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


CONCLUSIONS
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.
Liu
Ping
P
Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China. liuliver@online.sh.cn
Hu
Yi-Yang
YY
Liu
Cheng
C
Zhu
Da-Yuan
DY
Xue
Hui-Ming
HM
Xu
Zhi-Qiang
ZQ
Xu
Lie-Ming
LM
Liu
Cheng-Hai
CH
Gu
Hong-Tu
HT
Zhang
Zhi-Qing
ZQ
D000328:Adult; D001572:Benzofurans / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007371:Interferon-gamma / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D008297:Male; D008517:Phytotherapy; D011994:Recombinant Proteins; D053630:Depsides
D001572:Benzofurans; D004365:Drugs, Chinese Herbal; D007371:Interferon-gamma; D011994:Recombinant Proteins; C076944:salvianolic acid B; D053630:Depsides