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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
1
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pubmed:dateCreated |
2007-12-6
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pubmed:abstractText |
Post-kala-azar dermal leishmaniasis (PKDL) is a recognized dermatosis that follows successful treatment of visceral leishmaniasis in the Sudan. This randomized and double-blind study aimed to assess safety, immunogenicity and curative potentials of a novel immunochemotherapy regimen in patients with persistent PKDL. Following informed consent, 30 patients were randomized to receive alum-precipitated autoclaved Leishmania major (Alum/ALM) vaccine+Bacille Calmette-Guérin (BCG) and sodium stibogluconate (SSG) or vaccine diluent and SSG. The SSG+Alum/ALM+BCG proved safe with minimal local adverse events. In the SSG+vaccine group, 87% of the patients were cured by day 60 compared with 53% in the SSG alone group (SSG+vaccine efficacy=71%, 95% CI for risk ratio 0.7-1.16). On day 90 of follow-up there were two relapses in the SSG alone arm and none in the SSG+vaccine arm. Pre-treatment cytokines showed high IFN-gamma or high IFN-gamma/IL-10 levels and leishmanin skin test (LST) non-reactivity, while healing/clinical improvement were associated with LST reactivity and low IFN-gamma levels in both study groups (P=0.004). In conclusion, SSG+Alum/ALM+BCG is safe and immunogenic with significant healing potentials in persistent PKDL lesions. Immunochemotherapy probably augmented IFN-gamma production, which induced healing. Leishmanin skin reactivity is a good surrogate marker of cure in persistent PKDL lesions.
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:month |
Jan
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pubmed:issn |
0035-9203
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pubmed:author |
pubmed-author:AboudMona HusseinMH,
pubmed-author:El-HassanAhmed MohamedAM,
pubmed-author:ElgawiSara Hamad HassabSH,
pubmed-author:ElkadaruAbd Elgadir Mohamed YousifAE,
pubmed-author:GhalibHashim WarsamaHW,
pubmed-author:KhalilEltahir Awad GasimEA,
pubmed-author:Leishmaniasis Research Group/Sudan,
pubmed-author:MahgoubFawzi Abd ElrahimFA,
pubmed-author:ModabberFarroukhF,
pubmed-author:MusaAhmed MudawiAM,
pubmed-author:NoazinSassanS
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pubmed:issnType |
Print
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pubmed:volume |
102
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
58-63
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pubmed:dateRevised |
2008-11-21
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pubmed:meshHeading |
pubmed-meshheading:17963805-Adolescent,
pubmed-meshheading:17963805-Adult,
pubmed-meshheading:17963805-Antimony Sodium Gluconate,
pubmed-meshheading:17963805-Antiprotozoal Agents,
pubmed-meshheading:17963805-BCG Vaccine,
pubmed-meshheading:17963805-Child,
pubmed-meshheading:17963805-Double-Blind Method,
pubmed-meshheading:17963805-Female,
pubmed-meshheading:17963805-Humans,
pubmed-meshheading:17963805-Interferon-gamma,
pubmed-meshheading:17963805-Interleukin-10,
pubmed-meshheading:17963805-Leishmaniasis, Visceral,
pubmed-meshheading:17963805-Leishmaniasis Vaccines,
pubmed-meshheading:17963805-Male,
pubmed-meshheading:17963805-Middle Aged,
pubmed-meshheading:17963805-Statistics as Topic,
pubmed-meshheading:17963805-Sudan,
pubmed-meshheading:17963805-Treatment Outcome,
pubmed-meshheading:17963805-Vaccines, Combined
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pubmed:year |
2008
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pubmed:articleTitle |
Immunochemotherapy of persistent post-kala-azar dermal leishmaniasis: a novel approach to treatment.
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pubmed:affiliation |
Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
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pubmed:publicationType |
Journal Article,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't
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