Clinical Study On The Treatment Of Hepatitis B Cirrhosis In The Compensated Stage By The Biejiaruanganjianpifang

Background:Hepatitis B Cirrhosis is a progressive,diffuse lesion of the liver under the long-term attack of the Hepatitis B Virus.In modern medicine,the prevention and treatment of hepatitis B cirrhosis are based on antiviral and anti-fibrosis,but its safety and efficacy have not yet been strongly verified by evidence-based medicine,while Chinese medicine has been widely recognized for its effectiveness and safety in anti-cirrhosis,especially in reversing liver fibrosis,after years of clinical practice.Guangdong is located in the southern part of the country,and because of its unique geographical characteristics,its unique basic etiology and pathogenesis are the weakness of the spleen and stomach,the external exposure to dampness and heat and poisonous evil,and the evolution of the pathogenesis is the transmission of liver disease to the spleen and the mixture of deficiency and reality.After years of clinical practice,Prof.HeSongqi creatively proposed the treatment principle of supporting righteousness and attacking the evil,treating the liver and spleen together,treating the symptoms by clearing the damp-heat,strengthening the spleen by benefiting the qi and consolidating the essence,softening the hardness,dispersing the nodules,detoxifying and activating the blood circulation,and resolving the blood stasis throughout the treatment.The formula is based on clearing heat and detoxifying toxins,and at the same time activating blood circulation,removing blood stasis,softening hardness and dispersing nodules,and at the same time using a large number of drugs to benefit the qi and strengthen the spleen to protect the spleen and stomach,especially using the characteristic herb of Lingnan,the pearl under the leaf,which has great advantages in treating the compensated stage of hepatitis B cirrhosis in Lingnan area.Objective:To evaluate the clinical efficacy and safety of the combined use of Biejiaruanganjianpifang compared with Western medicine alone in the treatment of patients with hepatitis B cirrhosis in the compensated stage,and to provide a scientific and effective drug idea for the combined Chinese and Western medicine treatment of patients with hepatitis B cirrhosis in the Lingnan area.Methods:A retrospective cohort study design was used to include a total of 90 patients with compensated hepatitis B cirrhosis from April 2017 to April 2022 at the Southern Medical University Hospital of Integrative Medicine.Patients were divided into 39 cases in the combined drug group and 51 cases in the ETV group according to whether they were taking Biejiaruanganjianpifang.By propensity matching and according to the duration of treatment,they were divided into 40 patients within three months of treatment,totaling 20 pairs,and 36 patients within nine months of treatment,totaling 18 pairs.The hepatobiliary-pancreatic-splenic ultrasound score,Liver Stiffness Measurement(LSM),quantitative TCM symptom score,liver function,alpha-fetoprotein(AFP),hepatitis B virus quantification(HBV-DNA mark,HBV-DNA)levels before and after treatment were compared between the two groups,The safety of the drug was determined by comparing the changes in blood routine,urinary routine,renal function and clinical adverse reactions of the two groups before and after treatment.Results:At 9 months of treatment,the hepatobiliary,pancreatic,and splenic ultrasound scores and LSM values were significantly lower in the combination drug group compared with the ETV group(P<0.01);in terms of overall efficiency,the combination drug group was higher than the ETV group,with statistical differences(P<0.05).Throughout the treatment process,compared with the ETV group,the levels of quantitative TCM symptom score,ALT,AST,TBIL,and IBIL decreased in the combination drug group compared with those before treatment,with significant decreases in quantitative TCM symptom score starting from March,ALT and TBIL from June,and AST and IBIL until September(P<0.01).Throughout the treatment process,there were no significant changes in HBsAg serological conversion,HBV-DNA load,and AFP in the two groups before and after treatment,and the differences were not statistically significant(P>0.05);no abnormal safety indicators were observed in both groups,and no adverse events occurred.Conclusion:The combination of Biejiaruanganjianpifang was effective in improving liver morphology,LSM values,clinical symptoms,and liver function in patients with hepatitis B cirrhosis in the compensated stage compared with western medicine alone,especially in improving liver morphology,clinical symptoms and reducing LSM values,ALT and TBIL,but not in improving viral serological conversion,reducing HBV-DNA load,DBIL,and AFP.The effect was not significant.Therefore,Soft Liver and Spleen Formula can effectively slow down the process of the hepatitis B cirrhosis compensation phase with definite clinical efficacy and high safety.