Hepatitis B-related cirrhosis
Conditions
Interventions
Compensated Hepatitis B-related Cirrhosis Treatment Group:First-line nucleos(t)ide analog antiviral therapy combined with TCM treatment based on syndrome and constitution differentiation
Compensated Hepatitis B-related Cirrhosis Control Group:First-line nucleos(t)ide analog antiviral therapy
Decompensated Hepatitis B-related Cirrhosis Treatment Group:First-line nucleos(t)ide analog (NAs) antiviral therapy combined with conventional symptomatic treatment and TCM treatment based on syndrome
Decompensated Hepatitis B-related Cirrhosis Control Group:First-line nucleos(t)ide analog (NAs) antiviral therapy combined with conventional symptomatic treatment and TCM treatment based on syndrome
Sponsors
Xinjiang Uyghur Autonomous Region Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnostic Criteria 1) The diagnostic criteria for chronic hepatitis B refer to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition) formulated by the Chinese Society of Hepatology and Chinese Society of Infectious Diseases, Chinese Medical Association;2) The diagnostic criteria for cirrhosis refer to the Clinical Practice Consensus on Liver Cirrhosis in China (2023) formulated by the Chinese Society of Gastroenterology, Chinese Medical Association. 2. Inclusion Criteria 1) Patients with either compensated hepatitis B-related cirrhosis (HBRC) or decompensated HBRC who meet the above diagnostic criteria;2) Aged 18-65 years old, regardless of gender;3) Signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Suspected of hepatocellular carcinoma (HCC); 2) Complicated with other liver diseases; 3) Complicated with severe primary diseases of other systems or malignant tumors; 4) Pregnant or lactating females, or those with recent fertility intentions; 5) Patients with severe mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic Tissue Fibrosis Reversal Rate in Patients with Compensated Hepatitis B-related Cirrhosis (defined as a reduction of =1 stage in fibrosis staging by Ishak score based on liver biopsy);Cirrhosis Recompensation Rate in Patients with Decompensated Hepatitis B-related Cirrhosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence Rate of Cirrhosis Decompensation in Patients with Compensated Hepatitis B-related Cirrhosis;Incidence Rate of Hepatocellular Carcinoma in Patients with Compensated Hepatitis B-related Cirrhosis;Liver Disease-related Mortality Rate in Patients with Compensated Hepatitis B-related Cirrhosis;CTP Score Improvement Rate in Patients with Compensated Hepatitis B-related Cirrhosis;MELD Score Improvement Rate in Patients with Compensated Hepatitis B-related Cirrhosis;Traditional Chinese Medicine Symptom Improvement Rate in Patients with Compensated Hepatitis B-related Cirrhosis;Incidence Rate of Hepatocellular Carcinoma in Patients with Decompensated Hepatitis B-related Cirrhosis;Incidence Rate of Cirrhosis Decompensation after Recompensation in Patients with Decompensated Hepatitis B-related Cirrhosis;Liver Disease-related Mortality Rate in Patients with Decompensated Hepatitis B-related Cirrhosis;CTP Score Improvement Rate in Patients with Decompensated Hepatitis B-related Cirrhosis;MELD Score Improvement Rate in Patients with Decompensated Hepatitis B-related Cirrhosis;Traditional Chinese Medicine Symptom Improvement Rate in Patients with Decompensated Hepatitis B-related Cirrhosis; | — |
Countries
China
Contacts
Public ContactWANG Xiaozhong
Xinjiang Uyghur Autonomous Region Hospital of Traditional Chinese Medicine
Outcome results
None listed