Donadio J V, Bergstralh E J, Offord K P, Holley K E, Spencer D C
Division of Nephrology and Internal Medicine, Mayo Clinic, Rochester, MN 55905.
Clin Nephrol. 1994 Feb;41(2):65-71.
A multicenter, double-blind, placebo-controlled, randomized trial of fish oil in proteinuric patients with IgA nephropathy is being conducted by the Mayo Nephrology Collaborative Group. We completed enrollment of 106 patients into the trial in December 1991. The treatment period is for two years. Hypertension is being managed in all patients with enalapril maleate (Vasotec). We evaluated the associations between a variety of clinical and renal morphologic features and renal function at the entry of all enrolled patients. Among 78 males and 28 females [age(mean +/- SD) 36 +/- 14 years], older age at treatment randomization, hypertension, at disease discovery as well as at study entry, increased fractional excretion of albumin, increased serum triglyceride levels, and more severe tubulointerstitial, vascular, and combined glomerular and tubulointerstitial histologic lesions were all univariately associated (p < or = 0.01) with poorer renal function measured by reciprocal serum creatinine and creatinine clearance levels. In a multiple regression analysis used to predict baseline reciprocal creatinine, the best final model (R2 = 0.48) included male sex (p < .001), hypertension at treatment randomization (p = .001), decreased peripheral blood erythrocytes (p = .001), increased tubulointerstitial score (p = .004), and increased fractional excretion of albumin (p = .025) as independent predictors of decreased kidney function. These associations are similar to those seen in the high-risk subset of patients with IgA nephropathy who develop end-stage renal disease. In the eventual outcome analysis of the clinical trial, we will examine the effects of treatment on the two potentially modifiable risk factors, hypertension and proteinuria, on renal function.
梅奥肾脏病协作组正在进行一项关于鱼油治疗IgA肾病蛋白尿患者的多中心、双盲、安慰剂对照、随机试验。1991年12月我们完成了106例患者的入组。治疗期为两年。所有患者均使用马来酸依那普利(悦宁定)控制高血压。我们评估了所有入组患者入组时各种临床和肾脏形态学特征与肾功能之间的关联。在78名男性和28名女性中(年龄[平均±标准差]36±14岁),治疗随机分组时年龄较大、疾病发现时以及研究入组时患有高血压、白蛋白排泄分数增加、血清甘油三酯水平升高,以及更严重的肾小管间质、血管和肾小球与肾小管间质联合组织学病变,单因素分析均与血清肌酐倒数和肌酐清除率所衡量的较差肾功能相关(p≤0.01)。在用于预测基线肌酐倒数的多元回归分析中,最佳最终模型(R2 = 0.48)包括男性性别(p <.001)、治疗随机分组时的高血压(p = 0.001)、外周血红细胞减少(p = 0.001)、肾小管间质评分增加(p = 0.004)以及白蛋白排泄分数增加(p = 0.025)作为肾功能下降的独立预测因素。这些关联与在发展为终末期肾病的IgA肾病高危亚组患者中所见的关联相似。在该临床试验的最终结果分析中,我们将研究治疗对两个潜在可改变的危险因素,即高血压和蛋白尿,对肾功能的影响。