富马酸丙酚替诺福韦治疗初治失代偿期乙型肝炎肝硬化患者的临床研究

Clinical study of tenofovir alafenamide in the newly treated patients with decompensated hepatitis B cirrhosis

目的探讨富马酸丙酚替诺福韦(TAF)治疗初治失代偿期乙型肝炎肝硬化患者的疗效和安全性。方法回顾性分析2021年10月—2023年10月在甘肃武威肿瘤医院初治失代偿期乙型肝炎肝硬化患者72例,接受TAF治疗患者34例,TDF治疗患者38例。比较两组治疗24周和48周时ALT、TBil、Alb、PT、CTP评分的变化,以及病毒学应答(HBV DNA<20 IU/mL)的患者比例。安全性方面,比较两组24周、48周Scr、BUN的变化以及药物相关不良事件。结果TAF治疗48周时中位ALT为27.10 U/L,低于TDF组30.90 U/L(P<0.05);治疗24周、48周后TAF组Alb分别为39.73、41.69 g/L,与TDF组比较,改善Alb水平更优(P<0.05);TAF组和TDF组治疗48周时HBV DNA转阴率分别为97.1%、81.6%,表明TAF病毒应答率优于TDF(P<0.05);两组Child-Pugh评分在24周和48周时均改善,差异无统计学意义(P>0.05)。安全性方面,治疗48周时,TAF组的BUN、Scr水平显著低于TDF组(P<0.05),治疗期间两组未发现药物相关不良事件或严重不良事件。结论TAF对失代偿期乙型肝炎肝硬化患者具有良好的有效性和安全性。

Objective To investigate the efficacy and safety of Tenofovir alafenamide?(TAF)in the the newly treated patients with decompensated hepatitis B cirrhosis.Methods A total of 72 patients were retrospectively analysed in the study,34 of whom received TAF treatment and 38 of whom received TDF treatment in Wuwei tumor Hospital of Gansu from October 2021 to October 2023.After 24 weeks and 48 weeks of treatment,we compared the changes in ALT,TBil,Alb,PT,CTP scores,and the proportion of patients with virological response(HBVDNA<20 IU/mL)between the two groups.In terms of safety,we compared changes in Scr and BUN,as well as drug-related adverse events.Results After 48 weeks of treatment,the median ALT was 27.10 U/L in the TAF group,which was significantly lower than the median ALT of 30.90 U/L in the TDF group(P<0.05).Additionally,the Alb level in the TAF group was 39.73 g/L and 41.69 g/L after 24 and 48 weeks of treatment respectively,and this improvement was superior to the TDF group(P<0.05).The virological response rate of HBV DNA was 97.1%and 81.6%in the TAF and TDF groups after 48 weeks of treatment respectively,indicating a better viral response rate for TAF(P<0.05).The Child-Pugh scores significantly decreased in both groups after 24 and 48 weeks of treatment,but the difference was not statistically significant(P>0.05).Regarding safety,after 48 weeks of TAF treatment.BUN and Scr levels were significantly lower in the TAF group compared to the TDF group(P<0.05).No drug-related adverse events or serious adverse events were reported during the treatment period.Conclusion TAF is effective and safe for patients with decompensated hepatitis B liver cirrhosis.