Objective To evaluate the treatment effect of Fuzheng Huayu capsules combined with entecavir on liver fibrosis in patients with chronic hepatitis B (CHB) and the value of two-dimensional shear wave elastography (2D-SWE) in therapeutic efficacy assessment. Methods A total of 93 CHB patients with liver fibrosis were randomly divided into a control group (n=47) or an observation group (n=46). The control group was treated with entecavir, while the observation group was treated with entecavir and Fuzheng Huayu capsules. Both groups were treated for 48 weeks. Before treatment, at 24 weeks after treatment, and at 48 weeks after treatment, imaging indicators (2D-SWE elastic modulus) and laboratory indicators (alanine aminotransferase [ALT], aspartate aminotransferase [AST], platelet count) were collected; laboratory-derived indices (fibrosis-4 index [FIB‑4], aspartate aminotransferase-to-platelet ratio index [APRI], and AST/ALT ratio [AAR]) were calculated; liver biopsy was performed to obtain METAVIR scores (grade of inflammatory activity: G0-G3; fibrosis stage: S0-S4). Intra- and inter-group differences in indicators were compared, and Spearman correlation analysis and receiver operating characteristic (ROC) curves were used to explore the non‑invasive diagnostic value of 2D-SWE elastic modulus and laboratory‑derived indices for liver fibrosis staging. Results (1) Comparison of indicators: ① Intergroup comparison: Before treatment, there were no statistically significant differences in all indicators between the two groups (all P>0.05); at 24 weeks after treatment, the serum ALT level and APRI in the observation group were lower than those in the control group, while its platelet count was higher (all P<0.05); at 48 weeks after treatment, serum ALT and AST levels, as well as APRI, in the observation group were lower than those in the control group (all P<0.05). ② Intra-group comparison: In the control group, the 2D-SWE elastic modulus at 24 weeks after treatment and serum ALT and AST levels at 48 weeks after treatment were lower than those before treatment (all P<0.05). In the observation group, FIB-4, APRI, and 2D-SWE elastic modulus at 24 weeks after treatment, as well as serum ALT and AST levels, FIB-4, APRI, and 2D-SWE elastic modulus at 48 weeks after treatment, were lower than those before treatment; serum ALT and AST levels and 2D-SWE elastic modulus at 48 weeks after treatment were lower than those at 24 weeks after treatment (all P<0.05). (2)Comparison of inflammatory activity and fibrosis stage: At 48 weeks after treatment, fibrosis stage in the observation group was better than that in the control group (P<0.05). Compared with those before treatment, inflammatory activity was improved in the control group at 24 weeks after treatment, while both fibrosis stage and inflammatory activity were improved in the observation group (all P<0.05); compared with those before treatment and those at 24 weeks after treatment, inflammatory activity and fibrosis stage in both groups were improved at 48 weeks after treatment (all P<0.05). (3) Correlations: The 2D‑SWE elastic modulus, FIB‑4, and APRI were positively correlated with inflammatory activity and liver fibrosis stage at all time points (all P<0.05), whereas AAR showed no statistically significant correlation with inflammatory activity or fibrosis stage (all P>0.05). (4) Diagnostic performance: The areas under the ROC curves of 2D-SWE elastic modulus for diagnosing each fibrosis stage (S1-S4) were all relatively high (all >0.750), especially for S2 and S4 (the areas under the ROC curves were all ≥0.900). When 2D-SWE elastic modulus was combined with laboratory‑derived indices such as FIB-4 and APRI, the diagnostic performance for S2, S3, and S4 was further improved compared with 2D‑SWE elastic modulus alone. Conclusion Fuzheng Huayu capsules plus entecavir is superior to entecavir alone in reducing liver stiffness (2D‑SWE elastic modulus) and improving liver fibrosis stage in the treatment of CHB-related liver fibrosis. The combination of 2D‑SWE elastic modulus and laboratory-derived indices such as FIB-4 and APRI exhibits favorable diagnostic performance for staging of CHB-related liver fibrosis.

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