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 wilh 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 0. 75 g/m2BSA 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 ereatinine was stable in two groups. No severe adverse events were observed during the course of treatment. Conclusion; 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.%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＞3.5 g/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0.5 mg/(kg·d),4周后停药,双月予环磷酰胺(CTX)冲击,剂量0.75 g/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160 mg/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.
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