| Objective: To evaluate the efficacy and safety of Chaixiong Huaxian granule combined with Entecavir in the treatment of liver fibrosis in patients with chronic hepatitis B of qi stagnation and blood stasis,so as to provide reference for clinical application.Methods: Sixty patients with liver fibrosis of chronic hepatitis B who met the inclusion criteria in the outpatient Department of Hepatology of Zaozhuang traditional Chinese Medicine Hospital from December 2021 to December 2022 were randomly divided into control group(n=30)and experimental group(n=30).The control group was treated with Entecavir dispersible tablets,and the experimental group was treated with Chaixiong Huaxian granule for 12 weeks.During medication,avoid raw,cold,spicy,greasy and other foods and other drugs that may affect the clinical efficacy.Before and after treatment,liver function(ALT,AST,TBIL,ALB),HBV-DNA,four items of liver fibrosis(HA,LN,PCⅢ,CIV),LSM,hepatobiliary and pancreatic splenic ultrasound(internal diameter of portal vein and thickness of spleen)and safety indexes were detected before and after treatment.The symptoms of the patients were recorded and the TCM syndrome scores were calculated,and the curative effect was determined.The collected data were collated and analyzed by statistical software SPSS25.0.To evaluate the clinical efficacy and safety of Chaixiong Huaxian granule combined with Entecavir.Results:(1)Liver function index: After 12 weeks of treatment,the serum levels of ALT,AST and TBIL in the control group and the experimental group were significantly decreased,and the level of ALB in the serum was also significantly increased.The level of ALT in the experimental group was better than that in the control group,and the levels of AST,TBIL and ALB in the experimental group were significantly better than those in the control group.(2)HBV-DNA: After 12 weeks of treatment,the level of HBV-DNA in the control group and the experimental group decreased significantly,and there was no significant difference between the control group and the experimental group.The results showed that there was no significant difference between the experimental group and the control group in reducing the level of HBV-DNA.(3)Four items of hepatic fibrosis: After treatment,the levels of HA,LN,PC Ⅲ and C Ⅳ in the control group and the experimental group were significantly decreased,and the effect of improving the four indexes of hepatic fibrosis in the experimental group was better than that in the control group.(4)LSM: After treatment,the LSM values of the control group and the experimental group were significantly lower than those before treatment,and the LSM value of the experimental group was better than that of the control group(P<0.05).(5)Hepatobiliary pancreas and spleen color ultrasound: after treatment,the diameter of portal vein and the thickness of spleen in the control group and the experimental group decreased significantly(P<0.01),and the experimental group was better than the control group(P<0.05).(6)The curative effect of TCM syndrome: The scores of TCM syndrome in the control group and the experimental group were lower than those before treatment,and the score in the experimental group was significantly better than that in the control group(P<0.01).The effective rate of TCM syndrome in the control group was 63.33%,and that in the experimental group was 93.33%,indicating that the experimental group could significantly improve the clinical performance of patients,and its curative effect was significantly better than that in the control group(P<0.01).(7)Clinical comprehensive effect: The effective rate of the control group was 63.33%,and that of the experimental group was86.67%,and the clinical comprehensive effect of the experimental group was better than that of the control group(P<0.05).(8)Safety: There were no adverse reactions in the control group and the experimental group during the whole treatment,and there were no obvious abnormalities in blood routine,urine sediment,fecal sediment,electrocardiogram,blood coagulation and renal function.Conclusion: In the treatment of chronic hepatitis B fibrosis with qi stagnation and blood stasis,the combination of Chaixiong Huayxin granules and Entecavir has the same efficacy as that of Entecavir dispersive tablets alone in reducing HBV-DNA level.The comprehensive clinical efficacy of the former is superior to the latter.The combined treatment of Chaixionghuaoxian granules with Entecavir can more effectively relieve the clinical symptoms of patients,reduce the serum ALT,AST and TBIL levels of patients,increase the serum ALB level,reduce the liver fibrosis index level,reduce the liver hardness value,portal vein diameter and spleen thickness,inhibit and improve the degree of liver fibrosis.The clinical safety is good,worthy of promotion and application. |
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