软肝再生颗粒联合恩替卡韦抗肝纤维化效果观察

Efficacy Observation on Liver Fibrosis Treated with Ruangan Zaisheng Granules and Entecavir

目的评价软肝再生颗粒联合恩替卡韦抗肝纤维化的临床疗效。方法采用开放、非随机的方法纳入慢性乙型肝炎合并肝纤维化患者123例,分恩替卡韦单药组(A组)、软肝再生颗粒联合恩替卡韦组(B组)、复方鳖甲软肝片联合恩替卡韦组(C组)3组。观察治疗前后各组肝功能、凝血功能、肝纤维化指标、肝脏超声(门静脉、脾静脉宽度,脾脏厚度)、Fibro Scan肝脏硬度值(LSM)等指标的变化。结果治疗后,各组患者谷氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、总胆红素(TBIL)、血清白蛋白(ALB)、凝血酶原时间(PT)均有明显改善;治疗后24周和48周,B组、C组上述指标恢复情况均优于A组(P<0.05,P<0.01)。治疗48周,脾脏厚度缩小程度B组、C组均优于A组(P<0.05)。治疗48周,B组、C组肝纤维化指标及LSM改善程度明显优于A组(P<0.01)。治疗48周,B组与C组各个观察指标比较,差异均无统计学意义(P>0.05)。结论软肝再生颗粒联合恩替卡韦治疗可显著改善患者肝功能,对于慢性乙型肝炎导致的肝纤维化有明显疗效,可抑制肝纤维化及脾肿大进展,与复方鳖甲软肝片联合恩替卡韦效果相当。

Objective To evaluate the clinical efficacy on liver fibrosis treated with ruangan zaisheng granules and entecavir. Methods The open and non- randomization method was used to enroll 123 cases of chronic hepatitis B combined with liver fibrosis. They were divided into an entecavir group( A group),the combined medication of ruangan zaisheng granules and entecavir group( B group) and the combined medication of compound biejia ruangan tablets and entecair group( C group). Before and after treatment,the liver function,coagulation function,liver fibrosis indexes,liver ultrasound( portal vein,splenic venous width and spleen thickness) and Fibro Scan liver stiffness measurement( LSM) were observed in each group. Results After treatment,the levels of ALT,AST,TBIL,ALB and PT were all improved apparently in each group. In 24 and 48 weeks of treatment,the recovery of the above indexes in the B and C groups was better than that in the A group( P < 0. 05). In 48 weeks of treatment,the improvements in the liver fibrosis indexes and LSM in the B and C groups were apparently better than those in the A group( P < 0. 01). In 48 weeks of treatment,the differences in all the observed indexes were not significant between the B and C groups( P > 0. 05). Conclusion The combined medication of ruangan zaisheng granules and entecavir significantly improves liver function,has apparently efficacy on liver fibrosis induced by chronic hepatitis B and inhibits the development of liver fibrosis and spleen enlargement. The efficacy is similar to that achieved by the combined medication of biejia ruangan tablets and entecair.