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, p = 0.002), age (OR = 0.971, 95% CI = 0.949–0.994, p = 0.006), and body weight (OR = 0.960, 95% CI = 0.940–0.982, p < 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.

中文翻译：

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他克莫司诱发肾移植受者异质性肝损伤的发生率、临床特征及危险因素：巢式病例对照研究

罕见的数据报告了现实世界中他克莫司引起的肝损伤 (tac-DILI)。我们对 1,010 名肾移植受者进行了巢式病例对照分析。患有 tac-DILI 的接受者在入院年份以 1:4 的比例随机匹配到其余没有 tac-DILI 的接受者，以探索风险因素。tac-DILI 的发生率为 8.9%（95% CI = 7.2–10.7%）。最常见的类型是胆汁淤积型（6.7%，95% CI = 5.2-8.3%），其次是肝细胞型（1.6%，95% CI = 0.8-2.4%）和混合型（0.6%，95% CI = 0.1- 1.1%)。98.9% 的 tac-DILI 接受者病情较轻。总的、肝细胞、分别为混合型和胆汁淤积型。基线 ALP 水平（OR = 1.015，p= 0.002), 年龄 (OR = 0.971, 95% CI = 0.949–0.994, 磷= 0.006）和体重（OR = 0.960，95% CI = 0.940–0.982，p< 0.001) 是独立的危险因素。总之，胆汁淤积模式代表了最常见的 tac-DILI 类型。年轻、低体重和基线 ALP 水平异常是危险因素。