Premium
Ensayo abierto e internacional con regimenes uniformes de múltiples medicamentos durante seis meses para todo tipos de pacientes leprosos: fundamento, diseño y resultados preliminares
Author(s) -
Kroger Axel,
Pannikar V.,
Htoon M. T.,
Jamesh A.,
Katoch K.,
Krishnamurthy P.,
Ramalingam K.,
Jianping Shen,
Jadhav Vitthal,
Gupte M. D.,
Manickam P.
Publication year - 2008
Publication title -
tropical medicine and international health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.056
H-Index - 114
eISSN - 1365-3156
pISSN - 1360-2276
DOI - 10.1111/j.1365-3156.2008.02045.x
Subject(s) - medicine , clofazimine , regimen , clinical trial , surgery , leprosy , dermatology
Summary Objective To describe the rationale, design and preliminary results of an open trial of 6 months uniform multi‐drug therapy (U‐MDT) for all types of leprosy patients assuming a cumulative relapse rate not exceeding 5% over 5 years of follow‐up. Methods We intended to recruit 2500 patients each in multi‐bacillary (MB) and pauci‐bacillary (PB) groups from India (five centres) and China (two centres). Standardized clinical criteria were used to assess skin lesions in the field. Results A total of 2912 patients enrolled from November 2003 to May 2007 (India, 2746; China, 166). MB patients constituted 39% and 3% had grade 2 disability. During follow‐up, 27 patients (0.9%) developed new lesions. Of these, 78% were on account of reactions. Six patients had clinically confirmed relapse. Clofazimine‐related skin pigmentation was short‐lived and was acceptable to patients. We analysed data for clinical status of skin lesions. About 2.9% of patients were lost to follow‐up; 85.9% completed treatment, of whom 19% had inactive skin lesions. PB patients responded better than MB patients (27% vs . 6%; P < 0.001). At the end of the first ( n = 2013) and second year ( n = 807) of follow‐up post‐U‐MDT, in 49% and 46% patients, lesions were inactive, respectively (59% and 57% in PB, 37% and 28% in MB; P < 0.001). Conclusion U‐MDT appears to be promising with respect to clinical status of skin lesions.