Efficacy of a Chinese herbal formula on hepatitis B e antigenpositive chronic hepatitis B patients  

作　　者：Yu-Feng Xing Chun-Shan Wei Tian-Ran Zhou Dan-Ping Huang Wei-Chao Zhong Bin Chen Hua Jin Xiao-Yu Hu Zhi-Yun Yang Qing He Kai-Ping Jiang Jun-Min Jiang Zhen-Bin Hu Xin Deng Fan Yang Feng-Yi Li Gang Zhao Li-Chun Wang Yu-Qiang Mi Zuo-Jiong Gong Peng Guo Jian-Hua Wu Wei-Qun Shi Hong-Zhi Yang Da-Qiao Zhou Guang-Dong Tong 

机构地区：[1]Department of Hepatology,Shenzhen Traditional Chinese Medicine Hospital,The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine,Shenzhen 518033,Guangdong Province,China [2]Department of Hepatology,The First Hospital of Hunan University of Chinese Medicine,Changsha 410007,Hunan Province,China [3]Department of Integrated Traditional and Western Medicine on Liver Diseases,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China [4]Department of Infectious Disease,The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610032,Sichuan Province,China [5]Department of Integrated Traditional and Western Medicine on Liver Diseases,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China [6]The First Department of Hepatology,Shenzhen No.3 People’s Hospital,Shenzhen 518100,Guangdong Province,China [7]Department of Hepatology,Foshan Hospital of Traditional Chinese Medicine,Foshan 528000,Guangdong Province,China [8]Department of Hepatology,Guangdong Hospital of Traditional Chinese Medicine,Guangzhou 510006,Guangdong Province,China [9]Department of Hepatology,The First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning 530012,Guangxi Province,China [10]Department of Hepatology,Ruikang Hospital,Guangxi University of Chinese Medicine,Nanning 530012,Guangxi Province,China [11]Hubei Provincial Hospital of Traditional Chinese Medicine,Wuhan 430060,Hubei Province,China [12]Treatment and Research Center of Infectious Disease,302 Military Hospital of China,Beijing 100039,China [13]Department of Hepatology,Shuguang Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 201204,China [14]Center of Infectious Disease,Huaxi Hospital,Sichuan University,Chengdu 610044,Sichuan Province,China [15]Department of Infectious Disease,Tianjin Infectious Disease Hospital,Tianjin 300192,China [16]Department of Infectious Disease,Hubei People’s Hospital,Wuhan 430060,Hubei Province,China [17]Department of Hepatology,Xiyuan Hospital,

出　　处：《World Journal of Gastroenterology》2020年第30期4501-4522,共22页世界胃肠病学杂志（英文版）

基　　金：Supported by the National Natural Science Foundation of China,No.81174263;National Science and Technology Major Project during the 12th Five-year Plan Period,No.2012ZX1005006;Sanming Project of Medicine in Shenzhen,Guangdong Province,China,No.SZSM201612074;and Science and Technology Planning Project of Guangdong Province,China,No.2017A020213016.

摘　　要：BACKGROUND No guideline recommends antiviral therapy for hepatitis B e antigen(HBeAg)-positive chronic hepatitis B patients with persistently normal alanine aminotransferase levels and a high hepatitis B virus(HBV)DNA viral load.AIM To evaluate the feasibility and safety of a Chinese herbal formula as a therapeutic option for chronic HBV infection.METHODS In total,395 patients(30–65 years old)with confirmed HBeAg-positive chronic hepatitis B infection and persistently normal alanine aminotransferase were randomized to receive either Chinese herbal formula or placebo for 96 wk.Endpoints to evaluate therapeutic efficacy included:(1)HBV DNA levels decreased to less than 4 log10 IU/mL at weeks 48 and 96;and(2)HBeAg clearance and seroconversion rates at weeks 48 and 96.RESULTS HBV DNA levels≤4 log10 IU/mL were 10.05%at week 48 and 18.59%at week 96 in the treatment group.The HBeAg clearance and conversion rates were 8.54%and 8.04%at week 48 and 16.08%and 14.57%at week 96,respectively.However,HBV DNA levels≤4 log10 IU/mL were 2.55%and 2.55%at weeks 48 and 96,respectively,and the HBeAg clearance rates were 3.06%and 5.61%at weeks 48 and 96,respectively,in the control group.The quantitative hepatitis B surface antigen and HBeAg levels at baseline and changes during the treatment period as well as the alanine aminotransferase elevation at weeks 12 and 24 were strong predictors of HBeAg clearance.CONCLUSION High rates of HBV DNA reduction,HBeAg clearance and seroconversion could be achieved with Chinese herbal formula treatments,and the treatments were relatively safe for HBeAg-positive chronic hepatitis B-infected patients with persistently normal alanine aminotransferase.The ability of the compound to modulate host immune function probably contributed to this effect.

关 键 词：Chronic hepatitis B Chinese Herbal Formula treatment Hepatitis B e antigen clearance Hepatitis B e antigen seroconversion Hepatitis B virus DNA reduction Clinical trial 

分 类 号：R259[医药卫生—中西医结合]