Synergistic Effect of Biejia-Ruangan on Fibrosis Regression in Patients With Chronic Hepatitis B Treated With Entecavir: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
J Infect Dis
; 225(6): 1091-1099, 2022 03 15.
Article
em En
| MEDLINE
| ID: mdl-32437567
ABSTRACT
BACKGROUND:
Long-term nucleos(t)ide analogue (NA) treatment can reverse liver fibrosis in chronic hepatitis B (CHB), but its effect on fibrosis regression remains limited. Biejia-Ruangan (BR) has been approved in China as an antifibrotic traditional Chinese medicine drug in patients with chronic liver diseases. A multicenter randomized controlled trial aims to evaluate the effect of BR on fibrosis regression in CHB patients treated with NAs.METHODS:
CHB patients with histologically confirmed advanced fibrosis or cirrhosis were randomly assigned to receive entecavir (ETV) (0.5 mg per day) plus BR (2 g 3 times a day) or placebo for 72 weeks. Liver fibrosis regression was defined as a reduction ofâ ≥â 1 point by the Ishak fibrosis stage (IFS).RESULTS:
Overall, 500 patients were enrolled in each group as the intention-to-treat population. The rate of fibrosis regression after 72 weeks of treatment was significantly higher in the ETVâ +â BR group (40% vs 31.8%; Pâ =â .0069). Among 388 patients with cirrhosis (ie, IFSâ ≥â 5) at baseline, the rate of cirrhosis reversal (ie, IFSâ ≤â 4) was significantly higher in the ETVâ +â BR group (41.5% vs 30.7%; Pâ =â .0103).CONCLUSIONS:
Addition of BR to the current standard treatment with NAs in CHB patients with advanced fibrosis or cirrhosis can improve liver fibrosis regression. CLINICAL TRIALS REGISTRATION NCT01965418.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Medicinas Tradicionais:
Medicinas_tradicionales_de_asia
/
Medicina_china
Assunto principal:
Hepatite B Crônica
Idioma:
En
Revista:
J Infect Dis
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
China