马来酸恩替卡韦片治疗HBeAg阴性慢性乙型肝炎的随机、双盲、双模拟对照、多中心临床研究48周结果
마래산은체잡위편치료HBeAg음성만성을형간염적수궤、쌍맹、쌍모의대조、다중심림상연구48주결과
A randomized, double-blind, double-dummy, controlled, multicenter study of entecavir maleate versus entecavir for treatment of HBeAg-negative chronic hepatitis B: results at week 48
  • 万方数据
    中华肝脏病杂志 중화간장병잡지
    CHINESE JOURNAL OF HEPATOLOGY
    2012年 7期 512-516 ,共5页

    徐京杭%于岩岩%斯崇文%曾争%李军%毛青%张大志%唐红%盛吉芳%陈新月%宁琴%施光峰%谢青%张喜全%戴峻%徐中南

    서경항%우암암%사숭문%증쟁%리군%모청%장대지%당홍%성길방%진신월%저금%시광봉%사청%장희전%대준%서중남

    肝炎,乙型,慢性%治疗结果%安全性%马来酸恩替卡韦%恩替卡韦 肝炎,乙型,慢性%治療結果%安全性%馬來痠恩替卡韋%恩替卡韋
    간염,을형,만성%치료결과%안전성%마래산은체잡위%은체잡위
    Hepatitis B,chronic%Treatment outcome%Safety%Entecavir maleate%Entecavir
    目的 比较马来酸恩替卡韦和恩替卡韦治疗HBeAg阴性慢性乙型肝炎患者的疗效及安全性. 方法 随机、双盲、双模拟、阳性药对照的多中心临床研究.入选患者随机分为A组和B组,分别接受恩替卡韦片0.5 mg/d或马来酸恩替卡韦片0.5 mg/d治疗,疗程为48周.于12、24、48周检测血清HBV标志物,定期随访患者,记录不良事件.HBV DNA用罗氏(Cobas Ampliprep/Cobas Taqman)第二代实时PCR法.符合参数分析条件的计量资料采用t检验,等级资料的组间比较用秩和检验,计数资料组间比较采用Fisher's精确概率法进行统计学分析.结果 共入组57例HBeAg阴性慢性乙型肝炎患者,A组26例,二次揭盲后为对照药恩替卡韦;B组31例,二次揭盲后为试验药马来酸恩替卡韦.两组基线各指标具可比性(P＞ 0.05).治疗12、24、48周时,A组和B组HBVDNA较基线下降值分别为4.24 log10 IU/ml对比4.01 log10 IU/ml(P＞ 0.05)、4.61 log10 IU/ml对比4.50log10 IU/ml(P＞0.05)、4.88 log10 IU/ml对比4.99 log10 IU/ml (P＞ 0.05).治疗48周时A组和B组HBV DNA不可测(HBV DNA水平低于20IU/ml)率分别为59.23％和80.65％(P＞0.05),ALT复常率分别为:96.00％对比83.87％(P＞0.05).不良事件发生率为:22.22％对比9.38％(P＞ 0.05).结论 马来酸恩替卡韦片与恩替卡韦均能有效治疗HBeAg阴性慢性乙型肝炎,两者疗效和安全性相似.
    목적 비교마래산은체잡위화은체잡위치료HBeAg음성만성을형간염환자적료효급안전성. 방법 수궤、쌍맹、쌍모의、양성약대조적다중심림상연구.입선환자수궤분위A조화B조,분별접수은체잡위편0.5 mg/d혹마래산은체잡위편0.5 mg/d치료,료정위48주.우12、24、48주검측혈청HBV표지물,정기수방환자,기록불량사건.HBV DNA용라씨(Cobas Ampliprep/Cobas Taqman)제이대실시PCR법.부합삼수분석조건적계량자료채용t검험,등급자료적조간비교용질화검험,계수자료조간비교채용Fisher's정학개솔법진행통계학분석.결과 공입조57례HBeAg음성만성을형간염환자,A조26례,이차게맹후위대조약은체잡위;B조31례,이차게맹후위시험약마래산은체잡위.량조기선각지표구가비성(P＞ 0.05).치료12、24、48주시,A조화B조HBVDNA교기선하강치분별위4.24 log10 IU/ml대비4.01 log10 IU/ml(P＞ 0.05)、4.61 log10 IU/ml대비4.50log10 IU/ml(P＞0.05)、4.88 log10 IU/ml대비4.99 log10 IU/ml (P＞ 0.05).치료48주시A조화B조HBV DNA불가측(HBV DNA수평저우20IU/ml)솔분별위59.23％화80.65％(P＞0.05),ALT복상솔분별위:96.00％대비83.87％(P＞0.05).불량사건발생솔위:22.22％대비9.38％(P＞ 0.05).결론 마래산은체잡위편여은체잡위균능유효치료HBeAg음성만성을형간염,량자료효화안전성상사.
    Objective To evaluate the efficacy and safety of entecavir (ETV) maleate versus ETV in Chinese patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB).Methods This was a randomized,double-blind,double-dummy,controlled,multicenter study.Patients were randomly assigned to receive 48 weeks of treatment with 0.5 mg/day ETV (group A;n=26) or0.5 mg/day ETV maleate (n=31).Hepatitis B virus (HBV) DNA levels were measured at weeks 12,24,and 48 by the Roche Cobas Ampliprep/Taqman PCR assay.Adverse events (AE) were recorded.Results Baseline characteristics were similar between the two groups.At weeks 12,24,and 48,the mean HBV DNA level had similarly decreased from baseline in both groups (A:by 4.24,4.61 and 4.88 log10 IU/mL vs.B:4.01,4.50 and 4.99 log10 IU/mL,respectively; all P＞0.05).Patients who achieved undetectable levels of serum HBV DNA (＜20 IU/mL) at week 48 were similar in the two groups (A:69.23％ vs.B:80.65％; P＞0.05).Both groups achieved similar normalization of ALT at week 48 (A:96.00％ vs.B:83.87％;P＞0.05).The overall AE incidence was similar for the two groups (A:22.22％ vs.B:9.38％; P＞0.05).Conclusion Entecavir maleate and entecavir showed similar efficacy and safety in patients with HBeAg-negative CHB.
    원문보기 원문다운로드 사이트로이동
저자의 최근 논문