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[Clinical effect and safety of pegylated interferon-α-2b injection (Y shape, 40 kD) in treatment of HBeAg-positive chronic hepatitis B patients].

Authors
  • Hou, F Q1
  • Yin, Y L2
  • Zeng, L Y2
  • Shang, J3
  • Gong, G Z4
  • Pan, C5
  • Zhang, M X6
  • Yin, C B7
  • Xie, Q8
  • Peng, Y Z9
  • Chen, S J10
  • Mao, Q11
  • Chen, Y P12
  • Mao, Q G13
  • Zhang, D Z14
  • Han, T15
  • Wang, M R16
  • Zhao, W17
  • Liu, J J18
  • Han, Y19
  • And 25 more
  • 1 Department of Infectious Diseases, Center for Liver Diseases, Peking University First Hospital, Beijing 100034, China. , (China)
  • 2 Xiamen Amoytop Biotech Co., Ltd, Xiamen 361028, China. , (China)
  • 3 Henan Provincial People's Hospital, Zhengzhou 450003, China. , (China)
  • 4 The Second Xiangya Hospital of Central South University, Changsha 410011, China. , (China)
  • 5 Fuzhou Infectious Disease Hospital, Fuzhou 350025, China. , (China)
  • 6 The Sixth People's Hospital of Shenyang, Shenyang 110006, China. , (China)
  • 7 Guangzhou Eighth People's Hospital, Guangzhou 510060, China. , (China)
  • 8 Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China. , (China)
  • 9 Peking University Shenzhen Hospital, Shenzhen 518036, China. , (China)
  • 10 Jinan Infectious Disease Hospital, Jinan 250021, China. , (China)
  • 11 Southeast Hospital, Third Military Medical University, Chongqing 400038, China. , (China)
  • 12 The First Affiliated Hospital of Wenzhou Medical University, Wenzhou 325000, China. , (China)
  • 13 Xiamen Hospital of T.C.M, Xiamen 361001, China. , (China)
  • 14 The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China. , (China)
  • 15 Tianjin Third Central Hospital, Tianjin 300170, China. , (China)
  • 16 81th Hospital of People's Liberation Army, Nanjing 210002, China. , (China)
  • 17 The Second Affiliated Hospital of the Southeast University, Nanjing 210003, China. , (China)
  • 18 The First Affiliated Hospital of Xiamen University, Xiamen 361003, China. , (China)
  • 19 Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China. , (China)
  • 20 The First Affiliated Hospital of Shanxi University, Taiyuan 030001, China. , (China)
  • 21 The First Affiliated Hospital of Guangxi Medical Universtiy, Nanning 530021, China. , (China)
  • 22 Huashan Hospital, Shanghai 200040, China. , (China)
  • 23 Nangfang Hospital, Southern Medical University, Guangzhou 510510, China. , (China)
  • 24 Xiangya Hospital Central South University, Changsha 410008, China. , (China)
  • 25 Shengjing Hospital of China Medical University, Shenyang 110022, China. , (China)
  • 26 West China Hospital, Sichuan University, Chengdu 610041, China. , (China)
  • 27 Peking University People's Hospital, Beijing 100044, China. , (China)
  • 28 The First Affiliated Hospital of Xinjiang Medical University, Urumqi 830054, China. , (China)
  • 29 Jiangsu Provincial People's Hospital, Nanjing 210029, China. , (China)
  • 30 The First Affiliated Hospital of Nanchang University, Nanchang 360102, China. , (China)
  • 31 Shanghai Public Health Clinical Center, Shanghai 201508, China. , (China)
  • 32 Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China. , (China)
  • 33 85th Hospital of People's Liberation Army, Shanghai 200052, China. , (China)
  • 34 The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang 050051, China. , (China)
  • 35 302 Military Hospital of China, Beijing 100039, China. , (China)
  • 36 The First Bethune Hospital of Jilin University, Chanchun 130062, China. , (China)
  • 37 Beijing Youan Hospital, Captial Medical University, Beijing 100069, China. , (China)
  • 38 The First Hospital of Lanzhou University, Lanzhou 730000, China. , (China)
  • 39 Tangdu Hospital, Fourth Military Medical University, Xi'an 710038, China. , (China)
  • 40 The 2nd Affiliated Hospital of Harbin Medical University, Harbin 150001, China. , (China)
  • 41 The First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China. , (China)
  • 42 Beijing Ditan Hospital Capital Medical University, Beijing 100015, China. , (China)
Type
Published Article
Journal
Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology
Publication Date
Aug 20, 2017
Volume
25
Issue
8
Pages
589–596
Identifiers
DOI: 10.3760/cma.j.issn.1007-3418.2017.08.007
PMID: 29056008
Source
Medline
Keywords
License
Unknown

Abstract

目的: 以标准剂量聚乙二醇干扰素α-2a(Peg-IFN α-2a)作为阳性药对照,评价长效干扰素Peg-IFN α-2b (Y型,40 kD)注射液(180 μg/周)治疗HBeAg阳性慢性乙型肝炎(CHB)患者的疗效和安全性。 方法: 多中心、随机开放、阳性药平行对照的III期临床试验。筛选合格的HBeAg阳性CHB患者按照2∶1随机分配到Peg-IFN α-2b(Y型,40 kD)组(试验组)和Peg-IFN α-2a组(对照组),治疗48周,停药随访24周。在筛选、基线、12周、24周、48周,60周和72周时保留受试者血浆用于中心化检测,用COBAS(®) Ampliprep/COBAS(®) TaqMan(®) HBV Test,Version 2.0荧光定量PCR检测HBV DNA定量,用Elecsys试剂盒电化学发光免疫分析法检测HBV标志物(HBsAg、抗-HBs、HBeAg、抗-HBe)。详细记录不良事件。主要疗效指标为治疗48周随访24周后的HBeAg血清学转换率,并进行非劣效检验。计算两组治疗后HBeAg血清转换率差值(试验组-对照组)及其双侧95%可信区间(CI),当95% CI的下限大于-10%时,非劣效结论成立。根据不同的数据类型及特点分别采用t检验、χ(2)检验、秩和检验等。 结果: 入组HBeAg阳性CHB患者855例,实际治疗820例(试验组538例,对照组282例)。全分析集数据显示,试验组和对照组的72周HBeAg血清学转换率分别为27.32%和22.70%,率差为4.63%,95% CI:-1.54%~10.80%,P = 0.149 3。符合方案分析集数据显示,试验组与对照组的HBeAg血清学转换率分别为30.75%和27.14%,率差为3.61%,95% CI:-3.87%~11.09%,P = 0.343 6。95% CI符合非劣效标准,试验组非劣效于对照组。试验组与对照组整体不良事件、严重不良事件及常见不良事件发生率均相似。 结论: Peg-IFN α治疗HBeAg阳性CHB患者的方案中,新药Peg-IFN α-2b (Y型,40 kD)具有与对照药Peg-IFN α-2a相当的疗效和安全性。.

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