Immunochemotherapy of persistent post-kala-azar dermal leishmaniasis: a novel approach to treatment

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Date
2007
Authors
Ahmed Mudawi Musa
Eltahir Awad Gasim Khalil
Fawzi Abd Elrahim Mahgoub
Sara Hamad Hassab Elgawi
Farroukh Modabber
Abd Elgadir Mohamed Yousif Elkadaru
Mona Hussein Aboud
Sassan Noazin
Hashim Warsma Ghalib
Ahmed Mohamed El-Hassan
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Publisher
Elsevier
Abstract
Post-kala-azar dermal leishmaniasis (PKDL) is a recognized dermatosis that follows successful treatment of visceral leishmaniasis in the Sudan. This randomized and doubleblind 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-Gu´erin (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. Pretreatment cytokines showed high IFN- or high IFN- /IL-10 levels and leishmanin skin test (LST) non-reactivity, while healing/clinical improvement were associated with LST reactivity and low
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Musa, A.M., Khalil, E.A.G., Mahgoub, F.A.E., Elgawi, S.H.H., Modabber, F., Elkadaru, A.E.M.Y., Aboud, M.H., Noazin, S., Ghalib, H.W. and El-Hassan, A.M., 2008. Immunochemotherapy of persistent post-kala-azar dermal leishmaniasis: a novel approach to treatment. Transactions of the Royal Society of Tropical Medicine and Hygiene, 102(1), pp.58-63.
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