Clinical efficacy of Fufang Biejia Ruangan tablets combined with entecavir for patients with chronic hepatitis B and hepatic fibrosis
Objective To investigate the effect of Fufang Biejia Ruangan tablets combined with entecavir for patients with chronic hepatitis B(CHB)and hepatic fibrosis.Methods A total of 80 patients with CHB and liver fibrosis treated at Zhengzhou Sixth People's Hospital from August 2020 to August 2021 were selected for the randomized controlled trial,and were divided into an observation group and a control group by the random number table method,with 40 cases in each group.Three cases dropped out in the observation group[7.5％(3/40)],and 2 cases in the control group[5.00％(2/40)].There were 37 cases in the observation group,including 27 males and 10 females;they were(40.34±9.62)years old;the hepatitis B E antigen(HBeAg)positive rate was 62.20％(23/37);the alanine transaminase(ALT)level was(198.52±50.73)U/L;there were 6,16,10,and 5 cases of F1-F4 of fibrosis stage,respectively.There were 38 cases in the control group,including 29 males and 9 females;they were(39.58±10.17)years old;the HBeAg positive rate was 22(57.90％);the ALT level was(193.66±47.79)U/L;there were 7,14,12,and 5 cases of F1-F4 of fibrosis stages,respectively.The control group orally took entecavir tablets,0.5 mg/time,once per day,and the observation group orally took entecavir tablets,0.5 mg/time,once per day,and Fufang Biejia Ruangan tablets,2.0 g/time,3 times/d,for 12 months.The normalcy rates of ALT and negative conversion rates of hepatitis B virus deoxyribonucleic acid(HBV DNA)were compared between the two groups before the treatment and after 6 and 12 months'treatment.The serum markers of liver fibrosis[hyaluronic acid(HA),procollagen type Ⅲ protein(PCⅢ),laminin(LN),and type Ⅳ collagen(CⅣ)]in both groups were determined by chemiluminescence before the treatment and after 6 and 12 months'treatment.The liver stiffness measurements(LSM)were measured by a transient elastic tester.At the same time,the incidences of adverse reactions in the two groups were analyzed.x2 and t tests and analysis of variance were applied.Results After 6 and 12 months'treatment,the ALT normalcy rates in both the observation group and the control group were higher than those before the treatment(x2=75.542 and 71.356;both P＜0.05).There were no statistical differences in the ALT normalcy rates after 6 and 12 months'treatment between the two groups(both P＞0.05).After 6 and 12 months'treatment,the negative HBV DNA conversion rates in the observation group and the control group were higher than those before the treatment(x2=71.101 and 73.020;both P＜0.05).After 6 and 12 months'treatment,the levels of HA[(103.90±33.78)μg/L vs.(121.53±37.04)μg/L and(86.68±26.72)μg/L vs.(100.61±28.73)μg/L],PC Ⅲ[(116.73±29.54)μg/L vs.(132.73±32.79)μg/L and(89.21±25.30)μg/L vs.(104.51±28.27)μg/L],LN[(110.72±30.97)μg/L vs.(126.84±33.80)μg/L and(92.50±28.40)μg/L vs.(107.42±30.21)μg/L],and CⅣ[(92.50±32.61)μg/L vs.(109.15±35.34)μg/L and(73.38±23.05)μg/L vs.(86.77±26.85)μg/L]in the observation group were lower than those in the control group(all P＜0.05).After 6 and 12 months'treatment,the LSM's in the observation group were significantly lower than those in the control group[(7.27±2.15)kPa vs.(9.84±2.52)kPa and(6.50±1.94)kPa vs.(7.61±2.26)kPa;both P＜0.05].No serious adverse events were observed in all the patients.Conclusion Fufang Biejia Ruangan tablets combined with entecavir has obvious synergistic effect on reversing liver fibrosis in patients with CHB,and the long-term treatment is beneficial to continuously and stably improve the patients'liver fibrosis and is safe.
Hepatic fibrosis caused by chronic hepatitis BEntecavirFufang Biejia Ruangan tabletsHepatic fibrosis markersLiver stiffness measurement value
万方数据
维普
