The efficacy of a four-week, ofloxacin-containing regimen compared with standard WHO-MDT in PB leprosy.
OBJECTIVE
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.


METHODS
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 + ofloxacin 400 mg, plus 5 months of placebo. Patients were regularly monitored for clinical response and for signs of relapse after treatment completion.


RESULTS
Patients enrolled in the ofloxacin group had a mean follow-up of 10.8 years (628 patient-years) with 1 early relapse at 3 years after treatment completion. On relapse, this patient remained smear negative but was reclassified by current WHO criteria (> or =6 skin lesions) as multibacillary (MB). Patients on the WHO-MDT regimen had a mean follow-up of 11.3 years (749 patient-years) with two late relapses at 8 and 12 years, both still classified as PB on relapse.


CONCLUSIONS
In conclusion, both regimens appeared generally efficacious, and, in particular, resulted in few relapses.
Balagon
Marivic F
MF
Leonard Wood Memorial Center for Leprosy Research, Cebu, Philippines. csc_epi@yahoo.com
Cellona
Roland V
RV
Abalos
Rodolfo M
RM
Gelber
Robert H
RH
Saunderson
Paul R
PR
D000328:Adult; D003622:Dapsone / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007917:Leprostatic Agents / Q000627:therapeutic use*; D056005:Leprosy, Paucibacillary / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use*; D012008:Recurrence; D012293:Rifampin / Q000627:therapeutic use*; D012867:Skin / Q000382:microbiology; D013997:Time Factors; D016896:Treatment Outcome; D014944:World Health Organization
D007917:Leprostatic Agents; D003622:Dapsone; D015242:Ofloxacin; D012293:Rifampin