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Free Content International open trial of uniform multi-drug therapy regimen for 6 months for all types of leprosy patients: rationale, design and preliminary results

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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%. 6%;  < 0.001). At the end of the first ( = 2013) and second year ( = 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;  < 0.001). Conclusion  U-MDT appears to be promising with respect to clinical status of skin lesions.


Décrire la logique, la conception et les résultats préliminaires d’un essai clinique ouvert de 6 mois avec une thérapie uniforme multi-médicamenteuse (U-MDT) pour tous les types de lèpre en supposant un taux cumulé de rechute ne dépassant pas 5% sur 5 ans de suivi. Méthodes 

Nous avions l’intention de recruter 2500 patients autant dans le groupe des multibacillaires (MB) que chez les paucibacillaires (PB) de l’Inde (5 centres) et de la Chine (2 centres). Des critères cliniques standardisés ont été utilisés pour évaluer les lésions cutanées sur le terrain. Résultats 

2912 patients ont été recrutés entre novembre 2003 et mai 2007 (Inde: 2746, Chine: 166). Les patients MB représentaient 39% et 3% avaient un handicap de grade 2. Au cours du suivi, 27 patients (0,9%) ont développé de nouvelles lésions. Pour 78% de ceux-ci, il s’agissait de réactions normales. Des rechutes ont été confirmées cliniquement chez 6 patients. La pigmentation de la peau liée à clofazimine était de courte durée et était acceptable pour les patients. Nous avons analysé les données de l’état clinique des lésions de la peau. 2,9% des patients ont été perdus au suivi; 85,9% ont terminé leur traitement dont 19% avec des lésions inactives de la peau. Les patients PB ont répondu mieux au traitement que les patients MB (27% contre 6%; P < 0,001). À la fin de la première (n = 2013) et de la deuxième année (n = 807) de suivi post U-MDT, les lésions étaient inactives chez 49% et 46% des patients, respectivement (59% et 57% chez les PB, 37% et 28% chez les MB, P < 0,001). Conclusion 

l’ U-MDT semble être prometteuse à l’égard de l’état clinique des lésions de la peau.
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Keywords: Ensayo quimioterapia lepra; clinical trial; ensayo clínico; essai chimiothérapique de la lèpre; essai clinique; leprosy chemotherapy trial; múltiples medicamentos; terapia uniforme; thérapie uniforme multi-médicamenteuse; uniform multi-drug therapy

Document Type: Research Article

Affiliations: 1:  UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), WHO, Switzerland 2:  WHO Regional office for South-East Asia, New Delhi, India 3:  Office of the Deputy Director of Medical Services (Leprosy), Villupuram, Tamil Nadu, India 4:  National JALMA Institute of Leprosy and other Mycobacterial diseases, Agra, Uttar Pradesh, India 5:  Damien Foundation India Trust, Chennai, Tamil Nadu, India 6:  Office of the Deputy Director of Medical Services (Leprosy), Tiruvannamalai, Tamil Nadu, India 7:  National Center for STD and Leprosy Control, Nanjing, China 8:  Principal Investigator-U-MDT trial Pune centre, Pune, Maharashtra, India 9:  National Institute of Epidemiology, Chennai, Tamil Nadu, India

Publication date: 2008-05-01

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