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时间:2020-05-04
《恩替卡韦胶囊与拉米夫定治疗慢性乙型肝炎的对照研究-论文.pdf》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
1、886中华肝脏病杂志2013年12月第21卷第l2期ChinJHepatol,December2013,Vo1.21,No.12病毒断炎恩替卡韦胶囊与拉米夫定治疗慢性乙型肝炎的对照研究徐道振蔡皓东马秀云李趺旗陆宪中俞海英孙爱民赵龙凤.张缭云高晓宏【摘要】目的探讨恩替卡韦胶囊治疗慢性乙型肝炎的安全性和有效性。方法采用多中心、随机、双盲、阳性药物平行对照的研究方法,为期96周,共有232例患者入组。前48周按1:1比例随机给予恩替卡韦(ETV)0.5mg/d,或拉米夫定(LAM)100mg/d。48
2、周双盲治疗期结束后,进入开放性ETV胶囊0.5mg/d治疗,观察至96周。计量资料符合正态分布者用方差分析和检验,不符合正态分布者用秩和检验方法进行统计分析。计数资料采用检验进行比较。结果服药48周后,病毒学完全应答率(HBVDNA<500拷贝/ml,PCR法),ETV组和LAM组分别为90.3%和59.4%;病毒学反弹发生率分别为1.9%和13.9%。服药96周后,病毒学完全应答率,ETV组和LAM组分别为86.0%和71.4%;但HBVDNA>5logl0拷贝/ml的患者,ETV组仅1例(1
3、.2%),LAM组有10例(11.9%),两组差异有统计学意义(尸=0.005)。结论ETV胶囊能迅速持续抑制HBV的复制,且耐药发生率低,长期治疗慢性乙型肝炎其疗效优于LAM。【关键词】肝炎病毒,乙型;肝炎,乙型,慢l生;拉米夫定;临房试验;恩替卡韦ComparativeanalysisoftheelticaeiesofentecavircapsulesandlamivudineinchronichepatitisBpatien~XUDao-zhen,CAIHao—dong,MAXiu-yun
4、,L1Yue—qLLUXian-zhong,YUHai-ying,SUNAi—min,ZHA0Long-feng,ZHANGLiao-yun,GAOXiao—hong.BeijingDitanHospitalCapitalMedicalUniversity,LiverD&easesBranch,Beijing100015,ChinaCorrespondingauthor:CAIHao—dong,Email:chddt@163.com[Abstract]ObjectiveToinvestigate
5、theeficacyprofileofentecavircapsule(ETV)asachronichepatitisBtherapy,ascomparedtolamivudine(LAM).MethodsInthismulticenter,randomized,double—blind,parallelgroupevaluationofETV,232subjectswereadministereda96·weekcourseof0.5mg/dayETVor100mg/dayLAM.PCRmea
6、surementofhepatitisBvirusrHBV)wasconductedthroughoutthetreatmentcoursetodetermineachievementofcompletevirologicresponse(CVR;definedas<500copies/mlofHBVDNA)orexperienceofvirologyreboundf>500copies/mlofHBVDNAafterachievementofCVR).ResultsAfterweek-48of
7、treatment,theFⅣgroupshowedahigherCVRrate(90.3%VS.LAM:59.4%)andlowervirologyreboundrate(1.9%VS.LAM:13.9%).Afterweek-96oftreatment,theETVgroupcontinuedtohaveahigherCVRrate(86.0%VS.LAM:71.4%),andvirologyreboundwasexperiencedbysignificantlylesssubjec~int
8、heETVgroup(1.2%VS.LAM:11.9%,P=0.oo5).ConclusionETVtherapycanquicklyandcontinuouslysuppressHBVreplicationinchronichepatitisBpatients,andhasalowerresistanceratethanLAM.ComparedtoLAM.ETVmaybeasuperiorlong-termtreatmentchoiceforchronichepatitisB.[Keyword
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