Yang Nian-Huan, Yuan Guo-Sheng, Zhou Yu-Chen, Liu Jun-Wei, Huang Hua-Ping, Hu Cheng-Guang, Xiong Ling, Li Yuan, Zhou Fu-Yuan, Yang Shu-Ling, Zhou Yuan-Ping
uangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China. E-mail:
Nan Fang Yi Ke Da Xue Xue Bao. 2016 Jun;36(6):775-9.
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.
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.
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.
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.
评估恩替卡韦与复方鳖甲软肝片长期治疗对慢性乙型肝炎（CHB）相关纤维化患者的疗效，并探索加速肝纤维化逆转的协同治疗方案。
2010年6月至2015年6月期间，从南方医院招募了197例CHB相关纤维化患者。根据年龄、性别和肝脏硬度测量值（LSM）匹配后，将患者分为两组，即A组（n = 98）接受复方鳖甲软肝片加恩替卡韦治疗，B组（n = 99）仅接受恩替卡韦治疗。每12周记录HBV DNA定量、HBV血清学指标、血液生化指标以及腹部超声和FibroScan检查结果。将FibroScan值转换为Metavir分期。
两组患者血清HBV DNA、丙氨酸氨基转移酶（ALT）水平和LSM值较基线均显著下降（均P < 0.05）。A组达到Metavir纤维化分期改善的中位时间为72周，B组为96周（P < 0.05）；A组达到ALT和AST正常化的中位时间分别为12周和24周，显著短于B组（P < 0.05）。两组在HBV DNA不可检测率和HBeAg血清学转换率方面无显著差异。
复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎肝纤维化患者的疗效优于单用恩替卡韦，复方鳖甲软肝片对这些患者具有明显的保肝作用。
