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恩替卡韦单药治疗慢性乙型肝炎患者5年HBsAg与HBV DNA的动态变化 被引量:13

Dynamic changes of HBsAg and hepatitis B virus DNA in chronic hepatitis B patients with entecavir monotherapy for 5 years
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摘要 目的分析慢性乙型肝炎(CHB)患者单用恩替卡韦(ETV)治疗5年血清HBsAg和HBV DNA的动态变化。方法回顾性收集2012年1月—2020年8月就诊于西安交通大学第二附属医院的单用ETV治疗≥5年的CHB患者918例,其中初始治疗时HBeAg阳性患者556例,HBeAg阴性患者362例。收集患者在治疗基线、1年、2年、3年、4年、5年时的血清HBsAg水平和HBV DNA载量并分析其动态变化。符合正态分布的计量资料2组间比较采用t检验,不符合正态分布的计量资料2组间比较采用Mann-Whitney U检验;不符合正态分布的重复测量资料先进行log10对数转换,组内或组间比较采用重复测量资料的方差分析;计数资料2组间比较采用χ2检验。结果HBeAg阳性和HBeAg阴性患者随着ETV治疗时间的延长,HBsAg水平均呈逐渐下降趋势,组内比较差异有统计学意义(F值分别为174.168、49.845,P值均<0.001)。HBeAg阳性患者基线HBsAg水平为18043.1(7868.9~26342.4)IU/ml,ETV治疗5年后降至1397.6(626.4~3419.4)IU/ml,差异具有统计学意义(P<0.001);HBeAg阳性患者基线HBV DNA载量为(6.7±1.7)log10 IU/ml,ETV治疗5年后HBV DNA阴转率为100%。HBeAg阴性患者的基线HBsAg水平为2420.0(662.6~5621.2)IU/ml,ETV治疗5年后降至407.2(56.7~1104.7)IU/ml,差异具有统计学意义(P<0.001);HBeAg阴性患者基线HBV DNA载量为(4.9±1.4)log10 IU/ml,ETV治疗5年后HBV DNA阴转率亦为100%。HBeAg阳性患者的中位HBsAg水平在各时间点上均高于HBeAg阴性患者(P值均<0.001)。HBeAg阳性和阴性患者的HBsAg下降均呈现出“先快后慢”的趋势,ETV治疗前两年的HBsAg年均下降速率显著大于后3年(HBeAg阳性:Z=-13.605,P<0.001;HBeAg阴性:Z=-5.950,P<0.001)。HBeAg阳性患者除ETV治疗1年时HBV DNA阴转率显著低于HBeAg阴性患者外(χ2=71.013,P<0.001),其余时间点上两组患者的HBV DNA阴转率均为100%。此外,ETV治疗5年,累计HBsAg转阴、<200 IU/ml、<1000 IU/ml、<1500 IU/ml的患者的比例分别为3.6%、23.9%、57.0%、67.3%。结论ETV治疗CHB、HBsAg和HBV DNA水平逐渐下降,并且HBsAg水平的下降呈“先快后慢”的趋势。单用ETV治疗5年,67.3%的患者可以达到HBsAg<1500 IU/ml。 Objective To investigate the dynamic changes of serum HBsAg and hepatitis B virus(HBV)DNA in chronic hepatitis B patients(CHB)with entecavir(ETV)monotherapy for 5 years.Methods A retrospective analysis was performed for the clinical data of 918 CHB patients who attended the Second Affiliated Hospital of Xi’an Jiaotong University from January 2012 to August 2020 and received ETV monotherapy for≥5 years,among whom 556 had positive HBeAg and 362 had negative HBeAg at initial treatment.Serum HBsAg level and HBV DNA load at baseline and at 1,2,3,4,and 5 years of treatment were collected to analyze their dynamic changes.The t-test was used for comparison of normally distributed continuous data between two groups,and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups;log10 logarithmic transformation was performed for non-normally distributed repeated measurement data,and then a repeated-measures analysis of variance was used for comparison between groups or within each group;the chi-square test was used for comparison of categorical data between two groups.Results Both HBeAg-positive and HBeAg-negative patients had a significant reduction in HBsAg level over the time of ETV treatment(F=174.168 and 49.845,both P<0.001).The HBeAg-positive patients had a baseline HBsAg level of 18043.1(7868.9-26342.4)IU/ml,which significantly decreased to 1397.6(626.4-3419.4)IU/ml after 5 years of ETV treatment(P<0.001);the HBeAg-positive patients had a baseline HBV DNA load of(6.7±1.7)log10 IU/ml and achieved an HBV DNA clearance rate of 100%after 5 years of ETV treatment.The HBeAg-negative patients had a baseline HBsAg level of 2420.0(662.6-5621.2)IU/ml,which significantly decreased to 407.2(56.7-1104.7)IU/ml after 5 years of ETV treatment(P<0.001);the HBeAg-negative patients had a baseline HBV DNA load of 4.9±1.4 log10 IU/ml and achieved an HBV DNA clearance rate of 100%after 5 years of ETV treatment.The HBeAg-positive patients had a significantly higher median HBsAg level than the HBeAg-negative patients at each time point(all P<0.001).Both HBeAg-positive and HBeAg-negative patients showed a changing trend of rapid reduction followed by slow reduction in HBsAg,and the mean annual rate of reduction in HBsAg in the first 2 years of ETV treatment was significantly higher than that in the last 3 years of ETV treatment(HBeAg-positive:Z=-13.605,P<0.001;HBeAg-negative:Z=-5.950,P<0.001).The HBeAg-positive patients had a significantly lower HBV DNA clearance rate than the HBeAg-negative patients at 1 year of ETV treatment(χ2=71.013,P<0.001),and both HBeAg-positive and HBeAg-negative patients achieved an HBV DNA clearance rate of 100%at 2,3,4,and 5 years of treatment.After 5 years of ETV treatment,the cumulative proportions of patients with HBsAg clearance,HBsAg<200 IU/ml,HBsAg<1000 IU/ml,and HBsAg<1500 IU/ml were 3.6%,23.9%,57.0%,and 67.3%,respectively.Conclusion During the EVT treatment of CHB,the levels of HBsAg and HBV DNA gradually decrease,and the level of HBsAg shows a trend of rapid reduction followed by slow reduction.After 5 years of ETV monotherapy,67.3%of the patients can achieve an HBsAg level of<1500 IU/ml.
作者 吴凤萍 李妙羡 王怡恺 鲁瑞 刘怡欣 党双锁 WU Fengping;LI Miaoxian;WANG Yikai;LU Rui;LIU Yixin;DANG Shuangsuo(Department of Infectious Diseases,The Second Affiliated Hospital of Xi’an Jiaotong University,Xi’an 710004,China;Department of Clinical Laboratory,The Second Affiliated Hospital of Xi’an Jiaotong University,Xi’an 710004,China)
出处 《临床肝胆病杂志》 CAS 北大核心 2021年第5期1047-1052,共6页 Journal of Clinical Hepatology
基金 陕西省重点研发计划项目(2020SF-297)。
关键词 乙型肝炎 慢性 乙型肝炎表面抗原 病毒载量 恩替卡韦 Hepatitis B,Chronic Hepatitis B Surface Antigens Viral Load Entecavir
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