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培哚普利与尼群地平治疗早期糖尿病肾病的双盲试验。

A double-blind trial of perindopril and nitrendipine in incipient diabetic nephropathy.

作者信息

Kopf D, Schmitz H, Beyer J, Frank M, Bockisch A, Lehnert H

机构信息

Department of Endocrinology and Metabolism, University of Magdeburg, Germany.

出版信息

Diabetes Nutr Metab. 2001 Oct;14(5):245-52.

Abstract

UNLABELLED

We conducted a randomised, double-blind multicentre trial to compare the efficacy of the inhibitor of the angiotensin-converting enzyme (ACE) perindopril (P) with nitrendipine (N) in incipient diabetic nephropathy.

METHODS

Forty-six patients with insulin-treated diabetes mellitus and mild-to-moderate hypertension and stable microalbuminuria were examined. P 4 or 8 mg once daily was compared to N 20 or 40 mg once daily; an optional open combination treatment with indapamide 2.5 mg once daily was given when needed. Main outcome measures were urinary albumin excretion rate, creatinine clearance and isotopic clearance measurements after 12 months.

RESULTS

Baseline characteristics (blood pressure, HbA1, renal function) were highly comparable between groups. No serious adverse events occurred during the study period. Blood pressure was controlled (<140/90 mmHg) in all patients except for one in each group who dropped out. At the end of the study, albumin excretion rate was stabilized in both groups (P: 72% of baseline, N: 108%, NS). There were no significant differences found in radiometric clearance measurements. Creatinine clearance rose in patients treated with P by 10.0 ml/min on average, while it decreased by 9.8 m/min under N treatment (group effect: p<0.05).

CONCLUSIONS

In this head-to-head comparison, P and N were effective in stabilising most parameters of renal function in incipient diabetic nephropathy.

摘要

未标记

我们进行了一项随机、双盲多中心试验,以比较血管紧张素转换酶(ACE)抑制剂培哚普利(P)与尼群地平(N)在早期糖尿病肾病中的疗效。

方法

对46例接受胰岛素治疗的糖尿病患者进行检查,这些患者患有轻度至中度高血压且微量白蛋白尿稳定。将每日一次服用4或8毫克的P与每日一次服用20或40毫克的N进行比较;必要时可选择每日一次服用2.5毫克吲达帕胺的开放联合治疗。主要观察指标为12个月后的尿白蛋白排泄率、肌酐清除率和同位素清除率测量值。

结果

各组间基线特征(血压、糖化血红蛋白、肾功能)具有高度可比性。研究期间未发生严重不良事件。除每组各有一名退出者外,所有患者的血压均得到控制(<140/90 mmHg)。研究结束时,两组的白蛋白排泄率均稳定(P组:为基线的72%,N组:为108%,无显著性差异)。放射性清除率测量值无显著差异。接受P治疗的患者肌酐清除率平均升高10.0毫升/分钟,而接受N治疗的患者肌酐清除率平均降低9.8毫升/分钟(组间效应:p<0.05)。

结论

在这项直接比较中,P和N在稳定早期糖尿病肾病的大多数肾功能参数方面均有效。

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