【摘要】 目的 研究中药制剂达美施乙肝三号治疗乙肝后肝纤维化、肝硬化的治疗效果及安全性。方法 随机双盲对照试验，60例乙肝后肝纤维化、肝硬化患者随机分为治疗组(达美施乙肝三号组)及对照组(天然维生素组)。疗程为52周，每12周随访1次，并于停药12周后随访。部分病人治疗前、后做肝活检。所有病人治疗前、治疗中、治疗后进行临床症状和体征的评估、相关肝功能检查、肝纤维化血清标志物(透明质酸-HA、层黏蛋白-LN、Ⅲ型前胶原-PCⅢ、Ⅳ型胶原-CⅣ)检测及影像学B超检查。结果 共有60例病人入选，58例病人按方案要求完成治疗。共有20例病人做二次肝活检，其中治疗组10例，对照组10例。治疗52周后，治疗组肝纤维化病理组织学疗效总有效率为74.13%，显著高于对照组21.95%(P<0.05)，血清肝纤维化标志物改善的总有效率治疗组为70.10%，显著高于对照组的30.24%(P<0.05)，治疗后治疗组肝纤维化非创伤性指标疗效的总有效率为76.08%，显著高于对照组19.41%(P<0.05)。两组均无药物不良反应发生。结论 达美施乙肝三号中药复方能有效、安全地治疗乙肝后肝纤维化、肝硬化。

    【关键词】 中药复方；达美施乙肝三号；肝纤维化；肝硬化；治疗

    Observation of therapeutic effect of TINMAX HB-3 in patients with hepatofibrosis post hepatitis B and cirrhosis

    YING Tian-ming.Shenzhen Institute For Hepatic Disease of TINMAX，Shenzhen 518003，China

    【Abstract】 Objective To evaluate the efficiency and safety of “TINMAX” HB-3 herbal compound (cpd) in treatment of hepatofibrosis and cirrhosis post chronic hepatitis B.Methods A double-blind randomized method was employed.60 patients of hepatofibrosis or cirrhosis post hepatitis B were separated into study group (“TINMAX” HB-3 group) and control group (natural vitamin group) by randomized method. The course was 52 weeks. Patients visited once every 12 weeks and the last visit each 12 weeks after the cessation of treatment. Part of patients had liver biopsies before and after treatment. Clinical symptoms, liver function test, serum markers of hepatofibrosis (HA,LN,PCⅢ,CⅣ) were tested, ultrasound evaluation was performed before, during the course and at the end of therapy.Results 60 patients enrolled in the evaluation.58 patients completed the evaluation according to the protocol. 20 patients had liver biopsies twice, 10 patients in study group and 10 patients in control group. At the end of therapy, the total effective rate of hepatofibrosis in histopathology is 74.13% in study group, much higher than that of 21.95% in control group (P<0.05). The total effective rate of serum markers of hepatofibrosis at the end of therapy in study group was 70.10%, much higher than that of 30.24% in control group (P<0.05). The total effective rate of non-invasion markers of hepatofibrosis at the end of therapy in study group was 76.08%, much higher than that of 19.41% in control group (P<0.05). The drugs of adverse event had not happened in both groups.Conclusion “TINMAX”HB-3 herbal compound (cpd) is effective and safe in treatment of hepatofibrosis and cirrhosis post chronic hepatitis B. ......