吗替麦考酚酯联合激素治疗特发性膜性肾病36个月的前瞻对照性研究

目的 观察吗替麦考酚酯(MMF)联合糖皮质激素(泼尼松)治疗特发性膜性肾病(IMN)肾病综合征36个月的疗效及安全性,并与环磷酰胺(CTX)联合泼尼松疗法相比较。方法 肾病综合征膜性肾病患者26例(男17例,女9例),年龄20~68岁,中位年龄为43岁。随机平均分为2组:CTX联合泼尼松治疗组(C组)和MMF联合泼尼松治疗组(M组)。泼尼松初始剂量均为1 mg/(kg·d)早上一次顿服,后逐渐减量,两组维持治疗方案基本一致。用药前及用药后3、12、24、36个月分别检测24 h尿蛋白定量、血清白蛋白、肝功能、肾功能以及血常规。总疗程平均为(36.1±7.8)个月。结果 C组和M组患者尿蛋白排泄量的减少和血浆白蛋白的升高在治疗后3、12、24、36个月程度相似,组间比较差异无统计学意义;C组和M组肾病综合征总体缓解率在治疗后36个月分别为69.2%、77.0%,两组间各时间点差异均无统计学意义;两组肾功能均保持稳定,两组白细胞减少症、肝酶升高等不良反应较多。结论 MMF联合激素对IMN肾病综合征的36个月疗效与CTX联合激素相近,MMF安全性较好。提示MMF为难治性IMN选用免疫抑制剂的可靠选择药物之一。

Mycophenolate mofetil combined with prednisone for treatment of idiopathic membranous nephropathy with nephrotic syndrome: a 36-month prospective controlled study

Objective To explore the efficacy and safety of mycophenolate mofetil(MMF) combined with corticosteroid(prednisone) for treatment of idiopathic membranous nephropathy(IMN) for 36 months by comparing with cyclophosphamide(CTX) combined with prednisone.Methods A prospective,randomized controlled study was performed.A total of 26 patients with biopsy-proved IMN and nephritic syndrome were recruited in this study.There were 17 males and 9 females,with a median age of 43.They were evenly randomized into two groups: CTX plus prednisone(group C) and MMF plus prednisone(group M).The initial dose of prednisone was 1 mg/(kg·d) in the morning and then gradually decreased in both groups.The 24-hour urinary protein excreation,serum albumin and creatitine,estimated glomerular filtration rate(eGFR) and white cell count were examined before and 3,12,24 and 36 months after drug administration.The average median follow-up was(36.1±7.8) months.Results The proteinuria reduction and serum albumin elevation were similar in the two groups at 3,12,24 and 36 months after drug treatment,with no significant difference found at specific time points.The overall remission rates of nephrotic syndrome(’complete’ and ’partial’) was 69.2% in group C and 77.0% in group M at 36 months after treatment,showing no significant difference between the two groups.Serum creatinine and eGFR remained stable in the two groups during follow-up.Group C had more leucopenia and abnormality of liver enzyme compared with group M.Conclusion A 36-month treatment with MMF plus prednisone is as effective as the conventional treatment with CTX plus prednisone for primary treatment of IMN with nephrotic syndrome;MMF has less adverse effects than CTX for long term treatment.It is indicated that MMF may be a reliable drug for patients with refractory IMN.