实用肝脏病杂志 ›› 2023, Vol. 26 ›› Issue (3): 336-339.doi: 10.3969/j.issn.1672-5069.2023.03.009

• 病毒性肝炎 • 上一篇    下一篇

艾米替诺福韦治疗慢性乙型肝炎患者早期疗效研究*

张丹蕾, 徐静   

  1. 233030 安徽省蚌埠市 蚌埠医学院研究生院(张丹蕾,徐静);中国科学技术大学附属安徽省立医院感染病科(徐静)
  • 收稿日期:2022-11-04 出版日期:2023-05-10 发布日期:2023-05-08
  • 通讯作者: 徐静,E-mail:xj3979@163.com
  • 作者简介:张丹蕾,女,27岁,硕士研究生。E-mail:zdl2719@163.com
  • 基金资助:
    *安徽省公益性研究联动计划项目(编号:15011d04029)

Early antiviral efficacy of tenofovir amibufenamide in treatment of naïve patients with chronic hepatitis B

Zhang Danlei, Xu Jing   

  1. Bengbu Medical College Graduate school, Bengbu 233030, Anhui Province, China
  • Received:2022-11-04 Online:2023-05-10 Published:2023-05-08

摘要: 目的 评价艾米替诺福韦(TMF)治疗慢性乙型肝炎(CHB)患者的早期疗效。方法 2020年1月~2022年3月中国科学技术大学附属安徽省立医院收治的初始抗病毒治疗的CHB患者90例,被分为观察组(n=50)和对照组(n=40),分别给予TMF和富马酸替诺福韦二吡呋酯(TDF)治疗48周。采用PCR法检测血清HBV DNA定量,采用ELISA法检测血清HBsAg和HBeAg水平。结果 在治疗12周、24周、36周和48周时,观察组血清ALT水平分别为38.0(25.0,55.0)U/L、31.5(23.8,35.0)U/L、29.5(22.8,35.0) U/L和26.0(21.8,34.0)U/ L,与对照组的38.5(25.0,60.0)U/L、30.0(22.0,44.0)U/L、31.0(22.8,44.5)U/L和28.0(19.8,42.0)U/L比,差异均无统计学意义(P>0. 05),观察组血清HBV DNA载量分别为0(0,3)lgIU/ml、0(0,0.5)lgIU/ml、0(0,0)lgIU/ml和0(0,0)lgIU/ml,与对照组的2(0,3)lgIU/ml、0(0,2)lgIU/ml、0(0,1.5)lgIU/ml和0(0,0)lgIU/ml比,差异无统计学意义(P >0.05);观察组血清HBV DNA阴转率分别为58%、76%、78%和88%,与对照组的45%、65%、75%和85%比,差异均无统计学意义(P >0.05);在治疗12周、24周和36周时,观察组血清ALT复常率分别为56%、80%和92%,与对照组的55%、70%和65%比,差异均无统计学意义(P>0.05)。在治疗48周时,观察组ALT复常率为100.0%,显著高于对照组的72.5%(P<0.01);在治疗过程中,两组均未发生明显的不良反应。结论 对于初治治疗的CHB患者,应用TMF抗病毒治疗的疗效与TDF类似,但用量小,其长期疗效和对肾功能等的影响仍需要观察。

关键词: 慢性乙型肝炎, 艾米替诺福韦, 治疗

Abstract: Objective The aim of this study was to investigate the early efficacy of tenofovir amibufenamide (TMF) in the treatment of naïve patients with chronic hepatitis B (CHB). Methods A total of 90 naïve patients with CHB were recruited in the First Affiliated Hospital, China University of Science and Technology between January 2020 and March 2022, and were divided into observation (n=50) and control group (n=40), receiving TMF or tenofovir disoproxil fumarate (TDF) treatment for 48 weeks. Serum alanine transaminase (ALT), HBV DNA loads, HBeAg and HBsAg levels were detected routinely. Results At 12, 24, 36 and 48 weeks of treatment, serum ALT levels in the observation group were 38.0(25.0,55.0)U/L, 31.5(23.8,35.0)U/L, 29.5(22.8,35.0) U/L and 26.0(21.8,34.0)U/L, all not significantly different compared to 38.5(25.0,60.0)U/L, 30.0(22.0,44.0)U/L, 31.0(22.8,44.5)U/L and 28.0(19.8,42.0)U/L (P>0. 05), serum HBV DNA loads were 0(0, 3)lgIU/ml, 0(0, 0.5)lgIU/ml, 0(0, 0)lgIU/ml and 0(0, 0)lgIU/ml, not significantly different compared to 2(0, 3)lgIU/ml, 0(0, 2)lgIU/ml, 0(0, 1.5)lgIU/ml and 0(0,0)lgIU/ml (P >0.05) in the control; serum HBV DNA loss were 58%, 76%, 78% and 88%, not significantly different compared to 45%, 65%, 75% and 85%(P >0.05) in the control; at 12, 24 and 36 week treatment, serum ALT normalization rates in the observation group were 56%, 80% and 92%, all not significantly different compared to 55%, 70% and 65%(P >0.05) , while at the end of treatment 48 week, serum ALT normalization rate in the observation group was 100.0%, much higher than 72.5%(P<0.01) in the control; during the period of antiviral regimen, there was no obvious untoward effects in the two groups. Conclusion The antiviral performance of TMF in the treatment of naïve patients with CHB is as efficacious as of TDF, while the long-term efficacy and its impact on renal functions needs further clinical investigation.

Key words: Hepatitis B, Tenofovir amibufenamide, Therapy