02697nas a2200481 4500000000100000008004100001260001300042653001500055653001000070653000900080653001000089653001000099653001600109653001200125653003000137653001100167653001100178653001000189653002300199653001200222653000900234653001600243653001300259653002900272653002200301100001300323700001500336700001400351700001300365700001300378700002000391700001700411700001500428700001300443700001400456700001500470245015800485856007700643300001200720490000700732520146200739022001402201 2008 d c2008 May10aAdolescent10aAdult10aAged10aChild10aChina10aClofazimine10aDapsone10aDrug Therapy, Combination10aFemale10aHumans10aIndia10aLeprostatic Agents10aleprosy10aMale10aMiddle Aged10aRifampin10aSkin Diseases, Bacterial10aTreatment Outcome1 aKroger A1 aPannikar V1 aHtoon M T1 aJamesh A1 aKatoch K1 aKrishnamurthy P1 aRamalingam K1 aJianping S1 aJadhav V1 aGupte M D1 aManickam P00aInternational open trial of uniform multi-drug therapy regimen for 6 months for all types of leprosy patients: rationale, design and preliminary results. uhttp://onlinelibrary.wiley.com/doi/10.1111/j.1365-3156.2008.02045.x/epdf a594-6020 v133 a
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.
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