Drug-induced liver injury
Conditions
Interventions
Observation group:None
Sponsors
Zhongda Hospital, Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Hospitalized patients aged 18–85 years, regardless of gender; (2) Those treated with traditional Chinese medicinal materials, decoction pieces, or formula granules; (3) Those with confirmed drug-induced liver injury (DILI), or presenting with a marked elevation of ALT, AST, ALP, or TBil after drug administration; for those with abnormal baseline liver enzymes, a post-drug elevation of more than twice the available baseline average level that cannot be explained by underlying liver disease; those developing obvious non-specific liver disease-related symptoms after drug administration; or those with unexplained liver injury or liver disease, especially after exclusion of other common etiologies; (4) Complete clinical data and documentation (including general patient information, symptoms and signs, four-examination information in traditional Chinese medicine, Chinese and Western medicine diagnoses, syndrome differentiation, therapeutic principles and methods, prescription name and composition, auxiliary examinations, etc.).
Exclusion criteria
Exclusion criteria: (1) Patients with incomplete medical record data that may affect evaluation or data analysis; (2) Those co-infected with HIV, or with a history of viral hepatitis, or positive serological markers for hepatitis viruses; (3) Those who have undergone liver transplantation; those with acute or exacerbated liver injury due to various causes; those with liver failure; those complicated with grade 3/4 hepatic encephalopathy; those with active hepatocellular carcinoma lesions; those with esophagogastric variceal bleeding; those with severe/advanced peritoneal or pleural effusion requiring puncture drainage or albumin supplementation; those with hepatorenal syndrome, or other conditions deemed by the investigator as unsuitable for participation; (4) Those complicated with severe primary diseases of the cardiovascular, cerebrovascular, renal, or hematopoietic systems, or with peptic ulcer disease, or with serious diseases affecting survival (e.g., malignancies), or with mental or legal disabilities; (5) Those with suspected or confirmed history of alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT = 5 × ULN;ALP = 2×ULN, especially when accompanied by elevated 5'-nucleotidase or GGT, and excluding those caused by bone diseases.;ALT = 3 × ULN and TBil = 2 × ULN;If a patient presents with ALT = 3×ULN, especially accompanied by elevated TBil, increased INR, and/or significant clinical symptoms, and if the abnormal liver biochemical indicators are reasonably associated with the timing of drug administration or discontinuation, and other non-drug-related causes of liver injury can be ruled out, the possibility of drug-induced liver injury should be considered. Assessment of the relationship between the drug and liver injury: Use the liver injury causality assessment scale to evaluate the likelihood (e.g., RUCAM/RECAM = 6 points).; | — |
Countries
China
Contacts
Public ContactLinlin Hu
Zhongda Hospital, Southeast University
Outcome results
None listed