摘要目的:比较富马酸替诺福韦酯(TDF)与富马酸丙酚替诺福韦(TAF)治疗高病毒载量慢性乙型肝炎(CHB)患者的疗效及安全性。方法:纳入2022年12月1日至2023年12月1日于江南大学附属无锡五院就诊的TDF(155例)和TAF(157例)单药治疗的高病毒载量[乙型肝炎病毒(HBV)DNA>7 lg IU/mL]CHB患者，比较两组治疗48周时HBV DNA低于检测下限(20 IU/mL)率、丙氨酸转氨酶(ALT)复常率、乙型肝炎e抗原(HBeAg)血清学转换率及肾功能、血脂水平。统计学分析采用两独立样本 t检验、曼-惠特尼 U检验、 χ2检验或Fisher确切概率法。 结果:治疗48周时，TDF组患者HBV DNA低于检测下限率[49.03%(76/155)和29.30%(46/157)]和下降幅度[(6.05±0.81) lg IU/mL和(5.57±1.02) lg IU/mL]均高于TAF组，差异均有统计学意义( χ2＝12.75， t＝－4.65，均 P<0.001)；TDF组和TAF组患者ALT复常率分别为77.19%(88/114)和72.50%(87/120)，HBeAg血清学转换率分别为4.00%(6/150)和2.67%(4/150)，差异均无统计学意义(均 P>0.05)。TDF组和TAF组肾功能指标(血清肌酐和估算肾小球滤过率变化水平)差异均无统计学意义(均 P>0.05)；TDF组高密度脂蛋白胆固醇下降幅度[0.15(－0.02，0.38) mmol/L和0.06(－0.06，0.20) mmol/L]和异常率[27.73%(33/119)和16.39%(20/122)]高于TAF组，低密度脂蛋白胆固醇[－0.09(－0.39，0.25) mmol/L和0.05(－0.31，0.42) mmol/L]、总胆固醇[－0.23(－0.75，0.23) mmol/L和0.08(－0.35，0.57) mmol/L]、甘油三酯[－0.12(－0.40，0.06) mmol/L和0.00(－0.19，0.24) mmol/L]上升幅度和总胆固醇异常率[4.31%(5/116)和15.75%(20/127)]低于TAF组，差异均有统计学意义( Z＝－3.19， χ2＝4.51， Z＝2.17， Z＝4.09， Z＝3.71， χ2＝8.59，均 P<0.05)。 结论:TDF治疗高病毒载量CHB患者疗效优于TAF，且更安全。

abstractsObjective:Comparative efficacy and safety profiles of tenofovir disoproxil fumarate (TDF) versus tenofovir alafenamide fumarate (TAF) in chronic hepatitis B (CHB) patients with high viral load.Methods:CHB patients with high viral load (hepatitis B virus (HBV) DNA>7 lg IU/mL) receiving TDF ( n=155) or TAF ( n=157) monotherapy were included between December 1st, 2022 and December 1st, 2023, to compare the rates of undetectable HBV DNA (<20 IU/mL), the alanine transaminase (ALT) normalization rate, hepatitis B e antigen (HBeAg) seroconversion rate, renal function and lipid profiles at 48 weeks of treatment. The statistical analysis was performed by the two independent samples t test, Mann-Whitney U test, chi-square test or Fisher′s exact probability test. Results:At week 48 of treatment, the TDF group achieved significantly higher HBV DNA undetectability rates (49.03%(76/155) vs 29.30%(46/157)) and greater mean reduction ((6.05±0.81) lg IU/mL vs (5.57±1.02) lg IU/mL) than the TAF group ( χ2=12.75, t=-4.65, both P<0.001). The ALT normalization rate of patients in the TDF and TAF groups were 77.19%(88/114) and 72.50%(87/120), and HBeAg seroconversion rates were 4.00%(6/150) and 2.67%(4/150), respectively, with no statistically significant differences between the two groups (all P>0.05). The differences in the changes and abnormal rates of serum creatinine and estimated glomerular filtration rate between the two groups of patients were not statistically significant (both P>0.05). The magnitude of decrease (0.15(-0.02, 0.38) mmol/L vs 0.06(-0.06, 0.20) mmol/L) and abnormal rate (27.73%(33/119) vs 16.39%(20/122)) in high-density lipoprotein cholesterol in the TDF group was higher than those in the TAF group, while the increases in low-density lipoprotein cholesterol (-0.09(-0.39, 0.25) mmol/L vs 0.05(-0.31, 0.42) mmol/L), total cholesterol (TC) (-0.23(-0.75, 0.23) mmol/L vs 0.08(-0.35, 0.57) mmol/L), and triglyceride (-0.12(-0.40, 0.06) mmol/L vs 0.00(-0.19, 0.24) mmol/L), as well as the abnormal rate of TC (4.31%(5/116) vs 15.75%(20/127)), in the TDF group were lower than those in the TAF group ( Z=-3.19, χ2=4.51, Z=2.17, Z=4.09, Z=3.71, χ2=8.59, all P<0.05). Conclusion:TDF demonstrated superior efficacy and better safety profiles compared to TAF in high viral load CHB patients.