Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach
Nenhuma Miniatura disponível
Data
2018
Título da Revista
ISSN da Revista
Título de Volume
Editor
Resumo
BACKGROUND: The Clinical Trial for Uniform Multidrug Therapy for Leprosy Patients in Brazil (U-MDT/CT-BR), de signed to evaluate the effectiveness of a six-months regimen, assessed the adverse effects caused by the drugs.
OBJECTIVE: Describe adverse effects due to MDT in U-MDT/CT-BR, comparing the uniform regimen (U-MDT) to the current
:+2 UHJLPHQ 5 0'7 3DWLHQWV DQG PHWKRGV $IWHU RSHUDWLRQDO FODVVLÀFDWLRQ SDWLHQWV ZHUH UDQGRPO\ DOORFDWHG WR WKH VWXG\
groups. U-MDT PB and U-MDT MB groups, received the U-MDT regimen, six doses of MB-MDT (rifampicin, dapsone and
clofazimine). R-MDT PB and R-MDT MB groups, received the WHO regimens: six doses (rifampicin and dapsone) for PB and
12 doses (rifampicin, dapsone and clofazimine) for MB. During treatment, patients returned monthly for clinical and labora torial evaluation. Patients with single lesion were not included in this trial.
RESULTS: Skin pigmentation (21.7%) and xerosis (16.9%) were the most frequent complaints among 753 patients. Laboratory ex ams showed hemoglobin concentration lower than 10g/dL in 23.3% of the patients, glutamic oxaloacetic transaminase (GOT)
above 40U/L in 29.5% and glutamic pyruvic transaminase (GPT) above 40U/L in 28.5%. Twenty-four patients (3.2%) stopped
dapsone intake due to adverse effects, of whom 16.6% due to severe anemia. One case of sulfone syndrome was reported.
STUDY LIMITATIONS: Loss of some monthly laboratory sample collection.
CONCLUSIONS: There was no statistical difference regarding adverse effects in the R-MDT and U-MDT groups but anemia was
greater in patients from R-MDT/MB group, therefore adverse effects do not represent a constraint to recommend the six month uniform regimen of treatment for all leprosy patients.
Descrição
Palavras-chave
Abnormalities, Drug-induced, Drug monitoring, Leprosy, Therapeutics
Citação
CRUZ, Rossilene Conceição da Silva et al. Clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): adverse effects approach. Anais Brasileiros de Dermatologia, Rio de Janeiro, v. 93, n. 3, p. 377-384, 2018. DOI: 10.1590/abd1806-4841.20186709. Disponível em: https://www.sciencedirect.com/science/article/pii/S0365059620304396?via%3Dihub. Acesso em: 11 fev. 2025.