恩替卡韦联合复方鳖甲软肝片治疗慢性乙型肝炎肝纤维化临床研究

The clinical efficacy research of entecavir combined with Fufang Biejia Ruangan tablet in treatment ofpatients with chronic hepatitis B

目的:探讨恩替卡韦联合复方鳖甲软肝片治疗慢性乙型肝炎(CHB)肝纤维化的疗效。方法:216例慢CHB肝纤维化患者按1:1随机分为采用恩替卡韦单药治疗的对照组和恩替卡韦联合复方鳖甲软肝片治疗的治疗组,各108例。疗程为48周,观察两组患者治疗前后的ALT、TBil、HBV DNA及肝硬度值(LSM)、APRI值,并进行比较。结果:治疗后两组患者ALT、TBil、HBV DNA水平均较治疗前明显降低,但两组比较,差异无显著性意义(P>0.05);而治疗后两组患者的肝纤维化指标均有不同程度地下降,治疗组患者LSM值从(12.1±7.4)KPa降至(8.3±4.9)KPa、APRI值从(1.68±1.12)降至(0.76±0.87);对照组的LSM值从(13.1±7.8)KPa降至(9.8士5.5)KPa、APRI值从(1.76±1.23)降至(0.97±0.73),治疗组的降低幅度高于对照组(P<0.05)。结论:恩替卡韦联合复方鳖甲软肝片治疗CHB肝纤维患者的疗效优于单用恩替卡韦。

Objective： To Approach the clinical effect of entecavir combined compound Biejiaruangan tablet in treatment of liver fibrosis with chronic hepatitis B. Methods： 216 cases of chronic hepatitis B patients randomised 1：1 for entecavir monotherapy group treatment and entecavir combined with Biejiaruangan tablet treatment group, the course of treatment was 48 weeks, observat two groups of ALT, TBil, HBV DNA and liver stiffness, APRI values. Results： After treatment, the ALT, TBil, HBV DNA level of Combined treatment group and monother- apy group was significantly lower than before treatment , but the two groups compared no significant difference （ P 〉 0.05 ） ; two groups of liver fibrosis were varying degrees of decline, The LSM values of combined treatment group reduced from （ 12.1 ± 7.4 ） KPa to （ 8.3 ± 4.9 ） KPa, APRI values reduced from （ 1.68 ± 1.12） to （0.76 ±0.87） , The LSM values of entecavir monotherapy group reduced from （ 13.1 ± 7.8） KPa to（9.8 ± 5.5 ） KPa, APRI values reduced from （ 1.76 ± 1.23 ） to （0.97 ± 0.73 ） , The liver fibrosis index of combined treatment group decreased faster than that of enteeavir treatment group（P 〈 0.05 ）. Conclusion：Entecavir combined with Fufangbiejiaruangan tablet for improving the efficacy of hepatic fibrosis of hepatitis B is better than cntecavir monotherapy.