AIM: To observe the effectiveness and safety of the effect of bupleurum root and dan-shen root compound decoction against hepatic fibrosis. METHODS: ①Sixty-two outpatients and inpatients in all with chronic type B hepatitis or cirrhosis, aged 16 through 65 years, were selected from the Department of Gastroenterology, Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine between August 2002 and August 2004. The subjects were divided into two groups according to the random digits table: Treatment group (n=32) and control group (n=30). All the subjects signed the informed consent.②Patients in the treatment group orally took condensed decoction with the effect of dispersing and depressing liver-energy and dissolving stasis (Ingredients: bupleurum root, nutgrass galingale rhizome, danshen root, terra merita, safflower, villous amomum fruit, turtle shell, fructus meliae toosendan etc., which were manufactured in the Department of Pharmaceutics of First Hospital Affiliated to Heilongjiang University of Traditional Chinese Medicine; Preparative method: Materials were water-decocted and extracted following fiat pulvis to make into physic liquor with the concentration of 1 g/mL; 100 mL/sack), twice a day and one sack for each time at one hour after the meal. Patients in the control group orally took dahuang shuchong tablet (manufactured by Hunan Huichuntang pharmaceutical factory, 243020397, 3 g/tablet), twice a day and 3.0 g each time; All the patients were intervened for one course (3 months). Further consultation was conducted in the follow up at 6 months after the course to observe the curative effects.③Levels of plasma pre-collagen Ⅲ peptide, hyaluronic acid, laminin and type Ⅳ collagen were detected with radio-immunity method before and after the treatment; Semi-automatic biochemical meter was adopted to measure the activities of alanine aminotransferase and aspartate aminotransferase. After treatment, enzyme linked immunosorbent assay was used to inspect the main markers of serum hepatitis virus. Changes of indexes of liver and spleen in B-ultrasound were observed before and after the treatment.④Standard of symptom rating scale: Patients were rated according to 4 ranks, i.
e. non, slight, mild and severe. "-" meant non, "+" meant slignt, "?荻" meant mild, "?莘" meant severe; One point for each "+" and "-" worth zero. Specific evaluations: Pain in ribs, tongue demonstration, hepatauxe, enlarged spleen, spider telangiectasia in liver palm. ⑤Safety were evaluated on patients of both groups in the treatment.⑥Differences in efficacy of both groups were analyzed with Chi-square test; Differences in measurement indexes were compared with single-factor analysis of variance; SNK was used for comparison between each two groups. RESULTS: In the observation, one patient in the treatment group did not take medicine as regulation, whose curative effect could not be judged, and two patients naturally withdrew from the study, who were then enrolled in the invalid cases to be analyzed; There were no subjects withdrew in the control group; In evaluation on other indexes, 32 cases in the treatment group and 30 cases in the control group were included.①Scores on pain in ribs and tongue demonstration in the treatment group after treatment were obviously lower than those before treatment and those in the control group after treatment (P < 0.05-0.01).②Activities of plasma glutamate-pyruvate transaminase and aspartate aminotransferase in both groups were markedly lower than those before treatment (P < 0.01), while the activity of glutamate-pyruvate transaminase in the treatment group after treatment was remarkably higher than that in the control group (P < 0.05).③The oblique diameter of right lobe of liver in both groups after treatment was significantly smaller than that before treatment (P < 0.05).④Differences in hepatitis B virus antigen and antibody reversing ratio of both groups after treatment were not obvious.⑤Levels of plas