| Autor: |
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 |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Brazilian Journal of Infectious Diseases, Vol 28, Iss 2, Pp 103745- (2024) |
| Druh dokumentu: |
article |
| ISSN: |
1413-8670 |
| DOI: |
10.1016/j.bjid.2024.103745 |
| Popis: |
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. Trial registration: ClinicalTrials.gov: NCT00669643. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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