The main characteristics and mechanism of liver injury caused by the combination of Chinese and Western drugs

Phase 1

• Conditions: drug-induced liver injury

• Registration Number: ITMCTR2000003728
• Lead Sponsor: Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Prospective follow-up cohort of liver injury caused by tripterygium wilfordii preparation combined with different Western medicine:
(1) patients with rheumatoid arthritis (ra) basic diseases, one of the admission diagnosis of drug-induced liver injury or drug-induced liver disease or drug-induced hepatitis or drug-induced liver damage or drug cirrhosis or drug-induced liver failure or use other diagnostic terminology hints may be an various types of drug-induced liver injury patients, diagnostic criteria, meet above drug-induced liver injury and causation RUCAM score of 3 or more cases;
(2) No limitation on age and gender; sign informed consent.
Clinical study on DILI induced by immunocheckpoint inhibitor combined with Traditional Chinese medicine:
(1) basic diseases of liver cancer patients, the hospital diagnosis of drug-induced liver injury or drug-induced liver disease or drug-induced hepatitis or drug-induced liver damage or drug cirrhosis or drug-induced liver failure or use other diagnostic terminology hints may be an various types of drug-induced liver injury patients, diagnostic criteria, meet above drug-induced liver injury and causation RUCAM score of 3 or more cases;
(2) No limitation on age and gender; sign informed consent.

Exclusion Criteria

Prospective follow-up cohort of liver injury caused by tripterygium wilfordii preparation combined with different Western medicine:
(1) The possibility of drug-induced liver injury has been clearly excluded at the time of discharge diagnosis of various types of liver injury;
(2) Patients with incomplete clinical key data, unable to make clinical judgment on DILI diagnosis or unable to use RUCAM scale for causal assessment;
(3) Liver damage caused by exposure to toxic chemicals;
(4) Patients with liver injury combined with other factors such as virus, immunity, alcohol, genetic metabolism, bile duct, blood vessel, etc.;
(5) Non-rheumatoid arthritis patients.
Clinical study on DILI induced by immunocheckpoint inhibitor combined with Traditional Chinese medicine:
(1) The possibility of drug-induced liver injury has been clearly excluded at the time of discharge diagnosis of various types of liver injury;
(2) Patients with incomplete clinical key data, unable to make clinical judgment on DILI diagnosis or unable to use RUCAM scale for causal assessment;
(3) Liver damage caused by exposure to toxic chemicals;
(4) Patients with liver injury combined with other factors such as virus, immunity, alcohol, genetic metabolism, bile duct, blood vessel, etc.;
(5) Non-liver cancer patients.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
outcoms related to viral hepatitis A;Renal biochemical;outcoms related to viral hepatitis B;outcoms related to viral hepatitis C;blood routine examination;B-mode ultrasound;autoantibody;routine urine test;ECG;immune globulin;liver biochemical;outcoms related to viral hepatitis E;outcoms related to viral hepatitis D;