PDF(Pubmed)
Abstract：
BACKGROUND: The diagnosis of primary aldosteronism (PA) is comprehensive, which includes case-detection testing, case confirmation followed by subtype classification. In certain instances, such as in the setting of spontaneous hypokalemia, suppressed renin activity (PRA) plus plasma aldosterone concentration (PAC) of > 15 ng/dL, one may not proceed with confirmatory tests. However, the quality of evidence behind this approach is very low. This study sought to evaluate the proposed \"simplified confirmatory pathway\" that can spare confirmatory testing for primary aldosteronism by evaluating the diagnostic performances of the various pre-specified PAC thresholds in combination with findings of suppressed renin and spontaneous hypokalemia.
METHODS: This is a multi-center, retrospective diagnostic accuracy cohort-selected cross-sectional study. A total of 133 participants aged 18 years and above underwent saline infusion test between January 2010 to March 2024. The outcome measures comprise of the diagnostic performances of the different index test combinations (baseline PAC, baseline PRA and presence of spontaneous hypokalemia): sensitivity, specificity, negative predictive value, positive predictive value, positive likelihood ratio, negative likelihood ratio, and diagnostic accuracy. Data analysis was performed using SPSS 29.0.1.0 & MedCalc 20.218.
RESULTS: Of the 133 patients who underwent saline infusion test, 88 (66.17%) were diagnosed with PA. A PAC of > 25 ng/dL plus PRA < 1.0 ng/dL/hr with spontaneous hypokalemia showed the highest specificity at 100% (95% CI 90.51%, 100.00%) and positive predictive value at 100% (85.18 - 100.00%). The minimum acceptable combination criteria were determined to be a PAC of > 20 ng/dL plus PRA < 0.6 ng/dL/hr, and presence of spontaneous hypokalemia. It has high specificity (94.59%; 95% CI 81.81%, 99.34%), positive predictive value (93.55%, 95% CI 78.49%, 98.29%), and moderate positive likelihood ratio (LR+) (6.39, 95% CI 1.61, 25.38) CONCLUSION: A hypertensive patient with spontaneous hypokalemia and screening findings of PAC > 20 ng/dL and suppressed PRA of < 0.6 ng/ml/hr, may be classified as \"overt primary aldosteronism confirmed\" and may not need to proceed with dynamic confirmatory testing.
UNASSIGNED: SRCTN34186253.
METHODS: This is a multi-center, retrospective diagnostic accuracy cohort-selected cross-sectional study. A total of 133 participants aged 18 years and above underwent saline infusion test between January 2010 to March 2024. The outcome measures comprise of the diagnostic performances of the different index test combinations (baseline PAC, baseline PRA and presence of spontaneous hypokalemia): sensitivity, specificity, negative predictive value, positive predictive value, positive likelihood ratio, negative likelihood ratio, and diagnostic accuracy. Data analysis was performed using SPSS 29.0.1.0 & MedCalc 20.218.
RESULTS: Of the 133 patients who underwent saline infusion test, 88 (66.17%) were diagnosed with PA. A PAC of > 25 ng/dL plus PRA < 1.0 ng/dL/hr with spontaneous hypokalemia showed the highest specificity at 100% (95% CI 90.51%, 100.00%) and positive predictive value at 100% (85.18 - 100.00%). The minimum acceptable combination criteria were determined to be a PAC of > 20 ng/dL plus PRA < 0.6 ng/dL/hr, and presence of spontaneous hypokalemia. It has high specificity (94.59%; 95% CI 81.81%, 99.34%), positive predictive value (93.55%, 95% CI 78.49%, 98.29%), and moderate positive likelihood ratio (LR+) (6.39, 95% CI 1.61, 25.38) CONCLUSION: A hypertensive patient with spontaneous hypokalemia and screening findings of PAC > 20 ng/dL and suppressed PRA of < 0.6 ng/ml/hr, may be classified as \"overt primary aldosteronism confirmed\" and may not need to proceed with dynamic confirmatory testing.
UNASSIGNED: SRCTN34186253.
摘要：
背景：原发性醛固酮增多症（PA）的诊断是全面的，其中包括案例检测测试，病例确认，然后进行亚型分类。在某些情况下,例如在自发性低钾血症的背景下，抑制肾素活性（PRA）加上血浆醛固酮浓度（PAC）>15ng/dL，一个人可能不会继续进行验证性测试。然而,这种方法背后的证据质量非常低。本研究旨在通过评估各种预先指定的PAC阈值的诊断性能，结合肾素抑制和自发性低钾血症的发现，评估拟议的“简化的确认途径”，可以节省原发性醛固酮增多症的确认测试。
方法：这是一个多中心，回顾性诊断准确性队列选择横断面研究.在2010年1月至2024年3月期间，共有133名18岁及以上的参与者接受了盐水输注测试。结果测量包括不同指数测试组合的诊断性能(基线PAC，基线PRA和自发性低钾血症的存在)：敏感性，特异性，负预测值，正预测值，正似然比，负似然比，和诊断的准确性。使用SPSS29.0.1.0&MedCalc20.218进行数据分析。
结果：在133名接受生理盐水输注试验的患者中，88例（66.17%）被诊断为PA。>25ng/dL的PAC加上PRA<1.0ng/dL/hr伴自发性低钾血症的特异性最高，为100％（95％CI90.51％，100.00%)，阳性预测值为100%(85.18-100.00%)。最小可接受组合标准被确定为PAC>20ng/dL加上PRA<0.6ng/dL/hr,和自发性低钾血症的存在。它具有很高的特异性(94.59%；95%CI81.81%，99.34%），阳性预测值（93.55%，95%CI78.49%，98.29%），和中度阳性似然比（LR）（6.39，95％CI1.61，25.38）结论：自发性低钾血症的高血压患者，筛查发现PAC>20ng/dL，PRA抑制<0.6ng/ml/hr，可能被归类为“明确的原发性醛固酮增多症确认”，并且可能不需要进行动态确认测试。
■SRCTN34186253。
方法：这是一个多中心，回顾性诊断准确性队列选择横断面研究.在2010年1月至2024年3月期间，共有133名18岁及以上的参与者接受了盐水输注测试。结果测量包括不同指数测试组合的诊断性能(基线PAC，基线PRA和自发性低钾血症的存在)：敏感性，特异性，负预测值，正预测值，正似然比，负似然比，和诊断的准确性。使用SPSS29.0.1.0&MedCalc20.218进行数据分析。
结果：在133名接受生理盐水输注试验的患者中，88例（66.17%）被诊断为PA。>25ng/dL的PAC加上PRA<1.0ng/dL/hr伴自发性低钾血症的特异性最高，为100％（95％CI90.51％，100.00%)，阳性预测值为100%(85.18-100.00%)。最小可接受组合标准被确定为PAC>20ng/dL加上PRA<0.6ng/dL/hr,和自发性低钾血症的存在。它具有很高的特异性(94.59%；95%CI81.81%，99.34%），阳性预测值（93.55%，95%CI78.49%，98.29%），和中度阳性似然比（LR）（6.39，95％CI1.61，25.38）结论：自发性低钾血症的高血压患者，筛查发现PAC>20ng/dL，PRA抑制<0.6ng/ml/hr，可能被归类为“明确的原发性醛固酮增多症确认”，并且可能不需要进行动态确认测试。
■SRCTN34186253。
