Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multicener, double-blind, randomized controlled trial in China.
机构：[1]Institute of Liver Diseases, Beijing University of Chinese Medicine,Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine,Beijing 100700, China[2]Department of Hepatology, Shenzhen TraditionalChinese Medicine Hospital, Shenzhen 518033, Guangdong Province, China深圳市康宁医院深圳医学信息中心[3]Department of Hepatology, Chongqing Traditional Chinese MedicineHospital, Chongqing 400021, China[4]Department of Hepatology, GuangdongHospital of Traditional Chinese Medicine, Guangzhou 510006, China[5]Department of Hepatology, Liaoning Hospital of Traditional ChineseMedicine, Shenyang 110032, China[6]Department of Hepatology, BeijingDitan Hospital, Beijing 100015, China[7]Department of Hepatology, The FirstAffiliated Hospital of Guangxi University of Chinese Medicine, Nanning530023, China[8]Department of Hepatology, Mengchao HepatobiliaryHospital of Fujian Medical University, Fuzhou 350025, China[9]Department ofHepatology, Shaanxi Hospital of Traditional Chinese Medicine, Xi’an 710003,China[10]Department of Hepatology, The Third People’s Hospital ofShenzhen, Shenzhen 518112, Guangdong Province, China深圳市康宁医院深圳医学信息中心[11]Department ofHepatology, The Sixth People’s Hospital of Shenyang, Shenyang 110006,China[12]Department of Hepatology, Public Health Clinical Center ofChengdu, Chengdu 610066, China[13]Department of Hepatology, Affiliatedtraditional Chinese Medicine Hospital of Southwest Medical University,Luzhou 646699, China[14]Department of Hepatology, 302 Military Hospital ofChina, Beijing 100039, China[15]Department of Hepatology, ShanghaiShuguang Hospital, Shanghai 200021, China[16]Department of Hepatology,Shandong Hospital of Traditional Chinese Medicine, Jinan 250011, China[17]Department of Hepatology, Beijing Chinese Medicine Hospital, Beijing100010, China[18]Department of Hepatology, The Second People’s Hospital ofTianjin, Tianjin 300000, China[19]Department of Gastroenterology, The SecondHospital of Shandong University, Jinan 250100, China
Nucleos(t)ide analogues (NAs) are the first-line option against chronic hepatitis B (CHB). NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation. The combined therapy of NAs plus traditional Chinese medicine (TCM) is widely accepted and has been recognized as a prospective alternative approach in China. Based on preliminary works, this study was designed to observe the therapeutic effect of TCM plus entecavir (ETV) against HBeAg-positive chronic hepatitis B with respect to reducing the recurrence risk after NA withdrawal.
The study is a nationwide, multicenter, double-blind, randomized, placebo-controlled trial with a duration of 120 weeks. A total of 18 hospitals and 490 eligible Chinese HBeAg-positive CHB patients will be enrolled and randomly allocated into the experimental group and control group in a 1:1 ratio. Patients in the experimental group will be prescribed TCM formulae (Tiaogan-BuXu-Jiedu granules) plus ETV 0.5 mg per day for consolidation therapy for 96 weeks. Patients in the control group will be prescribed TCM granule placebo plus ETV 0.5 mg per day for the same course. After consolidation therapy, all patients will discontinue their trial drugs and be closely monitored over the next 24 weeks. Once clinical recurrence (CR) occurs, ETV treatment will be restarted. The primary outcome is the cumulative rate of CR at the end of this trial.
This study is the first of its kind to observe therapeutic effects with respect to reducing recurrence after NA withdrawals after unified integrative consolidation therapy in the CHB population.
Chinese Clinical Trial Registry No. ChiCTR1900021232 . Registered on February 2, 2019.
基金：
China National Science and Technology major projects 13th 5-year plan [2018ZX10725505]
第一作者机构：[1]Institute of Liver Diseases, Beijing University of Chinese Medicine,Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine,Beijing 100700, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Li Xiaoke,Zhang Ludan,Qiu Mei,et al.Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multicener, double-blind, randomized controlled trial in China.[J].TRIALS.2020,21(1):doi:10.1186/s13063-020-04417-9.
APA：
Li Xiaoke,Zhang Ludan,Qiu Mei,Huang Yi,Xiao Huanming...&Ye Yong'an.(2020).Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multicener, double-blind, randomized controlled trial in China..TRIALS,21,(1)
MLA：
Li Xiaoke,et al."Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multicener, double-blind, randomized controlled trial in China.".TRIALS 21..1(2020)
