[Compliance, tolerance and effectiveness of a short chemoprophylaxis regimen for the treatment of tuberculosis]

Abstract

Objective: To evaluate compliance, side effects and the efficacy of a short course of chemoprophylaxis for tuberculosis with isoniazid plus rifampin during 3 months, compared with the classic course of isoniazid for 9 months.

Patients and methods: Prospective, comparative, randomized and open study of patients with the suitable criteria for chemoprophylaxis, in accordance with the guidelines of the Centers for Disease Control of 1990. Patients were divided into 2 groups: the group of isoniazid plus rifampin, received isoniazid (300 mg per day) plus rifampin (600 mg per day) for 3 months, and the group of isoniazid, that received isoniazid at a dose of 300 mg per day for 9 months.

Results: 238 patients were included, of which 42 refused chemoprophylaxis. Of the remaining 196 patients, 98 were included in each group. Both groups were comparable at base level. The side effects, neither light nor severe showed significant differences. The appearance of adverse effects obliged the suspension of treatment in 7 patients in group isoniazid and of 9 patients in group isoniazid plus rifampin. Three patients in group isoniazid plus rifampin and 11 in group isoniazid stopped treatment (OR 4.14, 95% CI 1.02-19.45; p = 0.04). Efficacy was comparable in the two groups; only one case of tuberculosis was detected in a patient who gave up chemoprophylaxis at day 30.

Conclusions: Tolerance in group isoniazid plus rifampin compared with group I was similar. Compliance was better in the short-term group with a lower percentage of abandonment. On comparing, both groups have shown similar efficacy in preventing the appearance of tuberculosis.