核苷(酸)类似物序贯联合聚乙二醇干扰素α治疗血清HBsAg低水平的慢性乙型肝炎患者疗效分析*

doi:10.3969/j.issn.1672-5069.2021.05.018

摘要/Abstract

摘要： 目的探讨核苷(酸)类似物(NAs)序贯联合聚乙二醇干扰素α(Peg-IFN-α)治疗血清HBsAg低水平的慢性乙型肝炎(CHB)患者的疗效和安全性。方法 2015年11月～2018年10月我院NAs经治的HBsAg ≤ 1500 IU/mL的CHB患者106例,其中42例在继续NAs治疗的基础上联合Peg-IFNα-2a/2b治疗48 w(序贯联合),停用Peg-IFN-α后再随访48 w;另64例继续口服原NAs治疗(NAs治疗组),定期随访观察96 w。结果序贯联合组中有2例患者失访,NAs组中有4例患者失访。意向性分析(ITT分析)显示两组基线资料具有可比性;在治疗48 w结束时,序贯联合组血清HBsAg转阴率和血清学转换率分别为19.0%和14.3%,均显著高于对照组的0.0%和0.0%(P均<0.001);在随访48 w结束时,序贯联合组血清HBsAg转阴率和血清学转换率分别为21.4%和19.0%,均显著高于NAs组的1.6% 和1.6%(P均<0.001);序贯联合组肝脏硬度检测(LSM)值为(7.2±0.3) kPa,显著低于NAs治疗组【(12.5±0.4)kPa,P <0.001】。结论 NAs序贯联合Peg-IFN-α治疗血清HBsAg低水平的CHB患者可以显著提高血清HBsAg转阴率及其血清学转换率,改善肝纤维化程度,可使一部分患者获得临床治愈。

关键词: 慢性乙型肝炎, 聚乙二醇干扰素α, 核苷(酸)类似物, 序贯联合治疗, HBsAg清除

Abstract: Objective The aim of this study was to analyze the efficacy and safety of sequential combination of nucleos(t)ide analogs (NAs) with peginterferon alpha (Peg-IFN-α) in the treatment of patients with chronic hepatitis B (CHB) with low serum HBsAg levels. Methods A total of 106 CHB patients with serum HBsAg levels less than 1500 IU/mL after NAs treatment were enrolled in our hospital between November 2015 and October 2018. 42 patients were given sequential combination therapy of NAs and Peg-IFNα-2a/2b for 48 weeks, and 64 patients were continuously treated with NAs who had always taken. All patients were followed-up to week 96 (48 weeks after discontinuation of Peg-IFN-α). Results Two patients in the sequential combination group and 4 patients in the NAs group were lost; the intention- to-treat (ITT) analysis showed that the baseline materials in the two groups were comparable; serum HBsAg clearance rate and anti-HBs seroconversion rate in the sequential combination group were 19.0% and 14.3% at the end of 48-week treatment, both significantly higher than 0.0% and 0.0%, respectively, in the NAs group (P <0.001); the rates of serum HBsAg clearance and anti-HBs seroconversion at the end of 48-week follow-up in the sequential combination group were 21.4% and 19.0%, both significantly higher than 1.6% and 1.6%,respectively (P <0.001)in the NAs group; the liver stiffness measurement (LSM) was (7.2±0.3) kPa, significantly lower than in the NAs group, Conclusion The sequential combination of NAs and Peg-IFN-α treatment ameliorate serum HBsAg clearance and seroconversion, which might improve liver fibrosis in CHB patients with low levels of HBsAg, and gain clinical recovery.

Key words: Hepatitis B, Peginterferon alpha, Nucleos(t)ide analogs, Sequential combination, Serum HBsAg clearance

吴凤萍, 鲁瑞, 刘怡欣, 王怡恺, 田燕, 张欣, 贾晓黎, 党双锁. 核苷(酸)类似物序贯联合聚乙二醇干扰素α治疗血清HBsAg低水平的慢性乙型肝炎患者疗效分析^*[J]. 实用肝脏病杂志, 2021, 24(5): 677-680.

Wu Fengping, Lu Rui, Liu Yixin, et al. Serum HBsAg clearance in sequential combination of peginterferon alpha-treated patients with chronic hepatitis B with low serum HBsAg levels after nucleos(t)ide analogs treatment[J]. Journal of Practical Hepatology, 2021, 24(5): 677-680.

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核苷(酸)类似物序贯联合聚乙二醇干扰素α治疗血清HBsAg低水平的慢性乙型肝炎患者疗效分析^*

Serum HBsAg clearance in sequential combination of peginterferon alpha-treated patients with chronic hepatitis B with low serum HBsAg levels after nucleos(t)ide analogs treatment

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