Journal
JOURNAL OF CLINICAL AND TRANSLATIONAL HEPATOLOGY
Volume 8, Issue 3, Pages 277-284Publisher
XIA & HE PUBLISHING INC
DOI: 10.14218/JCTH.2020.00004
Keywords
Chronic hepatitis B; Fibrosis; Fuzheng Huayu tablet; Entecavir
Categories
Funding
- Shanghai Three-Year Plan of the Key Subjects Construction in Public Health-Infectious Diseases and Pathogenic Microorganism [15GWZK0102]
- Shanghai Three-Year Plan of the Clinical Skills and Innovations [16CR1002A]
- Shanghai Municipal Key Clinical Specialty [shslczdzk01103]
- Key Projects in the National Science and Technology Pillar Program during the Thirteen Five-year Plan Period [2017ZX10203202, 2017ZX10203201-008, 2017ZX10202202-005-004, 2018ZX09201016-003-001]
Ask authors/readers for more resources
Background and Aims: To evaluate the efficacy of Fuzheng Huayu (FZHY), a Chinese herbal formula, plus entecavir (ETV) in regression of liver fibrosis in chronic hepatitis B (CHB) patients with significant fibrosis/cirrhosis. Methods: The current study was a two-center, randomized, double-blind and placebo-controlled pilot study. Fifty-two currently untreated chronic hepatitis B patients with Ishak fibrosis score >= 3 points were identified and 1:1 randomized into FZHY plus ETV combination and placebo plus ETV groups. The second liver biopsy was performed after 48-week treatment. Necroinflammatory improvement and regression of fibrosis were assessed. Fine changes in different collagen features in paired liver biopsies were evaluated by dual-photon microscopy for both groups. Results: Forty-nine patients completed the full course of treatment; forty-six of them underwent second liver biopsy (for which twenty-two were in the combination group and twenty-four were in the control group). Compared to those in the control group, patients in the combination group had significantly higher rate of fibrosis regression (82% vs. 54%) (p<0.05). Furthermore, the necroinflammatory improvement was greater in the combination group than in the control group (59% vs. 25%, p<0.05). Among the more than 80 collagen parameters in the dual-photon analysis, 5 decreased significantly in the combination group compared to the control group (p<0.05). However, no significant improvement was detected in either biochemical, virologic or serologic responses between these two groups at week 48. Conclusions: The combination therapy of FZHY plus ETV for 48 weeks resulted in a higher rate of necroinflammatory improvement and fibrosis regression than ETV alone in chronic hepatitis B patients with significant fibrosis/cirrhosis.The clinical trial number is ChiCTR-TRC-11001377.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available