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1、達美施乙肝三號治療乙肝后肝纖維化、肝硬化的療效觀察【關鍵詞】達美施 【摘要】目的研究中藥制劑達美施乙肝三號治療乙肝后肝纖維化、肝硬化的治療效果及安全性。方法隨機雙盲對照試驗,60例乙肝后肝纖維化、肝硬化患者隨機分為治療組(達美施乙肝三號組)及對照組(天然維生素組)。療程為52周,每12周隨訪1次,并于停藥12周后隨訪。部分病人治療前、后做肝活檢。所有病人治療前、治療中、治療后進行臨床癥狀和體征的評估、相關肝功能檢查、肝纖維化血清標志物(透明質酸-HA、層黏蛋白-LN、Ⅲ型前膠原-PCⅢ、Ⅳ型膠原-CⅣ)檢測及影像學B超檢查。結果共有60例病人入選,58例病人按方案要求完成治療。共有20
2、例病人做二次肝活檢,其中治療組10例,對照組10例。治療52周后,治療組肝纖維化病理組織學療效總有效率為74.13%,顯著高于對照組21.95%(P<0.05),血清肝纖維化標志物改善的總有效率治療組為70.10%,顯著高于對照組的30.24%(P<0.05),治療后治療組肝纖維化非創(chuàng)傷性指標療效的總有效率為76.08%,顯著高于對照組19.41%(P<0.05)。兩組均無藥物不良反應發(fā)生。結論達美施乙肝三號中藥復方能有效、安全地治療乙肝后肝纖維化、肝硬化?! 娟P鍵詞】中藥復方;達美施乙肝三號;肝纖維化;肝硬化;治療 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