Ofloxacin-containing combined drug regimens in the treatment of lepromatous leprosy.

A total of 26 clinically diagnosed adult patients, with active untreated lepromatous leprosy, with a Bacteriological Index of 4+ or more, were admitted to the hospital of the Central Leprosy Teaching and Research institute, Chengalpattu, India, between 1989 and 1991. After prescribed investigations, the patients were randomly allocated in groups of 3 to 3 treatment regimens, namely: 1, clofazimine 50 mg daily and 300 mg once in 4 weeks + dapsone 100 mg daily (AA); 2, (AA)+ofloxacin 400 mg daily (BB); and 3, (AA)+ofloxacin 800 mg daily (CC). The drugs were administered for 56 days continuously under supervision. Sequential biopsy results on day 0, 7, 14, 28 and 56 in normal mouse footpad revealed no growth by day 28 and 56 in all patients treated with CC and BB regimens, respectively. Calculation of the proportion of viable Mycobacterium leprae through analysis of median infectious dose (ID50) showed significant differences on day 7 in the percentage of kill between the ofloxacin-containing regimens and the other. Moderate to marked clinical improvement has been observed in a significantly higher proportion of patients treated with ofloxacin-containing regimens. All the 3 regimens were well tolerated. No severe complications or side-effects to the drugs were noticed with any of the regimens that required any suspension of treatment or the administration of steroids. Addition of ofloxacin to the standard WHO recommended MDT regimen for multibacillary patients may reduce the present duration of therapy. Ofloxacin may also be considered as an alternative drug in rifampicin-resistant cases or where rifampicin is contraindicated.