达美施乙肝三号治疗乙肝后肝纤维化、肝硬化的疗效观察.doc

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1、达美施乙肝三号治疗乙肝后肝纤维化、肝硬化的疗效观察【关键词】达美施　【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

2、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　　Observationoftherapeuticeffectof

3、TINMAXHB-3inpatientswithhepatofibrosisposthepatitisBandcirrhosis　　【Abstract】ObjectiveToevaluatetheefficiencyandsafetyof“TINMAX”HB-3herbalcompound(cpd)intreatmentofhepatofibrosisandcirrhosispostchronichepatitisB.MethodsAdouble-blindrandomizedmethodwasemployed.60patientsofhepatofibrosisorcirrhosis

4、posthepatitisBwereseparatedintostudygroup(“TINMAX”HB-3group)andcontrolgroup(naturalvitamingroup)byrandomizedmethod.Thecoursewas52weeks.Patientsvisitedonceevery12weeksandthelastvisiteach12weeksafterthecessationoftreatment.Partofpatientshadliverbiopsiesbeforeandaftertreatment.Clinicalsymptoms,live

5、rfunctiontest,serummarkersofhepatofibrosis(HA,LN,PCⅢ,CⅣ)weretested,ultrasoundevaluationwasperformedbefore,duringthecourseandattheendoftherapy.Results60patientsenrolledintheevaluation.58patientscompletedtheevaluationaccordingtotheprotocol.20patientshadliverbiopsiestwice,10patientsinstudygroupand1

6、0patientsincontrolgroup.Attheendoftherapy,thetotaleffectiverateofhepatofibrosisinhistopathologyis74.13%instudygroup,muchhigherthanthatof21.95%incontrolgroup(P＜0.05).Thetotaleffectiverateofserummarkersofhepatofibrosisat5theendoftherapyinstudygroupwas70.10%,muchhigherthanthatof30.24%incontrolgroup

7、(P＜0.05).Thetotaleffectiverateofnon-invasionmarkersofhepatofibrosisattheendoftherapyinstudygroupwas76.08%,muchhigherthanthatof19.41%incontrolgroup(P＜0.05).Thedrugsofadverseeventhadnothappenedinbothgroups.Conclusion“TINMAX”HB