复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化的临床研究

目的验证复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化的临床疗效和安全性。方法将420例慢性乙型肝炎肝纤维化患者随机分为两组：治疗组300例，口服复方鳖甲软肝片，对照组120例，口服和络舒肝胶囊，6个月为1疗程。结果治疗组的患者在改善症状和体征，恢复肝功能总疗效方面，显效率和总有效率分别为55．67％和81．67％，对照组分别为15．80％和60．00％，治疗组明显优于对照组（P〈0．01）。结论复方鳖甲软肝片在改善中医症状，血清学肝纤维化及肝组织病理指标等方面疗效确切，可以有效治疗慢性乙型肝炎肝纤维化。

Efficacy and safety of Fufang Biejia Ruangan tablet in patients with chronic hepatitis B complicated with hepatic fibrosis

OBJECTIVE: To study the clinical therapeutic effects and safety of Fufang Biejia Ruangan tablet (FBRt) in patients with chronic hepatitis B complicated with hepatic fibrosis. METHODS: Totally 420 patients were randomly divided into two groups, FBRt group (300 cases) were treated with Fufang Biejia Ruangan tablets and control group (120 cases) were treated with He Luo Shu Gan capsule, the patients in both groups were treated for 6 months. RESULTS: The cure rate and total effective rate of FBRt group were significantly higher than those of control group (55.67 percent and 81.67 percent vs. 15.8 percent and 60.00 percent, P less than 0.01). CONCLUSION: Fufang Biejia Ruangan tablet could alleviate clinical symptoms and hepatic fibrosis. Fufang Biejia Ruangan tablet is effective and safe in treatment of patients with chronic hepatitis B complicated with liver fibrosis.