实用肝脏病杂志 ›› 2025, Vol. 28 ›› Issue (2): 178-181.doi: 10.3969/j.issn.1672-5069.2025.02.005

• 病毒性肝炎 • 上一篇    下一篇

高敏HBV DNA检测技术在低病毒血症慢性乙型肝炎患者抗病毒疗效监测中的应用*

陈婷婷, 丁蓉, 姬文莉, 吴梦秋   

  1. 211102 南京市 东南大学医学院附属南京同仁医院检验科
  • 收稿日期:2024-03-28 出版日期:2025-03-10 发布日期:2025-03-11
  • 通讯作者: 吴梦秋,E-mail:18168428450@163.com
  • 作者简介:陈婷婷,女,33岁,大学本科,主管技师。E-mail:chentingting50104@163.com
  • 基金资助:
    *南京同仁医院院长科研基金资助项目(编号:2022E009)

Fluoresce quantity PCR assay in monitoring antiviral efficacy in patients with chronic hepatitis B with low-level viremia

Chen Tingting, Ding Rong, Ji Wenli, et al   

  1. Clinical Laboratory, Tongren Hospital Affiliated to Southeast University School of Medicine, Nanjing 211102, Jiangsu Province, China
  • Received:2024-03-28 Online:2025-03-10 Published:2025-03-11

摘要: 目的 探讨采用高敏HBV DNA检测技术在低病毒血症(LLV)慢性乙型肝炎(CHB)患者抗病毒治疗疗效监测中的应用价值。方法 2019年1月~2022年12月我院诊治的200例CHB患者,纳入患者均接受恩替卡韦(ETV)治疗48 w或以上,对获得完全病毒学应答(CVR)患者继续口服ETV治疗,对未获得CVR患者,均改为富马酸丙酚替诺福韦(TAF)治疗,观察48周。分别采用实时荧光定量PCR(qPCR)和高荧光质量PCR(fq-PCR)法检测血清HBV DNA载量。 结果 在200例经ETV治疗48 w的CHB患者,经fq-PCR检测发现CVR者145例(72.5%),血清HBV DNA载量>2000 IU/mL(PR)者13例(6.5%),血清HBV DNA载量在21~2000 IU/mL(LLV)者42例(21.0%); 在TAF继续治疗48 w末,经qPCR检测发现PR组获得CVR者13例(100.0%),而经fq-PCR检测发现只有5例(38.5%,P<0.05),LLV组则分别为41例(97.6%)和30例(71.4%,P<0.05),fq-PCR检测两组CVR比较,差异具有统计学意义(x2=4.662,P<0.05);PR组和LLV组血清AST和ALT水平均正常,无统计学差异(P>0.05),而LLV组血清HBV DNA载量为(125.6±114.2)IU/mL,显著低于PR组【(370.4±217.8)IU/mL,P<0.05】。 结论 采用高敏PCR检测技术可以帮助发现接受抗病毒治疗而处于LLV状态的CHB患者,以帮助临床做出治疗决策,其临床意义还有待于进一步观察。

关键词: 慢性乙型肝炎, 恩替卡韦, 丙酚替诺福韦, 低病毒血症, 高荧光质量PCR法, 治疗

Abstract: Objective The aim of this study was to investigate fluoresce quantity PCR (fq-PCR) assay in monitoring antiviral efficacy in patients with chronic hepatitis B (CHB) with low-level viremia (LLV). Methods A total of 200 patients with CHB were encountered in our hospital between January 2019 and December 2022, and the alleged patients met oral entecavir (ETV) treatment for at least 48 weeks. All patients with complete virologic response (CVR) continued ETV treatment, those without switched to tenofovir alafenamide fumarate (TAF) antiviral treatment, and all patients were followed-up for 48 weeks. Serum HBV DNA loads were detected by quantitative real-time PCR (qPCR) and fq-PCR, respectively. Results Of 200 ETV-treated patient enrolled in this study, fq-PCR assay found CVR in 145 cases (72.5%), serum HBV DNA loads were greater than 2000 IU/mL(PR) in 13 cases (6.5%), and serum HBV DNA loads were at range of 21 to 2000 IU/mL(LLV) in 42 cases (21.0%); by end of 48 week TAF treatment, CVR by qPCR in PR group was found in 13 cases (100.0%), while only in 5 cases(38.5%, P<0.05) by fq-PCR, and in LLV group were in 41 cases (97.6%) and in 30 cases (71.4%, P<0.05), in which there was a significant difference between CVR in PR group and in LLV group by fq-PCR (x2=4.662, P<0.05); there were no significant differences as respect to serum AST and ALT levels in patients with PR and with LLV(P>0.05), while serum HBV DNA loads in LLV group was (125.6±114.2)IU/mL, much lower than [(370.4±217.8)IU/mL, P<0.05] in those with PR. Conclusion Surveillance of serum HBV DNA loads by high-sensitivity PCR detection could help clinicians find CHB patients receiving nucleos(t)ide analogue treatment at LLV status, and make an appropriate antiviral options as early as possible.

Key words: Hepatitis B, Entecavir, Tenofovir alafenamide fumarate, Low-level viremia, Fluoresce quantity PCR, Quantitative real-time PCR, Efficacy monitoring