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Immunochemotherapy of persistent post-kala-azar dermal leishmaniasis: a novel approach to treatment.
Trans R Soc Trop Med Hyg. 2008 Jan; 102(1):58-63.TR

Abstract

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.

Authors+Show Affiliations

Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17963805

Citation

Musa, Ahmed Mudawi, et al. "Immunochemotherapy of Persistent Post-kala-azar Dermal Leishmaniasis: a Novel Approach to Treatment." Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 102, no. 1, 2008, pp. 58-63.
Musa AM, Khalil EA, Mahgoub FA, et al. Immunochemotherapy of persistent post-kala-azar dermal leishmaniasis: a novel approach to treatment. Trans R Soc Trop Med Hyg. 2008;102(1):58-63.
Musa, A. M., Khalil, E. A., Mahgoub, F. A., Elgawi, S. H., Modabber, F., Elkadaru, A. E., Aboud, M. H., Noazin, S., Ghalib, H. W., & 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), 58-63.
Musa AM, et al. Immunochemotherapy of Persistent Post-kala-azar Dermal Leishmaniasis: a Novel Approach to Treatment. Trans R Soc Trop Med Hyg. 2008;102(1):58-63. PubMed PMID: 17963805.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunochemotherapy of persistent post-kala-azar dermal leishmaniasis: a novel approach to treatment. AU - Musa,Ahmed Mudawi, AU - Khalil,Eltahir Awad Gasim, AU - Mahgoub,Fawzi Abd Elrahim, AU - Elgawi,Sara Hamad Hassab, AU - Modabber,Farroukh, AU - Elkadaru,Abd Elgadir Mohamed Yousif, AU - Aboud,Mona Hussein, AU - Noazin,Sassan, AU - Ghalib,Hashim Warsama, AU - El-Hassan,Ahmed Mohamed, AU - ,, Y1 - 2007/10/25/ PY - 2007/02/11/received PY - 2007/08/17/revised PY - 2007/08/20/accepted PY - 2007/10/30/pubmed PY - 2008/3/5/medline PY - 2007/10/30/entrez SP - 58 EP - 63 JF - Transactions of the Royal Society of Tropical Medicine and Hygiene JO - Trans R Soc Trop Med Hyg VL - 102 IS - 1 N2 - 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. SN - 0035-9203 UR - https://www.unboundmedicine.com/medline/citation/17963805/Immunochemotherapy_of_persistent_post_kala_azar_dermal_leishmaniasis:_a_novel_approach_to_treatment_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0035-9203(07)00276-3 DB - PRIME DP - Unbound Medicine ER -