Efficacy and safety of bifidobacterium triple viable capsules combined with entecavir in the treatment of Hepatitis B cirrhosis

BACKGROUND: Liver cirrhosis caused by hepatitis B is a critical progression of chronic hepatitis B. It is often accompanied by intestinal dysbiosis and impaired intestinal mucosal barrier function, which further exacerbate hepatic inflammation and fibrosis. Therefore, exploring effective combined therapeutic approaches to improve patient outcomes is of significant importance. OBJECTIVE: This study compares the efficacy and safety of entecavir combined with bifidobacterium triple viable capsules versus entecavir alone in treating Hepatitis B cirrhosis. METHODS: This retrospective case-control study enrolled 110 patients with Hepatitis B cirrhosis diagnosed and treated from January 2021 to January 2024. The control group received entecavir alone, while the observation group received entecavir combined with bifidobacterium triple viable capsules Efficacy was assessed at 24 weeks and 48 weeks post-treatment. Comparisons were made between the two groups regarding changes in intestinal flora count, intestinal mucosal barrier function, liver function, HBV-DNA negativity rate, liver fibrosis indices, liver stiffness measurement (LSM), inflammatory factor indices, and treatment safety. RESULTS: At 24 weeks and 48 weeks post-treatment, the observation group exhibited significant modulation of the intestinal microecology, with a notable decrease in the count of pathogenic bacteria (Candida albicans, Enterobacteriaceae, Enterococcus) in feces compared to pre-treatment and the control group (all P<0.05), and a significant increase in the count of probiotics (Lactobacillus, Bifidobacterium) (all P<0.05). Meanwhile, the observation group showed more significant improvement in intestinal mucosal barrier function, with lower levels of endotoxin, D-lactic acid, and diamine oxidase compared to the control group (all P<0.05). Regarding liver-related indices, the observation group demonstrated significantly greater improvement in liver function (ALT, AST, TBIL, ALB), liver fibrosis markers (HA, PC-III, IV-C, LN), and LSM compared to the control group (all P<0.05), with more pronounced improvement at 48 weeks than at 24 weeks (P<0.05). Notably, the observation group exhibited a higher HBV-DNA negativity rate at 48 weeks (90.91% vs 76.36%, P=0.039) and superior regulation of inflammatory factors (decreased TNF-α, IL-6, IL-8, and increased IL-10) (all P<0.05). The final clinical efficacy assessment revealed a significantly higher total effective rate in the observation group compared to the control group (83.64% vs 65.45%, P=0.029). Adverse event rates were comparable between the observation and control groups (7.27% vs. 10.91%, P=0.507), supporting the safety of the intervention. CONCLUSION: The treatment regimen of bifidobacterium triple viable capsules combined with entecavir is significantly superior to entecavir alone in improving intestinal flora, repairing the intestinal mucosal barrier, promoting liver function recovery, and alleviating liver fibrosis in patients with Hepatitis B cirrhosis. It also demonstrates more pronounced long-term efficacy, a higher HBV-DNA negativity rate, superior overall clinical efficacy, and good safety.