Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver Disease

Capital Medical University

Status: Completed

Conditions: Autoimmune Liver Disease

Treatments: Drug: Glycyrrhizic acid preparation

Study type: Observational

Funder types: Other

Identifiers

NCT04028869

DTXY018

Details and patient eligibility

About

This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.

Full description

This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.

Enrollment: 400 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Patients with autoimmune liver disease: All enrolled autoimmune liver diseases meet the diagnostic criteria of China's Consensus on Diagnosis and Treatment of Autoimmune Liver Disease (2015);
• 2. no hormones and / or immunosuppressants and other liver protection drugs;
• 3. Sign the written informed consent form.

Exclusion criteria

• 1. Combine other hepatitis virus (HCV, HDV) infections;
• 2. viral liver disease;
• 3. HIV infection;
• 4. long-term alcohol abuse and / or other liver damage drugs;
• 5. mental illness;
• 6. Evidence of liver tumors (liver cancer or AFP > 100 ng/ml);
• 7. decompensated cirrhosis;
• 8. Serious diseases such as heart, brain, lung, kidney, etc. can not participate in long-term follow-up;
• 9. There are hormones and / or immunosuppressants and other liver protection drugs.

Trial design

400 participants in 1 patient group

Glycyrrhizin preparation treatment group

Description:

Clinical effect of glycyrrhizic acid preparation for 144 weeks of autoimmune liver disease and safety during treatment

Treatment:

Drug: Glycyrrhizic acid preparation