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Efficacy of liposomal amphotericin B (AmBisome) in the treatment of persistent post-kala-azar dermal leishmaniasis (PKDL).

作者信息

Musa A M, Khalil E A G, Mahgoub F A, Hamad S, Elkadaru A M Y, El Hassan A M

机构信息

Department of Clinical Pathology and Immunology, Institute of Endemic Diseases, University of Khartoum, Sudan.

出版信息

Ann Trop Med Parasitol. 2005 Sep;99(6):563-9. doi: 10.1179/136485905X514127.


DOI:10.1179/136485905X514127
PMID:16156969
Abstract

A dermatosis commonly known as post-kala-azar dermal leishmaniasis (PKDL) may develop following the treatment of human visceral leishmaniasis (VL). In about 15% of PKDL cases the disfiguring lesions persist, sometimes for many years. Such persistent lesions currently require daily injections of sodium stibogluconate (SSG) for 2-4 months and even then treatment may not be successful. Alternative, quicker and cheaper treatment options that cause less toxicity are being explored. Immuno-chemotherapeutic regimens (based on leishmaniasis candidate vaccines/BCG with SSG) are still experimental but treatment with liposomal amphotericin B (AmBisome) has already been found effective, albeit in a small number of patients. AmBisome is considered less nephrotoxic than non-liposomal amphotericin B because it specifically targets the macrophages in which the Leishmania parasites develop. The aim of the present study was to evaluate further the usefulness of AmBisome in the treatment of persistent PKDL, in Sudan. The 12 subjects, all of whom gave their informed consent, had each had PKDL lesions for >6 months and shown no improvement after repeated injections of SSG. During the study period, they were hospitalized and regularly screened, haematologically and biochemically, for adverse effects. The AmBisome, given intravenously at 2.5 mg/kg.day for 20 days, completely cleared the skin rash of 10 (83%) of the patients and caused no detectable adverse effects. In the 10 patients who responded well to the treatment, the papular lesions regressed and became flat while the hypopigmented lesions darkened (continuing to do so even after the last AmBisome injections). Treatment outcome appeared to be unaffected by the age or gender of the patient (P = 0.7 for each) but the time taken for the PKDL lesions to heal was correlated with the age of the lesions (P = 0.009). The macular lesions healed more slowly than the papular (P = 0.02). In conclusion, Ambisome appears suitable for the treatment of persistent PKDL lesions in Sudan. Once certain favourable clinical signs (the regression and/or darkening of the PKDL lesions) have been noted, the lesions will probably continue to clear without the need for more injections.

摘要

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引用本文的文献

[1]
Post-kala-azar dermal leishmaniasis (PKDL) drug efficacy study landscape: A systematic scoping review of clinical trials and observational studies to assess the feasibility of establishing an individual participant-level data (IPD) platform.

PLoS Negl Trop Dis. 2024-4

[2]
Safety and efficacy of paromomycin/miltefosine/liposomal amphotericin B combinations for the treatment of post-kala-azar dermal leishmaniasis in Sudan: A phase II, open label, randomized, parallel arm study.

PLoS Negl Trop Dis. 2023-11

[3]
Post kala-azar dermal leishmaniasis in the Indian sub-continent: challenges and strategies for elimination.

Front Immunol. 2023

[4]
LEISH2b - A phase 2b study to assess the safety, efficacy, and immunogenicity of the Leishmania vaccine ChAd63-KH in post-kala azar dermal leishmaniasis.

Wellcome Open Res. 2022-8-3

[5]
Precision Medicine in Control of Visceral Leishmaniasis Caused by .

Front Cell Infect Microbiol. 2021

[6]
Therapeutic Modalities in Post Kala-azar Dermal Leishmaniasis: A Systematic Review of the Effectiveness and Safety of the Treatment Options.

Indian J Dermatol. 2021

[7]
Safety and immunogenicity of ChAd63-KH vaccine in post-kala-azar dermal leishmaniasis patients in Sudan.

Mol Ther. 2021-7-7

[8]
A randomized, open-label study to evaluate the efficacy and safety of liposomal amphotericin B (AmBisome) versus miltefosine in patients with post-kala-azar dermal leishmaniasis.

Indian J Dermatol Venereol Leprol. 2021

[9]
Challenges for management of post kala-azar dermal leishmaniasis and future directions.

Res Rep Trop Med. 2014-11-14

[10]
Post kala-azar dermal leishmaniasis: A threat to elimination program.

PLoS Negl Trop Dis. 2020-7-2

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