Bushen Jianpi Formula Combined with Entecavir for the Treatment of HBeAg-Negative Chronic Hepatitis B: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Autor: Zhang JH; Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China., Zhang X; Laboratory of Cellular Immunity, Shanghai Key Laboratory of Traditional Chinese Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China., Zhou ZH; Laboratory of Cellular Immunity, Shanghai Key Laboratory of Traditional Chinese Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China., Zhu XJ; Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China., Zheng C; Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China., Li M; Laboratory of Cellular Immunity, Shanghai Key Laboratory of Traditional Chinese Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China., Jin SG; Laboratory of Cellular Immunity, Shanghai Key Laboratory of Traditional Chinese Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China., Mao DW; Department of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning 530023, China., Xue JD; Department of Hepatology, Shaanxi Hospital of Traditional Chinese Medicine, Xi'an 710003, China., Shi WB; Department of Infectious Diseases, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, China., Chi XL; Department of Hepatology, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou 510006, China., Wang XB; Department of Integrated TCM and Western Medicine, Ditan Hospital Affiliated of Capital Medical University, Beijing 100015, China., Li XD; Department of Hepatology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China., Li Y; Department of Hepatology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250011, China., Wang H; Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China., Li Q; Department of Hepatology, Department of Infectious Disease, Fuzhou Infectious Diseases Hospital, Fuzhou 350000, China., Zhou DQ; Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen 518033, China., Wang CB; Department of Infectious Diseases, Linyi People's Hospital, Linyi 276003, China., Shi CH; Qingdao Liver Diseases Institute, Qingdao Hospital of Infectious Diseases, Qingdao 266033, China., Li CZ; Department of Infectious Diseases, The First Affiliated Hospital of Naval Medical University, Shanghai 200433, China., Wu JH; Department of Hepatopathy, Xiamen Hospital of Traditional Chinese Medicine, Xiamen 361001, China., Kong XN; Central Laboratory, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China., Sun XH; Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China., Gao YQ; Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.; Laboratory of Cellular Immunity, Shanghai Key Laboratory of Traditional Chinese Medicine, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.
Jazyk: angličtina
Zdroj: Evidence-based complementary and alternative medicine : eCAM [Evid Based Complement Alternat Med] 2022 Mar 25; Vol. 2022, pp. 6097221. Date of Electronic Publication: 2022 Mar 25 (Print Publication: 2022).
DOI: 10.1155/2022/6097221
Abstrakt: Background: Bushen Jianpi formula (BSJPF, also known as Lingmao formula) is a traditional Chinese medicine for chronic hepatitis B (CHB). The previous study has suggested that the treatment combination of BSJPF and entecavir (ETV) can achieve a significant loss of hepatitis B e antigen (HBeAg) and a significant decrease in serum level of hepatitis B virus (HBV) DNA in HBeAg-positive CHB patients with mildly elevated alanine aminotransferase.
Objective: This study aimed to evaluate the efficacy and safety of BSJPF combined with ETV for treating HBeAg-negative CHB patients.
Methods: A total of 640 patients were assigned randomly to the treatment group (receiving BSJPF combined with ETV for 96 weeks) or the control group (receiving a placebo combined with ETV for 96 weeks) in a 1 : 1 ratio. The primary endpoints are the rate of loss of hepatitis B surface antigen (HBsAg). The secondary outcomes included the rate of decrease in the HBsAg concentration to ≥1 lg·IU/mL, the HBV DNA suppression, the decline of the level of covalently closed circular DNA (cccDNA) in the liver, histological improvements, and the rate of ALT normalization.
Results: The rate of HBsAg loss in the treatment group was significantly higher than that of the control group (5.5% versus 1.8%, P =0.031). There were 11.1% of patients in the treatment group who recorded a reduction in HBsAg ≥1 lg·IU/mL, which is better than 5.9% of patients in the control group ( P =0.043). There was no significant difference between the two groups with regard to the rate of HBV DNA clearance, the reduction in intrahepatic cccDNA, and the rate of ALT normalization ( P > 0.05). The rate of liver fibrosis improvement in the treatment group was better than that of the control group (35.5% versus 11.8%, P =0.031), but there was no difference in necroinflammatory improvement ( P > 0.05). The adverse events (AEs) were similar between the two groups, except for the abnormal kidney function, with 2.2% in the control group and 0.0% in the treatment group ( P =0.028).
Conclusion: The combination of BSJPF and ETV can increase the rate of HBsAg loss and the rate of histological fibrosis improvement without serious adverse events in CHB patients. Trial Registration . This trial is registered with ChiCTR-IOR-16009880 on November 16, 2016-retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=16836.
Competing Interests: The authors declare no conflicts of interest.
(Copyright © 2022 Jing-Hao Zhang et al.)
Databáze: MEDLINE
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