[Clinical study on the efficacy of Wuling capsules combined with nucleos(t)ide analogues in the treatment of low-level viremia patients with chronic hepatitis B].

Authors

S X Zhao, W G Ren, M B Yang, X L Chi, H M Xiao, S P Ma, P Jia, Y M Nan

Published in

Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology. Volume 34. Issue 6. Pages 564-570. Jun 20, 2026.

Abstract

Objective: To comprehensively evaluate the efficacy and safety profile of Wuling capsules combined with nucleos(t)ide analogues in the treatment of low-level viremia in chronic hepatitis B. Methods: A randomized, controlled, multicenter clinical trial was conducted. One hundred patients with low-level viremia in chronic hepatitis B admitted between December 2021 and March 2024 were randomly divided into an experimental group and a control group, with 50 cases in each group. The experimental group received nucleos(t)ide analogues combined with Wuling capsules, while the control group received nucleos(t)ide analogues alone. Of the 100 subjects, 96 in the full analysis set (FAS) (experimental group: 47; control group: 49) were included for statistical analysis. Changes in hepatitis B virus (HBV) DNA levels, serological markers of hepatitis B, liver function parameters, and clinical symptom scores were compared following 180 days of treatment between the two groups. Categorical data were analyzed using the χ² test, with results expressed as percentages (%). Quantitative data were expressed as mean ± standard deviation (x¯±s) for normally distributed datasets and analyzed using the t-test. The Wilcoxon rank-sum test was used for non-normally distributed data. Results: The HBV DNA seroconversion rate was significantly higher in the experimental group compared to the control group [67.39% (31/46) vs. 48.98% (24/49), χ²=6.65, P<0.05], while HBsAg, HBeAg, and anti-HBc were all lower in the experimental group than the control group (P<0.05) following 180 days of treatment. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin were all significantly higher in the experimental group than in the control group [(24.17±10.07) U/L vs. (30.77±19.00) U/L, (23.70±6.58) U/L vs. (27.66±10.46) U/L, and (12.69±5.72) μmol/L vs. (15.36±5.90) μmol/L, P<0.05]. The normalization rates of ALT, AST, and γ-glutamyl transferase were significantly higher in the treatment group than those in the control group (85.71% vs. 66.67%, 83.33% vs. 60.00%, and 100% vs. 66.67%, P<0.05). The visual analogue scale (VAS) scores and clinical symptom scores were also superior in the treatment group to those in the control group (P<0.01 or P<0.05). The main symptoms of patients, including hypochondriac pain, belching, and anorexia, were significantly improved in the treatment group compared to the control group (P<0.05 or P<0.01). No adverse reactions related to Wuling Capsules were found. Conclusion: Wuling capsules combined with nucleos(t)ide analogues achieved significant efficacy in treating low-level viremia patients with chronic hepatitis B. This treatment significantly improved HBV DNA seroconversion rate, hepatitis B blood markers, liver function levels, and clinical symptoms, with a favorable safety profile.

PMID:
42373438
Bibliographic data and abstract were imported from PubMed on 30 Jun 2026.

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