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长期口服恩替卡韦治疗的慢性乙型肝炎患者换用α干扰素治疗临床疗效随访研究

Clinical efficacy and safety of switching from entecavir to interferon-α in patients with hepatitis B

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【作者】 王芳芳张国范郭春霞杨振浩潘延凤余祖江

【Author】 Wang Fangfang;Zhang Guofan;Guo Chunxia;Department of Infectious Diseases,First Affiliated Hospital,Nanyang Medical College;

【通讯作者】 张国范;

【机构】 南阳医学高等专科学校第一附属医院感染性疾病科郑州大学第一附属医院感染病科

【摘要】 目的对长期口服恩替卡韦治疗的慢性乙型肝炎(CHB)患者换用干扰素治疗,为临床上针对长期口服核苷(酸)类似物的CHB患者提供一种可行的安全停药方案。方法长期口服恩替卡韦治疗的CHB患者120例,接受恩替卡韦治疗时间为7~11(8.4±2.6)年。60例观察组患者采取口服恩替卡韦与注射重组人干扰素α2b联合治疗12 w,然后单独应用干扰素α2b至48 w,而60例对照组则继续口服恩替卡韦至48 w。两组均随访观察24 w。结果在停药随访24 w时,观察组病毒学复发率为11.7%,生化学复发率为8.3%,黄疸发生率为1.7%,均显著低于对照组的65.0%、43.3%和13.3%(P<0.05);观察组血清HBs Ag和HBe Ag转阴率分别为18.3%和21.7%,而对照组无血清HBs Ag和HBe Ag阴转病例(0.0%和0.0%,P<0.05);观察组血清HBV DNA复阳10例(16.7%),显著低于对照组的42例(70.0%,P<0.05);治疗前,两组血清HBs Ag水平无显著性差异(P>0.05),而在治疗24 w、48 w和停药24 w时,观察组血清HBs Ag水平分别为(1944.7±268.6)IU/ml、(530.7±261.3)IU/ml和(512.4±176.7)IU/ml,均显著低于对照组【(3080.4±255.1)IU/ml、(3087.1±264.1)IU/ml和(3148.5±212.3)IU/ml,P<0.01】。结论针对长期口服恩替卡韦治疗有停药要求的CHB患者,在给予人干扰素α2b巩固治疗后,可在严密观察下停药,临床预后比较好。

【Abstract】 Objective To evaluate the clinical efficacy and safety of switching from entecavir to interferon-αin patients with chronic hepatitis B(CHB).Methods A total of 120 patients with CHB long-term treated by oral entecavir were recruited in this study who had wished to discontinue the regimen.Out of them,60 received recombinant interferon alpha 2 b for 48 weeks with 12 week oral entecavir combination,and another 60 continued oral entevavir for 48 weeks.All the patients were followed-up for 24 weeks.Results At the end of 24 w followed-up,the viral rebound rate in interferon alpha 2 b-treated patients was 11.7%,serum ALT rebound rate was 8.3%,and elevated serum bilirubin level was 1.7%,significantly lower than 65.0%,43.3% and 13.3%(P <0.05) in entevavir-treated patients;serum HBs Ag and HBe Ag negative rates were 18.3% and 21.7%,while there was no serum HBs Ag and HBe Ag negative occurred(0.0% and 0.0%,P<0.05) in entevavir-treated patients;serum HBV DNA re-positive in 10 cases(16.7%),much lower than in 42 cases(70.0%,P<0.05) in entevavir-treated patients;at the time of recruitment,there was no significantly difference as respect to serum HBs Ag levels in the two groups(P>0.05),while at 24 w,48 w treatment and at the end of 24 w followed-up,serum HBs Ag levels in interferon-α2 b-treated group were(1944.7 ±268.6) IU/ml,(530.7 ±261.3) IU/ml and(512.4 ±176.7) IU/ml,much lower than 【(3080.4±255.1) IU/ml,(3087.1±264.1) IU/ml and(3148.5±212.3)IU/ml,P<0.01】 in entevavir-treated patients.Conclusions It might be feasible to safely stop nucleos(t)ide analogues treatment in CHB patients who have received long-term antiviral treatment and respond viralogically and biochemically properly,and serum HBs Ag levels might be a good parameter for determination of continuing or stopping the regimen.

  • 【文献出处】 实用肝脏病杂志 ,Journal of Practical Hepatology , 编辑部邮箱 ,2018年05期
  • 【分类号】R512.62
  • 【被引频次】11
  • 【下载频次】93
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