Mycophenolate mofetil monotherapy in membranous nephropathy: A 1-year randomized controlled trial
Mycophenolate mofetil monotherapy in membranous nephropathy: A 1-year randomized controlled trial
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DOI：
10.1053/j.ajkd.2008.04.013
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发表时间：
2008-10-01
影响因子：
13.2
通讯作者：
Berland, Yvon
中科院分区：
文献类型：
--
作者：
Dussol, Bertrand;Morange, Sophie;Berland, Yvon
背景资料：膜性肾小球肾炎（MGN）患者的治疗存在争议，因为免疫抑制方案对患者或肾脏存活率缺乏明确的益处。本研究的目的是评价霉酚酸酯（MMF）治疗MGN患者的有效性和安全性。研究设计：1年前瞻性、随机、对照临床试验。设置和参与者：36例经活检证实的原发性MGN和肾病综合征患者。干预：19例患者接受MMF（2 g/d）治疗12个月，17例患者为对照组。所有患者均接受相同的保守治疗，治疗方法包括：使用肾素-血管紧张素受体阻滞剂、他汀类药物、低盐低蛋白饮食和利尿剂（以防水肿）。结局和测量：终点为整个研究期间的平均蛋白尿与肌酐尿比率（mg/g）和1年（第12个月）时完全缓解和部分缓解的数量。数据进行了分析意向治疗analysis.Results：平均蛋白尿肌酐尿比是稳定的，在整个研究中，两组（P = 0.1）。平均蛋白尿/肌酐尿比值在MMF组为4，690 ± 2，212 mg/g，对照组为6，548 ± 4，601 mg/g（差异的95%置信区间为-619至+4，247; P = 0.1）。3例患者完全缓解（MMF组1例，对照组2例; P = 0.5），11例患者部分缓解（MMF组6例，对照组5例; P = 0.9）。12个月后，两组完全或部分缓解的概率没有差异（相对风险，0.92; 95%置信区间，0.48至1.75; P = 0.7）。肾功能是稳定的，在2组根据估计肾小球滤过率和血清肌酐level.Limitations：少数患者和短期随访防止generalizations.Conclusions：12个月的方案霉酚酸酯没有减少平均蛋白尿肌酐比或增加部分和完全缓解。在4例接受MMF的患者（20%）中观察到严重不良反应。
Background: Treatment of patients with membranous glomerulonephritis (MGN) is controversial because of the lack of clear benefit of the immunosuppressive regimens on patient or renal survival. The objective of this study is to evaluate the efficacy and safety of mycophenolate mofetil (MMF) for patients with MGN.Study Design: 1-year prospective, randomized, and controlled clinical trial.Setting & Participants: 36 patients with biopsy-proven idiopathic MGN and nephrotic syndrome.Intervention: 19 patients received MMF (2 g/d) for 12 months and 17 patients were in the control group. All patients had the same conservative treatment based on renin-angiotensin blockers, statins, low-salt and low-protein diet, and diuretics in case of edema.Outcomes & Measurements: End points were the mean proteinuria over creatinuria ratio in mg/g throughout the study and numbers of complete and partial remissions at 1 year (month 12). Data were analyzed on an intention-to-treat analysis.Results: Mean proteinuria over creatinuria ratio was stable in both groups throughout the study (P = 0.1). Mean proteinuria over creatinuria ratio was 4,690 +/- 2,212 mg/g in the MMF group and 6,548 4,601 mg/g in the control group (95% confidence interval of the difference, -619 to + 4,247; P = 0.1). Remission was complete in 3 patients (1 in the MMF group, 2 in the control group; P = 0.5) and partial in 11 patients (6 in the MMF group, 5 in the control group; P = 0.9). The probability of complete or partial remission did not differ between the 2 groups after 12 months (relative risk, 0.92; 95% confidence interval, 0.48 to 1.75; P = 0.7). Kidney function was stable in the 2 groups according to estimated glomerular filtration rate and serum creatinine level.Limitations: The small number of patients and short follow-up prevent generalizations.Conclusions: A 12-month regimen of MMF did not decrease mean proteinuria over creatinuria ratio or increase partial and complete remissions. Serious adverse effects were observed in 4 patients (20%) receiving MMF.