Received: December 22, 2006.

Accepted: December 22, 2006.

Abstract published online: January 29, 2007.

Full paper published online: February 28, 2007.

A THERAPEUTIC STUDY COMPARING THE ASSOCIATION OF RIFAMPIN, OFLOXACIN AND MINOCYCLINE WITH THE ASSOCIATION OF RIFAMPIN, CLOFAZIMINE AND DAPSONE IN MULTIBACILLARY LEPROSY PATIENTS

Thesis: S. Ura submitted this dissertation for his Masters in Tropical Diseases at Botucatu School of Medicine, São Paulo State University, UNESP, Botucatu, São Paulo, Brazil, 2007.

Advisor: Professor Benedito Barraviera

ABSTRACT: The present study compared two therapeutic schemes in multibacillary leprosy patients. Group 1 was the control group that received the conventional (Multi-drug therapy – multibacillary (rifampin, dapsone and clofazimine) MDT-MB) treatment. Group 2 was the test group that received the association of rifampin 600mg, ofloxacin 400mg and minocycline 100mg (ROM), administered once a month under supervision. Both groups were treated for two years. Initial evaluation of patients included: clinical examination, bacilloscopy, and histology. Bacilloscopy and skin biopsy were repeated at the end of the first and second years of treatment. Clinical evaluation was performed monthly concomitantly to administration of drugs. Fourteen patients were evaluated in Group 1. Bacilloscopic index (BI) before treatment varied from 2 to 4.8. Twelve patients were evaluated in Group 2. The BI before treatment in this group varied from 1.6 to 4.8. Both groups presented cutaneous lesions characteristic of the lepromatous type. The histological picture resembled active lepromatous leprosy, except for one patient of Group 2. At the end of the first year of treatment, all patients showed clinical improvement, the BI decreased and they presented regressive histological picture. This tendency to improvement was maintained and at the final evaluation in the second year all patients showed even better clinical, bacilloscopic and histological improvement. The statistical analysis of bacilloscopic and histological parameters showed there were not significant differences between the groups studied; therefore, treatments were equally efficacious. Occurrence of type 2 (erythema nodosum leprosum – ENL) reactional episodes was similar in both groups. In Group 1, all patients presented skin pigmentation due to clofazimine. These results demonstrated that monthly administration of rifampin plus ofloxacin plus minocycline is as efficacious and secure as the conventional scheme. Besides, it presents the advantage of not provoking skin pigmentation, it is given under supervision and can be used as an alternative treatment scheme.

We pay homage to Professor Diltor Vladimir Araújo Opromolla – in memoriam.

KEY WORDS: multibacillary leprosy, rifampin, ofloxacin, minocycline, dapsone, clofazimine.

CORRESPONDENCE TO:

SOMEI URA, Departamento de Doenças Tropicais e Diagnóstico por Imagem, Faculdade de Medicina de Botucatu, UNESP, Distrito de Rubião Junior, s/n, 18618-000, Botucatu, SP, Brasil. Phone: 55 14 3811 6212. Email: somei.blv@terra.com.br