替比夫定联合复方鳖甲软肝片治疗慢性乙型病毒性肝炎肝纤维化研究

Clinical efficacy of telbivudine combined with compound Biejia Ruangan tablets in treatment of liver fibrosis caused by chronic hepatitis B

目的探讨替比夫定联合复方鳖甲软肝片治疗慢性乙型病毒性肝炎（CHB）肝纤维化的疗效。方法将150例CHB患者随机分为替比夫定单药治疗组（单药组）、替比夫定与复方鳖甲软肝片联合治疗组（联合组），各75例，分别于治疗后12、24、36、48周观察随访，检测肝功能、HBV—DNA定量、肝脏B超及肝脏瞬时弹性，比较患者肝脏硬度变化、肝脏B超检查数据、外周血白蛋白／球蛋白比值，推断两组抗纤维化疗效。结果单药组与联合组在治疗24、36、48周时，肝脏瞬时弹性扫描检查显示肝脏硬度值明显下降（P〈0．01），其中联合治疗组降低幅度更明显（P〈0．05）。超声影像学检查发现，单药治疗组在48周时，各指标与基线数据比较差异无统计学意义（P〉0．05）；联合治疗组在治疗48周后肝脏回声赋值和脾脏肋间厚度同步下降（P〈0．05）。多因素回归分析结果显示，治疗12周时丙氨酸氨基转移酶（ALT）恢复正常、治疗24周时HBV—DNA在低于检测值下限及使用复方鳖甲软肝片是患者肝脏硬度值恢复正常的独立影响因素（P〈0．05）。结论替比夫定与复方鳖甲软肝片联合治疗方案在逆转慢性乙型病毒性肝炎肝纤维化方面更具优势，肝脏瞬时弹性扫描可以早期评估抗纤维化疗效。

Objective To investigate the clinical efficacy of combination treatment of telbivudine and compound Biejia Ruangan tablets to the liver fibrosis caused by hepatitis B. Methods A total of 150 patients with liver fibrosis caused by chronic hepatitis B admitted to our hospital from February 2011 to August 2013 ,were randomly divided into antiviral treatment group（ n = 75 ） and combined treatment group （n = 75 ）. All patients received antiviral therapy with telbivudine, meanwhile the patients of combined treatment group were given compound Biejia Ruangan tablets as addition for 48 weeks. The liver function, HBV-DNA level,liver stiffness values and the B ultrasound examination data were evaluated in different time points of 12 weeks ,24 weeks ,36 weeks ,48 weeks after treatment. Results The liver stiffness values of both groups patients were significantly decreased compared with the corresponding baseline measurements after 24 weeks,36 weeks,48 weeks treatment respectively. Compared with that of antiviral treatment group, the liver stiffness values of combined treatment group decreased more significantly （ P 〈 0.05 ）. Ultrasonic imaging detection showed no difference between the measurements of baseline and of 48 weeks treatment in the antiviral treatment group （P 〉 0.05 ）. However, the liver echo assignment and spleen intercostal thickness declined synchronously,and there was significant difference （P 〈 0.05 ）. Multiple regression analysis showed that alanine aminotransferase normalization within 12 weeks treatment, the HBV-DNA below the detection value within 24-weeks treatment and the use of compound Biejia Ruangan tablets were independent influence factors of liver stiffness normalization （P 〈 0. 05 ）. Conclusion Combined therapy with telbivudine and compound Biejia Ruangan tablets has more advantage in the reversal of liver fibrosis caused by chronic hepatitis B. The reversal effect of hepatic fibrosis can be evaluated early by Fibroscan.