Análise retrospectiva de pacientes com hanseníase paucibacilar submetidos a ensaio clínico com ofloxacin

Abstract

Leprosy is a chronic and infectious disease caused by the intra cellular pathogen Mycobacterium leprae affecting mainly the skin and the nerves been endemic in Brazil. For the purpose of implement multidrugtherapy (MDT), leprosy patients can be classified as having multibacillary (MB) or paucibacillary (PB) leprosy. The six-month duration of MDT for PB leprosy is still relatively long. Powerful bactericidal activity against Mycobacterium leprae by pefloxacin and ofloxacin were reported. A retrospective study was carried out based on medical files records of the 142 PB leprosy patients who were participants of a multicentric double blind randomized trial designed and coordinated by World Health Organization (WHO). The trial was carried out from October, 1992 to June, 1994 with the objective to compare the therapeutic efficacy, in terms of the relapse rate, of a regimen consisting of rifampicin and ofloxacin administered for a shorter period, compared to the standard WHO/MDT in PB leprosy. The patients were followed up for an average of 13 years after released from treatment (RFT). Relapse was confirmed if the patient showed increase in the number of skin lesions or in lesion size without good response after at least two courses of steroids, and/or new nerve trunk enlargement. From 142 patients included in the trial, 133 (93,7%) completed the allocated regimens. From these, 66 received rifampin plus ofloxacin for 28 days and 67 patients the standard MDT/PB for 6 months. The ofloxacin group showed 5(7,6) relapse cases, one of them with 2,4 years of follow up after RFT and the remain four cases with more than 6 years of follow up after RFT. Among group standard MDT/PB, 4 (6,0%) relapses were detected , three of them ranging from 2,9 years to 4,2 years after RFT and one after 13 years of follow up. No statistical significance was observed between groups regarding relapse rates. Leprosy reaction observed in 19,5% of the patients during treatment and 23,3% after RFT . Leprosy reaction after RFT was associated a worsened of the disability grade at the end of the follow up period. Clinical aspects as large lesions and involvement of the different areas of the body, besides the large follow up period, could have influenced on the high number of relapses detected in both groups. Reinfection could not be discard specially in those cases that showed a long period for relapse. The regimens were well tolerated with few reports of side effects, mainly of them gastric or intestine complains. It was considered that standard WHO/MDT continues to be the alternative regimen for paucibaccilar leprosy due to its low price and more facility for field implementation.