title: Granulocyte colony-stimulating factor in severe alcoholic hepatitis: a randomized pilot study.
abstract: OBJECTIVE
  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.affiliation: Department of Hepatology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
authors.forename: Virendra
authors.initials: V
authors.lastname: Singh
authors.affiliation: Department of Hepatology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
authors.forename: Arun K
authors.initials: AK
authors.lastname: Sharma
authors.affiliation: Department of Internal Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
authors.forename: R Lakshmi
authors.initials: RL
authors.lastname: Narasimhan
authors.affiliation: Department of Internal Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
authors.forename: Ashish
authors.initials: A
authors.lastname: Bhalla
authors.affiliation: Department of Internal Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
authors.forename: Navneet
authors.initials: N
authors.lastname: Sharma
authors.affiliation: Department of Transfusion Medicine, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.
authors.forename: Ratiram
authors.initials: R
authors.lastname: Sharma
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D018952:Antigens, CD34 / Q000032:analysis; D001663:Bilirubin / Q000097:blood; D058625:End Stage Liver Disease / Q000209:etiology; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006412:Hematopoietic Stem Cells / Q000737:chemistry / Q000187:drug effects*; D006519:Hepatitis, Alcoholic / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009504:Neutrophils; D010865:Pilot Projects; D011446:Prospective Studies; D012720:Severity of Illness Index; D015996:Survival Rate
chemical_list: D018952:Antigens, CD34; D016179:Granulocyte Colony-Stimulating Factor; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D001663:Bilirubin