Drug induced liver injury
Conditions
Interventions
Patients with traditional Chinese medicine induced liver injury:None
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 100 Years
Inclusion criteria
Inclusion criteria: (1) Inclusion criteria for Drug-Induced Liver Injury (DILI): Patients with admission or discharge diagnoses including "drug-induced liver injury" "drug-induced liver disease" "drug-induced hepatitis" "drug-induced hepatic impairment" "drug-induced cirrhosis" "drug-induced liver failure" or other diagnostic terms suggestive of drug-related liver injury meeting the aforementioned DILI diagnostic criteria with cases selected using the RUCAM (Roussel Uclaf Causality Assessment Method) causality assessment protocol (RUCAM score >3). (2) Screening for Herb-Induced Liver Injury (HILI): From the DILI cohort HILI cases were further classified into "suspected diagnosis" "clinical diagnosis" and "confirmed diagnosis" based on the HILI diagnostic criteria.
Exclusion criteria
Exclusion criteria: (1) Cases with confirmed non-drug etiologies Patients whose liver injury was definitively attributed to non-drug causes upon discharge diagnosis (e.g. viral autoimmune or metabolic origins) excluding drug-induced mechanisms. (2) Insufficient clinical data Patients lacking key clinical data (e.g. medication history timeline of symptom onset or laboratory results) rendering clinical judgment of DILI or RUCAM causality assessment impossible. (3) Toxic chemical exposure Liver injury caused by exposure to industrial/environmental toxic chemicals (e.g. carbon tetrachloride aflatoxin). (4) Confounding comorbidities Patients with concurrent liver injury from established non-drug factors including: Viral hepatitis (HBV HCV HEV) Autoimmune hepatitis or primary biliary cholangitis Alcohol-related liver disease Genetic/metabolic disorders (e.g. Wilsons disease hemochromatosis) Biliary or vascular pathologies. (5) Indeterminate causality in herb-drug combinations Cases involving concurrent use of herbs and Western medications where the primary causative agent (herb vs. synthetic drug) cannot be definitively identified.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of HILI in the population; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical epidemiological characteristics of HILI;The relationship between HILI incidence and traditional Chinese medicine physical characteristics as well as traditional Chinese medicine syndromes/elements;Susceptibility genes of HILI; | — |
Countries
China
Contacts
Public ContactGao Yueqiu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed