Retrospective Clinical Study On The Treatment Of Hepatitis B Cirrhosis With Bielongruangan Tablet

Objective:The clinical efficacy and safety of Bielong Ruangan capsule combined with antiviral therapy for hepatitis B cirrhosis were analyzed by retrospective clinical study.Methods:Clinical data of patients diagnosed with hepatitis B cirrhosis who visited the inpatient department and outpatient department of hepatology,The First Affiliated Hospital of Hunan University of Chinese Medicine from January 2014 to December2016 were collected for 5 years.Patients were screened according to inclusion and exclusion criteria and were divided into the primary treatment group(n = 216)and the primary control group(n = 78).The patients in the original treatment group and the original control group were matched with propensity score according to baseline data(age,sex,drinking history,BMI,ALT,AST,PLT and Child-Pugh grading),and 138patients(69 in the control group and 69 in the treatment group)were matched.The occurrence and time of clinical endpoint events of cirrhosis in 5 years,digestive bleeding at different platelet levels and other adverse reactions in the treatment group were observed.Results : 1.Before PSM,there was no significant difference in the incidence of clinical endpoint events of cirrhosis between the primary treatment group and the control group(34.7% : 42.3%,P=0.234);After PSM,the incidence of clinical end-point events of cirrhosis in the treatment group was significantly lower than that in the control group(29% vs.44.9%,P=0.002).2.Before PSM,the mean time of clinical endpoint events of cirrhosis in the primary treatment group was later than that in the primary control group(33.87～12.25 months: 26.21～10.12 months,P=0.002).After PSM,the mean time of clinical endpoint events of cirrhosis in the treatment group was later than that in the control group(35.95～ 13.53 months: 26.55～ 10.33 months,P=0.007).3.Before PSM,there was no difference in the overall incidence of gastrointestinal bleeding between the original control group and the original treatment group(11.5% : 11.1%,P=0.918);After PSM,there was no difference in the overall incidence of gastrointestinal bleeding between the control group and the treatment group(11.6% : 8.7%,P=0.573).4.According to different PLT counts,315 patients(original treatment group + lost follow-up patients + withdrawal patients)were divided into 4 layers(PLT<30×109/L,30×109/L≤PLT<50×109/L,50×109/L≤PLT<100×109/L,PLT≥100×109/L).There were 3 cases(7.1%)of gastrointestinal bleeding in PLT< 30×109/L group,and 12 cases(28.6%)in PLT<50×109/L group.In the 50×109/L≤PLT<100×109/L group,25 patients(59.5%)had gastrointestinal bleeding,and in the PLT≥100×109/L group,2 patients(4.7%)had gastrointestinal bleeding.There was no statistical significance in the incidence of gastrointestinal bleeding among different levels(P=0.154>0.05).Conclusion: 1.Bielong Ruangan capsule can reduce and delay the occurrence of clinical endpoint events of cirrhosis,mainly by reducing the occurrence of ascites and SBP,and can delay the occurrence of clinical endpoint events of cirrhosis for 9.4months.2.Bielong Ruangan capsule has good clinical safety and does not increase the risk of gastrointestinal bleeding.