Asai Yuki, Yamamoto Takanori, Sato Yoshiharu
Pharmacy, National Hospital Organization Mie Chuo Medical Center; 2158-5 Hisaimyojincho, Tsu, Mie, 514-1101 Japan.
Pharmacy, National Hospital Organization Mie Chuo Medical Center; 2158-5 Hisaimyojincho, Tsu, Mie, 514-1101 Japan.
J Infect Chemother. 2022 May;28(5):690-695. doi: 10.1016/j.jiac.2022.01.024. Epub 2022 Feb 9.
INTRODUCTION: There is limited information regarding antifungal-induced liver injuries, which have high mortality rates. Therefore, we used the Japanese Adverse Drug Event Report (JADER) database for signal detection associated with antifungal-induced liver injuries and medical records for risk assessment. METHODS: Reports of antifungal-induced liver injuries from JADER data were analyzed to calculate the reporting odds ratio (ROR) and 95% confidence interval (CI). A medical record-based study involving 109 adult patients treated with micafungin shows liver injury as the primary outcome in patients treated with micafungin. The albumin-bilirubin (ALBI) score was calculated based on albumin and total bilirubin levels. We selected five explanatory factors for multivariable logistic regression: alanine aminotransferase ≥20 IU/L, alkaline phosphatase ≥372 IU/L, aspartate aminotransferase ≥25 IU/L, ALBI score ≥ -1.290, and age ≥65 years. RESULTS: Signal detection for micafungin was observed in both, hepatocellular and cholestatic injuries, as per data from JADER. Univariate analyses performed on medical records suggest that alanine aminotransferase (p = 0.008), aspartate aminotransferase (p = 0.036), alkaline phosphatase (p = 0.045), and ALBI score (p = 0.028) may be factors associated with micafungin-induced liver injury. Based on multivariable logistic regression, the adjusted odds ratio for micafungin-induced liver injury in patients with ALBI score ≥ -1.290 was 2.78 (95% CI: 1.014-7.605, p = 0.047), suggesting that low hepatic functional reserve could be a risk factor for micafungin-induced liver injury. CONCLUSIONS: Careful monitoring of liver function may be necessary for micafungin administration in patients with low hepatic functional reserve.
引言:关于抗真菌药物引起的肝损伤的信息有限,而此类肝损伤死亡率很高。因此,我们使用日本药品不良事件报告(JADER)数据库进行与抗真菌药物引起的肝损伤相关的信号检测,并通过医疗记录进行风险评估。 方法:分析JADER数据中抗真菌药物引起的肝损伤报告,以计算报告比值比(ROR)和95%置信区间(CI)。一项基于医疗记录的研究纳入了109例接受米卡芬净治疗的成年患者,将肝损伤作为接受米卡芬净治疗患者的主要结局。根据白蛋白和总胆红素水平计算白蛋白-胆红素(ALBI)评分。我们选择了五个解释因素进行多变量逻辑回归:丙氨酸氨基转移酶≥20 IU/L、碱性磷酸酶≥372 IU/L、天冬氨酸氨基转移酶≥25 IU/L、ALBI评分≥ -1.290以及年龄≥65岁。 结果:根据JADER数据,在肝细胞损伤和胆汁淤积性损伤中均观察到米卡芬净的信号检测。对医疗记录进行的单变量分析表明,丙氨酸氨基转移酶(p = 0.008)、天冬氨酸氨基转移酶(p = 0.036)、碱性磷酸酶(p = 0.045)和ALBI评分(p = 0.0
J Infect Chemother. 2023-9
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