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Synergistic Effect of Biejia-Ruangan on Fibrosis Regression in Patients with Chronic Hepatitis B Treated with Entecavir: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial.

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机构: [1]Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China. [2]Department of Infectious and Liver Diseases, Liver Research Center, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China. [3]Department of Infectious Disease, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China. [4]Fuzhou Infectious Diseases Hospital, Fuzhou, Fujian Province, China. [5]Department of Clinical &Translational Medicine, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China. [6]Liver Disease Department, Fuyang 2nd People's Hospital, Fuyang, Anhui Province, China. [7]Department of Infectious Diseases, Southwest Hospital, the Third Military Medical University, Chongqing, China. [8]Therapeutic Center for Liver Disease, the 88th Hospital of PLA, Taian, Shandong Province, China. [9]Guangzhou 8th People's Hospital, Guangzhou, Guangdong Province, China. [10]Department of Hepatic Diseases, Shanghai Public Health Clinical Center, Shanghai, China. [11]National Integrative Medicine Clinical Base for Infectious Diseases and Department of Infectious Diseases, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China. [12]Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, Sichuan Province, China. [13]Traditional Chinese Medicine Hospital of Chongqing, Chongqing, China. [14]Tianjin Second People's Hospital, Tianjin Institute of Hepatology, Tianjin, China. [15]Division of Gastroenterology, Vancouver General Hospital, Vancouver, British Columbia, V6T1Z4 Canada. [16]Liver Research Unit Medica Sur Clinic &Foundation &Faculty of Medicine, National Autonomous University of Mexico, Mexico City, Mexico. [17]Division of Gastroenterology and Hepatology, University of California, Irvine, School of Medicine, Orange, CA, USA. [18]Department of Gastroenterology, General Hospital of Northern Theater Command (formerly General Hospital of Shenyang Military Area), Shenyang, Liaoning Province, China.
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关键词: hepatitis B liver fibrosis liver cirrhosis entecavir traditional Chinese medicine

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Long-term nucleos(t)ide analogues (NAs) treatment can reverse liver fibrosis in chronic hepatitis B (CHB), but its effect on fibrosis regression remains limited. Biejia-Ruangan (BR) has been approved in China as an anti-fibrotic traditional Chinese medicine drug in patients with chronic liver diseases. A multicenter randomized controlled trial aims to evaluate the effect of BR on fibrosis regression in CHB patients treated with NAs.CHB patients with histologically confirmed advanced fibrosis or cirrhosis were randomly assigned to receive entecavir (ETV) (0.5mg per day) plus BR (2g three times a day) or placebo for 72 weeks. Liver fibrosis regression was defined as a reduction of ≥1 point by the Ishak Fibrosis Stage (IFS).Overall, 500 patients were enrolled in each group as the intention-to-treat population. The rate of fibrosis regression after 72 week treatment was significantly higher in ETV+BR group (40% versus 31.8%, P=0.0069). Among 388 patients with cirrhosis (i.e., IFS ≥5) at baseline, the rate of cirrhosis reversal (i.e., IFS ≤4) was significantly higher in ETV+BR group (41.5% versus 30.7%, P=0.0103).Addition of BR to the current standard treatment with NAs in CHB patients with advanced fibrosis or cirrhosis can improve liver fibrosis regression.© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America.

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出版当年[2019]版:
大类 | 2 区 医学
小类 | 2 区 免疫学 2 区 传染病学 2 区 微生物学
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 免疫学 2 区 传染病学 2 区 微生物学
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第一作者机构: [1]Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
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通讯机构: [1]Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center of Chinese PLA General Hospital, Beijing, China. [*1]Department of Liver Diseases & the Fifth Medical Center of the Chinese People’s Liberation Army General Hospital, Beijing 100039, China
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