Primary results of clinical trial for uniform multidrug therapy for leprosy patients in Brazil (U-MDT/CT-BR): reactions frequency in multibacillary patients.
METHODS
Many believe that the regular treatment for multibacillary (MB) leprosy cases could be shortened. A shorter treatment, allowing for uniform treatment for all cases, makes case classification superfluous and therefore simplifies leprosy control.


OBJECTIVE
To evaluate the association of the treatment duration with the frequency of reactions among MB patients.


METHODS
An open-label randomised clinical trial to compare the present routine treatment with one lasting six months. Patients were recruited between March 2007 and February 2012. We analysed the frequency of first reaction with the Kaplan-Meier method and of recurrent reaction with a Poisson regression, using the treatment group and baciloscopic index level (BI) as independent variables. Logistic regression was used to evaluate the statistical association of different reaction types and the treatment group.


RESULTS
Among those with BI < 3, we found a statistical significant difference of reaction frequencies between the treatment groups from 6 to 18 months since the beginning of treatment. This difference disappears at 2 years after the start of treatment. Multiple reactions were associated with the treatment group and with BI > or = 3. No specific types of reactions were associated with treatment duration.


CONCLUSIONS
Although this is the first report of U-MDT/CT-BR, the results presented here support the possibility of use of UMDT in the field.
Tropical Pathology and Public Health Institute, Federal University of Goias, Goiania, Goias, Brazil.
Maria Lucia Fernandes
ML
Penna
Samira
S
Buhrer-Sékula
Maria Araci De Andrade
MA
Pontes
Rossilene
R
Cruz
Heitor De Sá
Hde S
Gonçalves
Gerson Oliveira
GO
Penna
D000328:Adult; D001938:Brazil / Q000453:epidemiology; D004359:Drug Therapy, Combination; D004893:Erythema Nodosum / Q000175:diagnosis / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D007917:Leprostatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D056006:Leprosy, Multibacillary / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009166:Mycobacterium leprae / Q000187:drug effects* / Q000302:isolation & purification; D009443:Neuritis / Q000175:diagnosis / Q000453:epidemiology; D010525:Peripheral Nerves / Q000503:physiopathology; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome; D014944:World Health Organization
D007917:Leprostatic Agents