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

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

Author: Xiao-Ke LI ¹ ; Ming-Xiang ZHANG ² ; Feng-Zhen SHAO ³ ; Da-Qiao ZHOU ⁴ ; Jing-Dong XUE ⁵ ; Tie-Jun LIU ⁶ ; Xiao-Ling CHI ⁷ ; Bing-Jiu LU ⁸ ; Xian-Bo WANG ⁹ ; Qin LI ¹⁰ ; Jun LI ¹¹ ; De-Wen MAO ¹² ; Hua-Sheng YANG ¹³ ; Hong-Zhi YANG ¹⁴ ; Wen-Xia ZHAO ¹⁵ ; Yong LI ¹⁶ ; Guo-Liang ZHANG ¹⁷ ; Yi-Ming ZHAO ¹⁸ ; Jian-Dong ZOU ¹⁹ ; Meng-Yang LIU ¹ ; Ke-Ke ZHANG ¹ ; Xian-Zhao YANG ¹ ; Da-Nan GAN ¹ ; Ying LI ¹ ; Peng ZHANG ¹ ; Zhi-Guo LI ¹ ; Shuo LI ¹ ; Yong-An YE ²⁰
Author Information

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.
20. Department of Gastroenterology, Institute of Liver Disease, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. yeyongan@vip.163.com.
Publication Type:Journal Article
Keywords: Adefovir dipivoxil; Chinese medicine; HBeAg; Tiaogan Jianpi Hexue; Tiaogan Jiedu Huashi; combination therapy
MeSH: Adenine; analogs & derivatives; therapeutic use; Adult; Antiviral Agents; therapeutic use; Double-Blind Method; Drug Therapy, Combination; Drugs, Chinese Herbal; therapeutic use; Female; Hepatitis B e Antigens; immunology; Hepatitis B, Chronic; drug therapy; immunology; Humans; Male; Medicine, Chinese Traditional; Organophosphonates; therapeutic use; Young Adult
From: Chinese journal of integrative medicine 2020;26(5):330-338
CountryChina
Language:English
Abstract: OBJECTIVE:To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue () and Tiaogan Jiedu Huashi () 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, 24, 36, 48, respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24, 36, 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, 24, 36, 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 these group values on week 48 (P<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).