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

发布时间：2018-06-12 06:08

本文选题：慢性乙型肝炎 + 恩替卡韦　；参考：《郑州大学学报(医学版)》2017年05期

【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∶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 DNA5×102拷贝/m L)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 DNA1×105拷贝/m L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]:Objective: to investigate the efficacy and safety of domestic entecavir capsule in the treatment of chronic hepatitis B (CHB). Methods: a randomized, double blind, positive drug-controlled clinical study was conducted for 96 weeks. There were 28 patients in ETV group and 14 in lam group. In the first 48 weeks, the patients were randomly given orally at 1:1 the domestic entecavir capsule (ETV) 0.5 mg/d or lamivudine 100 mg/d.48 after the end of double-blind treatment. All the patients were treated with ETV capsule 0.5 mg/d for 96 weeks. Results: the total virological response rate of ETV group and Lam group was 78.6% and 57.1%, respectively, and the incidence of virology rebound was 7.1% and 21.4g in ETV group and Lam group, respectively. After 96 weeks, the complete response rates of virology in ETV group and Lam group were 78.6% and 71.4%, respectively, but there were 2 cases in ETV group with 1 脳 10 5 copies per mL HBV DNA. Conclusion WETV capsule can inhibit the replication of HBV DNA rapidly and continuously, the incidence of drug resistance is low, the safety is good, and it can be used to treat chronic hepatitis B for a long time.
【作者单位】：郑州大学医药科学研究院肝病研究室;
【基金】：河南省科技攻关计划项目0821002310003
【分类号】：R512.62

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