富马酸丙酚替诺福韦治疗青岛地区60岁及以上慢性乙型肝炎患者的有效性和安全性  

Efficacy and safety of tenofovir alafenamide fumarate in treatment of chronic hepatitis B patients aged≥60 years in Qingdao,China

作　　者：宋玉文 陈立震 金文文[1] 耿宁[1] 张旸[1] 杜水仙 赵本田 段建平 周永 毕春花[3] 马磊 胡欣欣 张吉宏 孙建涛 谭杰 辛永宁[1] SONG Yuwen;CHEN Lizhen;JIN Wenwen;GENG Ning;ZHANG Yang;DU Shuixian;ZHAO Bentian;DUAN Jianping;ZHOU Yong;BI Chunhua;MA Lei;HU Xinxin;ZHANG Jihong;SUN Jiantao;TAN Jie;XIN Yongning(Department of Infectious Diseases,Qingdao Municipal Hospital,Qingdao University,Qingdao,Shandong 266000,China;Department of Infectious Diseases,Qingdao Sixth People’s Hospital,Qingdao,Shandong 266000,China;Department of Infectious Diseases,The Affiliated Hospital of Qingdao University,Qingdao,Shandong 266000,China;Department of Infectious Diseases,Chengyang People’s Hospital,Qingdao,Shandong 266000,China;Department of Infectious Diseases,Jimo People’s Hospital,Qingdao,Shandong 266000,China)

机构地区：[1]青岛大学附属青岛市市立医院感染性疾病科,山东青岛266000 [2]青岛市第六人民医院感染性疾病科,山东青岛266000 [3]青岛大学附属医院感染性疾病科,山东青岛266000 [4]青岛市城阳区人民医院感染性疾病科,山东青岛266000 [5]青岛市即墨区人民医院感染性疾病科,山东青岛266000

出　　处：《临床肝胆病杂志》2023年第5期1061-1069,共9页Journal of Clinical Hepatology

基　　金：慢性乙型肝炎临床研究项目(IN-CN-320-5837)。

摘　　要：目的探讨富马酸丙酚替诺福韦(TAF)在老年慢性乙型肝炎(CHB)患者中的应用价值,明确其对骨骼和肾脏的影响。方法选取2021年6月—2022年10月在青岛市市立医院、青岛大学附属医院、青岛市第六人民医院、青岛市城阳人民医院、青岛市即墨人民医院接受TAF抗病毒治疗的60岁及以上CHB患者36例。所有患者接受TAF(25 mg/d)抗病毒治疗。收集患者基线期、48周病毒学指标、生化指标、尿蛋白电泳指标以及甲胎蛋白(AFP)、肝脏超声瞬时弹性成像测定(FibroScan)、骨密度测定数据。收集24周病毒学指标,生化指标,尿蛋白电泳指标。正态分布计量资料治疗前后进行配对t检验,非正态分布计量资料治疗前后比较采用Wilcoxon符号秩和检验。计数资料的比较采用χ^(2)检验或Fisher确切概率法。结果36例CHB患者完成了24周随访。TAF治疗24周后,完全病毒学应答率为83.3%(30/36),与基线期77.8%(28/36)比较,差异无统计学意义(χ^(2)=0.36,P=0.55)。24周DBil(t=-2.42,P=0.02)、Cys C(t=-4.34,P<0.001)显著下降,与基线比较差异均有统计学意义。18例CHB患者完成了48周随访。治疗48周后,完全病毒学应答率为94.4%(17/18),与基线期77.8%(14/18)比较,差异无统计学意义(χ^(2)=2.22,P=0.34);IBil(t=2.43,P=0.03)和TBA(Z=-2.24,P=0.03)均升高,腰椎(t=2.92,P=0.01)及股骨颈骨密度(t=2.42,P=0.03)T评分均升高,LSM水平降低(t=-2.31,P=0.03),与基线比较差异均有统计学意义。β2-MG、URBP、α1-MG在治疗前后差异均无统计学意义(P值均>0.05)。结论TAF在60岁及以上CHB患者中有良好的抗病毒效果,使更多CHB患者达到完全病毒学应答,未发现对肾脏造成损害,能够改善骨密度及肝纤维化程度。Objective To investigate the application value of tenofovir alafenamide fumarate(TAF)in elderly patients with chronic hepatitis B(CHB)and its influence on bones and kidneys.Methods A total of 36 CHB patients,aged≥60 years,who received TAF antiviral therapy in Qingdao Municipal Hospital,The Affiliated Hospital of Qingdao University,Qingdao Sixth People’s Hospital,Chengyang People’s Hospital,and Jimo People’s Hospital from June 2021 to October 2022 were enrolled in this study,and all patients received TAF(25 mg/d)antiviral therapy.Related data were collected at baseline and weeks 24 and 48 of treatment,including virological indicators,biochemical parameters,urinary protein electrophoresis indices,transient elastography(FibroScan),and bone mineral density.Virological indicators included high-sensitivity HBV DNA quantification;biochemical parameters included total bilirubin,direct bilirubin(DBil),indirect bilirubin(IBil),alanine aminotransferase,aspartate aminotransferase,alkaline phosphatase,gamma-glutamyl transpeptidase,total bile acid(TBA),glucose,blood urea nitrogen,creatinine,estimated glomerular filtration rate,and cystatin C(Cys C);urinary protein electrophoresis indices included urinaryβ2 microglobulin(β2-MG),urinary retinol(URBP),and urinaryα1 microspherin(α1-MG).The paired t-test was used for comparison of normally distributed continuous data before and after treatment,and the Wilcoxon signed-rank test was used for comparison of non-normally distributed continuous data before and after treatment;the chi-square test or the Fisher’s exact test was used for comparison of categorical data.Results A total of 36 CHB patients completed 24 weeks of follow-up.The complete virological response rate after 24 weeks of treatment was higher than that at baseline[83.3%(30/36)vs 77.8%(28/36),χ^(2)=0.36,P=0.55],and there were significant reductions in DBil(t=-2.42,P=0.02)and Cys C(t=-4.34,P<0.001)from baseline to week 24.A total of 18 CHB patients completed 48 weeks of follow-up.The complete virological respo

关 键 词：乙型肝炎 慢性 富马酸丙酚替诺福韦 治疗结果 老年人 

分 类 号：R512.62[医药卫生—内科学]