Non-alcoholic Fatty Liver Disease, Renal Function Impairment
Conditions
Keywords
Chronic hepatitis B, antiviral therapy, nucleoside analogs
Brief summary
This is a single-center retrospective observational study. A total of 300 patients with non-alcoholic fatty liver disease treated in our hospital will be included. We collect clinical data, laboratory indicators and imaging results, and analyze the correlation between long-term nucleoside antiviral drugs and renal function changes in patients. The study does not use any new intervention measures, and only conducts statistical analysis on existing medical record data.
Interventions
DRUGLong-term oral nucleos(t)ide analogs antiviral therapy
Oral nucleos(t)ide analog antiviral drugs, including tenofovir alafenamide, tenofovir disoproxil fumarate, entecavir, used for long-term treatment of chronic hepatitis B virus infection. This is a retrospective observational study analyzing renal safety after long-term antiviral treatment.
Sponsors
Foshan Hospital of Traditional Chinese Medicine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Meet the diagnostic criteria for chronic hepatitis B specified in the 2019 Chinese Society of Infectious Diseases guidelines. 2. Patients received continuous NAS antiviral treatment for at least 12 months. 3. Patients voluntarily participated in the study and signed informed consent. 4. Complete records of liver function, renal function, urinary indicators and HBV-DNA data are available.
Exclusion criteria
1. Combined with chronic nephritis, nephrotic syndrome and other primary kidney diseases. 2. Co-infection with hepatitis C virus, hepatitis E virus and other hepatitis viruses. 3. Duration of antiviral treatment less than 12 months. 4. Patients with drug resistance during anti-HBV treatment who switched or combined other antiviral agents. 5. Autoimmune hepatitis, alcoholic liver disease, schistosomal liver disease and other liver diseases. 6. Malignant tumor, severe cardiovascular and other systemic serious diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine level | At baseline (the index assessment). | Serum creatinine levels will be obtained from medical records and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Serum creatinine will be reported in μmol/L. |
| Estimated glomerular filtration rate | At baseline (the index assessment). | Estimated glomerular filtration rate will be determined from serum creatinine using the prespecified equation and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Values will be reported in mL/min/1.73 m². |
| Blood urea nitrogen level | At baseline (the index assessment). | Blood urea nitrogen levels will be obtained from medical records and compared among patients with chronic hepatitis B in the NA-untreated, entecavir-treated, and tenofovir disoproxil fumarate-treated groups. Blood urea nitrogen will be reported in mmol/L. |
Countries
China
Outcome results
None listed