Corticosteroids in IgA nephropathy: a randomised controlled trial

Corticosteroids in IgA nephropathy: a randomised controlled trial
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DOI:
10.1016/s0140-6736(98)03563-6
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发表时间:
1999-03-13
期刊:
影响因子:
168.9
通讯作者:
Locatelli, F
Locatelli, F
中科院分区:
医学1区
文献类型:
--
作者:
Pozzi, C;Bolasco, PG;Locatelli, F

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背景:在大多数病例中,IgA肾病是进行性的,并且还没有确定的治疗方法,在这项随机试验中,我们评估了为期6个月的激素治疗这种疾病的有效性和安全性。方法1987年7月至1995年9月,我们在意大利的7个肾脏单位连续招募了86名患者。符合条件的患者有经活检证实的IgA肾病,每日尿蛋白排泄量为1.0-3.5g,血肌酐浓度为133Mol/L(1.5 mg/dL)或更低。患者被随机分配到单独的支持治疗或类固醇治疗(在第1、3、5个月开始时,每天静脉注射甲基强的松龙Ig,连续3天,加上隔日口服强的松0.5 mg/kg,连续6个月)。主要终点是肾功能恶化,定义为血浆肌酐浓度较基线增加50%或100%。结果激素组43例患者中有9例和对照组43例患者中有14例在第5年的随访中达到主要终点(血肌酐增加50%)(p
Background IgA nephropathy is progressive in most cases and has no established therapy, In this randomised trial, we assessed the efficacy and safety of a 6-month course of steroids in this disorder,Methods Between July, 1987, and September, 1995, we enrolled 86 consecutive patients from seven renal units in Italy. Eligible patients had biopsy-proven IgA nephropathy, urine protein excretion of 1.0-3.5 g daily, and plasma creatinine concentrations of 133 mu mol/L (1.5 mg/dL) or less. Patients were randomly assigned either supportive therapy alone or steroid treatment (intravenous methylprednisolone Ig per day for 3 consecutive days at the beginning of months 1, 3, and 5, plus oral prednisone 0.5 mg/kg on alternate days for 6 months). The primary endpoint was deterioration in renal function defined as a 50% or 100% increase in plasma creatinine concentration from baseline. Analyses were by intention to treat.Findings Nine of 43 patients in the steroid group and 14 of 43 in the control group reached the primary endpoint (a 50% increase in plasma creatinine) by year 5 of follow-up (p