Abstract
Objective: To evaluate the effect of Zhenqi Fuzheng capsule combined with tenofovir amibufenamide (TMF) and TMF monotherapy on the immune functions of peripheral blood lymphocytes and the inhibition of HBV replication for chronic hepatitis B (CHB). Methods: Seventy CHB cases were randomly divided into a treatment and a control group based on the hepatoprotective therapy, with 36 and 34 cases in the treatment and control groups, respectively. The treatment group was treated with oral tenofovir amibufenamide 25 mg once a day, in combination with Zhenqi Fuzheng capsule 1.4 g three times a day. The control group was treated with oral TMF 25 mg once a day. The treatment course was compared at 48 weeks in both groups. Results: Peripheral blood lymphocyte immune function indicators: The CD4(+) cells, CD4(+)/CD8(+) ratio, and natural killer cell values in the treatment group were higher than those in the control group at 48 weeks of treatment (P<0.05). The treatment group had a serum HBeAg negative conversion rate of 50.0% at 48 weeks of treatment, while the control group had a rate of 26.3%. The difference between the two groups was statistically significant (χ(2)=6.98, P<0.05). HBV DNA load: The decrease in HBV DNA load in the two groups was statistically significant compared with the baseline HBV DNA value at 24 and 48 weeks of treatment (P<0.05). Conclusion: Zhenqi Fuzheng capsules combined with TMF therapy are superior for regulating immune function and reducing HBV DNA load and HBeAg-negative seroconversion rates compared to TMF alone.