摘要
目的探讨艾米替诺福韦(tenofovir amibufenamide,TMF)治疗乙肝病毒相关肝硬化患者的早期疗效及安全性。方法回顾性收集2021年4月至2022年9月就诊于郑州大学第一附属医院感染病科的54例初次使用TMF和富马酸丙酚替诺福韦片(tenofovir alafenamide fumarate,TAF)抗病毒治疗的乙肝病毒(hepatitis B virus,HBV)相关肝硬化患者为研究对象,其中TMF组30例,TAF组24例,采集其临床资料,比较两组基线数据、治疗24周时病毒学应答率(HBV DNA<20 IU/mL)、丙氨酸氨基转移酶(alanine aminotransferase,ALT)复常率、肝硬度测定值(liver stiffness measurement,LSM)、肾功能和血脂的变化情况等。结果基线时,TMF组和TAF组的年龄、HBV DNA、ALT、LSM分别为(47.27±10.33)vs(46.96±10.43)岁、1.28[1.28,4.75]vs 1.28[1.28,4.72]log10 IU/mL、(64.20±58.52)vs(59.21±60.54)U/L、(20.76±8.01)vs(21.44±11.76)kPa;两组各指标差异均无统计学意义(P>0.05)。治疗24周时,TMF组和TAF组病毒学应答率、ALT复常率、HBeAg血清学转换率分别为100%(11/11)vs 80%(8/10)、84.62%(11/13)vs 90.00%(9/10)、20%(2/10)vs 14.29%(1/7),LSM较基线下降3.96 vs 5.71 kPa,组间比较差异均无统计学意义(P>0.05);治疗24周时TMF组乙型肝炎病毒表面抗原(HBsAg)水平低于TAF组[(2.49±1.01)vs(3.04±0.88)log10 IU/mL,P<0.05]。肾功能方面,两组血清肌酐、估算的肾小球滤过率、血β2微球蛋白较各自基线均无显著改变;血脂方面,治疗24周时,TMF组高密度脂蛋白升高0.10 mmol/L、低密度脂蛋白升高0.28 mmol/L(组内比较P值分别为0.011、0.001),TAF组总胆固醇升高0.35 mmol/L(组内比较P<0.05);TMF组三酰甘油降低0.27 mmol/L,TAF组TG升高0.15 mmol/L,组间比较差异有统计学意义(P=0.001)。结论TMF和TAF治疗乙肝病毒相关肝硬化代偿期患者的早期疗效及安全性无显著差异,TMF在降低HBsAg、升高HDL和降低TG方面优于TAF。
Objective To investigate the early effectiveness and safety of tenofovir amibufenamide(TMF)in the treatment of patients with hepatitis B virus(HBV)related compensated cirrhosis.Methods A total of 54 HBV related cirrhotic,who were first treated with TMF and tenofovir alafenamide fumarate(TAF),were retrospectively collected from the Department of Infectious Diseases and Hepatology,the First Affiliated Hospital of Zhengzhou University from April 2021 to September 2022,and 30 patients were included in the TMF group and 24 patients were involved in the TAF group.The virological response rate(HBV DNA<20 IU/mL),alanine aminotransferase(ALT)recovery rate,liver stiffness measurement(LSM),renal function and blood lipid profile changes were compared between baseline and after 24 weeks of treatment(intergroup and/or intragroup).Results At baseline,the age,HBV DNA,ALT,and LSM levels of the patients in the TMF and the TAF group were(47.27±10.33)vs(46.96±10.43)years,1.28[1.28,4.75]vs 1.28[1.28,4.72]log10 IU/mL,(64.20±58.52)vs(59.21±60.54)U/L,and(20.76±8.01)vs(21.44±11.76)kPa,respectively,no statistical significance between two groups were observed(all P>0.05).After 24 weeks of treatment,the rates of virological response,ALT recovery,and HBeAg seroconversion in TMF group and TAF group were 100%(11/11)vs 80%(8/10),84.62%(11/13)vs 90.00%(9/10),20%(2/10)vs 14.29%(1/7),respectively,and the LSM decreased by 3.96 kPa in TMF group vs 5.71 kPa of decrease in TAF group from baseline,with no statistical significance between the two groups(P>0.05).Lower HBsAg levels were found in the TMF group compared to the TAF group after 24 weeks of treatment[(2.49±1.01)vs(3.04±0.88)log10 IU/mL,P<0.05].In terms of renal function,serum creatinine,estimated glomerular filtration rate,and bloodβ2 microglobulin did not change significantly from baseline to 24 weeks of treatment in either group.After 24 weeks of treatment in TMF group,an increase of 0.10 mmol/L and 0.28 mmol/L were observed in high density lipoprotein(P=0.011)and low density lipoprotein(P=0.001),respectively.Additionally,there was an increase of 0.35 mmol/L in total cholesterol after 24 weeks of TAF treatment(P<0.05).Furthermore,the TMF group exhibited a decrease of 0.27 mmol/L in triglycerides,whereas the TAF group displayed an increase of 0.15 mmol/L(P=0.001).Conclusion Patients with HBV-related cirrhosis exhibited similar early effectiveness and safety profiles when treated with TMF and TAF.However,TMF was more effective than TAF in decreasing HBsAg levels,increasing high density lipoprotein levels,and reducing triglycerides.
作者
吕雪艳
陈如悦
潘亚杰
华静
黄硕
李为哲
曾庆磊
LV Xueyan;CHEN Ruyue;PAN Yajie;HUA Jing;HUANG Shuo;LI Weizhe;ZENG Qinglei(Department of Infectious Disease and Hepatology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;Department of Gastroenterology,The First Affiliated Hospital of Henan University,Kaifeng 475000,China)
出处
《延安大学学报（医学科学版）》
2023年第3期74-82,共9页
Journal of Yan'an University:Medical Science Edition
基金
国家自然科学基金面上项目(82270629)
河南杰出青年科学基金项目(232300421011)
河南中青年卫生健康科技创新杰出青年人才项目(YXK2020024)。
作者简介
共同第一作者:吕雪艳(1998-),女,甘肃庆阳人,在读硕士研究生。研究方向:病毒性肝炎的防治;共同第一作者:陈如悦(1996-),女,河南周口人,在读硕士研究生。研究方向:病毒性肝炎的防治;通信作者:曾庆磊(1986-),男,河南信阳人,主任医师,博士研究生导师,医学博士。研究方向:病毒性肝炎的防治。E-mail:zengqinglei2009@163.com。
