Steroid treatment for severe childhood IgA nephropathy: A randomized, controlled trial

Steroid treatment for severe childhood IgA nephropathy: A randomized, controlled trial
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DOI:
10.2215/cjn.01120905
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发表时间:
2006-05-01
影响因子:
9.8
通讯作者:
Ito, Hiroshi
Ito, Hiroshi
中科院分区:
医学1区
文献类型:
--
作者:
Yoshikawa, Norishige;Honda, Masataka;Ito, Hiroshi

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先前的一项试验表明,在病程早期使用泼尼松龙、硫唑嘌呤、肝素-华法林和潘生丁治疗重度伊加肾病(IgAN)儿童2年,可降低免疫性肾损伤的严重程度,并防止硬化肾小球百分比的任何增加。本研究比较了泼尼松龙、硫唑嘌呤、华法林和双嘧达莫(联合)与泼尼松龙单独治疗80例新诊断的IgAN患儿的效果,这些患儿表现为弥漫性系膜增生。患者被随机分配接受联合或泼尼松龙单用2年。主要终点是蛋白尿的消失,定义为每天尿蛋白排泄< 0.1 g/m2,次要终点是治疗结束时的尿蛋白排泄、试验期间硬化肾小球百分比的变化和不良反应。两个研究组在基线特征方面相似。40名接受联合治疗的患者中有39名,40名接受泼尼松龙治疗的患者中有39名完成了试验。39例接受联合治疗的患者中有36例(92.3%)和39例接受泼尼松龙治疗的患者中有29例(74.4%)在2年随访时达到主要终点(P = 0.007对数秩)。接受联合治疗的患者中硬化性肾小球的百分比没有变化,但泼尼松龙组从3.1 ± 4.8%增加到14.6 ± 15.2%(P = 0.0003)。两组不良反应的发生率相似。结论:联合治疗对重症IgA肾病的疗效优于单用泼尼松龙。
A previous trial showed that treatment of children with severe IgA nephropathy (IgAN) using prednisolone, azathioprine, heparin-warfarin, and dipyridamole for 2 yr early in the course of disease reduced the severity of immunologic renal injury and prevented any increase in the percentage of sclerosed glomeruli. This study compared the effects of prednisolone, azathioprine, warfarin, and dipyridamole (combination) with those of prednisolone alone in 80 children with newly diagnosed IgAN that showed diffuse mesangial proliferation. Patients were randomly assigned to receive either the combination or prednisolone alone for 2 yr. The primary end point was the disappearance of proteinuria, defined as urinary protein excretion < 0.1 g/m(2) per d, and the secondary end points were urinary protein excretion at the end of treatment, the change in the percentage of sclerosed glomeruli during the trial, and adverse effects. The two study groups were similar in terms of baseline characteristics. Thirty-nine of the 40 patients who received the combination and 39 of the 40 who received prednisolone completed the trial. Thirty-six (92.3%) of the 39 patients who received the combination and 29 (74.4%) of the 39 who received prednisolone reached the primary end point by the 2-yr follow-up point (P = 0.007 log-rank). The percentage of sclerosed glomeruli was unchanged in the patients who received the combination but increased from 3.1 +/- 4.8 to 14.6 +/- 15.2% in the prednisolone group (P = 0.0003). The frequency of adverse effects was similar in the two groups. It is concluded that combination treatment may be better for severe IgAN than treatment with prednisolone alone.