Abstract：Objective：To observe the clinical effect of modified Fuzheng Jiedu Xiaoji Prescription combined with Entecavir in the treatment of chronic hepatitis B （CHB） with heat-toxin and blood-stasis syndrome. Methods：A total of 82 CHB patients with heat-toxin and blood-stasis syndrome treated in Yangjiang Hospital of Traditional Chinese Medicine from January to June 2024 were selected as research subjects. They were divided into the observation group and the control group by the random number table method，with 41 cases in each group. The control group was treated with Entecavir Dispersible Tablets，while the observation group was treated with modified Fuzheng Jiedu Xiaoji Prescription combined with Entecavir Dispersible Tablets. Both groups were treated for six months. The clinical effect，hepatitis B virus （HBV）-DNA negative conversion rate and HBV e antigen （HBeAg） negative conversion rate were compared between the two groups. The changes in liver fibrosis indexes [procollagen Ⅲ N-terminal peptide（ PⅢNP），laminin（ LN）， hyaluronic acid （HA）， type Ⅳ collagen （CⅣ）]， and inflammatory indexes [interleukin-18 （IL-18）， interleukin- 17 （IL-17）， tumor necrosis factor- α （TNF-α）， regulatory T cell （Treg）， and helper T cell 17 （Th17）] were observed before treatment and six months after treatment in both groups. Adverse reactions during treatment were recorded. Results：The total effective rate of clinical effect in the observation group was 90.24% （37/41），which was higher than 70.73% （29/41） in the control group （P＜0.05）. After six months of treatment， the negative conversion rates of HBV-DNA and HBeAg in the observation group [68.29% （28/41）， 51.22% （21/41）， respectively] were higher than those in the control group [43.90% （18/41），24.39% （10/41），respectively] （P＜0.05）. After six months of treatment，the levels of PⅢNP，LN，HA，CⅣ，IL-18，IL-17，TNF-α，Treg，and Th17 in both groups were decreased when compared with those before treatment （P＜0.05），and the levels of PⅢNP，LN，HA，CⅣ，IL-18， IL-17， TNF-α，Treg，and Th17 in the observation group were lower than those in the control group （P＜0.05）. No obvious adverse reactions occurred in both groups during treatment. Conclusion： Modified Fuzheng Jiedu Xiaoji Prescription combined with Entecavir has a significant effect in the treatment of CHB with heat-toxin and blood-stasis syndrome. It can improve liver fibrosis，regulate inflammatory response，increase the negative conversion rates of HBVDNA and HBeAg，and has great safety.