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时间:2020-05-24
《阿德福韦酯片治疗HBeAg阳性慢性乙型肝炎多中心临床研究.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、·440中华实验和临床病毒学杂志2013年12月第27卷第6期ChineseJExpClinVirol,December2013,Vol,27,No.6病毒病诊断与治疗.阿德福韦酯片治疗HBeAg阳性慢性乙型肝炎多中心临床研究臧红,丁晋彪,李进,柳芳芳,李晨,朱冰,刘婉妹,游绍莉,辛绍杰【摘要】目的评价国产阿德福韦酯片治疗成人HBeAg阳性慢性乙型肝炎的有效性和安全性。方法采用多中心、开放试验方法,入选1930例患者服用阿德福韦酯片10mg/d。随访观察采用标准操作规程(SOP),观察12周、24周、36周、52周的生化、病毒学指标及不良反应。结果1930例患者
2、治疗12周、24周、36周、52周,HBVDNA阴转率分别为16.42%、28.55%、37.25%、43.32%,ALT复常率分别为29.69%、49.02%、56.42%、62.95%。治疗24周、52周HBeAg阴转率分别为12.59%、19.38%。随着疗程延长,HBVDNA阴转率、ALT复常率、HBeAg阴转率越高。治疗52周时耐药率为0.17%。不良反应率0.72%,极少数病例出现尿常规轻微异常,未发现肾功或生殖系统受损。结论国产阿德福韦酯片治疗HBeAg阳性慢性乙型肝炎具有良好的有效性及安全性。【主题词】阿德福韦酯;肝炎,乙型,慢性Muiti-ce
3、nterclinicaltrialonefectofadefovirdipivoxiiintreatingchronichepatitisBwitheantigen-positiveZANGHong,DINGJin—biao,LIJin,LIUFang-fang,L1Chen,ZHUBing,un—shu,YOUshao—li,XINShao-jie.302HospitalofPLA,Be谤g100039,ChinaCorrespondingauthor:YOUshao—li,Email:youshaoli302@sohu.corn;,ⅣShao-fie,Ema
4、il:xinshaojie302@163.com【Abstract】ObjectiveToevaluatetheefficacyandsafetyofdomesticadefovirdipivoxilinthetreatmentofchronichepatitisBwitheantigen—positive.MethodsThemuhicenteropenclinicaltrialwasconducted,the1930patientsreceivedoraladefovirdipivoxil10mg/d.Follow—upobservationsbystand
5、ardoperatingprocedures(SOP).Thechangesinbiochemical,virologicalparametersandadversereactionswereobservedaftertreatmenton12weeks,24weeks.36weeksand52weeks.Resul~After12weeks,24weeks.36weeksand52weeksoftreatment.theratesoftheserumHBVDNAnegative-conversionandalanineaminotransferase(ALT)
6、renormalizationwerel6.42%,28.55%,37.25%,43.32%and29.69%,49.02%,56.42%,62.95%respectively.After24weeksand52weeksoftreatment,theratesofHBeAgnegative—conversionwere12.59%,19.38%respectively.Afterthat,asthetreatmentdurationprolonged,therewasanincreaseinthesel31mHBVDNAnegative—conversion,
7、ALTrenormalizationandHBeAgnegative.conversionrateresistanceratewas0.17%duringthetreatmentof52weeksperiod.Theadversereactionrateof0.72%.veryfeWcasesofurineroutineshowedmildabnormality.noimpairmentsofrenalfunctionorreproductivesystemwereemerge.ConclusionsDomesticadefovirdipivoxilfortre
8、atingchronic
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