Chronic hepatitis B, Metabolic dysfunction-associated steatotic liver disease and primary liver cancer
Conditions
Interventions
Task 1 "Efficacy Verification and Mechanism Study of Etiology Blockade Combined with Fufang Biejia Ruangan Tablets in Preventing Hepatocellular Carcinoma in Hepatitis B Patients with Qi Stagnation and
Task 1 "Efficacy Verification and Mechanism Study of Etiology Blockade Combined with Fufang Biejia Ruangan Tablets in Preventing Hepatocellular Carcinoma in MASLD Patients with Qi Stagnation and Blood
Task 2 "Efficacy Verification and Mechanism Study of Antiviral threapy Combined with Babao Dan Capsule in Preventing Hepatocellular Carcinoma in Hepatitis B Patients with Damp-Heat Toxin Accumulation
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) All patients have given informed consent to participate in this study and signed the informed consent form. (2) Aged 18 to 65 years old, regardless of gender. (3) The clinical diagnosis of CHB conforms to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition): positive for HBsAg and/or HBV DNA for more than 6 months. (4) The diagnosis of MASLD conforms to the Guidelines for the Prevention and Treatment of Metabolic-Associated (Non-Alcoholic) Fatty Liver Disease (2024 Edition): liver biopsy, imaging tests or serum biomarkers indicate hepatic steatosis, while meeting at least one abnormal metabolic risk factor, including overweight/obesity, type 2 diabetes mellitus (T2DM) or metabolic syndrome (MetS). (5) High-risk population for CHB-related liver cancer (meeting one of the following four criteria): aged >= 40 years old with a family history of liver cancer or liver cirrhosis; abnormal liver cancer-related serological indicators (such as AFP, AFP-L3, GP73, DCP); liver nodules detected by imaging; compensated liver cirrhosis caused by hepatitis B (Child-Pugh Class A). (6) High-risk population for MASLD-related liver cancer (meeting one of the following four criteria): FIB-4>2.67; FIB-4 between 1.3 and 2.67 combined with LSM > 15kPa (FibroScan®); combined with diabetes, FIB-4 between 1.3 and 2.67 combined with LSM > 10kPa (FibroScan®); liver biopsy showing >=F3 fibrosis. (7) TCM syndrome differentiation is "qi stagnation and blood stasis syndrome" or "damp-heat toxin accumulation syndrome".
Exclusion criteria
Exclusion criteria: (1) Patients with severe or end-stage liver diseases such as complicated chronic severe hepatitis, decompensated liver cirrhosis, or liver cancer. (2) Patients with other complicated liver diseases, such as alcoholic liver disease, autoimmune liver disease, and metabolic liver disease. (3) Pregnant women, lactating women, and patients planning to have children in the near future. (4) Patients with allergic diathesis or allergies to the used Fufang Biejia Ruangan Tablets/Babao Dan. (5) Patients using other drugs that have a significant impact on the immune system, such as thymopeptides, immunosuppressants, and glucocorticoids. (6) Patients with uncontrollable severe primary diseases of the heart, kidneys, lungs, endocrine system, blood system, metabolism, and gastrointestinal tract; patients with mental illness; or patients with autoimmune diseases. (7) Patients with complicated infections of other viral liver diseases (hepatitis A, hepatitis C, hepatitis D, hepatitis E, hepatitis caused by Epstein-Barr virus, and hepatitis caused by cytomegalovirus). (8) Patients with unceased alcoholism or drug addiction. (9) Patients with long-term use of liver-damaging drugs. (10) Patients deemed unsuitable for inclusion in this trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of liver cancer;Cumulative Liver Disease-Related Mortality Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine (TCM) Syndrome Score;Cumulative Incidence of Decompensated Liver Cirrhosis;Liver Transplantation Rate; | — |
Countries
China
Contacts
Public ContactShuangsuo Dang
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed