Effectiveness and safety of clofazimine inxc2xa0multidrug-resistant tuberculosis: axc2xa0nationwide report from Brazil

[摘要] Although clofazimine is used to treat multidrug-resistant tuberculosis (MDR-TB); there is scant information on its effectiveness and safety. The aim of this retrospective; observational study was to evaluate these factors as well as the tolerability of clofazimine in populations in Brazil; where it was administered at a daily dose of 100xe2x80x85mgxc2xb7dayxe2x88x921 (body weight xe2x89xa545xe2x80x85kg) as part of a standardised MDR-TB treatment regimen until 2006 (thereafter pyrazinamide was used).All MDR-TB patients included in the Sistema de Informaxc3xa7xc3xa3o de Tratamentos Especiais da Tuberculose (SITETB) individual electronic register were analysed. The effectiveness of clofazimine was assessed by comparing the treatment outcomes of patients undergoing clofazimine-containing regimens against those undergoing clofazimine-free regimens and its safety by describing clofazimine-attributed adverse events. Axc2xa0total of 1446 patients were treated with clofazimine-containing regimens and 1096 with pyrazinamide-containing regimens.Although success rates were similar in patients treated with clofazimine versus those treated with pyrazinamide (880 out of 1446; 60.9%; versus 708 out of 1096; 64.6%; p=0.054); clofazimine-treated cases exhibited higher death rates due to tuberculosis than pyrazinamide-treated ones (314 out of 1446; 21.7%; versus 120 out of 1096; 10.9%) but fewer failures (78 out of 1446; 5.4%; versus 95 out of 1096; 8.7%) and less loss to follow-up (144 out of 1446; 10.0%; versus 151 out of 1096; 13.8%). No relevant differences were detected when comparing adverse events in patients treated with clofazimine-containing regimens to those treated with clofazimine-free regimens. However; the incidence of side-effects was less than previously reported (gastro-intestinal complaints: 10.5%; hyper-pigmentation: 50.2%; neurological disturbances: 9xe2x80x9313%).

[学科分类] 呼吸医学