1. Project Background: Chronic hepatitis B with severe complications is a common and serious clinical syndrome in patients with chronic liver disease, characterized by rapid progression, multiple complications, and extremely high mortality rates, posing a significant threat to the health and lives of people. Currently, modern medicine lacks effective drugs and treatments for the internal management of chronic hepatitis B with severe complications. Traditional Chinese Medicine (TCM) has shown its uniqueness in the treatment of this condition. How to further embody and exploit these advantages of TCM treatment, thereby forming a feasible, safe, effective, and TCM-characteristic integrated traditional Chinese and Western medicine treatment plan for chronic hepatitis B with severe complications, is an important issue. 2. Main Content: Relying on the national 'Eleventh Five-Year' Science and Technology Major Special Project that the project team participates in, it is divided into two parts: The first part involves using prospective, randomized, controlled research methods. Observation of the clinical application of colonoscopy administration and high-position retention enema combined with conventional Western medicine therapy in chronic hepatitis B severe cases. The second part further investigates the mechanism of action of traditional Chinese medicine enema treatment for chronic hepatitis B severe through a rat liver failure model. The first part of the clinical application study used central randomization, divided into treatment and control groups, to observe the survival rate, mortality rate, incidence of complications, TCM clinical symptom scores, and laboratory indicators (ALT, AST, γ-GT, TBIL, DBIL, ALB, GLB, PT, PTA, NH3, TNF-α, ET, HMGB1, sICAM-1) of patients before treatment, at the 4th week of treatment, and at the 8th week of treatment. A total of 111 cases completed the clinical efficacy study, and it was found that compared with the control group, the treatment group had an increased clinical survival rate and decreased mortality rate at the 8th week of treatment. The incidence of complications decreased, and there was a significant improvement in TCM symptom scores, especially the alleviation of jaundice of the body and eyes, fatigue, yellow urine, loss of appetite, abdominal distension, etc. Laboratory test indicators also showed significant improvement. In the second part of the mechanism study, male Wistar rats were randomly divided into eight groups: a blank control group, a model control group, a prevention group (low, medium, high doses), and a treatment group (low, medium, high doses). Except for the blank control group, all other groups were given D-galactosamine + lipopolysaccharide to induce liver failure in rats. The prevention group was administered rhubarb and prunella combination enema 2 hours before modeling and 0 hours after modeling, while the treatment group was administered rhubarb and prunella combination enema at 0, 2, and 4 hours after modeling. After 12 hours of modeling, the rats were sacrificed to observe mortality rates, laboratory indicators (ALT, AST, TBIL, PT, NH3, TNF-α, ET), and changes in liver tissue among the groups. A total of 115 cases were completed in the mechanism study. The research found that enema with Rhubarb and Prunella Combination can control and alleviate liver inflammation, improve coagulation function, acidify the intestines, reduce NH3 absorption by improving endotoxin and blood ammonia levels in rats. 3. Key Innovation Points: For the first time in China, a randomized, controlled method was used to conduct clinical treatment applications for chronic hepatitis B with severe complications through colonic route administration combined with conventional Western medicine therapy. The results showed that this regimen could effectively improve clinical survival rate, reduce mortality rate, decrease the incidence of complications, and significantly improve traditional Chinese medicine symptoms. Enema with Colonic Route Treatment Instrument not only overcomes the shortcomings of shallow enema position and poor drug absorption but also improves comfort during enema and patient compliance by controlling temperature and flow rate. Established the first clinical case information database and serum bank for chronic hepatitis B with severe liver failure combined with traditional Chinese medicine in Shanghai area. 4. Promotion and application: It has been widely used in outpatient clinics and wards of Shanghai Shuguang Hospital, Shanghai Public Health Clinical Center, Pudong New Area Infectious Diseases Hospital, Shanghai Tongren Hospital, and Shanghai Baoshan District Traditional Chinese Medicine Hospital, achieving good economic and social benefits. The research results have been published in 21 papers, and the research papers have participated in domestic and international conferences 8 times. 5. Economic and social benefits: This project established colonic administration and high-position retention enema significantly reduced the mortality rate and complication incidence of chronic hepatitis B with severe liver failure, improved its survival rate, and provided an effective and relatively inexpensive traditional Chinese medicine preparation and treatment for chronic hepatitis B with severe liver failure.