Lv Binbin, Liu Longshan, Liu Xiaoman, Huang Min, Chen Xiao, Tang Kejing, Wang Changxi, Chen Pan
Department of Pharmacy, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China.
Front Pharmacol. 2023 Mar 13;14:1126765. doi: 10.3389/fphar.2023.1126765. eCollection 2023.
Rare data reported tacrolimus-induced liver injury (tac-DILI) in real world. We performed a nested case-control analysis of 1,010 renal transplant recipients. Recipients with tac-DILI were randomly matched at a ratio of 1:4 by the year of admission to the remaining recipients without tac-DILI to explore risk factors. The incidence of tac-DILI was 8.9% (95% CI = 7.2-10.7%). The most common type was cholestatic pattern (6.7%, 95% CI = 5.2-8.3%), followed by hepatocellular (1.6%, 95% CI = 0.8-2.4%) and mixed patterns (0.6%, 95% CI = 0.1-1.1%). 98.9% of recipients with tac-DILI have mild severity. The latency period were 42.0 (range, 21.5-99.8 days), 14.0 (range, 9.0-80.3 days), 16.0 (range, 11.5-24.5 days), and 49.0 days (range, 28.0-105.6 days) for total, hepatocellular, mixed, and cholestatic patterns, respectively. Baseline ALP level (OR = 1.015, 95% CI = 1.006-1.025, = 0.002), age (OR = 0.971, 95% CI = 0.949-0.994 = 0.006), and body weight (OR = 0.960, 95% CI = 0.940-0.982, < 0.001) were independent risk factors. In conclusion, cholestatic pattern represents the most frequent type of tac-DILI. Young age, low body weight and abnormal baseline ALP level were risk factors.
现实世界中有罕见数据报道了他克莫司所致肝损伤（他克莫司诱导的药物性肝损伤，tac-DILI）。我们对1010例肾移植受者进行了巢式病例对照分析。将发生tac-DILI的受者按入院年份以1:4的比例与其余未发生tac-DILI的受者进行随机匹配，以探究危险因素。tac-DILI的发生率为8.9%（95%置信区间=7.2-10.7%）。最常见的类型是胆汁淤积型（6.7%，95%置信区间=5.2-8.3%），其次是肝细胞型（1.6%，95%置信区间=0.8-2.4%）和混合型（0.6%，95%置信区间=0.1-1.1%）。98.9%的tac-DILI受者病情为轻度。总型、肝细胞型、混合型和胆汁淤积型的潜伏期分别为42.0天（范围21.5-99.8天）、14.0天（范围9.0-80.3天）、16.0天（范围11.5-24.5天）和49.0天（范围
