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LATE RELAPSES IN LEPROSY PATIENTS IN BRAZIL: 10-YEAR POST-TRIAL OF UNIFORM MULTIDRUG THERAPY (U-MDT/CT-BR)
Author
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Universidade de Brasília. Núcleo de Medicina Tropical. Brasília, DF, Brazil / Fundação Oswaldo Cruz. Escola de Governo Fiocruz Brasília. Brasília, DF, Brazil.
Centro de Referência em Dermatologia Dona Libânia. Fortaleza, CE, Brazil.
Fundação Hospitalar de Dermatologia Tropical e Venereologia Alfredo da Matta. Manaus, AM, Brazil.
Centro de Referência em Dermatologia Dona Libânia. Fortaleza, CE, Brazil.
Fundação Hospitalar de Dermatologia Tropical e Venereologia Alfredo da Matta. Manaus, AM, Brazil.
Universidade do Estado do Amazonas. Programa de Pós-Graduação em Ciências Aplicadas a Dermatologia. Manaus, AM, Brazil.
Fundação Hospitalar de Dermatologia Tropical e Venereologia Alfredo da Matta. Manaus, AM, Brazil.
Universidade Federal de Goiás. Instituto de Patologia Tropical e Saúde Pública. Goiânia, GO, Brazil.
Universidade Federal Fluminense. Departamento de Epidemiologia e Bioestatística. Rio de Janeiro, RJ, Brazil.
Centro de Referência em Dermatologia Dona Libânia. Fortaleza, CE, Brazil.
Fundação Hospitalar de Dermatologia Tropical e Venereologia Alfredo da Matta. Manaus, AM, Brazil.
Centro de Referência em Dermatologia Dona Libânia. Fortaleza, CE, Brazil.
Fundação Hospitalar de Dermatologia Tropical e Venereologia Alfredo da Matta. Manaus, AM, Brazil.
Universidade do Estado do Amazonas. Programa de Pós-Graduação em Ciências Aplicadas a Dermatologia. Manaus, AM, Brazil.
Fundação Hospitalar de Dermatologia Tropical e Venereologia Alfredo da Matta. Manaus, AM, Brazil.
Universidade Federal de Goiás. Instituto de Patologia Tropical e Saúde Pública. Goiânia, GO, Brazil.
Universidade Federal Fluminense. Departamento de Epidemiologia e Bioestatística. Rio de Janeiro, RJ, Brazil.
Abstract
Background: Leprosy is a neglected dermato-neurologic, infectious disease caused by Mycobacterium leprae or M. lepromatosis. Leprosy is treatable and curable by multidrug therapy/
MDT, consisting of 12 months rifampicin, dapsone and clofazimine for multibacillary/MB
patients and for 6 months for paucibacillary/PB patients. The relapse rate is considered a
crucial treatment outcome. A randomized Controlled Clinical Trial (U-MDT/CT-BR) conducted from 2007‒2012 compared clinical outcomes in MB patients after 12 months regular
MDT/R-MDT and 6 months uniform MDT/U-MDT in two highly endemic Brazilian areas.
Objectives: To estimate the 10 years relapse rate of MB patients treated with 6 months
U-MDT.
Methods: The statistical analyses treated the data as a case-control study, sampled from
the cohort generated for the randomized trial. Analyses estimated univariate odds
ratio and applied logistic regression for multivariate analysis, controlling the confounding variables.
Results: The overall relapse rate was 4.08 %: 4.95 % (16 out of 323) in the U-MDT group and
3.10 % (9 out of 290) in the regular/R-MDT group. The difference in relapse proportion
between U-MDT and R-MDT groups was 1.85 %, not statistically significant (Odds
Ratio = 1.63, 95 % CI 0.71 to 3.74). However, misdiagnosis of relapses, may have introduced
bias, underestimating the force of the association represented by the odds ratio. Conclusions: The relapse estimate of 10 years follow-up study of the first randomized, controlled study on U-MDT/CT-BR was similar to the R-MDT group, supporting strong evidence
that 6 months U-MDT for MB patients is an acceptable option to be adopted by leprosy
endemic countries worldwide.
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