Liver injury caused by Chronic hepatitis B
Conditions
Interventions
Control group:Reduced glutathione, 1.2 g / time, 1 time / day, 4 weeks of treatment
Treatment group:Shuganning injection, 20ml / time, 1 time / day, 4 weeks of treatment
8 weeks after stopping the drug
Sponsors
Beijing Youan Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, gender not limited; 2. Complete informed consent voluntarily, and temporarily has no intention to start antiviral treatment; 3. Patients with chronic hepatitis B liver injury, whose diagnostic criteria are accord with "viral hepatitis prevention and control plan" in 2000, and "guideline of the chronic hepatitis B prevention" in 2015 by the Chinese medical association; The specific standard is: (1) With history of chronic hepatitis B is longer than 6 months; (2) Serum HBsAg positive, HBeAg positive or negative, anti - HBe positive or negative, HBV DNA positive; (3) ALT:60 U/L-800 U/L;TBil =10ULN;PTA=50%;d. liver tissue pathology is accord with diagnosis of chronic hepatitis standards (appendix 1). (4) Diagnosis in accordance with the above standard (which have 1, 2, 3 or 1, 2, 4, can be diagnosed as chronic hepatitis B liver injury).
Exclusion criteria
Exclusion criteria: 1. Hepatitis A, hepatitis C, hepatitis E, CMV, EBV and other virus infection; 2. Other liver damage caused by autoimmune liver disease, drug-induced hepatitis, fatty hepatitis, chemicals and so on; 3. With severe cardiovascular, renal, endocrine, blood system, nerve system disease, mental disease and malignant tumor patients; 4. ALT>800 U/L, TBil >10ULN, PTA<50%; 5. Drug allergy to Shu Gan Ning injection; 6. Pregnancy and lactation women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total bilirubin;direct bilirubin;aspartate aminotransferase;alanine aminotransferase;Gamma - glutamate transpeptidase;alkaline phosphatase;albumin;Total bile acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| the largest diameter of right hepatic lobe;diameter of portal venous trunk;the spleen diameter;diameter of splenic vein;value of liver stiffness;value of liver steatosis;hyaluronic acid;laminin;? collagen;? collagen;HBV-DNA;HBsAg;HBsAb;HBeAg;HBeAb;HBcAb;triglyceride;high-density lipoprotein;low density lipoprotein;cholesterol;gamma-interferon;alpha-interferon;interleukin 4;interleukin 6;interleukin 8;interleukin 10;Symptoms and signs of TCM quantitative score;red blood cell count;hemoglobin;white blood cell count;neutrophil count;blood platelet count;leukocytes in urine;urine erythrocyte;urine protein;blood urea nitrogen;serum creatinine;electrocardiogram; | — |
Countries
China
Contacts
Public ContactDuan Zhongping
Beijing Youan Hospital, Capital Medical University
Outcome results
None listed