Clinical efficacy of entecavir combined with Biejiajian pills and its influence on TCM syndrome scores during the treatment of chronic hepatitis B with hepatic fibrosis and blood stasis syndrome.
10.3760/cma.j.cn501113-20230217-00065
- Author:
Dan Ying CHENG
1
;
Peng GUO
2
;
Feng Xia SUN
3
;
Xiao Jing WANG
4
;
Wei LI
1
;
Qin CHEN
5
;
Gui Qin ZHOU
4
;
Rong Bing WANG
4
;
Hui Chun XING
1
Author Information
1. Center of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
2. Department of Hepatology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.
3. Department of Infectious Disease, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.
4. Center of Integrated Traditional Chinese and Western Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.
5. China Traditional Chinese Medicine Holding Co., LTD. (The original name is Sinopharm Zhonglian Pharmaceutical Co., LTD.), Wuhan 430206, China.
- Publication Type:Randomized Controlled Trial
- Keywords:
Bijiajian pill;
Chronic hepatitis B;
Entecavir;
Fibrosis;
TCM syndrome;
Yu blood resistance syndrome
- MeSH:
Humans;
Antiviral Agents/therapeutic use*;
Hepatitis B, Chronic/drug therapy*;
Liver Cirrhosis/drug therapy*;
Prospective Studies;
Treatment Outcome
- From:
Chinese Journal of Hepatology
2023;31(6):608-613
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To investigate the clinical efficacy of entecavir combined with Biejiajian pills and its influence on TCM syndrome scores during the treatment of chronic hepatitis B with hepatic fibrosis and blood stasis syndrome by prospective, randomized and controlled study. Methods: Patients with chronic hepatitis B with hepatic fibrosis and blood stasis syndrome were selected as the research subjects and randomly divided into a treatment group and a control group. Entecavir plus Biejiajian pills or entecavir plus a simulant of Biejiajian pills were given for 48 weeks. The changes in liver stiffness measurement (LSM) and TCM syndrome scores before and after treatment were compared between the two groups to analyze the correlation. The data between groups were analyzed by t-test/Wilcoxon rank sum test or χ(2) test. Pearson correlation coefficient was used to analyze the correlation between TCM syndrome scores and LSM values. Results: After 48 weeks of treatment, the LSM values of the two groups were significantly lower than those of the baseline (P < 0.001), liver fibrosis was significantly improved, and the LSM values of the treatment group were lower than those of the control group [(8.67 ± 4.60) kPa and (10.13 ± 4.43) kPa, t = -2.011, P = 0.049]. After 48 weeks of treatment, the TCM syndrome scores of the two groups were significantly reduced compared with the baseline (P < 0.001), and the clinical symptoms were significantly relieved, and the total effective rates of the improvement of the TCM syndrome scores in the two groups were 74.19% and 72.97%, respectively, but the differences between the groups were not statistically significant (χ(2) = 0.013, P = 0.910). Correlation analysis showed that there was no obvious trend between TCM syndrome scores and LSM values. There were no serious adverse reactions associated with the drug during the observation period of this study. Conclusion: Based on antiviral treatment with entecavir, regardless of whether it is combined with the Biejiajian pill, it can effectively reduce the LSM value, improve liver fibrosis, reduce TCM syndrome scores, and alleviate symptoms in patients with chronic hepatitis B with liver fibrosis and blood stasis syndrome. Compared with entecavir alone, the combined Biejia pill has greater efficacy in improving liver fibrosis and a favorable safety profile, meriting its implementation and widespread application.
