Aims: The potential of mechanistic biomarkers to improve prediction of drug-induced liver injury (DILI) and hepatic regeneration is widely acknowledged. We sought to determine reference intervals for new biomarkers of DILI and regeneration, as well as to characterize their natural variability and impact of diurnal variation.
Methods: Serum samples from 227 healthy volunteers were recruited as part of a cross-sectional study; of these, 25 subjects had weekly serial sampling over 3 weeks, while 23 had intensive blood sampling over a 24h period. Alanine aminotransferase (ALT), MicroRNA-122 (miR-122), High Mobility Group Box-1 (HMGB1), total Keratin-18 (K18), caspase-cleaved Keratin-18 (ccK18), Glutamate Dehydrogenase (GLDH) and Macrophage Colony-Stimulating Factor-1 (CSF-1) were assayed.
Results: Reference intervals were established for each biomarker based on the 97.5% quantile (90% CI) following the assessment of fixed effects in univariate and multivariable models. Intra-individual variability was found to be non-significant, and there was no significant impact of diurnal variation.
Conclusion: Reference intervals for novel DILI biomarkers have been described. An upper limit of a reference range might represent the most appropriate mechanism to utilize these data. These data can now be used to interpret data from exploratory clinical DILI studies and to assist their further qualification as required by regulatory authorities.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1111/bcp.16371 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Association of fully branded, standardized packaging and limited flavor and brand descriptors of e-liquids with interest in trying products among youths in Great Britain.
Addiction
January 2025
Department of Addictions, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Background And Aims: Many vaping products feature bright colors and novel brand names and flavor descriptors, which may appeal to youth. We measured the strength of the associations between e-liquid packaging design (branded, white standardized or white standardized limiting brand and flavor descriptors) and perceived peer interest in trying the e-liquids among youth.
Design: A between-subjects online experiment.
Sex differences in the prognosis of nonsustained ventricular tachycardia detected on Holter recording.
Heart Rhythm O2
July 2024
Department of Cardiology, Bispebjerg and Frederiksberg Hospitals, Copenhagen University, Copenhagen, Denmark.
Background: Nonsustained ventricular tachycardia (NSVT) is a common finding during cardiac evaluation and has been linked to increased mortality. While some studies report a sex difference, most data stem from research cohorts.
Objective: This study aimed to assess the prognostic significance of NSVT in a real-life outpatient clinic, focusing on sex differences in mortality.
Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan.
Contemp Clin Trials Commun
February 2025
Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Background: Research on improving psychotherapy for youths with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy (CBT), should explore what works for whom and how by examining baseline moderators and potential mechanisms of change. Emotion dysregulation is proposed as an intermediate therapy factor in a transdiagnostic framework. This study investigates emotion dysregulation as an outcome, mechanism, and moderator of psychotherapy in youths aged 8-17 years with OCD.
View Article and Find Full Text PDFAssociation of sleep duration and all-cause and cancer-specific mortality: results of 2004 national health interview survey (NHIS).
Sleep Biol Rhythms
January 2025
Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, Georgia.
Epidemiologic research has demonstrated a connection between the duration of sleep and the risk of overall mortality. This research investigates the correlation between sleep duration (SD) and the likelihood of all-cause and cancer-specific mortality among cancer patients, exploring the association between SD and mortality risk. The study used the National Health Interview Survey (NHIS) data from 2004, a U.
View Article and Find Full Text PDFEvaluation of Plasma Neurodegenerative Biomarkers for Diagnosing Minimal Hepatic Encephalopathy and Predicting Overt Hepatic Encephalopathy in Chinese Patients with Hepatic Cirrhosis.
J Clin Transl Hepatol
January 2025
Department of Infectious Diseases, Tongji Hospital, Tongji Medical College and State Key Laboratory for Diagnosis and Treatment of Severe Zoonotic Infectious Diseases, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Background And Aims: The performance of neurodegenerative biomarkers-neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), tau, and ubiquitin carboxy-terminal hydrolase L1 (UCHL1)-in diagnosing minimal hepatic encephalopathy (MHE) has not been systematically evaluated, simultaneously, nor have their associations with the development of overt hepatic encephalopathy (OHE). This study aimed to evaluate the performance of plasma NfL, GFAP, tau, and UCHL1 in diagnosing MHE and predicting the development of OHE in Chinese patients with hepatic cirrhosis.
Methods: In this prospective study, 124 patients with hepatic cirrhosis were recruited.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!