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维生素E治疗IgA肾病:一项双盲、安慰剂对照研究。

Vitamin E therapy in IgA nephropathy: a double-blind, placebo-controlled study.

作者信息

Chan James C M, Mahan John D, Trachtman Howard, Scheinman Jon, Flynn Joseph T, Alon Uri S, Lande Marc B, Weiss Robert A, Norkus Edward P

机构信息

Virginia Commonwealth University, Richmond, Virginia, USA.

出版信息

Pediatr Nephrol. 2003 Oct;18(10):1015-9. doi: 10.1007/s00467-003-1205-2. Epub 2003 Aug 12.

DOI:10.1007/s00467-003-1205-2
PMID:12920628
Abstract

IgA nephropathy is the world's most common primary glomerulonephropathy. Recent evidence in a rat model implicated excessive production of oxygen-free radicals in the pathogenesis and suggested that vitamin E-treatment ameliorated progression. We studied this antioxidant therapy on the glomerular filtration rate (GFR), proteinuria and hematuria in biopsy-proven IgA nephropathy in children. The duration of treatment or placebo was 2 years, with vitamin E treatment consisting of 400 IU/day in children weighing <30 kg, and twice that dose for those >30 kg. We measured GFR at entry, midpoint and exit. At baseline and at 4-month intervals after randomization, urinary protein/creatinine ratios and urinalysis were examined. The mixed model procedure with log transformation was used in data analysis to test treatment difference as well as the potential time effect. Fifty-five patients were randomized and 38 completed at least 1 year of follow-up. At entry, the clinical characteristics were not different between the treatment and placebo groups. There was a trend toward better preservation of GFR in vitamin E-treated versus placebo patients, 127+/-50 vs. 112+/-31 ml/min/1.73 m(2), respectively ( P=0.09). The urinary protein/creatinine ratio was significantly lower in the vitamin E-treated group vs. placebo; 0.24+/-0.38 vs. 0.61+/-1.37 ( P<0.013). However, there was no difference in the prevalence of hematuria between the groups. Vitamin E treatment in our study patients was associated with significantly lower proteinuria, but no effect on hematuria. While there was a trend toward stabilization of GFR in the vitamin E-treated patients, long-term treatment and follow-up are needed to determine whether antioxidant therapy is associated with preservation of renal function in IgA nephropathy.

摘要

IgA 肾病是全球最常见的原发性肾小球肾炎。最近在大鼠模型中的证据表明,发病机制中存在过量的氧自由基产生,并提示维生素 E 治疗可改善病情进展。我们研究了这种抗氧化疗法对经活检证实的儿童 IgA 肾病患者的肾小球滤过率(GFR)、蛋白尿和血尿的影响。治疗或安慰剂的疗程为 2 年,维生素 E 治疗方案为:体重<30 kg 的儿童每日 400 IU,体重>30 kg 的儿童剂量加倍。我们在入组时、中期和结束时测量 GFR。在基线以及随机分组后每隔 4 个月,检测尿蛋白/肌酐比值和尿液分析。数据分析采用对数转换的混合模型程序来检验治疗差异以及潜在的时间效应。55 例患者被随机分组,38 例完成了至少 1 年的随访。入组时,治疗组和安慰剂组的临床特征无差异。维生素 E 治疗组患者的 GFR 较安慰剂组有更好的保留趋势,分别为 127±50 与 112±31 ml/min/1.73 m²(P = 0.09)。维生素 E 治疗组的尿蛋白/肌酐比值显著低于安慰剂组;分别为 0.24±0.38 与 0.61±1.37(P<0.013)。然而,两组间血尿的发生率无差异。在我们的研究患者中,维生素 E 治疗与显著降低蛋白尿相关,但对血尿无影响。虽然维生素 E 治疗组患者的 GFR 有稳定趋势,但需要长期治疗和随访来确定抗氧化疗法是否与 IgA 肾病患者的肾功能保留相关。

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