Abstract
Twenty-four patients with acute visceral leishmaniasis and leukopenia (< 1500 neutrophils/mm3) due to Leishmania chagasi were studied, 4 in an open-label pilot study and 20 in a double-blind, placebo-controlled trial. Patients received granulocyte-macrophage colony-stimulating factor (GM-CSF), 5 micrograms/kg daily, or placebo for 10 days, plus 10-20 mg/kg pentavalent antimony daily for 20 days. In GM-CSF recipients, neutrophil counts increased threefold and fourfold over baseline at 5 and 10 days, respectively, and were significantly higher than those in placebo recipients (P < .02). Eosinophil and monocyte counts were significantly increase in GM-CSF recipients at 10 days (P < or = .03). Secondary infections occurred in 3 GM-CSF and in 8 placebo recipients (P = .04). All patients had complete resolution of their leishmaniasis at 3 months. Few adverse events were recorded. GM-CSF, 5 micrograms/kg daily for 10 days, was safe, rapidly reversed neutropenia, and reduced the number of secondary infections in patients with leishmaniasis.
Publication types
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Clinical Trial
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
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Research Support, U.S. Gov't, P.H.S.
MeSH terms
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Adolescent
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Adult
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Antimony / economics
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Antimony / therapeutic use
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Antiprotozoal Agents / economics
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Antiprotozoal Agents / therapeutic use
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Bone Marrow / pathology
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Child
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Child, Preschool
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Cross Infection / prevention & control*
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Double-Blind Method
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Drug Therapy, Combination
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Female
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Granulocyte-Macrophage Colony-Stimulating Factor / economics
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Granulocyte-Macrophage Colony-Stimulating Factor / therapeutic use*
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Health Care Costs
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Humans
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Leishmaniasis, Visceral / blood
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Leishmaniasis, Visceral / complications
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Leishmaniasis, Visceral / drug therapy*
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Leukocyte Count
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Male
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Meglumine / economics
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Meglumine / therapeutic use
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Meglumine Antimoniate
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Neutropenia / complications
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Neutropenia / drug therapy*
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Neutropenia / etiology
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Organometallic Compounds / economics
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Organometallic Compounds / therapeutic use
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Pilot Projects
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Recombinant Proteins / economics
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Recombinant Proteins / therapeutic use
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Severity of Illness Index
Substances
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Antiprotozoal Agents
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Organometallic Compounds
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Recombinant Proteins
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Meglumine
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Meglumine Antimoniate
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Granulocyte-Macrophage Colony-Stimulating Factor
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Antimony