乙型肝炎肝移植受者肝移植受者乙型肝炎免疫球蛋白的疗效

StephenW

Ann Transplant. 2017 Dec 12;22:740-748.
A Multicenter Phase III Study to Evaluate the Efficacy and Safety of Hepabulin, a New Hepatitis B Immunoglobulin, in Liver Transplantation Recipients with Hepatitis B.Choi HJ1, Kim DG1, Kim SI2, Wang HJ3, Joh JW4, Suh KS5, Kim SH6.
Author information
1Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.2Department of Transplantation Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.3Department of Surgery, Ajou University School of Medicine, Suwon, South Korea.4Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.5Department of Surgery, College of Medicine, Seoul National University, Seoul, South Korea.6Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang, South Korea.

AbstractBACKGROUND This study was performed to evaluate the effects and stability of the new hepatitis B immunoglobulin (HBIG), Hepabulin, in patients undergoing liver transplantation for hepatitis B. MATERIAL AND METHODS A total of 87 patients undergoing liver transplantation for hepatitis B-related liver disease were enrolled in this multicenter, phase III, open-label, single-arm study. Seventy (80.5%) of the 87 enrolled patients completed the study during the 52-week study period. Hepabulin (10,000 units) was intravenously injected intraoperatively, daily for 1 week, weekly for 1 month, and then once per month. Hepabulin was used as monotherapy without antiviral agents. Hepatitis B recurrence was defined as conversion from negativity for surface antigen after HBIG administration to positivity. RESULTS There were no cases of hepatitis B recurrence during the 52-week observation period. A total of 876 adverse events (AEs) that occurred during the study period were observed in 83 (95.4%) of 87 patients, and serious AEs were seen in 119 cases in 44 (50.6%) of the 87 patients. None of the AEs showed a relationship with this drug. Hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) rapidly disappeared within 1 week after HBIG administration, but hepatitis B virus (HBV) DNA persisted for up to 8 weeks after surgery, which was related to HBV viral load. Hepatitis B surface antibody (HBsAb) was correlated with HBIG (Hepabulin) dose. CONCLUSIONS The new HBIG, Hepabulin, was shown to be safe and effective in preventing the recurrence of HBV after liver transplantation.


PMID:29229898

StephenW

Ann移植。 2017年12月12日; 22：740-748。
乙型肝炎肝移植受者肝移植受者乙型肝炎免疫球蛋白的疗效和安全性的多中心III期研究
Choi HJ1，Kim DG1，Kim SI2，Wang HJ3，Joh JW4，Suh KS5，Kim SH6。
作者信息

1
    首尔圣玛丽医院，医学院，韩国天主教大学，韩国汉城。
2
    韩国首尔延世大学医学院Severance医院移植外科。
3
    韩国水原市亚洲大学医学院外科。
4
    韩国首尔Sungkyunkwan大学医学院三星医疗中心外科。
五
    韩国汉城首尔大学医学院外科学系。
6
    韩国高阳国立癌症中心研究所和医院肝癌中心。

抽象

背景：本研究旨在评估乙肝免疫球蛋白（HBIG），肝素蛋白在接受乙肝肝移植患者中的疗效和稳定性。材料与方法87例接受肝移植的乙型肝炎相关肝病被纳入这个多中心，第三阶段，开放标签，单臂研究。 87名患者中有70名（80.5％）在52周研究期间完成了研究。在术中静脉注射肝素（10,000单位），每天1周，每周1个月，然后每月一次。单独使用肝素不含抗病毒药物。乙肝复发定义为HBIG给药后表面抗原阴性转换为阳性。结果52周观察期间无乙型肝炎复发病例。研究期间共发生876例不良事件（AEs），87例患者中有83例（95.4％）发生不良事件，87例患者中有44例（50.6％）119例发生严重不良事件。没有一个AE显示与这种药物的关系。乙肝表面抗原（HBsAg）和乙肝e抗原（HBeAg）在HBIG给药后1周内迅速消失，但乙肝病毒（HBV）DNA持续存在8周，与HBV病毒载量有关。乙肝表面抗体（HBsAb）与HBIG（Hepabulin）剂量相关。结论新的HBIG，肝素蛋白在肝移植后预防HBV复发方面是安全有效的。

结论：
    29229898