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前瞻性验证一种基于化学发光的自动化肾素和醛固酮检测方法在动脉高血压诊断中的应用。

Prospective validation of an automated chemiluminescence-based assay of renin and aldosterone for the work-up of arterial hypertension.

出版信息

Clin Chem Lab Med. 2016 Sep 1;54(9):1441-50. doi: 10.1515/cclm-2015-1094.

DOI:10.1515/cclm-2015-1094
PMID:26824982
Abstract

BACKGROUND

The availability of simple and accurate assays of plasma active renin (DRC) and aldosterone concentration (PAC) can improve the detection of secondary forms of arterial hypertension. Thus, we investigated the performance of an automated chemiluminescent assay for DRC and PAC in referred hypertensive patients.

METHODS

We prospectively recruited 260 consecutive hypertensive patients referred to an ESH Center for Hypertension. After exclusion of six protocol violations, 254 patients were analyzed: 67.3% had primary hypertension, 17.3% an aldosterone producing adenoma (APA), 11.4% idiopathic hyperaldosteronism (IHA), 2.4% renovascular hypertension (RVH), 0.8% familial hyperaldosteronism type 1 (FH-1), 0.4% apparent mineralocorticoid excess (AME), 0.4% a renin-producing tumor, and 3.9% were adrenalectomized APA patients. Bland-Altman plots and Deming regression were used to analyze results. The diagnostic accuracy (area under the curve, AUC of the ROC) of the DRC-based aldosterone-renin ratio (ARRCL) was compared with that of the PRA-based ARR (ARRRIA) using as reference the conclusive diagnosis of APA.

RESULTS

At Bland-Altman plot, the DRC and PAC assay showed no bias as compared to the PRA and PAC assay. A tight relation was found between the DRC and the PRA values (concordance correlation coefficient=0.92, p<0.0001) and the PAC values measured with radioimmunoassay and chemiluminescence (concordance correlation coefficient=0.93, p<0.001). For APA identification the AUC of the ARRCL was higher than that of the ARRRIA [0.974 (95% CI 0.940-0.991) vs. 0.894 (95% CI 0.841-0.933), p=0.02].

CONCLUSIONS

This rapid automated chemiluminescent DRC/PAC assay performed better than validated PRA/PAC radioimmunoassays for the identification of APA in referred hypertensive patients.

摘要

背景

简单而准确的血浆活性肾素(DRC)和醛固酮浓度(PAC)检测方法的出现,可以提高继发性高血压的检出率。因此,我们研究了一种自动化化学发光分析法检测 DRC 和 PAC 在转诊高血压患者中的应用。

方法

我们前瞻性招募了 260 名连续转诊至 ESH 高血压中心的高血压患者。排除 6 例违反方案的患者后,共分析了 254 例患者:67.3%为原发性高血压,17.3%为醛固酮分泌腺瘤(APA),11.4%为特发性醛固酮增多症(IHA),2.4%为肾血管性高血压(RVH),0.8%为家族性醛固酮增多症 1 型(FH-1),0.4%为假性盐皮质激素过多症(AME),0.4%为肾素分泌性肿瘤,3.9%为已行 APA 肾上腺切除术的患者。采用 Bland-Altman 图和 Deming 回归分析来评估结果。使用 APA 的确诊结果作为参考,比较了基于 DRC 的醛固酮-肾素比值(ARRCL)和基于 PRA 的 ARR(ARRRIa)的诊断准确性(ROC 曲线下面积,AUC)。

结果

在 Bland-Altman 图中,与 PRA 和 PAC 检测相比,DRC 和 PAC 检测无偏倚。DRC 值与 PRA 值之间存在紧密关系(一致性相关系数=0.92,p<0.0001),与放射免疫和化学发光法测量的 PAC 值之间也存在紧密关系(一致性相关系数=0.93,p<0.001)。对于 APA 的识别,ARRCL 的 AUC 高于 ARRRIA [0.974(95%CI 0.940-0.991)比 0.894(95%CI 0.841-0.933),p=0.02]。

结论

这种快速的自动化化学发光 DRC/PAC 检测方法,在检测转诊高血压患者中的 APA 方面,优于经过验证的 PRA/PAC 放射免疫分析。

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