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.