OBJECTIVETo investigate the indication of Fuzheng Huayu Capsule (FHC) against hepatic fibrosis and its non-invasive efficacy evaluation parameters.

METHODSData involving hepatic fibrotic patients received twice liver biopsy before and after FHC treatment were received from multi-center, randomized, double-blind, controlled clinical trials and analyzed. The changes of indexes related to inflammation of hepatic tissue and liver function, serological and virologic parameters of fibrosis, blood routine test, hepatic ultrasonic test as well as clinical symptoms and signs of patients were compared between patients alleviated (assigned to the effective group) and un-alleviated (assigned to the ineffective group) by the treatment.

RESULTS(1) The degree of liver fibrosis, ALT activity and the scores of symptoms of hypochondriac pain and dry mouth before treatment were remarkably higher in the effective group than those in the ineffective group. (2) Level of ALT activity decreased in both groups after treatment. In the effective group, the grading scores of hepatic inflammatory significantly decreased after treatment (P < 0.01), levels of AST and GGT decreased after 3 months' treatment, and levels of GGT and PT significantly decreased after treated for 6 months, as compared to those in the ineffective group, showing significant difference. (3) Levels of serum hyaluronic acid (HA) and collagen type III (P-III-P) remarkably decreased after 12 weeks' treatment in the effective group. (4) Symptoms and signs were improved at various degrees in the two groups, but the improvement in dim and blackish complexion was more significant in the effective group than that in the ineffective group. (5) The changes in virologic parameters of hepatitis B virus, blood routine and hepatic ultrasonic test between the two groups showed no significant difference respectively.

CONCLUSIONS(1) FHC showed better effect against hepatic fibrosis in patients of fibrotic stage around S3, with obvious active hepatic inflammation and symptoms of hypochondriac pain and dry mouth, which could be taken as a referential index in clinical practice for indication decision. (2) The increase of serum albumin, decrease of GGT, AST, PT, HA, and P-III-P as well as the improvement of signs of dim and blackish complexion could be regarded as the referential indexes of effectiveness of FHC against hepatic fibrosis. These parameters are valuable non-invasive indices for diagnosis of hepatic fibrosis and efficacy evaluation of its treatment.