Risk Factors for Pseudoaldosteronism with Yokukansan Use: Analysis Using the Japanese Adverse Drug Report (JADER) Database
Risk Factors for Pseudoaldosteronism with Yokukansan Use: Analysis Using the Japanese Adverse Drug Report (JADER) Database
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DOI：
10.1248/bpb.b20-00424
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发表时间：
2020-10-01
影响因子：
2
通讯作者：
Miyamura, Mitsuhiko
中科院分区：
文献类型：
--
作者：
Ishida, Tomoaki;Kawada, Kei;Miyamura, Mitsuhiko
Yokukansan是老年人常用的汉方配方，因为它有望改善痴呆和谵妄的外周症状。然而，在老年人中经常报告使用它的副作用。特别是，由横干散中含有的甘草引起的假性醛固酮增多症导致高血压、低钾血症和肌肉无力，这可能导致死亡。本研究的目的是确定使用育肝散引起假性醛固酮增多症的危险因素。使用日本不良药物报告（JADER）数据库中报告的病例，计算并比较报告比值比（ROR），以评估每种含甘草的汉方制剂的假醛固酮增多症风险。我们还分析了服用育肝散的患者发生假性醛固酮增多症的危险因素。Yokukansan（ROR 2.4，95%置信区间（CI）1.9-2.8; p < 0.001）与其他含甘草的汉方配方相比，具有更高的假醛固酮增多症风险。此外，对服用育肝散的患者进行逻辑回归分析的结果显示，甘草剂量（OR 1.5，95%CI 1.2-2.0; p < 0.01）、年龄（
Yokukansan is a Kampo formula that is commonly used by the elderly because it is expected to improve peripheral symptoms of dementia and delirium. However, side effects from its use are frequently reported in the elderly. In particular, pseudoaldosteronism caused by the licorice contained in yokukansan leads to hypertension, hypokalemia, and muscle weakness, which may result in death. This study aimed to identify the risk factors of pseudoaldosteronism with yokukansan use. Using cases reported in the Japanese Adverse Drug Report (JADER) database, the reporting odds ratio (ROR) was calculated and compared to assess the risk of pseudoaldosteronism for each licorice-containing Kampo formula. We also analyzed the risk factors for pseudoaldosteronism in patients taking yokukansan. Yokukansan (ROR 2.4, 95% confidence interval (CI) 1.9-2.8; p < 0.001) had a higher risk of pseudoaldosteronism than that of other licorice-containing Kampo formulas. Furthermore, the results of a logistic regression analysis in patients taking yokukansan showed that the licorice dose (OR 1.5, 95% CI 1.2-2.0; p < 0.01), older age (