Pamporaki Christina, Remde Hanna, Constantinescu Georgiana, Kürzinger Lydia, Fuss Carmina, Fuld Sybille, Peitzsch Mirko, Schulze Manuel, Alessi Francesco, Lee Myron, Yang Jun, Williams Tracy Ann, Brüdgam Denise, Reincke Martin, Gruber Sven, Beuschlein Felix, Lenders Jacques W M, Eisenhofer Graeme
Department of Medicine III, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden.
Department of Internal Medicine I, Division of Endocrinology and Diabetes, University Hospital, University of Würzburg, Würzburg.
J Hypertens. 2025 Jul 16. doi: 10.1097/HJH.0000000000004098.
Confirmation of primary aldosteronism with the saline infusion test requires accurate measurements of plasma aldosterone, which is best achieved by mass spectrometry. Diagnostic performance, appropriate cut-offs and intra-patient variability of the test remain inadequately defined. The objective of this prospective multicenter cohort study was to address these limitations.
Primary aldosteronism was confirmed and excluded using alternative criteria to confirmatory tests in 138 and 282 respective patients with suspected disease. Those criteria were not satisfied in 89 patients. Diagnostic performance of the saline infusion test and optimal cut-offs were determined from receiver operating characteristic curves. Intra-patient variability was determined in 57 patients.
Analysis of receiver operating characteristic curves indicated an area under the curve of 0.964 and a cut-off of 169 pmol/l for posttest aldosterone concentrations that provided 97% sensitivity and 89% specificity. A cut-off of 255 pmol/l enabled improved specificity of 95% at a sensitivity of 75%. Among the 57 patients in whom the saline infusion test was repeated, 15 (26%) had posttest aldosterone concentrations that were discordant using the 169 pmol/l cut-off. Eighty percent of the discordant results were from a single center. With exclusion of that center, which did not minimize ambulation during saline infusion, the area under the curve increased to 0.985 and an optimal cut-off of 169 pmol/l provided 96% specificity and sensitivity.
The seated saline infusion test with mass spectrometric measurements of aldosterone and the cut-offs documented here provides a useful confirmatory test, although this requires adherence to standard-operating procedures.
通过盐水输注试验确诊原发性醛固酮增多症需要准确测量血浆醛固酮，而这最好通过质谱法实现。该试验的诊断性能、合适的临界值以及患者内变异性仍未得到充分界定。这项前瞻性多中心队列研究的目的就是解决这些局限性。
分别采用替代标准而非确诊试验，对138例疑似原发性醛固酮增多症患者确诊，对282例患者排除该病。另有89例患者不符合这些标准。根据受试者操作特征曲线确定盐水输注试验的诊断性能和最佳临界值。对57例患者测定了患者内变异性。
受试者操作特征曲线分析表明，曲线下面积为0.964，试验后醛固酮浓度的临界值为169 pmol/l时，灵敏度为97%，特异度为89%。临界值为255 pmol/l时，在灵敏度为75%的情况下，特异度提高到95%。在重复进行盐水输注试验的57例患者中，15例（26%）试验后醛固酮浓度依据169 pmol/l的临界值出现不一致情况。80%的不一致结果来自单一中心。排除该中心（该中心在盐水输注期间未尽量减少活动）后，曲线下面积增至0.985，最佳临界值169 pmol/l时，特异度和灵敏度均为96%。
坐位盐水输注试验结合醛固酮的质谱测量以及本文记录的临界值可提供有效的确诊试验，不过这需要遵循标准操作程序。
