艾米替诺福韦治疗65岁以上慢性乙型肝炎及肝硬化患者的有效性及安全性  

Efficacy and safety of tenofovir amibufenamide in the treatment of patients over 65 years of age with chronic hepatitis B

作　　者：褚萨萨 刘兴[1] 徐成 邱国正 徐耀[1] 邓静[1] 付美丽 彭玉龙[1] 高峰[1] Chu Sasa;Liu Xing;Xu Cheng;Qiu Guozheng;Xu Yao;Deng Jing;Fu Meili;Peng Yulong;Gao Feng(Department of Infectious Diseases,Linyi People's Hospital,Linyi276000,China)

机构地区：[1]临沂市人民医院感染科,临沂276000

出　　处：《中华肝脏病杂志》2024年第10期904-909,共6页Chinese Journal of Hepatology

基　　金：临沂市重点研发计划(医学类)项目(2023YX0033);佑安肝病感染病专科医疗联盟科研专项(LM202011)。

摘　　要：目的探讨艾米替诺福韦(TMF)在治疗65岁以上慢性乙型肝炎及肝硬化患者中的有效性及安全性。方法纳入临沂市人民医院45例慢性乙型肝炎及肝硬化患者,TMF治疗48周比较治疗第12、24、48周时病毒学应答率、HBV DNA较基线下降水平,治疗前后乙型肝炎表面抗原(HBsAg)、丙氨酸转氨酶(ALT)、肾小球滤过率(eGFR)、肌酐、甘油三酯(TG)、总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)及血磷、血脂的变化及48周时ALT复常率变化。以P<0.05表示差异具有统计学意义。结果入组患者年龄为69.0(67.0,72.5)岁。TMF治疗12、24、48周的完全病毒学应答率为32.4%(12/37)、70.0%(28/40)、84.6%(33/39),HBV DNA较基线有明显下降(P值均<0.05)。治疗48周后HBsAg水平下降(P<0.05),未出现HBsAg转阴及血清转换患者。治疗48周后ALT水平下降(P<0.05)。治疗48周时ALT复常率分别为88.9%(16/18)、70.4%(19/27)。基线与治疗48周后的eGFR、肌酐、磷、TG、TC、HDL-C、LDL-C水平差异无统计学意义(P值均>0.05),暂未观察到严重不良反应事件发生。结论对于65岁以上慢性乙型肝炎及肝硬化患者,TMF可显著抑制HBV DNA复制,且ALT复常率高、耐受性好。ObjectiveTo investigate the efficacy and safety of tenofovir amibufenamide in patients over 65 years old with chronic hepatitis B and liver cirrhosis.MethodsWe recruited 45 patients in Linyi People's Hospital with chronic hepatitis B and liver cirrhosis who were treated with TMF antiviral therapy for 48 weeks,compared the virologic response rate and HBV DNA decrease level at 12,24 and 48 weeks,and the changes in hepatitis B surface antigen,alanine aminotransferase,glomerular filtration rate,creatinine,triglycerides,total cholesterol,high-density lipoprotein cholesterol,low-density lipoprotein cholesterol,serum phosphorus and blood lipids,and the changes in ALT normalization rate at 48 weeks.P<0.05 was statistically significant.ResultsThe age of the enrolled patients was 69.0(67.0,72.5)years.At 12,24,and 48 weeks of treatment,the complete virological response rates were 32.4%(12/37),70.0%(28/40),and 84.6%(33/39)respectively,and the level of HBV DNA decreased from baseline(P<0.05).After 48 weeks of treatment,the level of HBsAg decreased(P<0.05),and there was no negative HBsAg conversion and seroconversion.After 48 weeks of treatment,the level of ALT decreased(P<0.05).At 48 weeks of treatment,the rates of ALT reverted to normality were 88.9%(16/18)and 70.4%(19/27),respectively.There was no significant difference in the levels of glomerular filtration rate,creatinine,phosphorus,triglycerides,total cholesterol,high-density lipoprotein cholesterol and low-density lipoprotein cholesterol estimated at baseline before and after treatment(P>0.05),and no serious adverse events were observed.ConclusionsFor patients over 65 years old with chronic hepatitis B and liver cirrhosis,TMF can significantly inhibit HBV DNA replication,and the ALT normalization rate is high and well tolerated.

关 键 词：慢性乙型肝炎 肝硬化 疗效 安全性 艾米替诺福韦 

分 类 号：R512.62[医药卫生—内科学] R575.2[医药卫生—临床医学]