Aim: To evaluate the clinical efficacy of salvianolic acid B (SA-B) on liver fibrosis in chronic hepatitis B.
Methods: Sixty patients with definite diagnosis of liver fibrosis with hepatitis B were included in the trial. Interferon-gamma (IFN-gamma) was used as control drug. The patients took orally SA-B tablets or received muscular injection of IFN-gamma in the double blind randomized test. The complete course lasted 6 months. The histological changes of liver biopsy specimen before and after the treatment were the main evidence in evaluation, in combination with the results of contents of serum HA, LN, IV-C, P-III-P, liver ultrasound imaging, and symptoms and signs.
Results: Reverse rate of fibrotic stage was 36.67 % in SA-B group and 30.0 % in IFN-gamma group. Inflammatory alleviating rate was 40.0 % in SA-B group and 36.67 % in IFN-gamma group. The average content of HA and IV-C was significantly lower than that before treatment. The abnormal rate also decreased remarkably. Overall analysis of 4 serological fibrotic markers showed significant improvement in SA-B group as compared with the IFN-gamma group. Score of liver ultrasound imaging was lower in SA-B group than in IFN-gamma group (HA 36.7 % vs 80 %, IV-C 3.3 % vs 23.2 %). Before the treatment, ALT AST activity and total bilirubin content of patients who had regression of fibrosis after oral administration of SA-B, were significantly lower than those of patients who had aggravation of fibrosis after oral administration of SA-B. IFN-gamma showed certain side effects (fever and transient decrease of leukocytes, occurrence rates were 50 % and 3.23 %), but SA-B showed no side effects.
Conclusion: SA-B could effectively reverse liver fibrosis in chronic hepatitis B. SA-B was better than IFN-gamma in reduction of serum HA content, overall decrease of 4 serum fibrotic markers, and decrease of ultrasound imaging score. Liver fibrosis in chronic hepatitis B with slight liver injury was more suitable to SA-B in anti-fibrotic treatment. SA-B showed no obvious side effects.