[Clinical trial of a combination of three drugs in fixed proportions in the treatment of tuberculosis. Groupe de Travail sur la Chimiothérapie de la Tuberculose].
METHODS
The Matiben Chest Clinic at the West Algiers University Teaching Hospital, and 3 outpatient clinics specializing in tuberculosis and lung disease in Algiers.


OBJECTIVE
To determine the tolerance and efficacy of a fixed proportion combination of 3 antituberculosis drugs (per tablet: 50 mg isoniazid + 120 mg rifampicin + 300 mg pyrazinamide) given during the first 2 months of a daily 6-month chemotherapy regimen.


METHODS
Random prospective treatment trial comparing a group of 124 patients receiving the triple combination with another group of 126 patients receiving the 3 drugs separately during the initial treatment phase. The continuation phase was identical for the 2 groups. Comparison of tolerance in the first 2 months, and of the failure and relapse rates (respectively at the end of treatment and 24 months after the end of treatment).


RESULTS
During the first 2 months side-effects were significantly more common in the group receiving the drugs separately. At the end of treatment and during the following 24 months there were no significant differences in the cumulative rates of observed failures and relapses (2% and 1%).


CONCLUSIONS
The triple combination studied could replace the separate drugs in the initial treatment phase in countries where the bioavailability of the drugs used has been proven.
D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents; D000995:Antitubercular Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D007538:Isoniazid / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011718:Pyrazinamide / Q000009:adverse effects; D012008:Recurrence; D012293:Rifampin / Q000009:adverse effects; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D000995:Antitubercular Agents; D011718:Pyrazinamide; D007538:Isoniazid; D012293:Rifampin
Essai clinique d'une combinaison en proportions fixes de trois medicaments dans le traitement de la tuberculose. Groupe de Travail sur la Chimiothérapie de la Tuberculose.