Virendra Singh1, Arun K Sharma1, R Lakshmi Narasimhan2, Ashish Bhalla2, Navneet Sharma2, Ratiram Sharma3. 1. Department of Hepatology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. 2. Department of Internal Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. 3. Department of Transfusion Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
Abstract
OBJECTIVES:Severe alcoholic hepatitis has high short-term mortality. The aim of this study was to test the hypothesis that treatment of patients with alcoholic hepatitis withgranulocyte colony-stimulating factor (G-CSF) might mobilize bone marrow-derived stem cells and promote hepatic regeneration and thus improve survival. METHODS:Forty-six patients with severe alcoholic hepatitis were prospectively randomized in an open study to standard medical therapy (SMT) plus G-CSF (group A; n=23) at a dose of 5 μg/kg subcutaneously every 12 h for 5 consecutive days or to SMT alone (group B; n=23) at a tertiary care center. We assessed the mobilization of CD34(+) cells on day 6, Child-Turcotte-Pugh (CTP), model for end-stage liver disease (MELD), and modified Maddrey's discriminant function (mDF) scores, and survival until day 90. RESULTS: There was a statistically significant increase in the number of CD34(+) cells in peripheral blood in group A as compared with group B (P=0.019) after 5 days of G-GSF therapy. There was a significant reduction in median Δ change% in CTP, MELD, and mDF at 1, 2, and 3 months in group A as compared with group B (P<0.05). There was marked improvement in survival in group A as compared with group B (78.3% vs. 30.4%; P=0.001) at 90 days. CONCLUSIONS: G-CSF is safe and effective in the mobilization of hematopoietic stem cells and improves liver function as well as survival in patients with severe alcoholic hepatitis.
RCT Entities:
OBJECTIVES: Severe alcoholic hepatitis has high short-term mortality. The aim of this study was to test the hypothesis that treatment of patients with alcoholic hepatitis with granulocyte colony-stimulating factor (G-CSF) might mobilize bone marrow-derived stem cells and promote hepatic regeneration and thus improve survival. METHODS: Forty-six patients with severe alcoholic hepatitis were prospectively randomized in an open study to standard medical therapy (SMT) plus G-CSF (group A; n=23) at a dose of 5 μg/kg subcutaneously every 12 h for 5 consecutive days or to SMT alone (group B; n=23) at a tertiary care center. We assessed the mobilization of CD34(+) cells on day 6, Child-Turcotte-Pugh (CTP), model for end-stage liver disease (MELD), and modified Maddrey's discriminant function (mDF) scores, and survival until day 90. RESULTS: There was a statistically significant increase in the number of CD34(+) cells in peripheral blood in group A as compared with group B (P=0.019) after 5 days of G-GSF therapy. There was a significant reduction in median Δ change% in CTP, MELD, and mDF at 1, 2, and 3 months in group A as compared with group B (P<0.05). There was marked improvement in survival in group A as compared with group B (78.3% vs. 30.4%; P=0.001) at 90 days. CONCLUSIONS:G-CSF is safe and effective in the mobilization of hematopoietic stem cells and improves liver function as well as survival in patients with severe alcoholic hepatitis.
Authors: Christian M Lange; Wolf Otto Bechstein; Thomas Berg; Cornelius Engelmann; Tony Bruns; Ali Canbay; Richard Moreau; Jonel Trebicka Journal: Visc Med Date: 2018-07-12