IFN-α 1b治疗核苷(酸)类似物经治未达满意终点的CHB多中心疗效分析  

Effects of interferon alpha-1b in treating chronic hepatitis B patients who have poor response to nucleot(s)ide analogues

作　　者：金瑞[1] 郭新会[1] 徐志强[2] 焦成松[3] 胡国信[4] 

机构地区：[1]首都医科大学附属北京佑安医院,北京100069 [2]解放军第302医院,北京100039 [3]华中科技大学同济医学院附属同济医院,武汉430030 [4]北京大学深圳医院,广东深圳518035

出　　处：《中国肝脏病杂志（电子版）》2014年第4期63-67,共5页Chinese Journal of Liver Diseases：Electronic Version

摘　　要：目的评估序贯联合重组人干扰素α1b（IFN-α1b）治疗核苷（酸）类似物（NAs）经治HBe Ag阳性CHB患者48周的疗效与安全性。方法 159例NAs治疗12-36个月HBV DNA检测不到但未发生血清学应答的HBe Ag阳性CHB患者,77例接受序贯联合IFN-α1b治疗48周,82例继续NAs单药治疗48周。基线和治疗期间每12周进行生物化学、病毒学和血清学评估。计量资料采用t检验,计数资料采用χ^2检验。结果治疗48周,试验组HBe Ag低于检测下限和转换率分别为21.74%和20.29%,对照组HBe Ag低于检测下限和转换率分别为5.63%和5.63%,差异有统计学意义（χ^2=7.738、6.709,P〈0.05）。试验组和对照组HBs Ag清除率分别为7.25%和0%,差异有统计学意义（χ^2=5.335,P〈0.05）。试验组和对照组病毒学反弹率分别为0%和4.22%,差异无统计学意义（χ^2=2.979,P〉0.05）。无论是试验组还是对照组,HBs Ag基线水平高的患者（〉2000 IU/ml）的HBe Ag血清学转换率高于基线水平低（≤2000 IU/ml）的患者;差异无统计学意义（χ^2=2.833、0.147,P〉0.05）。HBs Ag下降幅度与HBe Ag下降幅度具有相关性（r=0.606）。NAs基础治疗时间可能对序贯联合干扰素后的HBe Ag低于检测下限和转换有一定影响,但无论基础治疗时间长短,序贯联合干扰素均可增加HBe Ag应答率。结论序贯联合IFN-α1b有助于提高NAs经治未达满意治疗终点的HBe Ag阳性CHB患者的血清学应答率。Objective To investigate the effi cacy and safety of an extended course（48-week） of sequential interferon alpha-1b therapy for patients with HBe Ag positive chronic hepatitis B（CHB） who have poor response to nucleot（s）ide analogue. Methods There were 159 HBe Ag positive CHB patients who had completed a 12-24 months of nucleot（s）ide analogues（NAs） monotherapy course, and who had achieved a virological response（HBV DNA 500 copies/ml） but without HBe Ag seroconversion were enrolled. The patients were randomly assigned to receive IFN-α 1b plus NAs（experimental group, n = 77） or continue NAs monotherapy（control group, n = 82）. Levels of biochemical, virological and serological were measured at baseline and at 12-week intervals throughout the treatment course. Inter-group differences were statistically evaluated by t-test or Chi-squared test. Results At treatment week 48, the experimental group showed signifi cantly higher rate of HBe Ag clearance（21.74% vs 7.04%, χ^ 2= 7.738, P〈 0.05） and seroconversion（20.29% vs 7.04%, χ^2 = 6.709, P〈 0.05）. The experimental group also showed higher rate of HBs Ag seroconversion（7.25% vs 0, χ^ 2= 5.335, P〈 0.05）. The rates of HBV DNA relapse were 0 and 4.22%, but the difference did not reach statistical signifi cance（χ^2 = 2.979, P〈 0.05）. The patients who had higher baseline HBs Ag（2000 IU/ml） showed lower HBe Ag seroconversion than the patients who had lower HBs Ag（≤ 2000 IU/ml）, but the differences did not reach statistical signifi cance（χ^2 = 2.833 and 0.147, both P〈 0.05）. Sequential plus IFN-α 1b could add the rated of HBe Ag seroconversion at any time, while it may had relationship between the course of NAs and the rate of HBe Ag seroconversion. Conclusions For patients with HBe Ag-positive CHB who had unsatisfactory response to NAs monotherapy, plus IFN-α 1b has higher rate of seroconversion.

关 键 词：肝炎 乙型 慢性 干扰素Α 1b 核苷酸类似物 

分 类 号：R512.62[医药卫生—内科学]