L Miao1, W N Yang2, X Q Dong2, Z Q Zhang3, S B Xie4, D Z Zhang5, X Q Zhang6, J Cheng7, G Zhang8, W F Zhao9, Q Xie10, Y X Liu11, A L Ma12, J Li13, J Shang14, L Bai15, L H Cao16, Z Q Zou17, J B Li18, F D Lyu19, H Liu19, Z J Wang20, M X Zhang21, L M Chen22, W F Liang23, H Gao2, H Zhuang24, H Zhao2, G Q Wang25. 1. Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, Beijing 100034, China; Department of Hepatology, the Third Hospital of Qinhuangdao, Qinhuangdao 066000, China. 2. Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, Beijing 100034, China. 3. Department of Hepatology, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China. 4. Department of Infectious Disease, the Third Affiliated Hospital Sun Yat Sen University, Guangzhou 510630, China. 5. Department of Infectious Diseases, Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China; the Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Zhejiang University, Hangzhou 310058, China. 6. Department of Infectious Diseases, the First Hospital Affiliated to Army Medical University, Chongqing 400038, China. 7. Beijing Ditan Hospital, Capital Medical University, Beijing 100000, China. 8. Department of Gastroenterology, the People's Hospital of Guangxizhuang Autonomous Region, Nanning 530021, China. 9. Department of Infectious Diseases, Xinxiang Medical University Third Hospital, Xinxiang 453000, China. 10. Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China. 11. Department of Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen 518112, China. 12. Department of Infectious Diseases, China-Japan Friendship Hospital, Beijing 100029, China. 13. Department of Infectious Diseases, the First Affiliated Hospital, Nanjing Medical University, Nanjing 210029, China. 14. Department of Infectious Diseases, the People's Hospital of Henan Province, Zhengzhou 450003, China. 15. Infectious Disease Department of West China Hospital, Sichuan University, Chengdu 610041, China. 16. Department of Hepatology, the Third Hospital of Qinhuangdao, Qinhuangdao 066000, China. 17. Yantai Infectious Diseases Hospital, Yantai 264000, China. 18. the First Affiliated Hospital of Anhui Medical University, Hehui 230022, China. 19. Beijing Youan Hospital, Capital Medical University, Beijing 100000, China. 20. the 305 Hospital of PLA, Beijing 100300, China. 21. the 6th People's Hospital of Shenyang, Shenyang 110006, China. 22. the 5th Medical Center of PLA General Hospital, Beijing 100039, China. 23. First Affiliated Hospital of Zhejiang University, Hangzhou 310058, China. 24. Department of Microbiology and Center of Infectious Diseases, Peking University Health Science Center, Beijing 100191, China. 25. Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, Beijing 100034, China; Department of Infectious Diseases, Peking University International Hospital, Beijing 102206, China; the Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Zhejiang University, Hangzhou 310058, China.
Abstract
Objective: To explore the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection who received entecavir alone or in combination with anluohuaxianwan for 78 weeks. Methods:Patients with chronic HBV infection were randomly treated with entecavir alone or in combination with anluohuaxian for 78 weeks. Ishak fibrosis score was used for blind interpretation of liver biopsy specimens. The improvement in liver fibrosis condition before and after the treatment was compared. Student's t test and non-parametric test (Mann-Whitney U-Test and Kruskal-Wallis test) were used to analyze the measurement data. The categorical variables were analyzed by Chi-square test method and Spearman's rank correlation coefficient was used to test bivariate associations. Results:Liver fibrosis improvement rate after 78 weeks of treatment was 36.53% (80/219) and the progression rate was 23.29% (51/219). The improvement of liver fibrosis was associated to the degree of baseline fibrosis and treatment methods (P < 0.05). The improvement rate of hepatic fibrosis in patients treated with anluohuaxianwan combined with entecavir at baseline F < 3 (54.74%, 52/95) was significantly higher than that in patients treated only with entecavir (33.33%, 16/48), P = 0.016 and the progression rate of hepatic fibrosis (13.68%, 13/95) was lower than that in patients treated alone (18.75%, 9/48), P = 0.466. In patients with baseline F < 3, the proportion of patients with improved and stable liver fibrosis in the combined treatment group (68.1%, 32/47) was higher than that in the treatment group alone (51.7%, 15/29). Conclusion:Combined anluohuaxianwan and entecavir treatment can significantly improve the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection. Furthermore, it has the tendency to improve the stability rate and reduce the rate of progression of liver fibrosis.
RCT Entities:
Objective: To explore the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection who received entecavir alone or in combination with anluohuaxianwan for 78 weeks. Methods:Patients with chronic HBV infection were randomly treated with entecavir alone or in combination with anluohuaxian for 78 weeks. Ishak fibrosis score was used for blind interpretation of liver biopsy specimens. The improvement in liver fibrosis condition before and after the treatment was compared. Student's t test and non-parametric test (Mann-Whitney U-Test and Kruskal-Wallis test) were used to analyze the measurement data. The categorical variables were analyzed by Chi-square test method and Spearman's rank correlation coefficient was used to test bivariate associations. Results:Liver fibrosis improvement rate after 78 weeks of treatment was 36.53% (80/219) and the progression rate was 23.29% (51/219). The improvement of liver fibrosis was associated to the degree of baseline fibrosis and treatment methods (P < 0.05). The improvement rate of hepatic fibrosis in patients treated with anluohuaxianwan combined with entecavir at baseline F < 3 (54.74%, 52/95) was significantly higher than that in patients treated only with entecavir (33.33%, 16/48), P = 0.016 and the progression rate of hepatic fibrosis (13.68%, 13/95) was lower than that in patients treated alone (18.75%, 9/48), P = 0.466. In patients with baseline F < 3, the proportion of patients with improved and stable liver fibrosis in the combined treatment group (68.1%, 32/47) was higher than that in the treatment group alone (51.7%, 15/29). Conclusion: Combined anluohuaxianwan and entecavir treatment can significantly improve the improvement rate of liver fibrosis in patients with chronic hepatitis B virus infection. Furthermore, it has the tendency to improve the stability rate and reduce the rate of progression of liver fibrosis.
Entities:
Keywords:
Hepatitis B virus; Liver fibrosis; Regression; Treatment