Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
We conducted a prospective, multicenter, open-label randomized trial to compare the
 antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF),
 Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and
 rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.
From Sept 2009 to Dec 2012, we recruited consecutive patients with hematological diseases
 undergoing allogeneic stem cell transplantation at 5 institutions in China. Recipients
 between ages of 14 to 60 years old were eligible. Eligible patients were randomized to
 receive once daily subcutaneous 5-7μg/kg/d GM-CSF (Molgramostim, TOPLEUCON®; Xiamen Amoytop
 Biotech Co., Ltd., China) (GM-CSF group), 5-7μg/kg/d G-CSF (G-CSF group), or a combination of
 2-3μg/kg/d GM-CSF and 2-3μg/kg/d G-CSF each (G-CSF+GM-CSF group). Administration of CSFs was
 started on day 5 post-transplant and continued until recovery from neutropenia (absolute
 neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). If absolute neutrophil count
 (ANC) decreased to < 1.5×10(9)/L within 5 days after withdrawal of CSFs, the same CSF would
 be resumed until the absolute neutrophil count (ANC) reached 1.5×10(9)/L again. All patients
 received antimicrobial prophylaxis with oral levofloxacin 500 mg daily and antifungal
 prophylaxis with oral fluconazole 200 mg daily.
Inclusion Criteria:

 -  Age 14~60 years old

 -  Allogenic hematological stem cell transplantation(HSCT) patients.

 -  Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or
 Alanine aminotransferase < 2 upper limit of normal, and/or total bilirubin < 2.5 upper
 limit of normal, creatinine < upper limit of normal.

 -  Informed consent.

 Exclusion Criteria:

 -  Evidence of proven, probable or possible fungal infection at the time of enrollment.

 -  Patients were receiving anti-fungal treatment with proven SFI before transplantation.

 -  A history of hypersensitivity to G-CSF or GM-CSF.