A randomized clinical trial of two single-dose treatments for paucibacillary leprosy.
We compared 2 single-dose regimens for the treatment of paucibacillary leprosy in a randomized clinical trial in Zaïre. The regimens were: C2 (rifampicin 40 mg/kg and 1200 mg clofazimine once) and C4 (rifampicin 40 mg/kg, clofazimine 100 mg, DDS 100 mg and ethionamide 500 mg once). An analysis of the results of patients enrolled between May 1987 and December 1988, with a maximum follow-up of 4 years, is presented. A total of 622 patients were enrolled and 14 paucibacillary and 1 multibacillary relapses occurred. The overall paucibacillary relapse rate was 2.4 per 100 person years. This relapse rate was higher for older patients as well as for patients with 3 or more lesions. The probability of cure at 3 years is 0.816 for C2 and 0.823 for C4, the difference not being statistically significant. The probability of cure at 3 years with either regimen is higher for patients with 1 or 2 lesions (0.872) than for patients with 3 or more lesions (0.787), and it is higher for patients with a bacterial index of 0 (0.831) than for patients with a bacterial index of 1 (0.699). These results are compared to other studies. We also discuss the potential of single-dose treatment regimens for paucibacillary leprosy.
Pattyn
S R
SR
University of Antwerp, Belgium.
Ghys
P
P
Janssens
L
L
Tshilumba
K
K
Kuykens
L
L
Karibushi
N
N
Denis
P
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D002991:Clofazimine / Q000008:administration & dosage*; D003622:Dapsone / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005000:Ethionamide / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007223:Infant; D007918:Leprosy / Q000188:drug therapy* / Q000382:microbiology / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012008:Recurrence; D012293:Rifampin / Q000008:administration & dosage*
D003622:Dapsone; D002991:Clofazimine; D005000:Ethionamide; D012293:Rifampin