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Value of liver biopsy in the diagnosis of drug-induced liver injury
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Liver biopsy can provide valuable histopathological information that may help clarify the diagnosis of DILI when it is difficult to exclude competing etiologies.
“Liver biopsy can provide valuable histopathological information that may help clarify the diagnosis of DILI when it is difficult to exclude competing etiologies [52].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [52]
Liver biopsy can significantly affect the RUCAM score.
“Recent studies suggest that liver biopsy can significantly affect the score of Roussel-Uclaf causality assessment method (RUCAM) [52].”
From Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update (2024) · cites this paper as [52]
The addition of histological data to the causality assessment process reduces intermediate probabilities and shifts likelihood scores to higher or lower categories, thereby strengthening causality assessment.
“The addition of histological data to the causality assessment process has been shown to reduce intermediate probabilities (more uncertain degrees of probability) and shift likelihood scores to higher or lower categories, thereby strengthening the causality assessment.”
From Methods for causality assessment of idiosyncratic drug‐induced liver injury (2025) · cites this paper as [47]
Histology review changed the causality score in 34 cases (68%), with an increase in DILI likelihood in 24 (48%) and a decrease in 10 (20%).
“Histology review changed the causality score in 34 cases (68%), with an increase in DILI likelihood in 24 (48%) and a decrease in 10 (20%).”
From Drug-induced liver injury. Part I: Classification, diagnosis and treatment (2025) · cites this paper as [23]
An analysis within DILIN covering over 2,000 patients showed that liver biopsy was performed statistically significantly more often when the time between taking a potentially hepatotoxic drug and the onset of liver injury symptoms was longer, on average 2 months, or when more severe liver damage was observed.
“An analysis conducted within the Drug-Induced Liver Injury Network (DILIN), a nationwide registry of DILI in the United States, covering over 2,000 patients, showed that liver biopsy was performed statistically significantly more often when the time between taking a potentially hepatotoxic drug and the onset of liver injury symptoms was longer, on average 2 months, or when more severe liver damage”
From Drug-induced liver injury. Part I: Classification, diagnosis and treatment (2025) · cites this paper as [23]
Only in 8 cases (16%) did the biopsy change the causality score clinically significantly, i.e. from probable to unlikely DILI.
“However, only in 8 cases (16%) did the biopsy change the causality score clinically significantly, i.e. from probable to unlikely DILI [23].”
From Drug-induced liver injury. Part I: Classification, diagnosis and treatment (2025) · cites this paper as [23]
There was no difference in determining causality between patients who underwent biopsy and those who did not.
“Ultimately, there was no difference in determining causality between this group of patients and those in whom biopsy was not performed.”
From Drug-induced liver injury. Part I: Classification, diagnosis and treatment (2025) · cites this paper as [23]
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Research works printed but not linked: 9
- Fontana, 2009, Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct, Drug Saf, 32, 55, 10.2165/00002018-200932010-00005 · DOI · Paper page
- Benichou, 1993, Causality assessment of adverse reactions to drugs--II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge, J Clin Epidemiol, 46, 1331, 10.1016/0895-4356(93)90102-7 · DOI · Paper page
- Rockey, 2010, Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method, Hepatology, 51, 2117, 10.1002/hep.23577 · DOI · Paper page
- Alqahtani, 2015, Identification and characterization of cefazolin-induced liver injury, Clin Gastroenterol Hepatol, 13, 1328, 10.1016/j.cgh.2014.11.036 · DOI
- Chalasani, 2015, United States drug induced liver injury network. Features and outcomes of 899 patients with drug-induced liver injury: the DILIN prospective study, Gastroenterology, 148, 1340, 10.1053/j.gastro.2015.03.006 · DOI · Paper page
- Kleiner, 2014, Hepatic histological findings in suspected drug-induced liver injury: systematic evaluation and clinical associations, Hepatology, 59, 661, 10.1002/hep.26709 · DOI · Paper page
- Suzuki, 2011, The use of liver biopsy evaluation in discrimination of idiopathic autoimmune hepatitis versus drug-induced liver injury, Hepatology, 54, 931, 10.1002/hep.24481 · DOI · Paper page
- Bonkovsky, 2017, Clinical presentations and outcomes of bile duct loss caused by drugs and herbal and dietary supplements, Hepatology, 65, 1267, 10.1002/hep.28967 · DOI · Paper page
- Fontana, 2015, Persistent liver biochemistry abnormalities are more common in older patients and those with cholestatic drug induced liver injury, Am J Gastroenterol, 110, 1450, 10.1038/ajg.2015.283 · DOI
Cited by
Sorted by citations
A revised electronic version of RUCAM for the diagnosis of DILI
Hayashi, P. H., Lucena, M. I., Fontana, R. J., Bjornsson, E. S., Aithal, G. P., Barnhart, H., Gonzalez‐Jimenez, A., Yang, Q., Gu, J., Andrade, R. J., et al. (2022) · Hepatology · doi:10.1002/hep.32327 · Cited by 160
Self-citationChinese guideline for the diagnosis and treatment of drug-induced liver injury: an update
Mao, Y., Ma, S., Liu, C., Liu, X., Su, M., Li, D., Li, Y., Chen, G., Chen, J., Chen, J., et al. (2024) · Hepatology International · doi:10.1007/s12072-023-10633-7 · Cited by 62
Methods for causality assessment of idiosyncratic drug‐induced liver injury
García‐Cortés, M., Matilla‐Cabello, G., & Lucena, M. I. (2025) · Liver International · doi:10.1111/liv.16083 · Cited by 15
The contemporary epidemiology, causes, and management of drug-induced liver injury
Swanson, L., & Fontana, R. J. (2026) · Hepatology Communications · doi:10.1097/hc9.0000000000001011
Metadata
- Authors
- Ahmad, J., Barnhart, H. X., Bonacini, M., Ghabril, M., Hayashi, P. H., Odin, J. A., Rockey, D. C., Rossi, S., Serrano, J., Tillmann, H. L., & Kleiner, D. E.
- ORCID
- Kleiner, David E.
- Venue
- Journal of Hepatology
- Publisher
- Elsevier BV
- Published
- 2022-05
- Volume
- 76
- Issue
- 5
- Pages
- 1070-1078
- ISSN
- 0168-8278
- PMC
- PMC9018618
- Cited by
- 71
- References
- 0
- Language
- en
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