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Multiple Cycles of Granulocyte Colony Stimulating Factor Increase Survival Times of Patients With Decompensated Cirrhosis in a Randomized Trial.
Clinical Gastroenterology and Hepatology ( IF 7.958 ) Pub Date : 2020-02-20 , DOI: 10.1016/j.cgh.2020.02.022
Arka De,Sunita Kumari,Akash Singh,Amritjyot Kaur,Rattiram Sharma,Ashish Bhalla,Navneet Sharma,Naveen Kalra,Virendra Singh

BACKGROUND & AIMS There is controversy over inclusion of granulocyte colony stimulating factor (G-CSF) in treatment of decompensated cirrhosis. Previous studies tested only a single cycle of G-CSF administration or were underpowered to detect changes in survival time. We performed an adequately powered study to determine whether multiple cycles of G-CSF increase survival of patients 1 year after the start of therapy. METHODS We conducted an open-label trial of 100 patients with decompensated cirrhosis without acute-on-chronic liver failure at a tertiary centre from July 2016 through June 2018. The patients were randomly assigned to a group given 5 days of G-CSF every 3 months, with standard medical therapy, in 4 cycles (group A, n=50) or standard medical therapy alone (group B, n=50). The primary outcome was survival for 12 months after treatment began. Secondary outcomes were increase in number of CD34+ cells at day 6 compared with day 0, along with reductions in Child Turcotte Pugh and model for end-stage liver disease scores, increased control of ascites, reduced decompensation and episodes of infection, fewer hospitalizations, lower liver stiffness measurements, increased quality of life and nutrition, fulfilment of liver transplant criteria, and fewer adverse events at 12 months after the start of treatment. RESULTS Groups A and B were comparable at baseline. Survival at 12 months after initiation of treatment was significantly higher in group A (74%) than group B (42%) (P<.001). Blood samples from patients in group A had significantly more CD34+ cells on day 6 than on day 0 (P<.001); there was no significant change in group B. Compared with patients in group B, patients in group A had significant reductions in Child Turcotte Pugh and model for end-stage liver disease scores, increased ascites control, fewer infections and hospitalizations, lower liver stiffness measurements, an increased quality of life, and a lower number fulfilled the liver transplant criteria (P<.05). There was no improvement in nutrition in either group, compared with baseline. G-CSF was safe and well tolerated. CONCLUSIONS Administration of multiple cycles of G-CSF increases numbers of hematopoietic stem cells and survival of patients with decompensated cirrhosis receiving standard medical treatment. Addition of G-CSF to medical treatment might provide a bridge to liver transplantation for these patients. ClincialTrials.gov no: NCT03415698.
更新日期:2020-02-21

 

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