艾米替诺福韦再治疗低病毒血症的慢性乙型肝炎患者临床疗效研究  

Tenofovir amibufenamide in re-treatment of patients with chronic hepatitis B and low-level viremia

作　　者：何振文 徐刚[2] 孟华 陈辉 周庆坤 He Zhenwen;Xu Gang;Meng Hua(Department of Infectious Diseases,Jintan First People's Hospital,Changzhou 222200,Jiangsu Province,China)

机构地区：[1]江苏省常州市金坛第一人民医院感染病科,222200 [2]东南大学医学院附属南京同仁医院普外科 [3]东南大学医学院附属南京同仁医院老年病科

出　　处：《实用肝脏病杂志》2024年第6期828-831,共4页Journal of Practical Hepatology

基　　金：国家临床重点专科建设基金资助项目(编号:2011873)。

摘　　要：目的探讨艾米替诺福韦(TMF)与恩替卡韦(ETV)治疗低病毒血症(LLV)的慢性乙型肝炎(CHB)患者临床疗效。方法2021年4月~2023年4月我院诊治的79例CHB患者,均经核苷(酸)类似物(NAs)抗病毒治疗4~22(12.1±3.6)年,血清HBV DNA载量为21~1999 IU/mL,被随机分为对照组39例和观察组40例,分别给予ETV或TMF治疗,在48 w末观察结果。采用高灵敏PCR法检测血清HBV DNA载量,采用化学发光免疫分析法检测血清HBsAg和HBeAg,使用FibroScan肝脏瞬时弹性成像仪行肝脏硬度检测(LSM),常规检测获得肝纤维化4因子指数(FIB-4)和估算的肾小球滤过率(eGFR),使用流式细胞仪检测外周血T淋巴细胞亚群。结果在治疗48 w末,观察组血清ALT和AST水平分别为(30.2±4.0)U/L和(31.8±6.2)U/L,与对照组[分别为(30.9±3.6)U/L和(33.7±7.0)U/L]比,无显著性差异(P>0.05),观察组血清HBV DNA载量为25(14.8,51.9)IU/mL,显著低于对照组[223.8(87.2,327.5)IU/mL,P<0.05];观察组LSM、FIB-4和eGFR分别为(7.0±0.8)kPa、(1.9±0.3)和(104.9±10.3)mL/min/1.73m^(2),与对照组比,无显著性差异[分别为(7.1±0.9)kPa、(1.8±0.3)和(105.1±11.2)mL/min/1.73m^(2),P>0.05];观察组外周血CD3^(+)、CD4^(+)、CD8^(+)细胞百分比和CD4^(+)/CD8^(+)细胞比值分别为(66.9±6.9)%、(37.5±4.9)%、(24.0±2.5)%和(1.5±0.3),与对照组比,无显著性差异[分别为(67.4±7.3)%、(38.8±4.6)%、(23.6±2.7)%和(1.6±0.4),P>0.05]。结论应用TMF继续治疗处理LLV的CHB患者能够抑制病毒复制,其远期获益还需要进一步观察。Objective The aim of this study was to investigate clinical antiviral efficacy of tenofovir amibufenamide(TMF)and entecavir(ETV)in the treatment of patients with chronic hepatitis B(CHB)and low-level viremia(LLV).Methods 79 patients with CHB were encountered in our hospital between April 2021 and April 2023,and all met enrollment criteria,e.g.,receiving nucleos(t)ide analogues(NAs),including lamivudine,adefovir and ETV antiviral treatment for 4 to 22(12.1±3.6)yrs and having LLV(21 to 1999 IU/mL).Patients were divided into control(n=39)and observation(n=40)groups,receiving ETV or TMF treatment for 12 months.Serum HBV DNA loads were detected by high-sensitive real-time fluorescence quantitative PCR,serum HBsAg and HBeAg were assayed by chemiluminescence immunoassay,and routine blood and biochemical parameters were determined to obtain fibrosis-4 index(FIB-4)and estimated glomerular filtration rate(eGFR).Liver stiffness measurement(LSM)was detected by Fibroscan.Peripheral blood T lymphocyte subsets were measured by flow cytometry.Results By end of 48-week treatment,serum ALT and AST levels in the observation group were(30.2±4.0)U/L and(31.8±6.2)U/L,both not significantly different compared to[(30.9±3.6)U/L and(33.7±7.0)U/L,respectively]in the control(P>0.05),while serum HBV DNA loads was 25(14.8,51.9)IU/mL,much lower than[223.8(87.2,327.5)IU/mL,P<0.05]in the control;LSM,FIB-4 and eGFR were(7.0±0.8)kPa,(1.9±0.3)and(104.9±10.3)mL/min/1.73m^(2),not significantly different as compared to[(7.1±0.9)kPa,(1.8±0.3)and(105.1±11.2)mL/min/1.73m^(2),respectively,P>0.05]in the control;percentages of peripheral blood CD3^(+),CD4^(+),CD8^(+)cells and CD4^(+)/CD8^(+)cell ratio were(66.9±6.9)%,(37.5±4.9)%,(24.0±2.5)%and(1.5±0.3),not significantly different compared to[(67.4±7.3)%,(38.8±4.6)%,(23.6±2.7)%and(1.6±0.4),respectively,P>0.05]in the control group.Conclusion TMF treatment could relatively radically inhibit HBV DNA replication in CHB patients with LLV,and long-term benefit needs further clinical investigatio

关 键 词：慢性乙型肝炎 低病毒血症 艾米替诺福韦 恩替卡韦 治疗 

分 类 号：R512.62[医药卫生—内科学]