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| Impact of Fuzheng Huayu tablet on antiviral effect of entecavir in patients with hepatitis B cirrhosis |
| Dan-Ying Cheng a , b , Zhi-Min Zhao c , Gang Wan b , d , Huan-Wei Zheng e , Jia-Quan Huang f , Cheng-Hai Liu c , ∗, Hui-Chun Xing a , b , ∗ |
a Center of Liver Diseases Division 3, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
b Peking University Ditan Teaching Hospital, Beijing 100000, China
c Institute of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
d Statistics Department, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China
e Department of Infectious Diseases, the Fifth Hospital of Shijiazhuang, Shijiazhuang 050021, China
f Department and Institute of Infectious Diseases, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
∗ Corresponding authors at: Hui-Chun Xing, Center of Liver Disease Division 3, Beijing Ditan Hospital, Capital Medical University, 8 Jingshundong Street, Chaoyang District, Beijing 10 0 015, China.
∗ Cheng-Hai Liu, Institute of Liver Diseases, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, 528 Zhangheng Road, Pudong New Area, Shanghai 201203, China.
E-mail addresses: chenghai.liu@outlook.com (C.-H. Liu), hchxing@sohu.com, hchxing@ccmu.edu.cn (H.-C. Xing). |
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Abstract Background: Fuzheng Huayu tablet is a traditional Chinese medicine (TCM) used for the treatment of liver fibrosis and cirrhosis. However, whether the combination with Fuzheng Huayu tablet could affect the antiviral efficacy of nucleos(t)ide remains a concern. The objective of this trial was to explore the impact of Fuzheng Huayu tablet on antiviral effect of entecavir in patients with hepatitis B cirrhosis.
Methods: A prospective, randomized control trial was conducted. Patients with compensated hepatitis B cirrhosis were randomly divided into the treatment group (entecavir capsule plus Fuzheng Huayu tablet) and the control group (entecavir capsule plus simulant of Fuzheng Huayu), and followed up for 48 weeks. The dynamic changes of HBV DNA load, the rate of serological conversion of HBeAg, liver function, renal function and liver stiffness measurement (LSM) were monitored. The general clinical data and adverse events were also recorded.
Results: There was no significant difference in the rate of virological response and cumulative virological response between the treatment group and the control group (P > 0.05). After 48 weeks of treatment, the HBeAg seroconversion rate, biochemical response rate and LSM value were 21.05% and 4.76% (P = 0.164), 86.96% and 65.96% (P = 0.017), 9.5 kpa and 10.6 kpa (P = 0.827) in the treatment group and the control group, respectively. No serious adverse events related to the study therapy occurred during the trial.
Conclusions: The antiviral entecavir combined with Fuzheng Huayu tablet did not affect the antiviral efficacy of entecavir, but could improve the rate of biochemical response, and had a tendency to improve the rate of serological conversion of HBeAg and liver fibrosis in patients with hepatitis B cirrhosis. Fuzheng Huayu tablet is clinically safe for patients with hepatitis B cirrhosis.
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2022, Vol. 21 
