Journal of Clinical and Translational Hepatology

Journal of Clinical and Translational Hepatology

Saturday, 10 / 24 / 2020

Articles

ORIGINAL ARTICLE

Histological Outcome of Fuzheng Huayu plus Entecavir Combination Therapy in Chronic Hepatitis B Patients with Significant Liver Fibrosis

Hong-lian Gui#,1, Chang-qing Zhao#,2, Yan Wang3Hong-tu Gu2Wei-jing Wang1,4, Wei Cai1, Qing Guo1, Shi-san Bao5, Lie-ming Xu*,2and Qing Xie*,1

1  Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
2  Department of Liver Cirrhosis, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
3  Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
4  Department of Infectious Diseases, Ruijin North Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
5  The Affiliated Hospital of Nankai University, Tianjin, China
#  These authors contributed equally to this work.
*Correspondence to: Qing Xie, Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China. Tel/Fax: +86-21-64454930, E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. ; Lie-ming Xu, Department of Liver Cirrhosis, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China. Tel/Fax: +86-21-20156520, E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Journal of Clinical and Translational Hepatology 2020;8(3):277-284 DOI: 10.14218/JCTH.2020.00004
Received: January 19, 2020 Accepted: June 30, 2020 Published online: July 21, 2020

Abstract

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.

Keywords

Chronic hepatitis B, Fibrosis, Fuzheng Huayu tablet, Entecavir

Journal of Clinical and Translational Hepatology 2020 vol. 8, 277-284  [ Html  ] [ PDF Full-text ]

© The Authors 2020. This article is published under the terms of the Creative Commons Attribution-Noncommercial License (CC BY-NC 4.0), which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license.

 logo

You are here: Home