Analysis of Clinical Characteristics of Chronic Hepatitis B Virus Infection Complicated With Metabolic Associated Fatty Liver Disease Among Patients With Different Traditional Chinese Medicine Syndrome Types: A Retrospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Liver stiffness measurement (LSM) value
Study Overview
Brief Summary
This is a retrospective cross-sectional observational clinical study. We will collect clinical medical records of patients diagnosed with chronic hepatitis B combined with metabolic associated fatty liver disease who received treatment at Foshan Hospital of Traditional Chinese Medicine. The main purpose is to explore the characteristics of renal function related indicators in these patients, analyze the influencing factors of early renal tubular injury caused by long-term antiviral therapy, and summarize the clinical correlation between liver metabolic abnormalities and early kidney damage. No additional invasive examinations or intervention measures will be performed on patients; only existing historical inpatient and outpatient medical data will be sorted out and statistically analyzed. All personal privacy information of subjects will be strictly desensitized and protected throughout the study
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged between 18 and 70 years old, male and female patients are both eligible.
- •Meet the diagnostic criteria of chronic hepatitis B (CHB): HBsAg positive for more than 6 months, detectable HBV DNA, accompanied by abnormal liver function, hepatic inflammation or liver fibrosis, and other liver diseases are excluded.
- •Diagnosed with metabolic associated fatty liver disease (MAFLD) confirmed by imaging examination (ultrasound, CT or MRI) with hepatic steatosis ≥5%; patients meet at least one metabolic abnormality standard: BMI ≥25kg/m², fasting glucose ≥5.6mmol/L or type 2 diabetes, hypertension, dyslipidemia; patients without other etiologies of liver injury such as alcoholic liver disease and drug-induced liver injury.
- •Classified into 5 TCM syndrome types by experienced physicians through four diagnostic methods: spleen damp-heat syndrome, liver depression and spleen deficiency syndrome, spleen deficiency and phlegm-damp syndrome, damp-heat accumulation syndrome, damp-heat blood stasis syndrome.
- •Patients fully understand the study content and voluntarily sign the written informed consent form.
- •Complete clinical laboratory, imaging and four-diagnosis record data available for retrospective analysis.
Exclusion Criteria
- •Patients with decompensated cirrhosis (Child-Pugh grade C) or liver failure.
- •Complicated with end-stage renal disease, malignant tumors, severe cardiovascular diseases and other severe systemic diseases.
- •Pregnant or lactating women.
- •Patients with mental disorders who cannot cooperate with data collection and clinical evaluation.
- •Long-term users of immunosuppressants.
- •Patients with incomplete medical records that cannot support complete index analysis.
- •Patients with other confounding liver diseases interfering with the judgment of MAFLD and CHB.
Outcomes
Primary Outcomes
Liver stiffness measurement (LSM) value
Time Frame: Baseline
Retrospectively collect liver stiffness measurement (LSM) data of patients diagnosed with chronic hepatitis B combined with metabolic associated fatty liver disease. We compare the differences in the degree of liver fibrosis among five different traditional Chinese medicine syndrome types.
Secondary Outcomes
No secondary outcomes reported
Investigators
Lan haiyan
Resident Physician, Department of Hepatology
Foshan Hospital of Traditional Chinese Medicine