关键词: 慢性乙型肝炎, 复方鳖甲软肝片, 血清肝纤维化指标, 临床疗效

Abstract: Objective To evaluate the efficacy of Compound Biejia Ruangan Tablets（RGP） on preventing the progression of liver fibrosis in patients with chronic hepatitis B（CHB）. Methods 304 patients with CHB were divided into treatment group（n=219），and control group （n=85）. The patients in treatment group were given RGP orally at dose of 4 tablets，3 times daily，and in control group given Anluo Huaxian pills （ALHX） orally，at dose of 6 g，2 times daily. The serum hyaluronan，laminin，collagen type Ⅳ，and PCⅢ levels were detected by ELISA. Results At the end of 24-week treatment，the significant improvement of Chinese medicine symptom as assessed by curative effect full analysis set（FAS） in treatment group was 72.9%，higher than 56.8%（P=0.004） in control group；the total efficiency in treatment group was 89.3%，higher than 80.7% in control group（P=0.029）；The curative effect analysis of four items for liver fibrosis showed that the significant efficiency in treatment group was 35.3%，better than 22.2% in control group（P=0.016）；the total effective rate was no statistically significantly different between the two groups；For serum liver fibrosis indexes，the hyaluronic acid in treatment group fell by（87.4±111.2） ng/mL，better than that in control group，which fell（61.2±66.2） ng/mL after treatment （P=0.01）；The changes of serum laminin，typeⅣcollagen and pro-collagen Ⅲ in the two groups had no statistical differences（P>0.05）；The normalization rates of liver function indexes after treatment had no statistically significant difference between the two groups（P>0.05）；In terms of safety，we found no adverse reaction in the two groups. Conclusion It is safe and effective to treat patients with CHB by RGP，which will improve the symptoms，and decrease serum liver fibrosis indexes.

Key words: Chronic hepatitis B, Compound Biejia Ruangan Tablet, Serum liver fibrosis index, Clinical