1999
DOI: 10.1086/315082
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Randomized, Double‐Blind Study of Stibogluconate Plus Human Granulocyte Macrophage Colony‐Stimulating Factor versus Stibogluconate Alone in the Treatment of Cutaneous Leishmaniasis

Abstract: The response to recombinant human granulocyte macrophage colony-stimulating factor (GM-CSF) in the treatment of cutaneous leishmaniasis was evaluated. Twenty patients with cutaneous leishmaniasis who had lesions for 60 days were enrolled in a double-blind placebo trial of GM-CSF with standard parenteral sodium stibogluconate (20 mg/kg-1/day-1) for 20 days. Ten patients were randomized to receive intralesionally injected GM-CSF (200 microgram) at enrollment and 1 week after, and 10 patients received saline as p… Show more

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Cited by 47 publications
(36 citation statements)
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“…However, excessive T H 1 cytokines have also been implicated in the pathogenesis of CL 4,5 and several lines of evidence support this information: 1) parasites are absent or scarce in CL lesions 6 ; 2) ulceration is preceded by a granulomatous vasculitis with lymphocytic infiltration 7 ; 3) use of antimony in the early pre-ulcer phase of CL does not prevent lesion formation 7 ; 4) pre-treatment elevations in IFN-γ and tumor necrosis factor-α (TNF-α) decrease with treatment 8 ; 5) immune modulatory drugs combined with Sb v accelerate healing in cutaneous and mucosal leishmaniasis. 9,10 Chronic infection with helminths is highly prevalent in rural areas in Brazil. Helminths modulate the immune response, altering the clinical presentation of immune-related diseases including asthma 11 and Crohn's disease.…”
Section: Introductionmentioning
confidence: 99%
“…However, excessive T H 1 cytokines have also been implicated in the pathogenesis of CL 4,5 and several lines of evidence support this information: 1) parasites are absent or scarce in CL lesions 6 ; 2) ulceration is preceded by a granulomatous vasculitis with lymphocytic infiltration 7 ; 3) use of antimony in the early pre-ulcer phase of CL does not prevent lesion formation 7 ; 4) pre-treatment elevations in IFN-γ and tumor necrosis factor-α (TNF-α) decrease with treatment 8 ; 5) immune modulatory drugs combined with Sb v accelerate healing in cutaneous and mucosal leishmaniasis. 9,10 Chronic infection with helminths is highly prevalent in rural areas in Brazil. Helminths modulate the immune response, altering the clinical presentation of immune-related diseases including asthma 11 and Crohn's disease.…”
Section: Introductionmentioning
confidence: 99%
“…The mechanism of action of imiquimod as an inducer of Th1-type immune response may be related to success in the treatment of patients cured with the combination of imiquimod and antimony; however, it is possible that the induction of a Th1 response is not the only target in the treatment of CL. 22 The use of rhGM-CSF as an adjuvant in the treatment with pentavalent antimonial significantly decreased the cure time of CL. Santos 33 showed that patients treated with rhGM-CSF exhibit a significant increase in the production of IL-10 as well as higher levels of INF-γ and TNF-α in comparison with the placebo group and suggested the hypothesis that the increased level of IL-10 in these patients may induce modulation of Th1-type immune response, partially blocking the effect of pro-inflammatory cytokines, with decreased inflammation and tissue damage.…”
Section: Discussionmentioning
confidence: 96%
“…21 The role of rhGM-CSF as an adjuvant in the treatment of CL was evaluated in two studies. The studies by Adams et al 22 and Santos et al 23 conducted in the endemic area …”
Section: Rhgm-csfmentioning
confidence: 99%
“…Due to the strong association between host immunological responses and pathogenesis of Leishmania infection, modulation of the immune response has been used as strategy to control and prevent Leishmania infection [33,[59][60][61][62]64]. In visceral leishmaniasis and diffuse cutaneous leishmaniasis, diseases associated with impairment in the Th1 type immune response to Leishmania antigens, administration of IFN-γ has proven to benefit patients.…”
Section: Discussionmentioning
confidence: 99%
“…Mucosal leishmaniasis is characterized by ulcerated lesions of the nasal septum which may lead to perforation and deformities of nasal pyramid, laringhx and pharinx might be affected [33]. Several studies suggest that pathology in cutaneous and mucosal leishmaniasis is associated with an immunological imbalance, leading to exacerbated inflammatory responses: 1) The lesions are characterized by a rich inflammatory infiltrate and parasites are rare or undetectable [55,56]; 2) High concentrations of IFN-γ and TNF-α are found in peripheral blood mononuclear cells (PBMC) and tissue [33,55]; 3) High frequency of CD4+ and CD8+ T cells expressing IFN-γ is observed in the lesions [55]; 4) There is a correlation between the frequency of inflammatory cytokine producing T cells and lesion size in cutaneous leishmaniasis [57,58]; 5) TNF-α and IFN-γ levels decrease after therapy and cure of these diseases [49]; 6) Treatment of leishmaniasis with antimony in an early phase of the disease before classical ulcerated cutaneous lesion appearance is associated with a high rate of failure, suggesting that the inflammatory response play a pivotal role in the appearance of the ulcer [54]; 7) Immunological studies performed in this CL patients before ulcer development showed cytotoxic T cell response with TIA-1 expression and a granulomatous vasculitis oblitering the vessel lumen [54,63]; 8) Drugs that down modulate the immune response associated with antimony therapy increase the cure rate and decrease the healing time of cutaneous and mucosal lesions [59][60][61][62].…”
Section: Immunopathogenesis Of Cutaneous and Mucosal Leishmaniasis (Ml)mentioning
confidence: 99%