白蛋白-胆红素评分在治疗药物监测中评估伏立康唑肝毒性的潜力:一项单中心回顾性队列研究。

IF 3.2 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Yuki Asai PhD , Hideo Kato PhD , Isao Tawara MD, PhD , Yuki Nakano PhD , Takuya Iwamoto PhD
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引用次数: 0

摘要

目的:尽管对伏立康唑实施了治疗药物监测(TDM),但其肝毒性发生率仍然很高。白蛋白胆红素(ALBI)评分可用于估计伏立康唑引起的肝毒性。本初步研究旨在探讨ALBI评分是否可以评估TDM实施期间伏立康唑引起的肝毒性。方法:本研究为单中心、回顾性队列研究,纳入134例患者。主要终点是伏立康唑引起的肝毒性。采用受试者工作特征曲线确定ALBI评分的截止值。使用Kaplan-Meier曲线分析和对数秩检验来评估肝毒性累积风险的临界值和ALBI分级。同时对伏立康唑谷浓度为1 ~ 4 μg/mL的患者组进行研究。结果:肝毒性发生率为13.4%(18/134)。ALBI评分的临界值为-1.91(敏感性为0.611;特异性,0.655;曲线下面积,0.615)。ALBI评分≥-1.91组肝毒性累积风险明显高于ALBI评分组。含义:该先导研究表明,即使进行TDM, ALBI评分≥-1.91也可能是伏立康唑诱导肝毒性的一个指标。由于本研究是单中心和小队列设计,进一步的研究应使用大数据集和转化研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Potential of Albumin-Bilirubin Score for Estimating the Voriconazole-Induced Hepatotoxicity Undergoing Therapeutic Drug Monitoring: A Single-Center Retrospective Cohort Study

Purpose

Despite implementation of therapeutic drug monitoring (TDM) for voriconazole, the incidence of hepatotoxicity remains high. The albumin-bilirubin (ALBI) score may be useful for estimating voriconazole-induced hepatotoxicity. This pilot study aimed to investigate whether the ALBI score could estimate voriconazole-induced hepatotoxicity during TDM implementation.

Methods

This single-center, retrospective cohort study included 134 patients. The primary outcome was voriconazole-induced hepatotoxicity. The cutoff value of the ALBI score was determined using a receiver operating characteristic curve. The cumulative risk of hepatotoxicity was evaluated using Kaplan–Meier curve analysis with a log-rank test for the cutoff value and ALBI grade. Moreover, the group of patients with the trough concentration of voriconazole 1−4 μg/mL was also investigated.

Findings

The incidence of hepatotoxicity was 13.4% (18/134). The cutoff value of the ALBI score was -1.91 (sensitivity, 0.611; specificity, 0.655; area under the curve, 0.615). The cumulative risk of hepatotoxicity was significantly higher in the ALBI score ≥-1.91 group than in the ALBI score <-1.91 group (P = 0.024) and patients with higher ALBI grades tended to be at higher risk (P = 0.080). The cumulative risk tended to be higher with ALBI ≥-1.91 in the trough concentration 1−4 μg/mL group; however, no significant difference was found (P = 0.134).

Implications

The pilot study indicated that the ALBI score ≥-1.91 may be an indicator for voriconazole-induced hepatotoxicity even when TDM is conducted. Because this study was a single-center and small cohort design, further studies should be conducted using a large datasets and translational research.
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来源期刊
Clinical therapeutics
Clinical therapeutics 医学-药学
CiteScore
6.00
自引率
3.10%
发文量
154
审稿时长
9 weeks
期刊介绍: Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug and other therapies as well as in diagnostics, pharmacoeconomics, health policy, treatment outcomes, and innovations in drug and biologics research. In addition Clinical Therapeutics features updates on specific topics collated by expert Topic Editors. Clinical Therapeutics is read by a large international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings. Articles are indexed by all major biomedical abstracting databases.
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