实用肝脏病杂志 ›› 2025, Vol. 28 ›› Issue (6): 818-821.doi: 10.3969/j.issn.1672-5069.2025.06.005

• 病毒性肝炎 • 上一篇    下一篇

艾米替诺福韦治疗经恩替卡韦治疗的低病毒血症的慢性乙型肝炎患者疗效研究*

华琪, 刘琼, 陈琦   

  1. 200021 上海市 上海中医药大学附属曙光医院药剂科
  • 收稿日期:2024-07-04 出版日期:2025-11-10 发布日期:2025-11-13
  • 作者简介:华琪,女,41岁,大学本科,主管药师。E-mail:gigi19830817@163.com
  • 基金资助:
    *上海市自然科学基金资助项目(编号:20ZR1456900)

Rescue antiviral therapy of tenofovir alafenamide in entecavir-treated chronic hepatitis B patients with low level viremia

Hua Qi, Liu Qiong, Chen Qi   

  1. Department of Pharmacy, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200021, China
  • Received:2024-07-04 Online:2025-11-10 Published:2025-11-13

摘要: 目的 研究转换核苷(酸)类治疗经恩替卡韦(ETV)治疗的出现低病毒血症(LLV)的慢性乙型肝炎(CHB)患者的有效性。方法 2021年9月~2023年2月上海中医药大学附属曙光医院收治的85例CHB患者,经恩替卡韦(ETV)治疗至少1年出现LLV,被分成A组(n=28)、B组(n=26)和C组(n=31)。A组继续接受ETV治疗,B组接受艾米替诺福韦(TMF)治疗,C组接受ETV联合TMF治疗,观察48 w。 采用化学发光免疫分析法定量检测血清HBsAg水平,采用实时荧光定量PCR法检测血清HBV DNA载量。常规行血液和血清检测,计算肝纤维化4因子指数(FIB-4)和估算的肾小球滤过率(eGFR),使用FibroScan瞬时弹性扫描仪行肝脏硬度检测(LSM)。结果 在治疗48 w末,C组血清HBV DNA载量为(12.3±3.4)IU/mL,显著低于B组【(31.3±5.8)IU/mL,P<0.05】或A组【(244.1±14.1)IU/mL,P<0.05】,但三组血清HBsAg水平比较,无显著性差异【分别为(4322.6±210.2)IU/mL、(4323.1±150.2)IU/mL和(4453.5±143.3)IU/mL,P>0.05】;三组血清TBIL、AST和ALT水平变化无统计学意义(P>0.05);C组LSM为(6.6±0.5)kPa,B组为(6.4±0.8)kPa,均显著低于A组【(7.6±1.2)kPa,P<0.05】,而三组FIB-4和eGFR水平比较,差异无统计学意义(P>0.05)。结论 对于经ETV治疗后出现LLV的CHB患者可以选择TMF挽救治疗,其远期获益还需要观察。至于是否需要联合用药,还值得研究。

关键词: 慢性乙型肝炎, 艾米替诺福韦, 恩替卡韦, 经治, 低病毒血症, 挽救治疗

Abstract: Objective This study was conducted to observe clinical efficacy of rescue antiviral therapy of tenofovir alafenamide (TMF) in entecavir(ETV)-treated chronic hepatitis B (CHB) patients with low level viremia (LLV). Methods 85 patients with CHB were encountered in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine between September 2021 and February 2023, all enrolled patients had been treated by ETV for at least 48 weeks, and LLV was found by quantitatively PCR detection. The patients were divided into group A, B and C, receiving ETV (n=28),TMF (n=26) or ETV and TMF combination (n=31) for 48 weeks. Serum HBsAg level was detected by chemiluminescent immunoassays and serum HBV DNA loads were determined by real-time fluorescent quantitative PCR. Fibrosis factor-4 (FIB-4) and estimated glomerular filtration rate (eGFR) were routinely obtained. Liver stiffness measurement (LSM) was detected by FibroScan. Results By end of 48 week antiviral treatment, serum HBV DNA load in group C was(12.3±3.4)IU/mL, much lower than [(31.3±5.8)IU/mL, P<0.05] in group B or [(244.1±14.1)IU/mL, P<0.05] in group A, while there were no significant differences respect to serum HBsAg levels among the three groups [(4322.6±210.2)IU/mL vs.(4323.1±150.2)IU/mL or vs.(4453.5±143.3)IU/mL, P>0.05]; there were no significant differences as respect to serum bilirubin, AST and ALT levels among the three groups (P>0.05); LSM in group C was (6.6±0.5)kPa, and in group B was (6.4±0.8)kPa, both significantly lower than [(7.6±1.2)kPa, P<0.05] in group A, while FIB-4 and eGFR were not significantly different among the three groups (P>0.05). Conclusion For CHB patients with LLV after ETV treatment, we recommend TMF rescue therapy, while combination of nucleos(t)ide analogue needs further clinical investigation.

Key words: Hepatitis B, Tenofovir alafenamide, Entecavir, Low level viremia, Rescue therapy