Ooi Hayahide, Asai Yuki, Kondo Yoshihiro, Tashiro Takumi, Zakoji Nobuyuki, Aoki Maria, Koriyama Yoshiki, Iwamoto Takuya, Takahashi Masaaki
Pharmacy, National Hospital Organization Mie Chuo Medical Center, Tsu, Japan.
Department of Pharmacy, Mie University Hospital, Faculty of Medicine, Mie University, Tsu, Japan.
Ann Pharmacother. 2025 Mar 12:10600280251319519. doi: 10.1177/10600280251319519.
Although therapeutic drug monitoring (TDM) maintains serum teicoplanin (TEIC) concentration between 15 and 30 μg/mL, TEIC-induced liver injury may still occur. The albumin-bilirubin (ALBI)-fibrosis-4 (FIB-4) score may be useful for predicting TEIC-induced liver injury in patients undergoing TDM.
This pilot study aimed to investigate whether the ALBI-FIB4 score can predict TEIC-induced abnormal liver enzyme levels in patients undergoing TDM.
The multicenter retrospective cohort study included 140 patients undergoing TDM of TEIC at steady state. The primary outcome was TEIC-induced abnormal liver enzyme levels. Cut-off values for the alanine aminotransferase (ALT), ALBI score, FIB-4 index, and ALBI-FIB4 score were detected using receiver-operating characteristic curves. The cumulative risk of TEIC-induced abnormal liver enzyme levels was evaluated using Kaplan-Meier curves analyzed log-rank test. Subgroup analysis was performed to examine cumulative risk in patients with serum TEIC concentration of <30 μg/mL.
The incidence of TEIC-induced abnormal liver enzyme levels was 14.3% (20/140). Cut-off values were 24 IU/L for ALT (sensitivity: 0.800; specificity: 0.692; area under the curve [AUC]: 0.753), -1.33 for the ALBI score (sensitivity: 0.550; specificity: 0.617; AUC: 0.539), 2.73 for the FIB-4 index (sensitivity: 0.700; specificity: 0.475; AUC: 0.550), and -0.85 for the ALBI-FIB4 score (sensitivity: 0.800; specificity: 0.467; AUC: 0.572). The cumulative risk of TEIC-induced abnormal liver enzyme levels was significantly higher for patients with ALT ≥24 IU/L ( < 0.01) and ALBI-FIB4 score ≥-0.85 ( = 0.042). Patients with a serum TEIC concentration of <30 µg/mL exhibited a similar trend, with a higher cumulative risk for patients with ALBI-FIB4 score ≥-0.85 ( = 0.058).
An ALBI-FIB4 score ≥-0.85 may serve as a potential predictor for TEIC-induced abnormal liver enzyme levels in patients undergoing TDM. However, evidence supporting this threshold requires further statistical validation using a larger dataset.
尽管治疗药物监测(TDM)可使替考拉宁(TEIC)血清浓度维持在15至30μg/mL之间,但仍可能发生TEIC诱导的肝损伤。白蛋白-胆红素(ALBI)-纤维化-4(FIB-4)评分可能有助于预测接受TDM的患者发生TEIC诱导的肝损伤。
本初步研究旨在调查ALBI-FIB4评分是否能预测接受TDM的患者发生TEIC诱导的肝酶水平异常。
这项多中心回顾性队列研究纳入了140例处于稳态接受TEIC TDM的患者。主要结局是TEIC诱导的肝酶水平异常。使用受试者工作特征曲线检测丙氨酸氨基转移酶(ALT)、ALBI评分、FIB-4指数和ALBI-FIB4评分的临界值。使用经对数秩检验分析的Kaplan-Meier曲线评估TEIC诱导的肝酶水平异常的累积风险。进行亚组分析以检查血清TEIC浓度<30μg/mL的患者的累积风险。
TEIC诱导的肝酶水平异常的发生率为14.3%(20/140)。ALT的临界值为24 IU/L(敏感性:0.800;特异性:0.692;曲线下面积[AUC]:0.753),ALBI评分为-1.33(敏感性:0.550;特异性:0.617;AUC:0.539),FIB-4指数为2.73(敏感性:0.700;特异性:0.475;AUC:0.550),ALBI-FIB4评分为-0.85(敏感性:0.800;特异性:0.467;AUC:0.572)。ALT≥24 IU/L(<0.01)和ALBI-FIB4评分≥-0.85(=0.042)的患者发生TEIC诱导的肝酶水平异常的累积风险显著更高。血清TEIC浓度<30µg/mL的患者表现出类似趋势,ALBI-FIB4评分≥-0.85的患者累积风险更高(=0.058)。
ALBI-FIB4评分≥-0.85可能是接受TDM的患者发生TEIC诱导的肝酶水平异常的潜在预测指标。然而,支持该阈值的证据需要使用更大的数据集进行进一步的统计学验证。