6 months, both groups demonstrated a significant increase in serum albumin levels and estimated glomerular filtration rate (eGFR) (both p-values <0.0001) as well as a decrease in 24-hour proteinuria (MMF + S group: p-value = 0.003, and mPR group: p-value <0.0001) and UPCR (both p-values <0.0001). However, the groups did not differ in any of these parameters at any of the monthly follow-up visits. Moreover, the groups did not differ significantly in terms of the composite remission rates (61.91% for MMF + S group and 71.43% for mPR group).
CONCLUSIONS: MMF + S and mPR had comparable tolerability and effectiveness, with MMF-associated advantage of reduced steroid exposure.
摘要：
背景：改良Ponticelli方案（mPR）是特发性膜性肾病（IMN）患者的一线治疗方法；然而，它的安全性较差。尽管肾脏疾病改善全球结果指南不推荐霉酚酸酯（MMF）+类固醇（S），由于具有较高的耐受性和类固醇节省作用，因此可以用作mPR的替代品。因此，我们比较了MMF+S和mPR方案在IMN患者中的安全性和有效性.
方法：这是随机的，开放标签研究纳入了成年型肾病综合征(NS)和活检证实的IMN患者.42例患者被分配到MMFS组（MMF1gm，每天两次，口服泼尼松龙0.5mg/kg/天；n=21）和mPR组[甲基泼尼松龙（静脉注射1gm）3天，然后在接下来的27天交替每月口服泼尼松龙（0.5mg/kg/天）和环磷酰胺（2mg/kg/天）6个月；n=21=]。主要结局指标是尿蛋白肌酐比率（UPCR）的变化。
结果：在6个月时，两组均显示血清白蛋白水平和估计肾小球滤过率(eGFR)显著升高(均p值<0.0001),24小时蛋白尿(MMF+S组:p值=0.003,mPR组:p值<0.0001)和UPCR(均p值<0.0001)均降低.然而,在任何月度随访中,两组的这些参数均无差异.此外，两组的复合缓解率无显著差异(MMF+S组为61.91%,mPR组为71.43%).
结论：MMF+S和mPR具有相当的耐受性和有效性，与MMF相关的类固醇暴露减少的优势。
方法：这是随机的，开放标签研究纳入了成年型肾病综合征(NS)和活检证实的IMN患者.42例患者被分配到MMFS组（MMF1gm，每天两次，口服泼尼松龙0.5mg/kg/天；n=21）和mPR组[甲基泼尼松龙（静脉注射1gm）3天，然后在接下来的27天交替每月口服泼尼松龙（0.5mg/kg/天）和环磷酰胺（2mg/kg/天）6个月；n=21=]。主要结局指标是尿蛋白肌酐比率（UPCR）的变化。
结果：在6个月时，两组均显示血清白蛋白水平和估计肾小球滤过率(eGFR)显著升高(均p值<0.0001),24小时蛋白尿(MMF+S组:p值=0.003,mPR组:p值<0.0001)和UPCR(均p值<0.0001)均降低.然而,在任何月度随访中,两组的这些参数均无差异.此外，两组的复合缓解率无显著差异(MMF+S组为61.91%,mPR组为71.43%).
结论：MMF+S和mPR具有相当的耐受性和有效性，与MMF相关的类固醇暴露减少的优势。
