中华肝脏病杂志
中華肝髒病雜誌
중화간장병잡지
CHINESE JOURNAL OF HEPATOLOGY
2013年
7期
502-505
,共4页
陈学福%陈小苹%马晓军%陈文莉%罗晓丹%廖金瑶
陳學福%陳小蘋%馬曉軍%陳文莉%囉曉丹%廖金瑤
진학복%진소평%마효군%진문리%라효단%료금요
肝炎,乙型,慢性%干扰素α-2a%恩替卡韦%再治疗
肝炎,乙型,慢性%榦擾素α-2a%恩替卡韋%再治療
간염,을형,만성%간우소α-2a%은체잡위%재치료
Hepatitis B,chronic%Interferon alfa-2a%Entecavir%Retreatment
目的 评估序贯聚乙二醇干扰素(Peg-IFN)α-2a治疗恩替卡韦经治HBeAg阳性慢性乙型肝炎的疗效与安全性.方法 57例恩替卡韦治疗96周达到HBV DNA<500拷贝/ml且0.227PEIU/ml<HBeAg≤50.000 PEIU/ml的HBeAg阳性慢性乙型肝炎患者,27例接受ETV与PegIFN α-2a联合治疗12周后改为Peg-IFN α-2a单药治疗至48周(试验组),30例继续接受恩替卡韦治疗48周(对照组),分别在治疗的24、48周进行生物化学、病毒学、血清学评估.统计学处理用t检验或x2检验.结果 试验组与对照组基线ALT、HBsAg、HBeAg水平有可比性.治疗48周,试验组HBeAg阴转率与HBeAg血清学转换率分别为40.7%和37.0%,与对照组的16.7%和13.3%相比,差异有统计学意义(x2值分别为4.079和5.11,P值均<0.05).试验组HBsAg清除率和HBV DNA反弹率分别7.4%与11.1%,对照组无HBsAg清除和HBV DNA反弹(x2值分别为2.307 和3.519,P值均>0.05).治疗48周,试验组HBsAg水平明显低于对照组[(2866.0±2580.4)IU/ml对比(4335.8±2650.0) IU/ml,t=5.11,P<0.05]. 结论 恩替卡韦经治的HBeAg阳性慢性乙型肝炎患者,序贯Peg-IFNα-2a治疗有助于实现HBeAg血清转换和HBsAg定量下降.
目的 評估序貫聚乙二醇榦擾素(Peg-IFN)α-2a治療恩替卡韋經治HBeAg暘性慢性乙型肝炎的療效與安全性.方法 57例恩替卡韋治療96週達到HBV DNA<500拷貝/ml且0.227PEIU/ml<HBeAg≤50.000 PEIU/ml的HBeAg暘性慢性乙型肝炎患者,27例接受ETV與PegIFN α-2a聯閤治療12週後改為Peg-IFN α-2a單藥治療至48週(試驗組),30例繼續接受恩替卡韋治療48週(對照組),分彆在治療的24、48週進行生物化學、病毒學、血清學評估.統計學處理用t檢驗或x2檢驗.結果 試驗組與對照組基線ALT、HBsAg、HBeAg水平有可比性.治療48週,試驗組HBeAg陰轉率與HBeAg血清學轉換率分彆為40.7%和37.0%,與對照組的16.7%和13.3%相比,差異有統計學意義(x2值分彆為4.079和5.11,P值均<0.05).試驗組HBsAg清除率和HBV DNA反彈率分彆7.4%與11.1%,對照組無HBsAg清除和HBV DNA反彈(x2值分彆為2.307 和3.519,P值均>0.05).治療48週,試驗組HBsAg水平明顯低于對照組[(2866.0±2580.4)IU/ml對比(4335.8±2650.0) IU/ml,t=5.11,P<0.05]. 結論 恩替卡韋經治的HBeAg暘性慢性乙型肝炎患者,序貫Peg-IFNα-2a治療有助于實現HBeAg血清轉換和HBsAg定量下降.
목적 평고서관취을이순간우소(Peg-IFN)α-2a치료은체잡위경치HBeAg양성만성을형간염적료효여안전성.방법 57례은체잡위치료96주체도HBV DNA<500고패/ml차0.227PEIU/ml<HBeAg≤50.000 PEIU/ml적HBeAg양성만성을형간염환자,27례접수ETV여PegIFN α-2a연합치료12주후개위Peg-IFN α-2a단약치료지48주(시험조),30례계속접수은체잡위치료48주(대조조),분별재치료적24、48주진행생물화학、병독학、혈청학평고.통계학처리용t검험혹x2검험.결과 시험조여대조조기선ALT、HBsAg、HBeAg수평유가비성.치료48주,시험조HBeAg음전솔여HBeAg혈청학전환솔분별위40.7%화37.0%,여대조조적16.7%화13.3%상비,차이유통계학의의(x2치분별위4.079화5.11,P치균<0.05).시험조HBsAg청제솔화HBV DNA반탄솔분별7.4%여11.1%,대조조무HBsAg청제화HBV DNA반탄(x2치분별위2.307 화3.519,P치균>0.05).치료48주,시험조HBsAg수평명현저우대조조[(2866.0±2580.4)IU/ml대비(4335.8±2650.0) IU/ml,t=5.11,P<0.05]. 결론 은체잡위경치적HBeAg양성만성을형간염환자,서관Peg-IFNα-2a치료유조우실현HBeAg혈청전환화HBsAg정량하강.
Objective To investigate the efficacy and safety of peginterferon alfa-2a (Peg-IFNα-2a) therapy for treating chronic hepatitis B (CHB) in patients who failed to achieve a satisfactory end point with entecavir (ETV) treatment.Methods Fifty-seven CHB patients with positivity for hepatitis B e antigen (HBeAg) who had completed a standard ETV monotherapy course,of at least 96 weeks,and who had achieved a virological response (defined as HBV DNA < 500 copies/ml) but without HBeAg seroconversion (defined as 0.227 PEI U/ml < HBeAg ≤ 50 PEI U/ml) were enrolled in the study.The patients were randomly assigned to receive a 48-week treatment with Peg-IFNα-2a (experimental group,n =27) or continued ETV therapy (control group,n =30).Serum samples were collected from all patients for assessment of biochemical,virological and serological responses to treatment.Inter-group differences were statistically evaluated by t-test or Chi-squared test.Results The baseline levels of alanine aminotransferase,hepatitis B surface antigen (HBsAg),and HBeAg were similar between the patients comprising the experimental and controls groups.At treatment week 48,the experimental group showed significantly higher rates of HBeAg clearance (Peg-IFNα-2a:40.7% vs.ETV:16.7%,x2 =4.079,P < 0.05)and seroconversion (37.0% vs.13.3%,x2 =5.110,P < 0.05).The experimental group also showed higher ates of HBsAg clearance (7.4% vs.0%) and HBV DNA relapse (11.1% vs.0%),but the differences did not reach statistical significance (x2 =2.307 and 3.519,both P > 0.05).However,the level of HBsAg was significantly lower in the experimental group (2866.0 + 2580.4 vs.4335.8 + 2650.0 IU/ml,t =5.11,P <0.05).Conclusion HBeAg-positive CHB paitents with unsatisfactory response to initial ETV monotherapy achieved HBeAg seroconversion and clearance following sequential Peg-IFN a-2a treatment.