再认识乙型肝炎病毒检验现状与慢性乙型肝炎临床诊治需求的距离  

Time to revisit the gap between current laboratory testing for hepatitis B virus and clinical needs for diagnosis and treatment of chronic hepatitis B

作　　者：杨瑞锋 陈红松[2] Yang Ruifeng;Chen Hongsong(Department of Clinical Laboratory,Peking University Shougang Hospital,Beijing100144,China;Infectious Disease and Hepatology Center of Peking University People′s Hospital,Peking University Hepatology Institute,National Clinical Research Center for Infectious Disease,Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases,Beijing100044,China)

机构地区：[1]北京大学首钢医院检验科,北京100144 [2]北京大学人民医院感染与肝病中心、北京大学肝病研究所、国家感染性疾病临床医学研究中心分中心、丙型肝炎和肝病免疫治疗北京市重点实验室,北京100044

出　　处：《中华检验医学杂志》2025年第1期8-14,共7页Chinese Journal of Laboratory Medicine

摘　　要：目前,乙型肝炎病毒(HBV)感染的根治性药物研发面临困境,治疗慢性乙型肝炎(CHB)仍以优化现有治疗方案为主。与此同时,HBV免疫学和分子生物学检验技术快速发展,高敏化、定量化成为了试剂研发的主流,新型HBV标志物也逐步应用于临床,使我们对HBV感染和CHB诊治的管理更加精细化,也使许多标志物的结果解读更复杂。HBV DNA检测灵敏度与HBV感染自然史分期和抗病毒治疗适应证密切相关,高敏HBV DNA的应用可能会引发对核苷(酸)类似物(NA)治疗中低病毒血症的过度关注。高敏HBsAg检测则挑战特殊人群抗病毒治疗适应证及CHB临床治愈的概念。HBV血清学(免疫学)标志物是否需要全部定量检测有待探讨。同时,应限定HBV前基因组RNA及核心相关抗原等新型标志物的临床场景,避免误用、滥用和对临床意义的过度解读。Development of curative drugs for hepatitis B virus(HBV)infection is facing challenges currently.Current treatment of chronic hepatitis B(CHB)still bases on optimizing the existing therapeutic regimens.Meanwhile,with the rapid development of immunology and molecular technologies,high-sensitivity and quantification have become the mainstream of diagnostic kits development in terms of HBV laboratory diagnosis,and new biomarkers are being developed and widely used clinically.Advancement of laboratory technology favors the personalized management of HBV infection and CHB in one hand and on the other hand,it makes the interpretation of the results of these biomarkers more complicated.The sensitivity of HBV DNA assay is closely related to the natural history of HBV infection and the indication of antiviral therapy.Application of ultra-sensitive HBV DNA assay may cause unnecessary excessive concern for the management of low level viremia on nucleos(t)ide analogue treatment.Availability of ultra-sensitive HBsAg assay challenges the antiviral therapy indication in special populations and the concept of clinical cure of CHB.Necessity of quantification of all HBV serological(immunological)markers remains an issue of debate.Meanwhile,the clinical scenarios of novel markers such as HBV pregenomic RNA and hepatitis B core-related antigen should be defined to avoid misuse,overuse and over-interpretation of their clinical significance.

关 键 词：肝炎病毒 乙型 肝炎 乙型 慢性 临床实验室技术 前基因组RNA 乙型肝炎核心相关抗原 

分 类 号：R512.62[医药卫生—内科学]