R. Badaro et al., GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR IN COMBINATION WITH PENTAVALENT ANTIMONY FOR THE TREATMENT OF VISCERAL LEISHMANIASIS, European journal of clinical microbiology & infectious diseases, 13, 1994, pp. 190000023-190000028
The efficacy of GM-CSF was investigated in 20 neutropenic patients (<
1500 neutrophils/mu l) with acute visceral leishmaniasis due to Leishm
ania chagasi. Patients were randomized to receive either GM-CSF, 5 mu
g/kg daily (intravenously or subcutaneously), or placebo for ten days,
in combination with pentavalent antimony, 10-20 mg/kg daily for 20 da
ys. Neutrophil counts mere significantly greater on days 5 and 10 of t
reatment in the GM-CSF group compared with the placebo group (p < 0.02
). Eosinophil and monocyte counts were also significantly increased in
the GM-CSF group at day 10 (p less than or equal to 0.03). Interestin
gly, at day 30, platelet counts were significantly higher in the GM-CS
F treated group (p = 0.007). Haemoglobin levels were significantly inc
reased in the GM-CSF group on days 5 and 10 (p = 0.04 and 0.02, respec
tively). Patients in the GM-CSF group experienced fewer secondary bact
erial or viral infections than placebo patients. Infections occurred i
n only three patients given GMCSF compared with eight patients given p
lacebo (p < 0.04). All patients had complete resolution of disease sym
ptoms at three months. Few adverse events were recorded. GM-CSF given
subcutaneously at a dose of 5 mu g/kg daily for ten days was well tole
rated, reversed neutropenia rapidly and reduced the number of secondar
y infections in patients with leishmaniasis.