Fujiwara Naoki, Haze Tatsuya, Wakui Hiromichi, Tamura Kouichi, Tsuiki Mika, Kamemura Kohei, Taura Daisuke, Ichijo Takamasa, Takahashi Yutaka, Watanabe Minemori, Kobayashi Hiroki, Nakamura Toshifumi, Izawa Shoichiro, Wada Norio, Yamada Tetsuya, Yokota Kenichi, Naruse Mitsuhide, Sone Masakatsu
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
YCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University Hospital, Yokohama, Japan.
Hypertens Res. 2025 Feb;48(2):540-552. doi: 10.1038/s41440-024-01943-w. Epub 2024 Oct 15.
The new Japanese guidelines for primary aldosteronism introduce a category in the judgment of functional confirmatory tests that is called the "borderline range," which is rare in the other international guidelines. The clinical characteristics of this borderline group are not yet understood. To investigate whether this borderline group has any significant differences in terms of target organ damage, we used data from a Japanese nationwide registry (JPAS-II) of individuals with primary aldosteronism or essential hypertension to compare the borderline group with the definitive-positive group and the negative group. We analyzed the cases of 1785 patients based on their captopril-challenge test results. Since the JPAS-II database contains plasma aldosterone concentration values obtained based on both radioimmunoassay (n = 1555) and chemiluminescent enzyme immunoassay (n = 230) principles, we converted these values to their equivalents as if measured by chemiluminescent enzyme immunoassay and conducted all analyses under the simulated condition. Multicovariate-adjusted models revealed significant prevalance odds ratios for chronic kidney disease (2.01, 95% confidence interval: 1.13 to 3.61), electrocardiographic abnormalities (1.66, 95% confidence interval: 1.16 to 2.37). No significant difference was observed between the borderline and negative groups in these assessments (odds ratio [95% confidence interval] for chronic kidney disease: 0.73 [0.26 to 2.02] and electrocardiographic abnormalities: 1.01 [0.60 to 1.70]). We confirmed that the prevalence of target organ damage increases linearly as the aldosterone-to-renin ratio rises following the captopril challenge test. These results provide material to consider regarding the significance of the provisionally established borderline group.
日本原发性醛固酮增多症新指南引入了功能确认试验判断中的一个类别,称为“临界范围”,这在其他国际指南中很少见。这个临界组的临床特征尚不清楚。为了研究这个临界组在靶器官损害方面是否存在任何显著差异,我们使用了来自日本全国原发性醛固酮增多症或原发性高血压患者登记处(JPAS-II)的数据,将临界组与确诊阳性组和阴性组进行比较。我们根据卡托普利激发试验结果分析了1785例患者的病例。由于JPAS-II数据库包含基于放射免疫分析(n = 1555)和化学发光酶免疫分析(n = 230)原理获得的血浆醛固酮浓度值,我们将这些值转换为仿佛通过化学发光酶免疫分析测量的等效值,并在模拟条件下进行所有分析。多变量调整模型显示慢性肾病(优势比2.01,95%置信区间:1.13至3.61)、心电图异常(优势比1.66,95%置信区间:1.16至2.37)的显著患病率优势比。在这些评估中,临界组和阴性组之间未观察到显著差异(慢性肾病的优势比[95%置信区间]:0.73[0.26至2.02],心电图异常:1.01[0.60至1.70])。我们证实,卡托普利激发试验后,随着醛固酮与肾素比值升高,靶器官损害的患病率呈线性增加。这些结果为考虑临时设立的临界组的意义提供了参考资料。