Efficacy of single-dose chemotherapy (rifampicin, ofloxacin and minocycline-ROM) in PB leprosy patients with 2 to 5 skin lesions, India: randomised double-blind trial.
نویسندگان
چکیده
UNLABELLED We conducted randomized double-blind trial for single-dose of Rifampicin, Ofloxacin and Minocycline (ROM) compared to WHO-PB-MDT among paucibacillary (PB) leprosy patients with 2-5 skin lesions. We enrolled 1526 patients from five centres (ROM=762; WHO-PB-MDT=764) and followed them for 36 months posttreatment during 1998-2003. We generated information on clearance of skin lesions and relapse rates per 100 person-years (PY) for all the five centres. At base-line, the patients in the two arms were comparable. Complete clearance of skin lesions was similar (72% vs. 72.1%; p=0.95) in both the arms. Clinical scores declined steadily and equally. Difference in relapse rates was statistically highly significant (ROM=1.13 and WHO-PB-MDT=0.35 per 100 PY; mid-p exact=0.001016). Twenty eight of 38 of these relapses occurred within 18 months. In all, 10 suspected adverse drug reactions were.observed (ROM=2; WHO-PB-MDT=8). We extended the follow-up to 48 months for 1082 of 1526 patients from two programme-based centres. No further relapses occurred. Decline in clinical score was not dependent on age, gender, number of lesions or affected body parts. Single dose ROM, though less effective than the standard WHO-PB-MDT regimen conceptually offers an alternative treatment regimen for PB leprosy patients with 2-5 lesions only when careful follow-up for relapse is possible. Registered at the Clinical Trials Registry of India; REGISTRATION NUMBER CTRI/2012/05/002645
منابع مشابه
A randomised controlled trial assessing the effect of adding clarithromycin to rifampicin, ofloxacin and minocycline in the treatment of single lesion paucibacillary leprosy in Agra District, India.
AIM To assess if there is any additional short and long-term effect of adding clarithromycin to rifampicin, ofloxacin and minocycline (ROM), the combination here after called C-ROM, in treating single lesion PB leprosy detected in the field. METHODS 300 patients, detected on active search in Agra district, who had single lesion leprosy but no nerve thickening, were randomly allocated (using r...
متن کاملDeveloping new MDT regimens for MB patients; time to test ROM 12 month regimens globally.
In this editorial we review the data on the use of multi-dose ROM (Rifampicin, Ofloxacin and Minocycline) as an alternative treatment to WHO-MDT (World Health Organisation multidrug therapy) comprising rifampicin, clofazimine and dapsone. There is now sufficient evidence to warrant a large trial of this new regimen. The adverse effects of the current MDT regimen are probably under-estimated and...
متن کاملThe efficacy of a four-week, ofloxacin-containing regimen compared with standard WHO-MDT in PB leprosy.
OBJECTIVES To compare the efficacy of a 4-week ofloxacin-containing regimen and the standard WHO-MDT regimen for PB leprosy, in terms of the rate and timing of relapse after treatment completion. DESIGN 124 PB patients were enrolled in a randomised, double-blind trial. Of these, 66 received the standard 6-month WHO-MDT regimen, whereas 58 received 28 daily supervised doses of rifampicin 600mg...
متن کاملLong-term follow-up of ROM treated cases.
Single dose treatment with Rifampicin, Ofloxacin, Minocycline combination, (referred to as ‘ROM’) for ‘single lesion paucibacillary leprosy’ (or ‘SLBP’ leprosy) was introduced in 1997 on recommendation of the World Health Organisation (WHO), in response to the publication of a multi-centre trial carried out in India. Thousands of patients have been treated with this multidrug therapy (MDT) sinc...
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عنوان ژورنال:
- Indian journal of leprosy
دوره 84 3 شماره
صفحات -
تاریخ انتشار 2012