中华肝脏病杂志
中華肝髒病雜誌
중화간장병잡지
CHINESE JOURNAL OF HEPATOLOGY
2013年
12期
886-890
,共5页
徐道振%蔡晧东%马秀云%李跃旗%陆宪中%俞海英%孙爱民%赵龙凤%张缭云
徐道振%蔡晧東%馬秀雲%李躍旂%陸憲中%俞海英%孫愛民%趙龍鳳%張繚雲
서도진%채호동%마수운%리약기%륙헌중%유해영%손애민%조룡봉%장료운
肝炎病毒,乙型%肝炎,乙型,慢性%拉米夫定%临床试验%恩替卡韦
肝炎病毒,乙型%肝炎,乙型,慢性%拉米伕定%臨床試驗%恩替卡韋
간염병독,을형%간염,을형,만성%랍미부정%림상시험%은체잡위
Hepatitis B virus%Hepatitis B,chronic%Lamivudine%Clinical trial%Entecavir
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)0.5 mg/d,或拉米夫定(LAM) 100 mg/d.48周双盲治疗期结束后,进入开放性ETV胶囊0.5 mg/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t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x2检验进行比较. 结果 服药48周后,病毒学完全应答率(HBV DNA＜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HBV DNA＞5 logm拷贝/ml的患者,ETV组仅1例(1.2％),LAM组有10例(11.9％),两组差异有统计学意义(P=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.
目的 探討恩替卡韋膠囊治療慢性乙型肝炎的安全性和有效性. 方法 採用多中心、隨機、雙盲、暘性藥物平行對照的研究方法,為期96週,共有232例患者入組.前48週按1:1比例隨機給予恩替卡韋(ETV)0.5 mg/d,或拉米伕定(LAM) 100 mg/d.48週雙盲治療期結束後,進入開放性ETV膠囊0.5 mg/d治療,觀察至96週.計量資料符閤正態分佈者用方差分析和t檢驗,不符閤正態分佈者用秩和檢驗方法進行統計分析.計數資料採用x2檢驗進行比較. 結果 服藥48週後,病毒學完全應答率(HBV DNA＜500拷貝/ml,PCR法),ETV組和LAM組分彆為90.3％和59.4％;病毒學反彈髮生率分彆為1.9％和13.9％.服藥96週後,病毒學完全應答率,ETV組和LAM組分彆為86.0％和71.4％;但HBV DNA＞5 logm拷貝/ml的患者,ETV組僅1例(1.2％),LAM組有10例(11.9％),兩組差異有統計學意義(P=0.005).結論 ETV膠囊能迅速持續抑製HBV的複製,且耐藥髮生率低,長期治療慢性乙型肝炎其療效優于LAM.
목적 탐토은체잡위효낭치료만성을형간염적안전성화유효성. 방법 채용다중심、수궤、쌍맹、양성약물평행대조적연구방법,위기96주,공유232례환자입조.전48주안1:1비례수궤급여은체잡위(ETV)0.5 mg/d,혹랍미부정(LAM) 100 mg/d.48주쌍맹치료기결속후,진입개방성ETV효낭0.5 mg/d치료,관찰지96주.계량자료부합정태분포자용방차분석화t검험,불부합정태분포자용질화검험방법진행통계분석.계수자료채용x2검험진행비교. 결과 복약48주후,병독학완전응답솔(HBV DNA＜500고패/ml,PCR법),ETV조화LAM조분별위90.3％화59.4％;병독학반탄발생솔분별위1.9％화13.9％.복약96주후,병독학완전응답솔,ETV조화LAM조분별위86.0％화71.4％;단HBV DNA＞5 logm고패/ml적환자,ETV조부1례(1.2％),LAM조유10례(11.9％),량조차이유통계학의의(P=0.005).결론 ETV효낭능신속지속억제HBV적복제,차내약발생솔저,장기치료만성을형간염기료효우우LAM.
Objective To investigate the efficacy profile of entecavir capsule (ETV) as a chronic hepatitis B therapy,as compared to lamivudine (LAM).Methods In this multicenter,randomized,double-blind,parallel group evaluation of ETV,232 subjects were administered a 96-week course of 0.5 mg/day ETV or 100 mg/day LAM.PCR measurement of hepatitis B virus (HBV) was conducted throughout the treatment course to determine achievement of complete virologic response (CVR; defined as ＜ 500 copies/ml of HBV DNA) or experience of virology rebound (＞ 500 copies/ml of HBV DNA after achievement of CVR).Results After week-48 of treatment,the ETV group showed a higher CVR rate (90.3％vs.LAM:59.4％) and lower virology rebound rate (1.9％ vs.LAM:13.9％).After week-96 of treatment,the ETV group continued to have a higher CVR rate (86.0％ vs.LAM:71.4％),and virology rebound was experienced by significantly less subjects in the ETV group (1.2％ vs.LAM:11.9％,P =0.005).Conclusion ETV therapy can quickly and continuously suppress HBV replication in chronic hepatitis B patients,and has a lower resistance rate than LAM.Compared to LAM,ETV may be a superior long-term treatment choice for chronic hepatitis B.
