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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Autoimmune Liver Disease

Intervention / Treatment
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* Drug: Glycyrrhizic acid preparation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glycyrrhizin preparation treatment group<br>Clinical effect of glycyrrhizic acid preparation for 144 weeks of autoimmune liver disease and safety during treatment | Drug: Glycyrrhizic acid preparation<br>* To analyze the clinical effect of glycyrrhizic acid preparation for autoimmune liver disease for 144 weeks and the safety during treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of sustained biochemical responses | The ratio of sustained biochemical responses at 96 weeks and 144 weeks after treatment with glycyrrhizic acid preparation in patients with autoimmune liver disease | at 96 weeks and 144 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of decompensated liver cirrhosis and liver cancer and its complications | The incidence of decompensated liver cirrhosis and liver cancer and its complications at 96 and 144 weeks after treatment with glycyrrhizic acid in patients with autoimmune liver disease | at 96 and 144 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autoimmune liver disease, glycyrrhizic acid, liver function