Department of Pharmacy, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital South Branch, Fujian Provincial Jinshan Hospital, Fuzhou, Fujian Province, China.
Department of Otorhinolaryngology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian Province, China.
J Clin Pharmacol. 2022 Nov;62(11):1426-1434. doi: 10.1002/jcph.2099. Epub 2022 Jul 5.
Tigecycline is a broad-spectrum antibacterial agent. As the incidence of multidrug-resistant bacterial infections has increased in intensive care units (ICUs) over the past decades, tigecycline is often used in ICUs. Information about tigecycline-associated hepatotoxicity in ICU patients is limited. To investigate the potential risk factors for tigecycline-associated hepatotoxicity in ICU patients, 148 patients from 2 centers who had received tigecycline for at least 4 days were retrospectively analyzed. Hepatotoxicity was classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (5.0) grading system. As a result, 33.8% of patients experienced hepatotoxicity events in the ICU. The multivariate analysis showed that an albumin concentration <25 g/L at baseline (odds ratio, 3.714; 95%CI, 1.082-12.744; P = .037) and treatment duration (odds ratio, 1.094; 95%CI, 1.032-1.160; P = .003) were significantly correlated with tigecycline-associated hepatotoxicity. The median time to onset of hepatotoxicity was 8.0 days. The median duration ICU stay and the in-hospital mortality rate were not different between the hepatotoxicity group and the nonhepatotoxicity group (33.5 days (interquartile range, 21.0-72.0) vs 31.0 days (interquartile range, 21-62.5), P = .850; 38.0% vs 43.8%; P = .504). Therefore, close monitoring of liver function is recommended for patients with baseline albumin concentrations <25 g/L or for patients who receive tigecycline therapy for >8 days.
替加环素是一种广谱抗菌药物。在过去几十年中，由于重症监护病房（ICU）中多重耐药菌感染的发病率增加，替加环素常在 ICU 中使用。有关 ICU 患者中替加环素相关肝毒性的信息有限。为了研究 ICU 患者中替加环素相关肝毒性的潜在危险因素，对来自 2 个中心的 148 例至少接受 4 天替加环素治疗的患者进行了回顾性分析。肝毒性根据国家癌症研究所不良事件通用术语标准（5.0）分级系统进行分类。结果，33.8%的患者在 ICU 中发生了肝毒性事件。多变量分析显示，基线时白蛋白浓度<25 g/L（比值比，3.714；95%置信区间，1.082-12.744；P=.037）和治疗持续时间（比值比，1.094；95%置信区间，1.032-1.160；P=.003）与替加环素相关肝毒性显著相关。肝毒性发生的中位时间为 8.0 天。肝毒性组和非肝毒性组的 ICU 住院时间中位数和院内死亡率无差异（33.5 天（四分位距，21.0-72.0）与 31.0 天（四分位距，21-62.5），P=.850；38.0%与 43.8%，P=.504）。因此，建议对基线白蛋白浓度<25 g/L 的患者或接受替加环素治疗>8 天的患者密切监测肝功能。
