Once-monthly rifampicin plus daily dapsone in initial treatment of lepromatous leprosy.

In an international multicentre controlled single-blind trial of 93 previously untreated lepromatous leprosy patients the therapeutic effects of adding rifampicin, 450 mg/day orally or 1,200 mg once monthly in a single oral dose, to dapsone (50 mg/day orally) for the first 6 months of treatment were compared. Clinical and histopathological improvements and bacteriological regression, indicated by the decreases in the bacterial and morphological indices of the skin and nose-blow smears, were satisfactory and practically identical after 6 months' treatment. The once-monthly rifampicin schedule was better tolerated than the daily one. In view of the good therapeutic efficacy and tolerability, the much lower cost of treatment (about one-tenth of that of the daily rifampicin regimen) and the possibility of administration under supervision, once-monthly rifampicin given in a single oral 1,200 mg dose should be recommended, along with a standard dapsone regimen, for large-scale, initial, and intensive combination treatment of patients with lepromatous and borderline-lepromatous leprosy, to help prevent an increase in dapsone resistance. A third antileprosy drug (e.g., clofazimine) may be added to this initial dual-treatment regimen.

[Developmental aspects of the Rubino reaction]. / Aspectos evolutivos de reação de Rubino.

The Rubino reaction was studied in 178 leprosy patients to correlate its positivity, clinical form, E.N.L., and time and activity of the disease. The patients studied were classified according to the criteria established by the 1953 Madrid Congress. The results show that the tuberculoid patients presented negative Rubino reactions regardless of any of the parameters studied. The borderline patients showed 9% positive Rubino reaction not related to any of the observed parameters studied. The lepromatous patients showed a significant difference of positivity to the Rubino reaction when grouped as to the disease's active or non-active presence. Active lepromatous patients showed 55% of positivity to the Rubino reaction whereas patients considered clinically inactive showed only 6% of positivity. The fact that the Rubino reaction is negative in the majority of patients who are clinically cured would indicate that this test could be included as part of the criteria used in determining which clinically cured lepromatous patients can discontinue medication without risking a relapse.

A controlled trial to compare the therapeutic effects of dapsone in combination with daily or once-monthly rifampin in patients with lepromatous leprosy.

In this controlled trial in 35 patients with lepromatous leprosy the therapeutic effects of adding rifampin 450 mg daily (Regimen A) or 1200 mg once a month (Regimen B) to a standard dapsone regimen of 50 mg daily were practically identical. Moderate to marked clinical improvement was observed in 88% and 83% of the patients treated with Regimens A and B respectively. The average rates of decrease in the MI of the skin smears and nose-blow smears were similar. The average decreases in the BI of the skin smears were 0.7 and 0.6 in patients on the Regimen A and B respectively. Following 6 months' treatment with Regimens A and B the average decreases in the Logarithmic Bacterial Indexes of Biopsies were 4.7% and 7% respectively. The once-monthly rifampin schedule was well tolerated and did not lead to "flu" syndrome, anuria, oliguria, hemolytic anemia, thrombocytopenia, or anaphylactic shock. This trial revealed the satisfactory efficacy, good tolerability, and practicability of a supervised once-monthly 1200 mg single oral dose rifampin schedule as a component of combination regimes for the initial treatment of patients with lepromatous (LLs and LLp) leprosy.