Yoshikawa Norishige, Honda Masataka, Iijima Kazumoto, Awazu Midori, Hattori Shinzaburou, Nakanishi Koichi, Ito Hiroshi
Department of Pediatrics, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8509, Japan.
Clin J Am Soc Nephrol. 2006 May;1(3):511-7. doi: 10.2215/CJN.01120905. Epub 2006 Apr 5.
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/m2 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.
一项先前的试验表明，在疾病早期使用泼尼松龙、硫唑嘌呤、肝素 - 华法林和双嘧达莫对重症IgA肾病（IgAN）儿童进行为期2年的治疗，可减轻免疫性肾损伤的严重程度，并防止硬化肾小球百分比增加。本研究比较了泼尼松龙、硫唑嘌呤、华法林和双嘧达莫（联合用药）与单独使用泼尼松龙对80例新诊断为IgAN且表现为弥漫性系膜增生的儿童的影响。患者被随机分配接受联合用药或单独使用泼尼松龙治疗2年。主要终点是蛋白尿消失，定义为尿蛋白排泄<0.1g/m² per d，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以及不良反应。两个研究组在基线特征方面相似。接受联合用药的40例患者中有39例、接受泼尼松龙的40例患者中有39例完成了试验。接受联合用药的39例患者中有36例（92.3%）、接受泼尼松龙的39例患者中有29例（74.4%）在2年随访时达到主要终点（P = 0.007对数秩检验）。接受联合用药的患者硬化肾小球百分比未发生变化，但泼尼松龙组从3.1±4.8%增加至14.6±15.2%（P = 0.0003）。两组不良反应的发生率相似。结论是，对于重症IgA肾病，联合治疗可能比单独使用泼尼松龙治疗效果更好。
