恩替卡韦联合扶正化淤胶囊治疗乙型肝炎肝纤维化的临床研究

目的观察乙型肝炎肝纤维化患者抗病毒、抗肝纤维化治疗的疗效和安全性。方法将126例乙型肝炎肝纤维化患者随机分为3组，A组38例，给予传统方法治疗；B组41例，给予传统方法＋恩替卡韦治疗；C组47例，给予传统方法＋恩替卡韦＋扶正化淤胶囊治疗。扶正化淤胶囊治疗24周，其他3组患者治疗观察48周。观察肺功能指标，肝纤维化指标，Child．Pugh评分和乙型肝炎病毒血清学改变效果。结果治疗后C组患者血清肝纤维化指标与A、B组比较透明质酸（HA）：（152．3±72．3）μg/L、（212．3±86．9）μg/L、（325．6±153．1）μg/L，F=30．18，P〈0．01]；层粘连蛋白（LN）：（104．7±23．9）μg／L、（139．9±28．9）μg/L、（127．7．4-76．0）μg/L，F=36．99，P〈0．01]；（Ⅲ型前胶原（PcⅢ）：（167．8±61．4）μg／L、（207．5±78．1）μg／L、（263．1±113．2）μg/L，F=30．34，P〈0．01）]和Child—Pugh评分（6．94±1．31、7．53±1．24、8．77±1．36，F=14．45，P〈0．01）下降均优于A组和B组，差异有统计学意义。治疗后C组患者肝功能与A、B组比较，差异有统计学意义丙氨酸氨基转移酶（ALT）：（58±41）U／L、（147±96）U／L、（75±19）U／L，F=16．82，P〈0．01]；白蛋白（ALB）：（38．1±1．7）g／L、（26．5±3．5）g/L、（35．4±1．8）g/L，F=4．69，P〈0．01]；总胆红素（TBil）：（31．9±12．7）μmol／L、（85．2±58．3）μmol／L、（46．1±17．8）μmol／L，F=15．10，P〈0．01]和凝血酶原活动度（PTA）的改善（76±24）％、（57±12）％、（73±18）％，F=79．26，P〈0．01）]。结论乙型肝炎肝纤维化患者抗病毒治疗，快速抑制乙型肝炎肝纤维化患者的病毒复制，改善肝功能。同时应用扶正化淤胶囊抗肝纤维化治疗可有效的改善患者肝纤维化和棍高廉者的向洁蛋白含骨．

Clinical values of Fuzheng Huayu capsule combined with entecavir in the treatment of hepatitis B- induced liver cirrhosis

Objective To investigate the efficacy and safety of Fuzheng huayu capsule in combination with anti-viral drugs in the treatment of hepatitis B-mediated liver cirrhosis. Methods One hundred and twenty- six patients with liver cirrhosis resulting from hepatitis B were randomized into group A （38 cases receiving conventional therapy） ,group B （41 cases receiving conventional therapy ± entecavir）and group C （47 cases receiving conventional therapy ± entecavir and anti-fibrosis treatment ）. The Fuzheng Huayu capsule was administrated for 24 weeks and all the patients were observed for 48 weeks. Results The liver cirrhosis-related parameters in Group C were more remarkably improved than that of Group A and Group B ： （HA）：（152.3±72.3）μg/L、（212.3±86.9）μg/L、（325.6±153.1）μg/L,F=30.18,P〈0.01];（LN）：（104.7±23.9）μg/L、（139.9±28.9）μg/L、（127.7.4-76.0）μg/L,F=36.99,P〈0.01], Pc Ⅲ （ 167. 8 ± 61.4] μg/L vs. 207. 5 ± 78. 1 ] μg/L, 263.1 ± 113.21 μg/L,F = 30. 34,P 〈0. 01 ） and Child-Pugh scale （ 6. 94 ± 1.31 ] vs. 7. 53 ± 1.24], 8.77 ± 1.36 ], F = 14.45, P 〈 0.01 ）. The liver function-related parameters in Group C were significantly different from that of Group A and Group B：ALT（ 58 ±41 ] U/L vs. 147 ±96] U/L, 75 ± 191 U/L,F=16.82,P〈0.01） ,ALB（38. 1 ± 1.7]g/L vs. 26.5 ±3.5]g/L,35.4 ± 1.8]g/L,F =4.69,P 〈 0. 01 ）, TBil （ 31.9 ± 12. 7 ] μmol/L vs. 85.2 ± 58. 3 ] μmol/L, C 46. 1 ± 17. 8 ] μmol/L, F = 15. 10, P 〈 0. 01 ） and PTA improvement （76 ±24]% vs. 57 ± 12]%, 73 ± 18]% ,F = 79. 26,P 〈0.01）. Conclusion Entecavir can rapidly and effectively inhibit the replication of HBV in patients with deeompensated hepatitis B- mediated cirrhosis and improve the liver function. When combined with fuzheng huayu capsule, enteeavir will effectively improve the cirrhosis and elevate the serum albumin level.