聚乙二醇干扰素α-2b治疗低HBeAg水平慢性乙型肝炎安全性及疗效预测因素  

Safety and predictive factors of efficacy of polyethylene glycol interferon in the treatment of chronic hepatitis B with low HBeAg level

作　　者：宫雪莲 王鹏雁 李卫 田昊 张艳 孙英华 陈锡莲 Gong Xuelian;Wang Pengyan;Li Wei;Tian Hao;Zhang Yan;Sun Yinghua;Chen Xilian(Pharmacy Department,Yantai Qishan Hospital,Yantai 264001,China;Science and Education Department,Yantai Qishan Hospital,Yantai 264001,China;Clinical Pharmacy Room,Yantai Qishan Hospital,Yantai 264001,China;Medical Imaging Department,Yantai Qishan Hospital,Yantai 264001,China;Clinical Lab,Yantai Qishan Hospital,Yantai 264001,China)

机构地区：[1]烟台市奇山医院药剂科,烟台264001 [2]烟台市奇山医院科教科,烟台264001 [3]烟台市奇山医院临床药学室,烟台264001 [4]烟台市奇山医院医学影像科,烟台264001 [5]烟台市奇山医院检验科,烟台264001

出　　处：《国际医药卫生导报》2024年第16期2771-2776,共6页International Medicine and Health Guidance News

基　　金：山东省医药卫生科技发展计划(202011000256);2023年烟台市药品不良反应监测哨点研究课题(2023YTADRKYYPO7)。

摘　　要：目的分析聚乙二醇干扰素α-2b(PEG-IFNα-2b)治疗低乙型肝炎e抗原(HBeAg)水平慢性乙型肝炎的安全性,并探讨预测疗效的相关因素。方法回顾性分析2020年6月至2023年6月于烟台市奇山医院首次接受PEG-IFNα-2b治疗的188例HBeAg阳性且定量<50 S/CO的慢性乙型肝炎患者临床资料,其中男137例,女51例,年龄(35.04±7.13)岁,PEG-IFNα-2b每周给药剂量(122.45±27.59)μg。正在接受核苷(酸)类似物(NAs)治疗的患者在原治疗基础上加用PEG-IFNα-2b,每周注射1次;首次接受抗病毒治疗的患者仅注射PEG-IFNα-2b,每周1次。若治疗48周前HBeAg转阴则巩固治疗12周,否则延长治疗至72~96周。根据疗效将患者分为HBeAg转阴组和HBeAg未转阴组。统计治疗过程中患者不良反应发生情况,分析其基线特征、生化指标及病毒学标志物。采用t检验、χ^(2)检验、秩和检验,应用多因素logistic回归分析影响PEG-IFNα-2b疗效的早期因素,并以受试者操作特征曲线(ROC)评估相关影响因素对疗效的预测效能。结果188例患者中,治疗12周、24周、48周、96周时分别有41例(21.81%)、58例(30.85%)、74例(39.36%)、89例(47.34%)患者实现HBeAg转阴;治疗过程中,有151例(80.32%)患者出现不良反应,经干预后119例(78.81%)患者得到好转。HbeAg转阴组和未转阴组的给药方案、入院时的乙型肝炎表面抗原(HBsAg)、HBeAg、乙型肝炎病毒脱氧核糖核酸(HBV DNA)、HBV前基因组RNA(pgRNA)、乙型肝炎核心相关抗原(HBcrAg)水平及治疗时间、治疗依从性比较,差异均有统计学意义(均P<0.05);多因素logistic回归分析显示,给药方案(OR=0.536,95%CI=0.348~0.826)、治疗依从性(OR=0.461,95%CI=0.256~0.831)、治疗时间(OR=0.546,95%CI=0.315~0.948)、HBeAg(OR=1.876,95%CI=1.537~2.289)、pgRNA(OR=2.070,95%CI=1.256~3.412)、HBcrAg(OR=1.602,95%CI=1.134~2.263)均是PEG-IFNα-2b治疗低HBeAg水平慢性乙型肝炎疗效的早期影响因素(均P<0.05);ROC分析显示,上述相关因素�Objective To analyze the safety of Polyethylene glycol interferonα-2b(PEG-IFNα-2b)in the treatment of chronic hepatitis B(CHB)with low hepatitis B e antigen(HBeAg)level,and to explore the related factors to predict the efficacy.Methods The clinical data of 188 CHB patients with HBeAg positive and quantitative<50 S/CO who received PEG-IFNα-2b treatment for the first time in Yantai Qishan Hospital from June 2020 to June 2023 were retrospectively analyzed.Among them,there were 137 males and 51 females,aged(35.04±7.13)years,and the weekly dose of PEG-IFNα-2b was(122.45±27.59)µg.The patients receiving nucleoside(acid)analogues(NAs)were given PEG-IFNα-2b once a week in addition to the original treatment;the patients receiving antiviral therapy for the first time were injected with PEG-IFNα-2b only once a week.If HBeAg turned negative before 48 weeks of treatment,the treatment was consolidated for 12 weeks,otherwise,the treatment was extended to 72 to 96 weeks.According to the efficacy of interferon,they were divided into a HBeAg negative group and a HBeAg non-negative group.The incidence of adverse reactions during the treatment was counted,and the baseline characteristics,biochemical indicators,and virological markers were analyzed.t test,χ^(2) test,and rank sum test were used.Multivariate logistic regression analysis was used to analyze the early factors affecting the efficacy of PEG-IFNα-2b,and the receiver operating characteristic curve(ROC)was used to evaluate the predictive efficacy of related influencing factors on the efficacy.Results Among the 188 patients,41 cases(21.81%),58 cases(30.85%),74 cases(39.36%),and 89 cases(47.34%)achieved HBeAg negative conversion after 12,24,48,and 96 weeks of treatment.During the treatment,151 patients(80.32%)had adverse reactions.After intervention,119 cases(78.81%)were improved.There were statistically significant differences in administration regimen,hepatitis B surface antigen(HBsAg),HBeAg,hepatitis B virus deoxyribonucleic acid(HBV DNA),HBV pregenomic RNA(pgRNA),

关 键 词：慢性乙型肝炎 聚乙二醇干扰素Α-2B 安全性 疗效 预测因素 

分 类 号：R512.62[医药卫生—内科学]