聚乙二醇干扰素α-2b治疗获得临床治愈的慢性乙型肝炎病毒感染者预后因素分析  

Prognostic factors analysis for chronic HBV-infected patients who achieved clinical cure with pegylated interferon-α-2b therapy

作　　者：常李军 李怡君 骆利敏 张野 CHANG Lijun;LI Yijun;LUO Limin;ZHANG Ye(Department of Infectious Diseases,Yuncheng Central Hospital affiliated to Shanxi Medical University,Yuncheng,Shanxi 044000,China;Education Department of Surgery,The First Affilated Hospital of Air Force Medical University(Xijng Hospital,Fourth Military Medical University),Xi'an,Shaanxi 710032,China;Department of Infectious Diseases,Air Force Hospital of Southern Theatre Command,Guangzhou,Guangdong 510602,China;Department of Infectious Diseases,The Second Affiliated Hospital of Air Force Medical University(Tangdu Hospital,Fourth Military Medical University),Xi'an,Shaanxi 710038,China)

机构地区：[1]山西医科大学附属运城市中心医院感染性疾病科,山西运城044000 [2]空军军医大学第一附属医院(第四军医大学西京医院)外科学教研室,陕西西安710032 [3]南部战区空军医院感染病科,广东广州510602 [4]空军军医大学第二附属医院(第四军医大学唐都医院)传染病科,陕西西安710038

出　　处：《中国热带医学》2025年第3期297-303,共7页China Tropical Medicine

基　　金：运城市大健康与生物领域科技计划项目(No.YCKJYD-202413)。

摘　　要：目的 分析基于聚乙二醇干扰素α-2b(pegylated interferon-α-2b, PEG-IFN-α-2b)的治疗方案获得临床治愈的慢性乙型肝炎病毒(hepatitis B virus, HBV)感染者的临床特征和相关转归因素。方法 本研究为回顾性研究,纳入2020年8月—2023年11月山西医科大学附属运城市中心医院接受PEG-IFN-α-2b治疗的慢性HBV感染者,初治患者单用PEG-IFN-α-2b治疗,核苷(酸)类似物[nucleoside(acid)analogs, NAs]经治患者在原治疗基础上加用使用PEG-IFN-α-2b治疗,研究终点为乙型肝炎表面抗原(hepatitis B surface antigen, HBsAg)转阴伴HBV DNA低于检测下限(疗程<48周)或疗程达到48周。收集基线和研究终点患者一般资料、病毒学指标、血常规、肝功能,采用独立样本t检验或Mann-Whitney U检验进行组间比较,采用单因素和多因素logistic逐步回归模型分析影响临床治愈的因素。结果 纳入61例慢性HBV感染者,男性39例,女性22例,年龄(39.13±7.53)岁,初治21例,NAs经治40例,基线HBV DNA阳性19例,基线HBsAg为211.30(50.93, 2 110.00)IU/mL。研究终点时,34例患者实现临床治愈,PEG-IFN-α-2b中位疗程为25.50周,27例患者未实现临床治愈,疗程均为48周。临床治愈组基线HBsAg水平低于非临床治愈组[78.66(19.54,204.60)IU/mL比2 078.00(442.20, 4 237.00)IU/mL,P<0.001]。研究终点时,白细胞、中性粒细胞、血小板、红细胞、血红蛋白水平均低于基线(P<0.05),丙氨酸氨基转移酶和天冬氨酸氨基转移酶水平均高于基线(P<0.05),但无论基线还是研究终点,2组在血常规、肝功能检查的差异均无统计学意义(P>0.05)。基线HBsAg水平是PEG-IFN-α-2b治疗的实现临床治愈的预后因素(OR=0.998;95%CI:0.998~0.999)。治疗过程中患者未发生严重不良事件。结论 基于PEGIFN-α-2b治疗方案安全性良好,在基线HBsAg低水平的慢性HBV感染者中可获得较高的临床治愈率。Objective To analyze the clinical characteristics and prognostic factors for clinical cure in chronic hepatitis B virus(HBV)infected patients with pegylated interferon-α-2b(PEG-IFN-α-2b)based therapy.Methods This is a retrospective study.Chronic HBV infected patients receiving PEG-IFN-α-2b therapy were enrolled in Yuncheng Central Hospital affiliated to Shanxi Medical University between August 2020 and November 2023.Treatment-naïve patients received PEG-IFN-α-2b monotherapy,while nucleoside(acid)analogs(NAs)-experienced patients received PEG-IFN-α-2b add-on therapy.The study endpoint was hepatitis B surface antigen(HBsAg)negative in accompany with HBV DNA below the detection limit (course of treatment < 48 weeks) or treatment for 48 weeks. The general characteristics, virological variables,blood routine test, and liver function of patients were collected at baseline and study endpoint. Student’s t test or MannWhitneyU test was used for comparison. The prognostic factors of clinical cure were examined using univariate andmultivariate stepwise logistic regression models. Results A total of 61 chronic HBV infected patients were enrolled,including 39 males and 22 females. The age were (39.13±7.53) years. Twenty-one cases were treatment-naïve, while 40patients were NAs-experienced. Nineteen cases were positive for HBV DNA at baseline. The baseline HBsAg levels were211.30(50.93, 2 110.00) IU/mL. Thirty-four patients achieved clinical cure at the study endpoint with 25.50 weeks of mediancourse of PEG-IFN-α-2b treatment. Twenty-seven patients did not achieve clinical cure at the study endpoint, and the courseof treatment was 48 weeks. Clinical cure group had significant lower baseline HBsAg level when compared with non-clinicalcure group [78.66(19.54, 204.60) IU/mL vs 2 078.00(442.20, 4 237.00) IU/mL, P<0.001]. At the study endpoint, the whiteblood cell, platelet, red blood cell, hemoglobin levels were lower than those in baseline (P<0.05), while alanineaminotransferase and asparatate aminotransferase levels w

关 键 词：乙型肝炎病毒 慢性感染 聚乙二醇干扰素 临床治愈 转归 

分 类 号：R575[医药卫生—消化系统]