World J Gastroenterol. 2002 Aug; 8(4): 679-85.

Clinical observation of salvianolic acid B in treatment of liver fibrosis in chronic hepatitis B.

Liu P, Hu YY, Liu C, Zhu DY, Xue HM, Xu ZQ, Xu LM, Liu CH, Gu HT, Zhang ZQ.

Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. liuliver@online.sh.cn

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.