Research on Efficacy and Safety of Generic and Original Entecavir in the Treatment of Chronic Hepatitis B

XIE Ying; MA Xiao; ZHAO Yanling

doi:10.14009/j.issn.1672-2124.2021.08.002

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Research on Efficacy and Safety of Generic and Original Entecavir in the Treatment of Chronic Hepatitis B

更新时间：2022-10-08

- Research on Efficacy and Safety of Generic and Original Entecavir in the Treatment of Chronic Hepatitis B
- Vol. 21, Issue 8, Pages: 905-907(2021)
- 作者机构：
  
  1. 解放军总医院第五医学中心药剂科
  2. 成都中医药大学药学院
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2021.08.002
  CLC： R512.62
- Published：2021，
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XIE Ying, MA Xiao, ZHAO Yanling. Research on Efficacy and Safety of Generic and Original Entecavir in the Treatment of Chronic Hepatitis B. [J]. 21(8):905-907(2021)
DOI：

XIE Ying, MA Xiao, ZHAO Yanling. Research on Efficacy and Safety of Generic and Original Entecavir in the Treatment of Chronic Hepatitis B. [J]. 21(8):905-907(2021) DOI： 10.14009/j.issn.1672-2124.2021.08.002.

摘要

目的:比较恩替卡韦仿制药与恩替卡韦原研药治疗慢性乙型肝炎的疗效及安全性。方法:采用多中心、回顾性真实世界研究

纳入2018年9月至2019年3月3家传染病特色医院门诊收治的慢性乙型肝炎患者

将入组患者分为恩替卡韦仿制药组与原研药组

给药剂量均为0.5 mg/d。收集患者入组时及治疗24周时的乙型肝炎病毒(HBV) DNA、HBV血清学标记物、血小板计数、血肌酸激酶和血肌酐水平。通过倾向性评分匹配后

比较两组患者病毒学应答率、乙型肝炎e抗原(HBe Ag)转阴率、HBe Ag血清学转换率、血小板减少率、肌酸激酶升高率和肌酐升高率。结果:纳入原研药组患者2 471例

仿制药组患者10 909例。两组患者病毒学应答率、HBe Ag转阴率、HBe Ag血清学转换率、血小板减少率、肌酸激酶升高率和肌酐升高率的差异均无统计学意义(P>0.05)。结论:恩替卡韦仿制药治疗慢性乙型肝炎的疗效及安全性不劣于原研药。

Abstract

OBJECTIVE: To compare the efficacy and safety between generic and original entecavir in the treatment of chronic hepatitis B. METHODS: Multi-center

retrospective real-world research. Patients with chronic hepatitis B admitted into the outpatient of three characteristic hospitals for infectious diseases from Sept. 2018 to Mar.2019 were involved

the enrolled patients were divided into entecavir generics group and original drug group

both groups were administered at a dose of 0. 5 mg/d. HBV DNA

HBV serologic markers

platelet counts

blood creatine kinase and blood creatinine levels of patients were collected at enrollment and 24 weeks of treatment. After matching by propensity score

the virological response rate

negative conversion rate of HBeAg

serological conversion rate of HBeAg

thrombocytopenia rate

creatine kinase elevation rate and creatinine elevation rate were compared between two groups. RESULTS: There were 2 471 patients in original drug group and 10 909 patients in generics group. The differences in virological response rate

negative conversion rate of HBeAg

serological conversion rate of HBeAg

thrombocytopenia rate

creatinine kinase elevation rate and creatinine elevation rate between two groups were not statistically significant（ P> 0. 05）. CONCLUSIONS: The efficacy and safety of generic entecavir in the treatment of patients with chronic hepatitis B were not inferior to those of the original drug.

关键词

恩替卡韦仿制药原研药

Keywords

EntecavirGeneric drugOriginal drug

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