评估慢性乙型病毒性肝炎患者换用集采恩替卡韦的疗效与安全性  

Evaluating the efficacy and safety of centrally collected Entecavir in patients with chronic hepatitis B

作　　者：黄炎清 张红宇[1] 李莎莎[1] 李淼晴 贾乔迪 梁红霞[1] HUANG Yanqing;ZHANG Hongyu;LI Shasha;LI Miaoqing;JIA Qiaodi;LIANG Hongxia(Department of Infectious Diseases,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院感染科,河南郑州450052

出　　处：《胃肠病学和肝病学杂志》2022年第4期434-437,共4页Chinese Journal of Gastroenterology and Hepatology

摘　　要：目的评估长期服用国产恩替卡韦治疗产生完全病毒学应答的慢性乙型病毒性肝炎(chronic hepatitis B,CHB)患者换为集采恩替卡韦治疗的有效性与安全性。方法纳入2019年1月1日至2021年5月18日在郑州大学第一附属医院河医院区感染肝病门诊就诊的服用国产恩替卡韦治疗超过1年已产生完全病毒学应答的CHB患者260例。根据纳入研究后是否换为集采恩替卡韦(北京百奥)抗病毒治疗,分为未换药组(一直服用国产恩替卡韦治疗的患者)和换药组(之前已服用国产恩替卡韦治疗超过1年并产生完全病毒学应答,但纳入后换为集采恩替卡韦治疗的患者)。利用SPSS 25.0软件回顾性分析患者纳入研究时的年龄、性别、ALT等基线情况,比较纳入研究后治疗24周及48周时的HBV-DNA、ALT、HBeAg、乙型肝炎病毒e抗体(HBeAg/抗-HBe)水平。结果共纳入260例患者,未换药组104例(40.0%),换药组156例(60.0%)。治疗24周时,未换药组完全病毒学应答率为97.12%(101/104),换药组为96.79%(151/156),组间比较,差异无统计学意义(P=1.000);治疗48周时两组患者HBV-DNA均低于检测下线,完全病毒学应答率均为100%。治疗24周和48周时,ALT复常率组间比较,差异均无统计学意义(χ^(2)=0.157,P=0.692;χ^(2)=2.316,P=0.128)。未换药组基线HBeAg(+)患者44例(42.3%),换药组基线HBeAg(+)患者69例(44.2%),组间比较,差异无统计学意义(χ^(2)=0.094,P=0.759);治疗24周时,两组分别有2例、3例HBeAg转阴,2例、0例产生抗-HBe;治疗48周时,两组分别有4例、9例HBeAg转阴,1例、3例产生抗-HBe,两组患者治疗24周和48周时,HBeAg转阴率、HBeAg/抗-HBe血清学转换率差异均无统计学意义(P均>0.05),两组均无不良反应发生。结论集采恩替卡韦的疗效和安全性与国产恩替卡韦相当。Objective To evaluate the efficacy and safety of chronic hepatitis B(CHB)patients treated with domestic Entecavir for a long period of time being switched to centrally collective Entecavir therapy.Methods A total of 260 CHB patients who received domestic Entecavir treatment for more than 1 year and had developed a complete virologic response were included in the study.They were admitted to the Outpatient Department of Infectious Liver Disease in the First Affiliated Hospital of Zhengzhou University from Jan.1st 2019 to May 18th 2021.According to whether they switched to centrally collective Entecavir antiviral therapy after enrollment,they were divided into unchanged group(patients who had been taking domestic Entecavir treatment)and changed group(patients who had previously been treated with domestic Entecavir for more than 1 year and had a complete virologic response were switched to centrally collective Entecavir therapy).Using SPSS 25.0 software to retrospectively analyze the age,gender,ALT and other baseline information of the patients when they were enrolled in the study.Comparison was made between 24 weeks and 48 weeks of treatment for HBV-DNA,ALT,HBeAg,hepatitis B virus e antibody(HBeAg/anti-HBe)levels.Results 260 patients were enrolled totally,including 104 patients(40.0%)in the unchanged group and 156 patients(60.0%)in the changed group.After 24 weeks of treatment,the complete virologic response rate was 97.12%(101/104)in the unchanged group,and 96.79%(151/156)in the changed group,showing no significant difference between two groups(P=1.000).After 48 weeks of treatment,HBV-DNA in both groups was lower than the detection threshold,and the complete virological response rate was 100%.There was no significant difference in ALT normalization rate between two groups at 24 weeks and 48 weeks of treatment(χ^(2)=0.157,P=0.692;χ^(2)=2.316,P=0.128).There were 44 patients(42.3%)HBeAg(+)patients in the unchanged group and 69 patients(44.2%)HBeAg(+)patients in the changed group at baseline,and there was no signific

关 键 词：慢性乙型病毒性肝炎 抗病毒药物 恩替卡韦 

分 类 号：R575[医药卫生—消化系统]