Chinese Herbal Medicine Combined with Entecavir for HBeAg Positive Chronic Hepatitis B:Study Protocol for a Multi-Center,Double-Blind Randomized-Controlled Trial

被引：0

作者：

YE Yongan ^{[1
]}

LI Xiaoke ^{[1
]}

ZHOU Daqiao ^{[2
]}

CHI Xiaoling ^{[3
]}

LI Qin ^{[4
]}

WANG Li ^{[5
]}

LU Bingjiu ^{[6
]}

MAO Dewen ^{[7
]}

WU Qikai ^{[8
]}

WANG Xianbo ^{[9
]}

ZHANG Mingxiang ^{[10
]}

XUE Jingdong ^{[11
]}

LI Yong ^{[12
]}

LU Wei ^{[13
]}

GUO Jianchun ^{[14
]}

JIANG Feng ^{[1
]}

ZHANG Xinwei ^{[15
]}

DU Hongbo ^{[1
]}

YANG Xianzhao ^{[1
]}

GUO Hui ^{[16
]}

GAN Danan ^{[1
]}

LI Zhiguo ^{[1
]}

机构：

[1] Institute of Liver Diseases,Beijing University of Chinese Medicine,Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

[2] Department of Hepatology,Shenzhen Traditional Chinese Medicine Hospital

[3] Department of Hepatology,Guangdong Hospital of Traditional Chinese Medicine

[4] Department of Hepatology,Mengchao Hepatobiliary Hospital of Fujian Medical University

[5] Department of Hepatology,Public Health Clinical Center of Chengdu

[6] Department of Hepatology,Liaoning Hospital of Traditional Chinese Medicine

[7] Department of Hepatology,the First Affiliated Hospital of Guangxi University of Chinese Medicine

[8] Department of Hepatology,the Third People's Hospital of Shenzhen

[9] Department of Hepatology,Beijing Ditan Hospital

[10] Department of Hepatology,the Sixth People's Hospital of Shenyang

[11] Department of Hepatology,Shaanxi Hospital of Traditional Chinese Medicine

[12] Department of Hepatology,Shandong Hospital of Traditional Chinese Medicine

[13] Department of Hepatology,the Second People's Hospital of Tianjin

[14] Department of Hepatology,Xixi Hospital of Hangzhou

[15] Department of Hepatology, Military Hospital of China

[16] Department of Hepatology,the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

来源：

Chinese Journal of Integrative Medicine | 2018年 / 24卷 / 09期

关键词：

chronic hepatitis B; Chinese herbal medicine; Tiaogan-Jianpi-Jiedu Granule; TiaoganYipi Granule; protocol; randomized-controlled trial;

D O I：

暂无

中图分类号：

R512.62 [];

学科分类号：

100401 ;

摘要：

Background: The domestic prevalence of chronic hepatitis B(CHB) in China is 7.18% in 2006, imposing great societal healthcare burdens. Nucleot(s)ide analogues(NUCs) anti-hepatitis B virus(HBV) therapies are widely applied despite the relatively low rate of seroconversion and high risk of drug-resistant mutation. More effective treatments for CHB deserve further explorations. Combined therapy of NUCs plus Chinese herbal medicine(CHM) is widely accepted in China, which is recognized as a prospective alternative approach. The study was primarily designed to confirm the hypothesis that Tiaogan-Yipi Granule(调肝益脾颗粒, TGYP) or Tiaogan-Jianpi-Jiedu Granule(调肝健脾解毒颗粒, TGJPJD) plus entecavir tablet(ETV) was superior over ETV monotherapy in enhancing HBeA g loss rate. Methods: The study was a nationwide, large-scale, multi-center, double-blind, randomized, placebo-control ed trial with a designed duration of 108 weeks. A total of 16 hospitals and 596 eligible Chinese HBeA g positive CHB patients were enrolled from November 2012 to September 2013 and randomly allocated into 2 groups in 1:1 ratio via central randomization system: experimental group(EG) and control group(CG). Subjects in EG received CM formulae(TGYP or TGJPJD, 50 g per dose, twice daily) plus ETV tablet(or ETV placebo) 0.5 mg per day in the first 24 weeks(stage 1), and CHM granule plus ETV tablet(0.5 mg per day) from week 25 to 108(stage 2). Subjects in CG received CHM Granule placebo plus ETV tablet(0.5 mg per day) for 108 weeks throughout the trial. The assessments of primary outcomes(HBV serum markers and HBV-DNA) were conducted by a third-party College of American Pathologists(CAP) qualified laboratory. Adverse effects were observed in the hospitals of recruitment. Discussion: The study was designed to compare the curative effect of CM plus ETV and ETV monotherapy in respect of HBe Ag loss, which is recognized by the European Association for the Study of the Liver as "a valuable endpoint". We believe this trial could provide a reliable status for patients' "journey" towards durable responses after treatment discontinuation. The trial was registered before recruitment on Chinese Clinical trial registry(No. ChiC TR-TRC-12002784, Version 1.0, 2015/12/23).

引用

页码：653 / 660

页数：8

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