[1]杨荟玉,孙爱民#,程豪为,等.国产恩替卡韦胶囊治疗慢性乙型肝炎的随机、双盲、阳性药物平行对照临床研究*[J].郑州大学学报(医学版),2017,(05):633-637.[doi:10.13705/j.issn.1671-6825.2017.05.029]
 YANG Huiyu,SUN Aimin,CHENG Haowei,et al.Randomized, double-blind, parallel clinical trial of entecavir capsules in treating patients with chronic hepatitis B[J].JOURNAL OF ZHENGZHOU UNIVERSITY(MEDICAL SCIENCES),2017,(05):633-637.[doi:10.13705/j.issn.1671-6825.2017.05.029]
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国产恩替卡韦胶囊治疗慢性乙型肝炎的随机、双盲、阳性药物平行对照临床研究*()
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《郑州大学学报(医学版)》[ISSN:1671-6825/CN:41-1340/R]

卷:
期数:
2017年05期
页码:
633-637
栏目:
应用研究
出版日期:
2017-09-15

文章信息/Info

Title:
Randomized, double-blind, parallel clinical trial of entecavir capsules in treating patients with chronic hepatitis B
作者:
杨荟玉孙爱民#程豪为陈宏涛
郑州大学医药科学研究院肝病研究室 郑州 450052
Author(s):
YANG Huiyu SUN Aimin CHENG Haowei CHEN Hongtao
Hepatology Laboratory,Institute of Medical and Pharmaceutical Sciences, Zhengzhou University,Zhengzhou 450052
关键词:
慢性乙型肝炎 恩替卡韦 拉米夫定 临床试验
Keywords:
chronic hepatitis B entecavir lamivudine clinical trial
分类号:
R978.7
DOI:
10.13705/j.issn.1671-6825.2017.05.029
摘要:
目的:探讨国产恩替卡韦胶囊治疗慢性乙型肝炎的疗效和安全性。方法:采用随机、双盲、阳性药物平行对照的临床研究方法,为期96周。入组患者28例,ETV组和LAM组各14例。前48周按1GA6FA1比例随机口服给予国产恩替卡韦胶囊(ETV)0.5 mg/d或拉米夫定(LAM)100 mg/d。48周双盲治疗期结束后,进入开放性治疗期,所有患者均给予ETV胶囊0.5 mg/d治疗,观察至96周。结果:服药48周后,ETV组和LAM组病毒学完全应答率(HBV DNA<5×102拷贝/mL)分别为78.6% 和57.1%; 病毒学反弹发生率分别为7.1%和21.4%。服药96周后,ETV组和 LAM组病毒学完全应答率分别为78.6%和71.4%; 但HBV DNA>1×105拷贝/mL的患者,ETV组为0,LAM组有2例。结论:ETV胶囊能迅速持续抑制 HBV DNA的复制,耐药发生率低、安全性好,可用于长期治疗慢性乙型肝炎。
Abstract:
Aim: To investigate the efficacy and safety of entecavir capsule(ETV)in treating patients with chronic hepatitis B.Methods: A randomized, double-blind, parallel clinical trial was adopted. A total of 28 subjects were administered a 96-week course of clinical trial. In the first 48 weeks, patients had 0.5 mg/d ETV or 100 mg/d lamivudine(LAM)randomly, after that, all patients had 0.5 mg/d ETV until the end of the trial.Results: After 48 week treatment, in ETV group and LAM group, the complete virologic response(CVR, defined as<5×102 copies/mL of HBV DNA)rate was 78.6% and 57.1% respectively; the virology rebound rate was 7.1% and 21.4% respectively.After 96 week treatment, the CVR rate of the ETV group was 78.6% and that of LAM group was 71.4%; the subject with HBV DNA>1×105 copies/mL was 0 in ETV group and 2 in LAM group.Conclusion: ETV capsule can quickly and continuously suppress HBV DNA replication in patients with chronic hepatitis B,and has a lower resistance rate than LAM.For long-term treament of chronic hepatitis B, ETV capsule may be a superior choice compared with LAM.

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备注/Memo

备注/Memo:
*河南省科技攻关计划项目 0821002310003
#通信作者,女,1953年4月生,本科,副主任医师,研究方向:肝病; E-mail:aiminsunzz@163.ocm
更新日期/Last Update: 2017-09-20