Department of Nephrology, National Center for Child Health and Development, Setagaya, Tokyo, Japan.
Clin J Am Soc Nephrol. 2011 Jun;6(6):1301-7. doi: 10.2215/CJN.08630910. Epub 2011 Apr 14.
Children with IgA nephropathy showing diffuse (>80%) mesangial proliferation are at high risk for end-stage renal failure (ESRF). A previous controlled trial showed that combination therapy consisting of prednisolone, azathioprine, heparin-warfarin, and dipyridamole early in the course of disease reduces immunologic renal injury and prevents the progression of sclerosed glomeruli. The objective of this study was to evaluate the long-term effectiveness of combination therapy in children with IgA nephropathy showing diffuse mesangial proliferation.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A secondary analysis of a multicenter, randomized, controlled trial involving 78 children with IgA nephropathy who received either 2-year combination therapy or heparin-warfarin and dipyridamole (control) therapy was conducted.
The median duration of observation was 10 years (range, 0.5 to 18). Two of 40 patients (5%) who received combination therapy and five of 34 patients (14.7%) who received control therapy developed ESRF. A Kaplan-Meier plot of renal survival showed that the outcomes of patients in the combined therapy group were better than those in the control therapy group (log-rank P = 0.03). The 10-year renal survival probability of each group was 97.1% (95% confidence interval, 81.4 to 99.6%) and 84.8% (95% confidence interval, 55.4 to 95.5%), respectively. The Cox proportional hazards model showed that the 2-year combination therapy was significantly associated with renal survival in both univariate and multivariate analyses.
Two-year combination therapy not only ameliorated the activity of the acute phase of nephritis but also improved the long-term outcome of severe childhood IgA nephropathy.
表现为弥漫性（>80%）系膜增殖的 IgA 肾病患儿有发展为终末期肾衰竭（ESRF）的高风险。一项先前的对照试验表明，在疾病早期联合应用泼尼松、硫唑嘌呤、肝素-华法林和双嘧达莫治疗，可减轻免疫性肾损伤并防止硬化性肾小球进展。本研究旨在评估联合治疗对表现为弥漫性系膜增殖的 IgA 肾病患儿的长期疗效。
设计、地点、参与者和测量：对一项多中心、随机、对照试验进行二次分析，该试验纳入了 78 例 IgA 肾病患儿，他们分别接受了 2 年的联合治疗或肝素-华法林和双嘧达莫（对照）治疗。
中位观察时间为 10 年（范围：0.5-18 年）。接受联合治疗的 40 例患者中有 2 例（5%）和接受对照治疗的 34 例患者中有 5 例（14.7%）发展为 ESRF。Kaplan-Meier 肾脏生存曲线显示，联合治疗组患者的结局优于对照组（对数秩 P=0.03）。两组患者的 10 年肾脏生存率分别为 97.1%（95%可信区间：81.4-99.6%）和 84.8%（95%可信区间：55.4-95.5%）。Cox 比例风险模型显示，2 年联合治疗在单因素和多因素分析中均与肾脏生存显著相关。
2 年联合治疗不仅改善了肾炎急性期的活动度，而且改善了严重儿童 IgA 肾病的长期预后。
