尿试纸条法（Micraltest II）在2型糖尿病和原发性高血压微量白蛋白尿筛查中的应用

Utility of the Dipstick Micraltest II in the screening of microalbuminuria of diabetes mellitus type 2 and essential hypertension.

作者信息

Cortés-Sanabria Laura, Martínez-Ramírez Héctor R, Hernández José L, Rojas-Campos Enrique, Canales-Muñoz José L, Cueto-Manzano Alfonso M

机构信息

Coordinación de Salud Pública, Delegación Jalisco, IMSS.

出版信息

Rev Invest Clin. 2006 May-Jun;58(3):190-7.

PMID:16958293

Abstract

BACKGROUND

In Mexico, diabetes mellitus type 2 and hypertension are leading causes of end-stage renal disease. Diagnosis of early renal damage with detection of microalbuminuria (microAlbU) is fundamental for treatment and prevention, and so avoiding the catastrophes of renal failure. For screening purposes, several simplified tests, including dipstick methods, fulfill the accuracy requirements for microAlbU detection compared with gold standards; however, no study has established the reliability of such tests in our setting.

AIM

To evaluate the utility of micraltest II as a screening test for microAlbU compared with nephelometry in patients with diabetes mellitus type 2 and non-diabetic patients with essential hypertension.

PATIENTS AND METHODS

Patients with diabetes mellitus type 2 as well as patients with essential hypertension of any age, sex and time of evolution, attending to three primary health-care units (UMF No. 3, 92 and 93, Guadalajara, Jalisco) were included. Patients with transitory albuminuria, secondary hypertension and serum creatinine > or = 2 mg/dL were excluded. Micraltest II was performed in the first morning urine sample, and nephelometry was performed in a 24-h urine collection. Diagnostic accuracy of the dipstick test was then determined.

RESULTS

245 patients were studied: 71 (29%) were diabetics without hypertension, 95 (39%) were diabetics with hypertension, and 79 (32%) had only essential hypertension. In diabetic patients, micraltest II sensitivity was 83%, specificity 96%, and positive and negative predictive values were 95% and 88%, respectively. Correlation between nephelometry and micraltest II results was 0.81 (p < 0.001). The best cut-off point for microAlbU was 30.5 mg/L, and area under the curve (+/- SEM) was 0.91 +/- 0.03 (confidence interval 95%: 0.85-0.96). In non-diabetic patients with essential hypertension, micraltest II sensitivity was 75%, specificity 95%, and positive and negative predictive values were 43% and 99%, respectively. Correlation between nephelometry and micraltest II results was 0.43 (p < 0.001). The best cut-off point for microAlbU was 28.2 mg/L, and area under the curve was 0.85 +/- 0.13 (0.60-1.10).

CONCLUSION

Micraltest II dispstick is a rapid, valid and reliable method for albuminuria screening in patients with diabetes mellitus type 2 and in those non-diabetic patients with essential hypertension in our setting.

摘要

背景

在墨西哥，2型糖尿病和高血压是终末期肾病的主要病因。通过检测微量白蛋白尿（微量AlbU）来诊断早期肾损伤对于治疗和预防至关重要，从而避免肾衰竭的灾难性后果。出于筛查目的，包括试纸法在内的几种简化检测方法与金标准相比，满足微量AlbU检测的准确性要求；然而，尚无研究确定此类检测方法在我们的环境中的可靠性。

目的

评估与比浊法相比，Micraltest II作为2型糖尿病患者和非糖尿病原发性高血压患者微量AlbU筛查试验的效用。

患者和方法

纳入在哈利斯科州瓜达拉哈拉市的三个初级卫生保健单位（第3、92和93号基层医疗单位）就诊的2型糖尿病患者以及任何年龄、性别和病程的原发性高血压患者。排除暂时性蛋白尿、继发性高血压和血清肌酐≥2mg/dL的患者。在晨尿样本中进行Micraltest II检测，在24小时尿液收集样本中进行比浊法检测。然后确定试纸检测的诊断准确性。

结果

共研究了245例患者：71例（29%）为无高血压的糖尿病患者，95例（39%）为有高血压的糖尿病患者，79例（32%）仅患有原发性高血压。在糖尿病患者中，Micraltest II的敏感性为83%，特异性为96%，阳性预测值和阴性预测值分别为95%和88%。比浊法与Micraltest II结果之间的相关性为0.81（p<0.001）。微量AlbU的最佳截断点为30.5mg/L，曲线下面积（±SEM）为0.91±0.03（95%置信区间：0.85-0.96）。在非糖尿病原发性高血压患者中，Micraltest II的敏感性为75%，特异性为95%，阳性预测值和阴性预测值分别为43%和99%。比浊法与Micraltest II结果之间的相关性为0.43（p<0.001）。微量AlbU的最佳截断点为28.2mg/L，曲线下面积为0.85±0.13（0.60-1.10）。