国产与进口恩替卡韦治疗慢性乙肝的疗效研究  

Efficacy study of domestic and imported entecavir in the treatment of chronic hepatitis B

作　　者：高扬 雷文娟 田敏 田金徽[4] 孟敏 葛斌[2,3] GAO Yang;LEI Wenjuan;TIAN Min(Department of Pharmacy,Tianjin Union Medical Center,The First Affiliated Hospital of Nankai University,Tianjin 300121,China;不详)

机构地区：[1]天津市人民医院/南开大学第一附属医院药学部,天津300121 [2]甘肃省药品临床综合评价技术中心,兰州730000 [3]甘肃省人民医院药剂科,兰州730000 [4]兰州大学循证医学中心,兰州730000 [5]甘肃中医药大学药学院,兰州730000

出　　处：《中国处方药》2025年第4期72-76,共5页Journal of China Prescription Drug

基　　金：2021年度甘肃省卫生健康委员会委托课题。

摘　　要：目的采用真实世界临床数据,对比分析国产与进口恩替卡韦治疗慢性乙型肝炎的有效性。方法回顾性收集甘肃省4家三甲医院2019年12月~2022年4月期间使用国产和进口恩替卡韦治疗的慢性乙型肝炎患者病例信息。根据用药情况,分为国产组和进口组,进一步根据患者初始乙型肝炎病毒E抗原(HBeAg)的检测值分为HBeAg阳性及HBeAg阴性患者。以3、6、12、24个月为用药周期,比较国产组与进口组乙型肝炎病毒脱氧核糖核酸(HBV-DNA)阴转率、血清HBeAg阴转率、丙氨酸氨基转移酶(ALT)复常率、甲胎蛋白及总胆红素水平。结果在HBeAg阳性患者中,国产组与进口组用药3、6、12、24个月的ALT复常率、HBV-DNA阴转率、甲胎蛋白及总胆红素水平改善率比较,差异无统计学意义(P>0.05),两组用药3、12、24个月的HBeAg阴转率差异无统计学意义(P>0.05),两组用药6个月的HBeAg阴转率差异有统计学意义(P<0.01)。在HBeAg阴性患者中,国产组与进口组用药3、6、12、24个月的ALT复常率、HBV-DNA阴转率、甲胎蛋白及总胆红素水平改善率比较,差异无统计学意义(P>0.05)。结论基于本研究的真实临床数据,国产与进口恩替卡韦短期(用药3个月和6个月)及长期(用药12个月和24个月)治疗慢性乙型肝炎的临床疗效相当。但受限于纳入研究的样本量差异较大,仍需大样本、多中心的随机对照试验(RCT)来证实该结论。Objective To compare and analyze the efficacy of domestic and imported entecavir in the treatment of chronic hepatitis B using real-world clinical data.Methods Case information of patients with chronic hepatitis B treated with domestic and imported entecavir between December 2019 and April 2022 was retrospectively collected from four tertiary hospitals in Gansu Province.They were divided into domestic and imported groups according to medication use,and further divided into hepatitis B virus E antigen(HBeAg)positive and negative patients according to their initial HBeAg detection values.The hepatitis B virus deoxyribonucleic acid(HBV-DNA)negative conversion rate,serum HBeAg negative conversion rate,alanine aminotransferase(ALT)reversion rate,and the levels of alpha-fetoprotein and total bilirubin were compared between domestic and imported group using 3,6,12 and 24 months as the dosing cycle.Results Among HBeAg positive patients,there was no significant difference in ALT reversion rate,HBV-DNA negative conversion rate and the improvement rates of alpha fetoprotein and total bilirubin levels between the domestic group and the imported group at 3,6,12 and 24 months(P>0.05).There was no significant difference in HBeAg negative conversion rate between the two groups at 3,12 and 24 months(P>0.05),while there was a significant difference in HBeAg negative conversion rate between the two groups at 6 months(P<0.01).In HBeAg negative patients,there was no significant difference in ALT reversion rate,HBV-DNA negative rate and the the improvement rates of alpha fetoprotein and total bilirubin levels between domestic group and imported group at 3,6,12 and 24 months(P>0.05).Conclusion Based on the real-world clinical data of this study,the clinical efficacy of domestic and imported entecavir in short-term(3 and 6 months)and long-term(12 and 24 months)treatment of chronic hepatitis B is comparable.However,due to the large differences in the sample size of the included studies,large sample and multi-center RCTS are still needed

关 键 词：恩替卡韦 慢性乙型肝炎 国产 进口 疗效 真实世界研究 

分 类 号：R512.62[医药卫生—内科学] R969.3[医药卫生—临床医学]