中华肝脏病杂志
中華肝髒病雜誌
중화간장병잡지
CHINESE JOURNAL OF HEPATOLOGY
2013年
12期
881-885
,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
徐京杭%于巖巖%斯崇文%曾爭%李軍%毛青%張大誌%唐紅%盛吉芳
서경항%우암암%사숭문%증쟁%리군%모청%장대지%당홍%성길방
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阳性慢性乙型肝炎患者的疗效及安全性. 方法 本研究为随机、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0.5mg/d治疗,疗程48周.于12、24和48周检测血清HBV标志物,定期随访患者,记录不良事件.HBV DNA检测用罗氏(CobasAmpliprep/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x2检验或Fisher’s精确概率法.结果 共入组218例HBeAg阳性慢性乙型肝炎患者,A组110例,二次揭盲后为对照药恩替卡韦; B组108例,二次揭盲后为试验药马来酸恩替卡韦.两组基线各指标均具有可比性(P值均＞ 0.05).治疗12、24、48周时,A组和B组的HBV DNA较基线下降值分别为4.28 log10 IU/ml对比4.46 log10 IU/ml(P＞ 0.05),5.00 log10 IU/ml对比4.99 log10 IU/ml(P＞0.05),5.53 log10 IU/ml对比5.51log10IU/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20 IU/ml)率分别为38.18％和35.19％(P＞ 0.05),HBeAg转阴率分别为10.91％和12.96％(P＞ 0.05),HBeAg血清转换率分别为7.77％和10.38％ (P＞0.05),ALT复常率分别为75.47％对比82.86％ (P＞0.05).A组和B组不良事件发生率为18.02％对比17.43％ (P＞0.05).结论 马来酸恩替卡韦片与恩替卡韦都能有效治疗HBeAg阳性慢性乙型肝炎,两者疗效和安全性相似.
目的 比較馬來痠恩替卡韋和恩替卡韋治療HBeAg暘性慢性乙型肝炎患者的療效及安全性. 方法 本研究為隨機、雙盲、雙模擬、暘性藥對照的多中心臨床研究.入選患者隨機分為A組和B組,分彆接受恩替卡韋片0.5 mg/d或馬來痠恩替卡韋片0.5mg/d治療,療程48週.于12、24和48週檢測血清HBV標誌物,定期隨訪患者,記錄不良事件.HBV DNA檢測用囉氏(CobasAmpliprep/Cobas Taqman)第二代實時PCR法.符閤參數分析條件的計量資料採用t檢驗,等級資料的組間比較用秩和檢驗,計數資料組間比較採用x2檢驗或Fisher’s精確概率法.結果 共入組218例HBeAg暘性慢性乙型肝炎患者,A組110例,二次揭盲後為對照藥恩替卡韋; B組108例,二次揭盲後為試驗藥馬來痠恩替卡韋.兩組基線各指標均具有可比性(P值均＞ 0.05).治療12、24、48週時,A組和B組的HBV DNA較基線下降值分彆為4.28 log10 IU/ml對比4.46 log10 IU/ml(P＞ 0.05),5.00 log10 IU/ml對比4.99 log10 IU/ml(P＞0.05),5.53 log10 IU/ml對比5.51log10IU/ml (P＞0.05).治療48週時A組和B組HBV DNA不可測(HBV DNA水平低于20 IU/ml)率分彆為38.18％和35.19％(P＞ 0.05),HBeAg轉陰率分彆為10.91％和12.96％(P＞ 0.05),HBeAg血清轉換率分彆為7.77％和10.38％ (P＞0.05),ALT複常率分彆為75.47％對比82.86％ (P＞0.05).A組和B組不良事件髮生率為18.02％對比17.43％ (P＞0.05).結論 馬來痠恩替卡韋片與恩替卡韋都能有效治療HBeAg暘性慢性乙型肝炎,兩者療效和安全性相似.
