Document Detail


Intralesional antimony for single lesions of bolivian cutaneous leishmaniasis.
MedLine Citation:
PMID:  23390069     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Cutaneous leishmaniasis is an ultimately self-curing disease for which systemic therapy with pentavalent antimony (Sb) is effective but with side effects. We evaluated 2 local treatments, intralesional (IL) Sb and cryotherapy, for single lesions due to Bolivian Leishmania (v.) braziliensis in a placebo-controlled study.
METHODS: Patients were randomized between IL Sb (650 µg/mm(2) of lesion area on days 1, 3, and 5), cryotherapy (days 1 and 14), and placebo cream (daily for 20 days) in a 3:2:3 allocation. Lesion area was measured prior to therapy, and at 1, 3, and 6 months after therapy. The criteria for lesion cure were as follows: not doubling in size at 1 month, at least 50% diminution in size at 3 months, and complete reepithelialization at 6 months. Local adverse effects were recorded.
RESULTS: Cure rates were 21 of 30 (70%; 95% confidence interval [CI], 52%-83%) for IL Sb, 4 of 20 (20%; 95% CI, 8%-42%) for cryotherapy, and 5 of 30 (17%; 95% CI, 7%-34%) for placebo cream (P < .001 for IL Sb vs each other group). IL Sb adverse events were limited to injection site pain, with a mean value of 1.0 (mild).
CONCLUSIONS: The comparative cure rate, small amount of drug administered, and tolerance data for IL Sb suggest that if local therapy for single L. braziliensis lesions is chosen, this treatment is attractive. Given the difficulties of performing placebo-controlled trials in the New World, the combined placebo and cryotherapy cure rate (18%; 95% CI, 10%-31%) is likely to become the standard against which future interventions for L. braziliensis are compared.
CLINICAL TRIALS REGISTRATION: NCT01300975.
Authors:
Jaime Soto; Ernesto Rojas; Miguel Guzman; Aleida Verduguez; Winne Nena; Maria Maldonado; Mary Cruz; Lineth Gracia; Darsi Villarroel; Isidoro Alavi; Julia Toledo; Jonathan Berman
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2013-02-06
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  56     ISSN:  1537-6591     ISO Abbreviation:  Clin. Infect. Dis.     Publication Date:  2013 May 
Date Detail:
Created Date:  2013-04-05     Completed Date:  2013-09-13     Revised Date:  2013-12-04    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1255-60     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT01300975
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Adolescent
Adult
Aged
Aged, 80 and over
Antimony / administration & dosage*,  adverse effects
Antiprotozoal Agents / administration & dosage*,  adverse effects
Bolivia
Child
Cryotherapy
Drug-Related Side Effects and Adverse Reactions / epidemiology,  pathology
Female
Humans
Leishmania braziliensis / drug effects,  isolation & purification
Leishmaniasis, Cutaneous / drug therapy*,  parasitology,  pathology
Male
Middle Aged
Placebos / administration & dosage
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Antiprotozoal Agents; 0/Placebos; 9IT35J3UV3/Antimony
Comments/Corrections
Comment In:
Clin Infect Dis. 2013 Nov;57(10):1502-3   [PMID:  23946223 ]
Clin Infect Dis. 2013 Nov;57(10):1503-4   [PMID:  23946219 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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