Journal of Hepatology ( IF 25.7 ) Pub Date : 2022-01-21 , DOI: 10.1016/j.jhep.2021.12.043 Jawad Ahmad 1 , Huiman X Barnhart 2 , Maurizio Bonacini 3 , Marwan Ghabril 4 , Paul H Hayashi 5 , Joseph A Odin 1 , Don C Rockey 6 , Simona Rossi 7 , Jose Serrano 8 , Hans L Tillmann 9 , David E Kleiner 10 ,
Background & Aims
The utility of liver biopsy in diagnosing or staging idiosyncratic drug-induced liver injury (DILI) is unclear. The aim of this study was to determine whether liver histology impacted causality assessment in suspected DILI using a novel simulation model.
Methods
Fifty patients enrolled in the DILI Network (DILIN) who had liver biopsies performed within 60 days of DILI onset were randomly selected. All had standard DILIN consensus causality scoring using a 5-point scale (1=definite, 2=highly likely, 3=probable, 4=possible, 5=unlikely) based on 6-month post-injury data. Three experienced hepatologists independently performed a causality assessment using redacted case records, with the biopsy and selected post-biopsy laboratory data removed. The 3 hepatologists also reviewed the liver histology with a hepatopathologist and then repeated causality assessment for each case.
Results
Of the 50 cases, there were 42 high causality DILI cases (1, 2 or 3) and 8 low causality cases (4 and 5). The hepatologists judged that liver biopsy was indicated in 62% of patients; after histology review, biopsy was judged to have been helpful in 70% of patients. Histology review changed the causality score in 68% of patients, with an increase in DILI likelihood in 48% and a decrease in 20%. Biopsy results changed diagnostic certainty from less certain (3 or 4) to highly certain (1, 2 or 5) in 38% of patients.
Conclusions
Liver histologic findings may help clarify the diagnosis of DILI. Histology appears to be particularly helpful in cholestatic or equivocal cases of DILI (possible or probable), shifting assessment toward a greater or lower certainty of a DILI diagnosis.
Lay summary
The utility of liver biopsy in diagnosing or staging idiosyncratic drug-induced liver injury (DILI) is unclear. Herein, we show that, in patients with suspected DILI, a liver biopsy can help physicians diagnose DILI or other causes of liver injury with more certainty.
中文翻译:
肝活检在药物性肝损伤诊断中的价值
背景与目标
肝活检在诊断或分期特殊药物性肝损伤 (DILI) 中的效用尚不清楚。本研究的目的是使用新型模拟模型确定肝脏组织学是否影响疑似 DILI 的因果关系评估。
方法
随机选择 50 名加入 DILI 网络 (DILIN) 的患者,这些患者在 DILI 发病后 60 天内进行了肝活检。所有患者均根据受伤后 6 个月的数据,使用 5 分制(1=确定、2=极有可能、3=可能、4=可能、5=不太可能)进行标准 DILIN 共识因果关系评分。三名经验丰富的肝病专家使用经过编辑的病例记录独立进行了因果关系评估,并删除了活检和选定的活检后实验室数据。三位肝病专家还与肝病理学家一起检查了肝脏组织学,然后对每个病例重复进行因果关系评估。
结果
在这 50 例病例中,有 42 例高因果关系 DILI 病例(1、2 或 3)和 8 例低因果关系病例(4 和 5)。肝病专家判断 62% 的患者适合进行肝活检;经过组织学检查后,活检被认为对 70% 的患者有帮助。组织学检查改变了 68% 患者的因果关系评分,DILI 可能性增加了 48%,减少了 20%。38% 的患者的活检结果使诊断确定性从不太确定(3 或 4)变为高度确定(1、2 或 5)。
结论
肝脏组织学检查结果可能有助于明确 DILI 的诊断。组织学似乎对胆汁淤积或模棱两可的 DILI 病例(可能或很可能)特别有帮助,可将评估转向更高或更低的 DILI 诊断确定性。
外行总结
肝活检在诊断或分期特殊药物性肝损伤 (DILI) 中的效用尚不清楚。在此,我们表明,对于疑似 DILI 的患者,肝活检可以帮助医生更确定地诊断 DILI 或其他肝损伤原因。