Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Treatment of Autoimmune Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The ratio of sustained biochemical responses
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
- •no hormones and / or immunosuppressants and other liver protection drugs;
- •Sign the written informed consent form.
排除标准
- •Combine other hepatitis virus (HCV, HDV) infections;
- •viral liver disease;
- •HIV infection;
- •long-term alcohol abuse and / or other liver damage drugs;
- •mental illness;
- •Evidence of liver tumors (liver cancer or AFP > 100 ng/ml);
- •decompensated cirrhosis;
- •Serious diseases such as heart, brain, lung, kidney, etc. can not participate in long-term follow-up;
- •There are hormones and / or immunosuppressants and other liver protection drugs.
研究组 & 干预措施
Glycyrrhizin preparation treatment group
Clinical effect of glycyrrhizic acid preparation for 144 weeks of autoimmune liver disease and safety during treatment
干预措施: Glycyrrhizic acid preparation (Drug)
结局指标
主要结局
The ratio of sustained biochemical responses
时间窗: at 96 weeks and 144 weeks after treatment
The ratio of sustained biochemical responses at 96 weeks and 144 weeks after treatment with glycyrrhizic acid preparation in patients with autoimmune liver disease
次要结局
- The incidence of decompensated liver cirrhosis and liver cancer and its complications(at 96 and 144 weeks after treatment)
研究者
Yao Xie
Director of the Second Division of Liver Diseases
Beijing Ditan Hospital