恩替卡韦与胸腺素α-1联合治疗HBV相关的代偿性肝硬化：一项

StephenW

Expert Opin Biol Ther. 2018 Jul;18(sup1):61-69. doi: 10.1080/14712598.2018.1451511.
Combination of entecavir with thymosin alpha-1 in HBV-related compensated cirrhosis: a prospective multicenter randomized open-label study.
Wu X1, Shi Y1, Zhou J1, Sun Y1, Piao H2, Jiang W3, Ma A4, Chen Y5, Xu M6, Xie W7, Cheng J8, Xie S9, Shang J10, Cheng J11, Xie Q12, Ding H13, Zhang X14, Bai L15, Zhang M16, Wang B1, Chen S1, Ma H1, Ou X1, Jia J1, You H1.
Author information

1
    a Liver Research Center, Beijing Friendship Hospital , Capital Medical University, Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis, National Clinical Research Center of Digestive Diseases , Beijing , China.
2
    b Infectious Department , Affiliated Hospital of Yanbian University , Yanji , China.
3
    c Department of Gastroenterology , Zhongshan Hospital, Fudan University , Shanghai , China.
4
    d Department of Infectious Diseases , China-Japan Friendship Hospital , Beijing , China.
5
    e Department of Infectious Diseases , Nanfang Hospital, Southern Medical University , Guangzhou , China.
6
    f Department of Gastroenterology and Hepatology , Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine , Shanghai , China.
7
    g Center of Liver Diseases , Beijing Ditan Hospital, Capital Medical University , Beijing , China.
8
    h Institute of Infectious Diseases , Beijing Ditan Hospital, Capital Medical University , Beijing , China.
9
    i Department of Infectious Diseases , Third Affiliated Hospital, Zhongshan University , Guangzhou , China.
10
    j Department of Infectious Diseases , Zhengzhou University People's Hospital , Zhengzhou , China.
11
    k Department of Gastroenterology , Shanghai Public Health Clinical Center , Shanghai , China.
12
    l Department of Infectious Diseases , Ruijin Hospital , Shanghai , China.
13
    m Department of Gastroenterology and Hepatology , Beijing Youan Hospital, Capital Medical University , Beijing , China.
14
    n Department of Infectious Disease , Southwest Hospital, Third Military Medical University , Chongqing , China.
15
    o Department of Infectious Disease , West China Hospital, Sichuan University , Chengdu , China.
16
    p Department of Hepatology , The Sixth People's Hospital of Shenyang , Shenyang , China.

Abstract

ABSTRACT Background: Thymosin alpha-1 (Ta-1) suppresses HBV viral replication, while the evidence of combination effect with nucleoide is still limited. We aimed to investigate the efficacy and safety of combination therapy of Ta-1 with entecavir (ETV) in patients with compensated liver cirrhosis.
RESEARCH DESIGN AND METHODS:

A total of 690 patients were randomized to receive Ta-1 plus ETV (n = 351) or ETV monotherapy (n = 339) for 52 weeks after 26 weeks of ETV treatment, followed by continued entecavir therapy. The primary endpoint was defined as liver decompensation, hepatocellular carcinoma (HCC) or death.
RESULTS:

The median followed up was 38.2 months. The cumulative incidence of liver decompensation, HCC, or death were similar between two groups. During the Ta-1 combination treatment, the HCC incidence was 1.7% in combination group and 2.1% in ETV group, without new HCC cases developed during week 39 to week 77 in combination group. The virologic response, serologic response, biochemical response was similar between two groups at week 104. Both therapies were well-tolerated.
CONCLUSION:

There was no significant difference between two groups in endpoint events, while combination therapy with Ta-1 has a tendency to inhibit the development of HCC.
KEYWORDS:

Hepatitis B virus; hepatocellular carcinoma; immune regulator; liver cirrhosis; thymosin alpha-1/Ta-1

PMID:
    30063860
DOI:
    10.1080/14712598.2018.1451511

StephenW

专家Opin Biol Ther。 2018年7月; 18（sup1）：61-69。 doi：10.1080 / 14712598.2018.1451511。
恩替卡韦与胸腺素α-1联合治疗HBV相关的代偿性肝硬化：一项前瞻性多中心随机开放性研究。
Wu X1，Shi Y1，Zhou J1，Sun Y1，Piao H2，Jiang W3，Ma A4，Chen Y5，Xu M6，Xie W7，Cheng J8，Xie S9，Shang J10，Cheng J11，Xie Q12，Ding H13，Zhang X14 ，白L15，张M16，王B1，陈S1，马H1，欧X1，贾J1，你H1。
作者信息

1
    首都医科大学附属北京友谊医院肝脏研究中心，北京市肝硬化转化医学重点实验室，国家消化病临床研究中心，北京，中国。
2
    b延边大学附属医院感染科，延吉，中国。
3
    c复旦大学附属中山医院消化内科，上海
4
    d中国 - 日本友好医院感染科，北京，中国。
五
    e南方医科大学南方医院传染病科，广州
6
    f上海交通大学医学院附属上海总医院消化内科，上海。
7
    g首都医科大学附属北京地坛医院肝病中心，北京
8
    h首都医科大学附属北京地坛医院传染病研究所，北京
9
    i中山大学附属第三医院感染科，广州
10
    j郑州大学人民医院感染科，郑州
11
    k上海市公共卫生临床中心消化内科，上海
12
    l上海瑞金医院感染科
13
    m首都医科大学附属北京佑安医院消化内科，肝病科，北京
14
    n第三军医大学西南医院感染病科，重庆
15
    o四川大学华西医院传染病科，中国成都。
16
    p沉阳市第六人民医院肝病科，沉阳

抽象

摘要背景：胸腺素α-1（Ta-1）抑制HBV病毒复制，而与核苷组合效应的证据仍然有限。我们的目的是研究Ta-1联合恩替卡韦（ETV）治疗代偿性肝硬化患者的疗效和安全性。
研究设计和方法：

共有690名患者在ETV治疗26周后随机接受Ta-1加ETV（n = 351）或ETV单一疗法（n = 339）52周，然后继续接受恩替卡韦治疗。主要终点定义为肝功能失代偿，肝细胞癌（HCC）或死亡。
结果：

中位随访时间为38.2个月。两组的肝功能失代偿，HCC或死亡的累积发生率相似。在Ta-1联合治疗期间，联合组HCC发生率为1.7％，ETV组为2.1％，联合组39周至第77周未发生新的HCC病例。在第104周，两组之间的病毒学应答，血清学应答，生化反应相似。两种疗法都具有良好的耐受性。
结论：

两组间终点事件无显着差异，而Ta-1联合治疗有抑制HCC发展的趋势。
关键词：

乙型肝炎病毒;肝细胞癌;免疫调节剂;肝硬化;胸腺素α-1 / Ta-1

结论：
    30063860
DOI：
    10.1080 / 14712598.2018.1451511