Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial

Xiao-ke LI; Ming-xiang ZHANG; Feng-zhen SHAO; Da-qiao ZHOU; Jing-dong XUE; Tie-jun LIU; Xiao-ling CHI; Bing-jiu LU; Xian-bo WANG; Qin LI; Jun LI; De-wen MAO; Hua-sheng YANG; Hong-zhi YANG; Wen-xia ZHAO; Yong LI; Guo-liang ZHANG; Yi-ming ZHAO; Jian-dong ZOU; Meng-yang LIU; Ke-ke ZHANG; Xian-zhao YANG; Da-nan GAN; Ying LI; Peng ZHANG; Zhi-guo LI; Shuo LI; Yong-an YE

doi:10.1007/s11655-020-3250-0

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Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial

Original Article | Updated：2021-08-23

- Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial
- Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial
- Chinese Journal of Integrative Medicine 2020年26卷第5期页码：330-338
- Affiliations：
  
  1.Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing (100700), China
  2.Department of Hepatology, the Sixth People's Hospital of Shenyang, Shenyang (110006), China
  3.Department of Hepatology, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin (300000), China
  4.Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen (518033), China
  5.Department of Hepatology, Shaanxi Hospital of Traditional Chinese Medicine, Xi'an (710003), China
  6.Affiliated Hospital of Changchun University of Chinese Medicine, Changchun (130021), China
  7.Department of Hepatology, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou (510006), China
  8.Department of Hepatology, Liaoning Hospital of Traditional Chinese Medicine, Shenyang (110032), China
  9.Department of Hepatology, Beijing Ditan Hospital, Beijing (100015), China
  10.Department of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou (350025), China
  11.Department of Hepatology, the 302 Military Hospital of PLA, Beijing (100039), China
  12.Department of Hepatology, the First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning (530023), China
  13.Department of Integrated Traditional Chinese Medicine and Western Medicine, Beijing YouAn Hospital, Capital Medical University, Beijing (100069), China
  14.Department of Traditional Chinese Medicine, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou (510630), China
  15.Department of Gastroenterology, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou (450000), China
  16.Department of Hepatology, Shandong Hospital of Traditional Chinese Medicine, Jinan (250011), China
  17.Department of Gastroenterology, Anhui Hospital of Traditional Chinese Medicine, Hefei (230031), China
  18.Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing (100191), China
  19.Clinical Research Center, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing (210029), China
- Author bio：
  
  Correspondence to: Prof. YE Yong-an, E-mail:yeyongan@vip.163.com
- Funds：
  
  the China National Science and Technology Major Projects, 11th 5-year Project(2008ZX10005-006)
- DOI：10.1007/s11655-020-3250-0
  中图分类号：
- 纸质出版日期：2020-05-01，
  
  网络出版日期：2020-01-10，
  
  录用日期：2019-05-15
Scan for full text
Xiao-ke LI, Ming-xiang ZHANG, Feng-zhen SHAO, 等. Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(5):330-338.

Xiao-ke LI, Ming-xiang ZHANG, Feng-zhen SHAO, et al. Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(5):330-338.
Xiao-ke LI, Ming-xiang ZHANG, Feng-zhen SHAO, 等. Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(5):330-338. DOI： 10.1007/s11655-020-3250-0.

Xiao-ke LI, Ming-xiang ZHANG, Feng-zhen SHAO, et al. Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial[J]. Chinese Journal of Integrative Medicine, 2020,26(5):330-338. DOI： 10.1007/s11655-020-3250-0.

摘要

Abstract

Objective:

To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy

namely Tiaogan Jianpi Hexue (调肝健脾和血) and Tiaogan Jiedu Huashi (调肝解毒化湿) fomulae

in hepatitis B e antigen (HBeAg)-positive Chinese patients.

Methods:

A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group (EG

received ADV plus CM) and control group (CG

received ADV plus CM-placebo) for 48 weeks. The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12

respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24

and 48. Routine blood

urine

and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations. Adverse events (AEs) were documented.

Results:

The combination therapy demonstrated superior HBeAg loss at 48 weeks

without additional AEs. The full analysis population was 560 and 280 in each group. In the EG

population achieved HBeAg loss on week 12

and 48 were 25 (8.90%)

34 (12.14%)

52 (18.57%)

and 83 (29.64%)

respectively; the equivalent numbers in the CG were 20 (7.14%)

41 (14.64%)

54 (19.29%)

and 50 (17.86%)

respectively. There was a statistically significant difference between two groups on week 48 (

0.01). No additional AEs were found in EG. Subgroup analysis suggested different outcomes among treatment patterns.

Conclusion:

Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy. The finding indicates that this combination therapy may provide an improved therapeutic effect and safety profile (ChiCTR-TRC-11001263).

关键词

Keywords

Adefovir dipivoxilTiaogan Jianpi HexueTiaogan Jiedu HuashiChinese medicineHBeAgcombination therapy

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