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肾脏病与透析肾移植杂志 ›› 2012, Vol. 21 ›› Issue (2): 109-114.

• 论文 • 上一篇    下一篇

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

  

  • 出版日期:2012-04-28 发布日期:2012-04-18

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

  • Online:2012-04-28 Published:2012-04-18

摘要:

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2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,后续泼尼松剂量为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)/隔月,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59例患者入组,其中治疗组29例,对照组30例,治疗6个月,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,适合汉族IMN患者诱导治疗,其长期疗效及复发率有待进一步研究观察。

Abstract:

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 > 3.5g/d were enrolled in this trial. They were randomized to be given methylprednisolone (0.5g intravenously for 3 consecutive days followed by oral predsine, 0.4mg/kg per d for 27d) alternated every other month with cyclophosphamide 0.75g/m2BSA intravenously (MP+CTX group) and Valsatan 160mg/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. 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.

Key words:  , idiopathic membranous nephropathy, intravenous pulse cyclophosphamide, Chinese patients