Autoimmune hepatitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Group I: Patients with cholestatic liver disease: (1) Age 18~70 years old (including 18 and 70 years old); (2) Elevated serum bilirubin levels; (3) Imaging examination suggests the presence of cholestasis or biliary tract dilatation; (4) Serum alkaline phosphatase (ALP) and ?-glutamyl transferase (GGT) levels were elevated; (5) Liver histology biopsy showed bile duct inflammation; (6) Other patients who may have cholestatic liver disease judged by the clinician to meet any of the above (1) can be enrolled; 2. Group 2: Metabolic-related fatty liver patients: based on liver biopsy histology or imaging or even blood biomarker examination suggesting the presence of fatty liver, and meeting one of the following three conditions: (1) Overweight/obesity: BMI>23kg/m^2; (2) Type 2 diabetes: The diagnostic criteria for type 2 diabetes include fasting blood glucose value greater than 70 mmol/L, random blood glucose value greater than 11.1 mmol/L, glucose load greater than 11.1 mmol/L after two hours, and accompanied by clinical symptoms of polydipsia, polyphagia, polyuria, and weight loss; (3) Metabolic dysfunction (presence of at least two risk factors for metabolic abnormalities): waist circumference: 90/80cm > males and females, respectively; Blood pressure > 130/85 mm Hg or on specific drug therapy; Plasma triglycerides >1.70 mmolL or treated with specific drugs; Plasma HDL-cholesterol: 40 mg/dL ( 2.5; plasma hypersensitive C-reactive protein level > 2 g/L; 3. Group 3: Patients with autoimmune hepatitis: (1) Age 18–70 years (inclusive of 18 and 70); (2) Elevated serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels; (3) Presence of one or more high-titer autoantibodies in the serum; (4) Increased IgG and/or gamma-globulin; (5) Liver histology showing moderate to severe interface hepatitis, lymphoplasmacytic infiltration in the portal and periportal areas, moderate lobular inflammation, or other specific types of AIH manifestations; (6) AIH simplified diagnostic score and comprehensive diagnostic score >10. Any patient meeting one of the above criteria (1) can be included in the group; 4. Group 4: Patients with viral hepatitis: (1) Age 18–70 years (inclusive); (2) Elevated serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels; (3) Presence of one or more high-titer virus-specific markers in serum, such as anti-HAV IgM (hepatitis A), HBsAg and HBV DNA (hepatitis B), HCV RNA (hepatitis C), HDV RNA and HBsAg (hepatitis D), anti-HEV IgM (hepatitis E); (4) Histological examination of the liver showing hepatocellular inflammation and necrosis, with viral inclusions visible in liver parenchyma, or chronic inflammatory changes such as liver fibrosis or cirrhosis. Patients meeting any of the above criteria (1) can be included in the group; 5. Group 5: Patients with hepatitis of other or unknown causes (including genetic, metabolic, and unknown causes):(1) Age 18 to 70 years (inclusive);(2) Elevated serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels.6. Group 6: Patients with normal liver enzymes who require liver bi
Exclusion criteria
Exclusion criteria: 1. Patients with combined liver diseases such as viral hepatitis, metabolic-associated fatty liver disease, Wilson's disease, etc.; 2. Pregnant or breastfeeding women, and patients planning to conceive in the near future; 3. Patients with a history of severe heart disease, including unstable or uncontrolled heart disease within the past 6 months; 4. Patients with a history of psychiatric disorders; 5. Patients with uncontrolled epilepsy; 6. Individuals who have not ceased alcohol or drug abuse; 7. Other conditions deemed unsuitable for enrollment by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alkaline phosphatase;MRI Assessment;Transaminase;bilirubin;autoantibody detection;liver B-ultrasound;immunoglobulin levels;blood routine;stool routine; | — |
Countries
China
Contacts
The First Affiliated Hospital of Wenzhou Medical University