[Therapeutic trial of a combination of isoniazid, rifampicin and pyrazinamide in the first 2 months of treatment of pulmonary tuberculosis].

250 patients suffering from smear positive pulmonary tuberculosis who had never been treated before, received a six-month regimen combining isoniazid and rifampicin every day with a supplement of pyrazinamide for the first eight weeks of treatment. The three drugs given during the initial phase of therapy were administered in two different forms: either as separate tablets or in a form combining all three drugs in fixed proportions (each tablet contained 50 mg of isoniazid, 120 mg of rifampicin and 300 mg of pyrazinamide). The patients were randomised into two groups of 125 receiving one or other combination of medications with the dose adapted for their weight. An analysis of the results at the end of the second month of treatment was carried out on 240 cases who could be analysed for tolerance and acceptability and in 193 cases who were analysed for the efficacy of therapy as judged by negative cultures. The treatment results were excellent in both groups, as was patient acceptability. The level of side effects was significantly lower in the group receiving combined medication (p less than 0.02). Both groups gave a similar proportion of negative cultures at the end of two months. The combined medicaments studied are thus well tolerated and at least as effective as individual drugs. They may thus replace them.

RCT Entities:   Population Interventions Outcomes