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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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收录情况： ◇ SCIE

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机构： [1]Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center ofChinese PLA General Hospital, Beijing 100039, China [2]Department of Infectious and Liver Diseases, Liver Research Center, the First AffiliatedHospital of Wenzhou Medical University, Wenzhou, Zhejiang Province 325000, China [3]Department of Infectious Disease, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province 450052, China [4]Fuzhou Infectious Diseases Hospital, Fuzhou, Fujian Province 350025, China [5]Department of Clinical & Translational Medicine, the Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China [6]Liver Disease Department, Fuyang 2nd People’s Hospital, Fuyang, Anhui Province 236015, China [7]Department of Infectious Diseases, Southwest Hospital, the Third Military Medical University, Chongqing 400038, China [8]Therapeutic Center for Liver Disease, the 88th Hospital of PLA, Taian, Shandong Province 271000, China [9]Guangzhou 8th People's Hospital, Guangzhou, Guangdong Province 510060, China [10]Department of Hepatic Diseases, Shanghai Public Health Clinical Center, Shanghai 201508, 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 610072, China [12]Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, Sichuan Province 610072, China [13]Traditional Chinese Medicine Hospital of Chongqing, Chongqing 400038, China [14]Tianjin Second People's Hospital, Tianjin Institute of Hepatology, Tianjin 300192, 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, 14050 Mexico [17]Division of Gastroenterology and Hepatology, University of California, Irvine, School of Medicine, Orange, CA, 92868 USA [18]Department of Gastroenterology, General Hospital of Northern Theater Command (formerly General Hospital of Shenyang Military Area), Shenyang, Liaoning Province, 110840 China

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关键词： Hepatitis B Liver fibrosis Liver cirrhosis Entecavir Traditional Chinese Medicine

摘要：

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[2021]版：

大类 | 2 区

医学

小类 | 1 区传染病学 2 区免疫学 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

JCR分区：

出版当年[2020]版：

Q1 INFECTIOUS DISEASES Q2 IMMUNOLOGY Q2 MICROBIOLOGY

最新[2023]版：

Q1 INFECTIOUS DISEASES Q1 MICROBIOLOGY Q2 IMMUNOLOGY

影响因子： 5 最新[2023版] 4.7 最新五年平均 5.226 出版当年[2020版] 5.802 出版当年五年平均 5.022 出版前一年[2019版] 7.759 出版后一年[2021版]

第一作者：

第一作者机构： [1]Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center ofChinese PLA General Hospital, Beijing 100039, China

共同第一作者：

通讯作者：

通讯机构： [1]Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center ofChinese PLA General Hospital, Beijing 100039, China [17]Division of Gastroenterology and Hepatology, University of California, Irvine, School of Medicine, Orange, CA, 92868 USA [18]Department of Gastroenterology, General Hospital of Northern Theater Command (formerly General Hospital of Shenyang Military Area), Shenyang, Liaoning Province, 110840 China [*1]Department of Liver Diseases of Chinese PLA General Hospital, the Fifth Medical Center of Chinese PLA General Hospial, Beijing 100039, China [*2]General Hospital of Northern Theater Command (formerly General Hospital of Shenyang Military Area), Shenyang, Liaoning Province, 100840 China [*3]Division of Gastroenterology and Hepatology, University of California, Irvine Medical Center, Orange, CA, 92868 USA

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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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