Publications>Journals>Journal of Clinical and Translational Hepatology>Article Full Text ORIGINAL ARTICLE OPEN ACCESS Histological Outcome of Fuzheng Huayu plus Entecavir Combination Therapy in Chronic Hepati...Publications>Journals>Journal of Clinical and Translational Hepatology>Article Full Text ORIGINAL ARTICLE OPEN ACCESS 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 Wang3,Hong-Tu Gu2,Wei-Jing Wang1,4,Wei Cai1,Qing Guo1,Shi-San Bao5,Lie-Ming Xu*,2 and Qing Xie*,1 Author information Journal of Clinical and Translational Hepatology 2020;8(3):277-284DOI:10.14218/JCTH.2020.00004 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.展开更多
基金supported by the Shanghai Three-Year Plan of the Key Subjects Construction in Public Health-Infectious Diseases and Pathogenic Microorganism(15GWZK0102)the Shanghai Three-Year Plan of the Clinical Skills and Innovations(16CR1002A)+1 种基金the 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).
文摘Publications>Journals>Journal of Clinical and Translational Hepatology>Article Full Text ORIGINAL ARTICLE OPEN ACCESS 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 Wang3,Hong-Tu Gu2,Wei-Jing Wang1,4,Wei Cai1,Qing Guo1,Shi-San Bao5,Lie-Ming Xu*,2 and Qing Xie*,1 Author information Journal of Clinical and Translational Hepatology 2020;8(3):277-284DOI:10.14218/JCTH.2020.00004 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.
