Granulocyte-macrophage colony-stimulating factor in combination with pentavalent antimony for the treatment of visceral Leishmaniasis.
The efficacy of GM-CSF was investigated in 20 neutropenic patients (< 1500 neutrophils/microliters) with acute visceral leishmaniasis due to Leishmania chagasi. Patients were randomized to receive either GM-CSF, 5 micrograms/kg daily (intravenously or subcutaneously), or placebo for ten days, in combination with pentavalent antimony, 10-20 mg/kg daily for 20 days. Neutrophil counts were significantly greater on days 5 and 10 of treatment 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 < or = 0.03). Interestingly, at day 30, platelet counts were significantly increased in the GM-CSF group on days 5 and 10 (p = 0.04 and 0.02, respectively). Patients in the GM-CSF group experienced fewer secondary bacterial or viral infections than placebo patients. Infections occurred in only three patients given GM-CSF compared with eight patients given placebo (p < 0.04). All patients had complete resolution of disease symptoms at three months. Few adverse events were recorded. GM-CSF given subcutaneously at a dose of 5 micrograms/kg daily for ten days was well tolerated, reversed neutropenia rapidly and reduced the number of secondary infections in patients with leishmaniasis.
Badaró
R
R
Federal University of Bahia, Salvador, Brazil.
Nascimento
C
C
Carvalho
J S
JS
Badaró
F
F
Russo
D
D
Ho
J L
JL
Reed
S G
SG
Johnson
W D
WD
Jones
T C
TC
D000293:Adolescent; D000328:Adult; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006403:Hematologic Tests; D006801:Humans; D007898:Leishmaniasis, Visceral / Q000188:drug therapy* / Q000503:physiopathology; D008536:Meglumine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077485:Meglumine Antimoniate; D008875:Middle Aged; D009503:Neutropenia / Q000188:drug therapy / Q000209:etiology; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015163:Superinfection / Q000209:etiology; D016896:Treatment Outcome
D000981:Antiprotozoal Agents; D009942:Organometallic Compounds; D008536:Meglumine; D000077485:Meglumine Antimoniate; D016178:Granulocyte-Macrophage Colony-Stimulating Factor