Gerson Oliveira Penna , Maria Araci de Andrade Pontes , Sinésio Talhari , Heitor de Sá Gonçalves , Carolina Talhari , Allen de Souza Pessoa , Valderiza Pedroza , Samira Bührer-Sékula , Mariane Martins de Araujo Stefani , Maria Lucia Fernandes Penna
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引用次数: 0
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.
期刊介绍:
The Brazilian Journal of Infectious Diseases is the official publication of the Brazilian Society of Infectious Diseases (SBI). It aims to publish relevant articles in the broadest sense on all aspects of microbiology, infectious diseases and immune response to infectious agents.
The BJID is a bimonthly publication and one of the most influential journals in its field in Brazil and Latin America with a high impact factor, since its inception it has garnered a growing share of the publishing market.