失代偿期肝硬化患者多个疗程的粒细胞集落刺激因子和生长

StephenW

Outcomes after Multiple courses of Granulocyte-Colony Stimulating Factor and Growth Hormone in Decompensated Cirrhosis: Randomized Trial

    Nipun Verma M.D, D.M.1,†, Amritjyot Kaur M.Sc.2, Ratiram Sharma M.D.3, Ashish Bhalla M.D.4, Navneet Sharma M.D.4, Arka De M.D.1 andVirendra Singh M.D., D.M., FASGE1,†,*

DOI: 10.1002/hep.29763

© 2017 by the American Association for the Study of Liver Diseases.

Issue
Vol. 67 Issue 1
Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

   1    Department of Hepatology, Post Graduate Institute of Medical Education and Research, Chandigarh, INDIA
    2    Department of Nuclear Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, INDIA
    3    Department of Transfusion Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, INDIA
    4    Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, INDIA

    †    Joint First Authors

Email: Virendra Singh M.D., D.M., FASGE ([email protected])

*Correspondence: Dr Virendra Singh, MD, DM, FASGE, Professor, Department of Hepatology, PGIMER, Chandigarh 160 012 (India), Email: [email protected], Phone-911722756338, Fax: 91-172-2744401

Keywords:

    G-CSF;GH;clinical trial;decompensated cirrhosis;liver regeneration

Abstract

Background and Aim: Decompensated cirrhosis carries a high mortality. Liver transplantation (LT) is the treatment of choice; however, the limited availability of donor organs has resulted in high waitlist mortality. The present study investigated the impact of multiple courses of granulocyte-colony stimulating factor (G-CSF) with or without growth hormone (GH) in these patients. Methods: Sixty-five patients with decompensated cirrhosis were randomized to standard medical therapy (SMT) plus G-CSF 3 monthly plus GH daily (group A; n=23) or SMT plus G-CSF (group B; n=21) or SMT alone (group C; n=21). The primary outcome was the transplant free survival (TFS) at 12 months. The secondary outcomes were mobilization of CD34+ cells at day 6; the improvement in clinical scores, liver stiffness, nutrition, episodes of infection and quality of life (QOL) at 12 months. Results: There was significantly better 12-month TFS in groups A and B than in group C (p=0.001). At day 6 of therapy, CD34+ cells increased in groups A and B compared to baseline (p<0.001). There was a significant decrease in clinical scores, improvement in nutrition, better control of ascites, reduction in liver stiffness, lesser infection episodes and improvement in QOL scores in groups A and B, at 12 months as compared to baseline (p<0.05). The therapies were well tolerated. Conclusions: Multiple courses of G-CSF improved 12-month TFS, mobilized hematopoietic stem cells, improved disease severity scores, nutrition, fibrosis, QOL scores, ascites control, reduced infections, and the need for LT in patients with decompensated cirrhosis. However, the use of GH was not found to have any additional benefit. (NCT02451033) This article is protected by copyright. All rights reserved.

StephenW

失代偿期肝硬化患者多个疗程的粒细胞集落刺激因子和生长激素治疗后随访结果

    Nipun Verma M.D，D.M.1，Amritjyot Kaur M.Sc.2，Ratiram Sharma M.D.3，Ashish Bhalla M.D.4，Navneet Sharma M.D.4，Arka De M.D.1和Virendra Singh M.D.，D.M.，FASGE1，*，

DOI：10.1002 / hep.29763

©2017由美国肝病研究协会。

问题
卷。 67问题1
肝病

接受的文章（接受，未经编辑的文章在线发表，可引用，未来将出现最终的编辑和排版版本）。

   1印度昌迪加尔医学教育与研究研究所肝脏病研究所
    2印度昌迪加尔医学教育与研究研究所核医学系
    3印度昌迪加尔医学教育与研究研究所输血医学系
    4印度昌迪加尔医学教育与研究研究所内科医学系

    †联合第一作者

电子邮件：Virendra Singh M.D.，D.M.，FASGE（[email protected]）

*电子邮件：[email protected]，电话-911722756338，传真：91-172-2744401电子邮件：[email protected]电子邮件：[email protected]联系人：Virendra Singh医师，MD，FASGE医学博士，PGIMER教授，Chandigarh 160 012

关键词：

    G-CSF; GH;临床试验;失代偿期肝硬化;肝再生

抽象

背景和目的：失代偿期肝硬化死亡率高。肝移植（LT）是治疗的选择;然而，供体器官的有限供应导致了高等候名单的死亡率。本研究调查了这些患者中有或没有生长激素（GH）的多个粒细胞集落刺激因子（G-CSF）疗程的影响。方法：将65例失代偿期肝硬化患者随机分为标准药物治疗组（SMT）加G-CSF 3个月加GH每日（A组; 23例）或SMT加G-CSF（B组; 21例）单独SMT（C组; n = 21）。主要结局是12个月时的无移植存活期（TFS）。次要结果是在第6天动员CD34 +细胞;在12个月时临床评分，肝硬度，营养，感染发作和生活质量（QOL）的改善。结果：A组和B组12个月TFS明显优于C组（P = 0.001）。在治疗的第6天，与基线相比，组A和B中的CD34 +细胞增加（p <0.001）。与基线相比，12个月时A组和B组的临床评分显着下降，营养状况改善，腹水控制更好，肝硬度下降，感染发生率降低，生活质量评分改善（p <0.05）。疗法很好耐受。结论：G-CSF多疗程改善失代偿期肝硬化患者12个月TFS，动员造血干细胞，提高疾病严重度评分，营养，纤维化，生活质量评分，腹水控制，感染减少和LT需求。然而，GH的使用没有被发现有任何额外的好处。 （NCT02451033）本文受版权保护。版权所有。