OBJECTIVETo generate a refined staging system of fibrosis in chronic viral hepatitis and to assess its accuracy and sensitivity for evaluating therapeutic efficacy of anti-fibrosis drug treatments.

METHODSA refined fibrosis staging system was established according to the detailed characteristics of progressive fibrosis. A total of 396 liver puncture biopsy specimens were collected from patients before and after anti-fibrosis therapy and used to evaluate the refined staging system. According to the original fibrosis staging system and refined fibrosis staging system, fibrosis staging differences from before and after treatment were analyzed by Chi-squared test and paired-samples t-test respectively.

RESULTSThe refined fibrosis staging system detected significant changes in fibrosis stage that occurred in response to treatment (before treatment: 6.55 +/- 2.93 vs. after treatment: 6.19 +/- 2.945, P less than 0.01). However, the original (unrefined) staging system was unable to differentiate therapy-related changes in fibrosis stage (x2= 3.144, P = 0.534).

CONCLUSIONThe newly-developed refined fibrosis staging system was able to effectively evaluate the therapeutic efficacy of anti-fibrosis drug treatment and performed better than the original staging system.