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学科主题: 感染疾病科
题名:
马来酸恩替卡韦片治疗HBeAg阳性慢性乙型肝炎的随机、双盲、双模拟、阳性药对照、多中心临床研究48周结果
其他题名: Analysis of a randomized, double-blind, double-dummy, controlled, multicenter study confirmed the siumilar therapeutic efficacies of entecavir maleate and entecavir for treatment of HBeAg-positive chronic hepatitis B
作者: 徐京杭1; 于岩岩1; 斯崇文1; 曾争1; 李军1; 毛青1; 张大志1; 唐红1; 盛吉芳1
关键词: 肝炎,乙型,慢性 ; 治疗结果 ; 安全性 ; 马来酸恩替卡韦 ; 恩替卡韦 ; Hepatitis B,chronic ; Treatment outcome ; Safety ; Entecavir maleate ; Entecavir
刊名: 中华肝脏病杂志
发表日期: 2013
DOI: 10.3760/cma.j.issn.1007-3418.2013.12.001
卷: 21, 期:12, 页:881-885
收录类别: 中国科技核心期刊 ; 中文核心期刊 ; CSCD
文章类型: Journal Article
摘要: 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. 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.
语种: 中文
原文出处: 查看原文
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内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/41878
Appears in Collections:北京大学第一临床医学院_感染疾病科_期刊论文

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作者单位: 1.100034,北京大学第一医院感染疾病科
2.南京医科大学第一附属医院感染病科
3.第三军医大学西南医院全军感染病研究所
4.重庆医科大学附属第二医院感染科
5.四川大学华西医院感染性疾病中心生物治疗国家重点实验室感染性疾病研究室
6.浙江大学医学院附属第一医院传染病诊治国家重点实验室
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