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96周的临床疗效

目的：观察恩替卡韦联合复方鳖甲软肝片对慢性乙型肝炎（CHB）肝纤维化患者的临床疗效，探索具有协同治疗作用、促进CHB肝纤维化逆转的联合治疗方案。方法2010年6月~2015年6月在南方医科大学南方医院感染内科接受抗病毒治疗的CHB肝纤维化患者197例构成随访队列，按年龄、性别、LSM配对后分为恩替卡韦联合复方鳖甲软肝片组（以下简称A组，n=98例）和单用恩替卡韦治疗组（以下简称B组，n=99例），每12周随访1次。检测两组患者HBV DNA定量、血清学指标、血生化指标，肝脏硬度值（LSM）采用FibroScan检测，并转换为Metavir分期。结果治疗后两组患者LSM均明显降低（P<0.05），A组与B组Metavir分级下降中位时间分别为72周、96周，差异有统计学显著性意义；A组和B组ALT复常中位时间分别为12周、24周， AST复常中位时间分别为24周、36周，差异均有统计学显著性意义。两组HBV DNA阴转率、HBeAg血清学转换率无明显差异。结论恩替卡韦联合复方鳖甲软肝片能进一步改善CHB肝纤维化患者的总体疗效；对CHB肝纤维化具有协同治疗效应；复方鳖甲软肝片尚具有独立的护肝降酶作用。

Entecavir combined with Fufang Biejia Ruangan tablet in treatment of chronic hepatitis B patients with liver fibrosis:96-week efficacy analyses

Objective To evaluate the effect of long-term therapy with entecavir and Fufang Biejia Ruangan tablet in patients with chronic hepatitis B (CHB)-associated fibrosis and explore the synergistic therapy that accelerates the reversion of liver fibrosis. Methods A total of 197 patients with CHB-associated fibrosis were recruited from Nanfang Hospital between June, 2010 and June, 2015. The patients were divided into two groups after matching for age, gender and liver stiffness measurement (LSM), namely group A (n=98) treated with Fufang Biejia Ruangan Tablet plus entecavir, and group B (n=99) to receive entecavir only. HBV DNA quantification, HBV serological indicators, blood biochemical indexes, and results of abdominal ultrasound and FibroScan were recorded every 12 weeks. FibroScan values were converted to Metavir staging. Results Both groups showed significant decreases in serum levels of HBV DNA, alanine aminotransferase (ALT), and LSM value from baseline (all P<0.05). The median time to achieve Metavir fibrosis staging improvement were 72 weeks in group A and 96 weeks in group B (P<0.05), and the median time to achieve ALT and AST normalization were 12 and 24 weeks in Group A, respectively, significantly shorter than the time in group B (P<0.05). No significant difference was found between the two groups in HBV DNA undetectable rate and HBeAg seroconversion rate. Conclusion The combination therapy with Fufang Biejia Ruangan tablet and entecavir produces a stronger efficacy than entecavir alone in the treatment of chronic hepatitis B patients with liver fibrosis, and Fufang Biejia Ruangan tablet shows an obvious hepatoprotective effect in these patients.