激素联合环磷酰胺治疗特发性膜性肾病前瞻性对照性临床观察

Combination therapy of prednisone and cyclophosphamide for patients with idiopathic membranous nephropathy:a prospective randomized controlled trial

目的:Ponticelli方案是KDIGO推荐的特发性膜性肾病(IMN)首选疗法,但其感染等不良反应发生率较高。本研究首次将改良Ponticelli方案治疗汉族IMN患者,前瞻性对照观察该治疗方案的疗效及不良反应。方法:经肾活检并结合临床诊断为IMN患者,尿蛋白>3.5g/24h,随机分为两组。改良Ponticelli方案治疗组:单月予甲泼尼龙(MP)0.5g连续3日静脉冲击,后续泼尼松0.5mg/(kg·d),4周后停药,双月予环磷酰胺(CTX)冲击,剂量0.75g/m2体表面积(BSA),停服泼尼松,总疗程为6月;对照组:单用缬沙坦160mg/d,观察6月后疗效及不良反应。结果:共入组59例患者,其中治疗组29例,对照组30例,治疗6月,治疗组9例(31.0%)患者完全缓解,8例(27.6%)患者部分缓解,有效率为58.6%;对照组无1例完全缓解,仅3例部分缓解,部分缓解率为9.7%;两组患者在治疗过程均未发现严重不良反应发生。结论:改良后的激素联合CTX交替治疗方案可有效减少IMN患者蛋白尿,疗效明显优于缬沙坦治疗对照组。患者安全耐受,治疗不良反应少,其长期疗效及复发率有待进一步研究观察。

Objective：A prospective randomized clinical trial was conducted to evaluate the efficacy and safety of modified methylprednisolone plus intravenous cyclophosphamide pulse therapy in Chinese patients with idiopathic membranous nephropathy （IMN）. Methodology：Fifty-nine patients with biopsy-proven IMN and proteinuria 〉 3.5 g/d were enrolled in this trial. They were randomized to be given methylprednisolone [ 0. 5g intravenously for 3 consecutive days followed by oral predsine, 0. 4 （mg/（kg-d） for 27d] alternated every other month with cyclophosphamide O. 75 g/m2 BSA intravenously （ MP ＋ CTX group） and Valsatan 160 mg/d （ control group）. The whole treatment lasted 6 months. The efficacy and safety of this regimen was evaluated. Results： They were 29 cases in MP ＋ CTX group and 31 cases in control group. The remission rate and complete remission rate were 31.0% and 27.6% in MP ＋ CTX group, 0 and 9.7% in control group respectively after 6 months treatment. The serum creatinine was stable in two groups. No severe adverse events were observed during the course of treatment. Conelusion：A 6-month course of treatment with modified Ponticelli regimen was a useful and safe therapy to reduce proteinuria in Chinese patients with nephrotic IMN.