富马酸丙酚替诺福韦治疗乙型肝炎肝硬化失代偿期患者的疗效和安全性研究  

Study on the efficacy and safety profile of tenofovir alafenamide fumarate in the treatment of patients with decompensated hepatitis B cirrhosis

作　　者：郭峰[1] 吴旭 窦婧 宁忠慧 王晓波[1] 徐强[1] 纪泛扑[3] 乐永红[1] 王转国[1] 党双锁[3] 王宏峰[1] 付强[1] 曾圣涛 左维泽[5] 王晓忠[1] Guo Feng;Wu Xu;Dou Jing;Ning Zhonghui;Wang Xiaobo;Xu Qiang;Ji Fanpu;Yue Yonghong;Wang Zhuanguo;Dang Shuangsuo;Wang Hongfeng;Fu Qiang;Zeng Shengtao;Zuo Weize;Wang Xiaozhong(Hepatology Department,Traditional Chinese Medical Hospital Affiliated to Xinjiang Medical University,Urumqi 830099,China;The Fourth Clinical Medical College of Xinjiang Medical University,Urumqi,830099,China;Department of Infectious Disease,the Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710004,China;Department of Infectious Disease,Yili Prefecture Xinhua Hospital,Yining,835100,China;Department of Infectious Disease,First Affiliated Hospital of Shihezi University,Shihezi,832003,China)

机构地区：[1]新疆医科大学附属中医医院肝病科,乌鲁木齐830099 [2]新疆医科大学第四临床医学院,乌鲁木齐830099 [3]西安交通大学第二附属医院感染科,西安710004 [4]伊犁州新华医院感染科,伊宁835100 [5]石河子大学第一附属医院感染科,石河子832003

出　　处：《中华肝脏病杂志》2024年第S2期14-20,共7页Chinese Journal of Hepatology

摘　　要：目的探讨富马酸丙酚替诺福韦(TAF)治疗乙型肝炎肝硬化失代偿期患者的疗效和安全性。方法采用双向队列研究方法,纳入2021年4月—2024年4月就诊于新疆维吾尔自治区中医医院等4家医疗中心的乙型肝炎肝硬化失代偿期患者,给予TAF治疗,随访48周。主要疗效指标为48周乙型肝炎病毒(HBV)DNA阴转率,次要疗效指标为48周丙氨酸转氨酶(ALT)复常率,并收集相关安全性指标、药物不良反应(ADR)以及临床不良结局。结果共纳入74例患者,其中男性52例,年龄为(53.14±9.15)岁。25例患者完成了24周随访,33例患者完成了48周随访。经48周TAF治疗后,HBV DNA阴转率96.97%(32/33),高于基线58.1%(43/74);ALT复常率72.73%(24/33),高于基线47.30%(35/74);肾功能、血脂水平在完成48周治疗后均较基线水平差异无统计学意义(P值均>0.05)。随访期间1例患者发生肝细胞癌,未发现肝移植或死亡等其他临床不良结局。结论富马酸丙酚替诺福韦治疗乙型肝炎肝硬化失代偿期患者具有良好的疗效及安全性。Objective To explore the efficacy and safety profile of tenofovir alafenamide fumarate(TAF)in the treatment of patients with decompensated hepatitis B cirrhosis.Methods A two-way cohort study method was used to enroll patients with decompensated hepatitis B cirrhosis who visited four medical centers,including Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine,from April 2021 to April 2024 and were treated with TAF and followed up for 48 weeks.The primary efficacy indicator was hepatitis B virus(HBV)DNA seronegative conversion rate at 48-weeks,and the secondary efficacy indicator was alanine aminotransferase(ALT)return to normal rate at 48-weeks.Relevant safety indicators,adverse drug reactions(ADRs),and clinical adverse outcomes were collected.Results A total of 74 cases were included.Of these,52 were males with an average age of(53.14±9.15)years.Twenty-five and thirty-three cases completed 24 and 48 weeks of follow-up,respectively.The HBV DNA negative conversion rate was 96.97%(32/33),which was higher than the baseline of 58.1%(43/74)following 48 weeks of TAF treatment.The ALT return to normal rate was 72.73%(24/33),which was higher than the baseline of 47.30%(35/74);however,the renal function and blood lipid levels did not change significantly compared with the baseline level after completing 48 weeks of treatment(P>0.05).During the follow-up period,one case developed hepatocellular carcinoma,and no other adverse clinical outcomes,such as liver transplantation or death,were reported.Conclusion TAF has a good efficacy and safety profile in the treatment of patients with decompensated hepatitis B cirrhosis.

关 键 词：乙型肝炎 乙型肝炎病毒 肝硬化失代偿期 治疗 富马酸丙酚替诺福韦 

分 类 号：R575.2[医药卫生—消化系统]