목적 비교마래산은체잡위화은체잡위치료HBeAg양성만성을형간염환자적료효급안전성. 방법 본연구위수궤、쌍맹、쌍모의、양성약대조적다중심림상연구.입선환자수궤분위A조화B조,분별접수은체잡위편0.5 mg/d혹마래산은체잡위편0.5mg/d치료,료정48주.우12、24화48주검측혈청HBV표지물,정기수방환자,기록불량사건.HBV DNA검측용라씨(CobasAmpliprep/Cobas Taqman)제이대실시PCR법.부합삼수분석조건적계량자료채용t검험,등급자료적조간비교용질화검험,계수자료조간비교채용x2검험혹Fisher’s정학개솔법.결과 공입조218례HBeAg양성만성을형간염환자,A조110례,이차게맹후위대조약은체잡위; B조108례,이차게맹후위시험약마래산은체잡위.량조기선각지표균구유가비성(P치균＞ 0.05).치료12、24、48주시,A조화B조적HBV DNA교기선하강치분별위4.28 log10 IU/ml대비4.46 log10 IU/ml(P＞ 0.05),5.00 log10 IU/ml대비4.99 log10 IU/ml(P＞0.05),5.53 log10 IU/ml대비5.51log10IU/ml (P＞0.05).치료48주시A조화B조HBV DNA불가측(HBV DNA수평저우20 IU/ml)솔분별위38.18％화35.19％(P＞ 0.05),HBeAg전음솔분별위10.91％화12.96％(P＞ 0.05),HBeAg혈청전환솔분별위7.77％화10.38％ (P＞0.05),ALT복상솔분별위75.47％대비82.86％ (P＞0.05).A조화B조불량사건발생솔위18.02％대비17.43％ (P＞0.05).결론 마래산은체잡위편여은체잡위도능유효치료HBeAg양성만성을형간염,량자료효화안전성상사.
Objective To evaluate the efficacy and safety of entecavir maleate (ETV) versus ETV in Chinese patients with hepatitis B e antigen(HBeAg)-positive chronic hepatitis B(CHB).Methods The patient population of this previously published randomized,double-blind,double-dummy,controlled,multicenter study was expanded by patients in the 0.5 mg/day ETV maleate group (totaln =110) and patients in the 0.5 mg/day ETV group (total n =108).At treatment weeks 12,24 and 48,hepatitis B virus (HBV)DNA levels were measured by the Roche Cobas Ampliprep/Cobas Taqman PCR assay.Adverse events (AE)were recorded.Results As in the original analysis,the two treatment groups showed similar characteristics at baseline.In addition,the results for the all therapeutic effects showed identical trends to the results obtained in the original analysis,ivcluding the statistically similar effects of ETV and ETV maleate treatment-induced decreases in mean HBV DNA level at weeks 12,24,and 48 (ETV:by 4.28,5.00,and 5.53 log10 IU/ml vs.ETV maleate:by 4.46,4.99,and 5.51 log10 IU/ml,respectively; all vs.baseline P ＞ 0.05),achievement ofundetectable levels of serum HBV DNA (＜ 20 IU/ml) at week 48 (ETV:38.18％ vs.ETV maleate:35.19％; P ＞ 0.05),HBeAg loss rates at week 48 (ETV:10.91％ vs.ETV maleate:12.96％; P ＞ 0.05),HBeAg seroconversion rates at week 48 (ETV:7.77％ vs.ETV maleate:10.38％;P ＞ 0.05),normalization of alanine aminotransferase at week 48 (ETV:75.47％ vs.ETV maleate:82.86％; P ＞ 0.05),and overall incidence ofAE (ETV:18.02％ vs.ETV maleate:17.43％;P ＞ 0.05).Conclusion Performing analysis of the therapeutic efficacies of entecavir maleate versus entecavir with a larger study population confirmed our original findings of similar efficacy and safety profiles for these two drugs in patients with HBeAg-positive CHB.
