[Results of a therapeutic trial comparing a 6-month regimen to a 12-month regimen in the treatment of pulmonary tuberculosis in the Algerian Sahara. Final report: results 3 years after the onset of treatment].

This study has compared a daily 6-month short-course chemotherapy regimen and a daily 12-month standard duration regimen in the treatment of smear positive pulmonary tuberculosis in a rural area of Algeria where the population contains a relatively high proportion of nomads. The 6-month regimen (6M) was isoniazid and rifampicin throughout with ethambutol and pyrazinamide in addition for the first 2 months, and the 12-month regimen (12M) was isoniazid and ethambutol supplemented by streptomycin during the first month. All the 601 patients admitted had one or more sputum smears positive on examination in the local laboratory and 70% had a positive culture in the reference laboratory in Algiers. Most patients were admitted to hospital initially for one or two months where chemotherapy was fully supervised and subsequently it was self-administered. In both nomads and settled residents known to have fully sensitive strains of tubercle bacilli pretreatment the 6-month regimen was highly effective with no failures during chemotherapy and only 3% relapses after stopping chemotherapy in 126 patients compared with a combined failure rate during chemotherapy and relapse rate of 21% in the 152 patients receiving the 12-month regimen (P less than 0.001). The results in patients with isoniazid-resistant strains pretreatment were also significantly better for the 6-month than for the 12-month regimen, one of 15 and 8 of 17 patients respectively being classified as failures or relapses (P = 0.03). To assess the results which might be achieved by these regimens under programme conditions the outcome at 3 years was also assessed in all patients admitted to the study irrespective of whether the disease was confirmed in the reference laboratory or at independent assessment and whether or not the allocated chemotherapy was modified or further courses of chemotherapy were given. At 3 years, 82% of the 6M and 80% of the 299 12M patients had achieved a favourable status and only one 6M patient and 4 12M patients were still known to have active disease with a positive culture. A further 23 6M and 22 12M patients were known to have died, 11 in each series probably or definitely from tuberculosis. The remaining 28 6M and 34 12M patients were lost from follow-up, but 24 and 22 respectively had completed their allocated chemotherapy before defaulting. It was estimated that, overall, 272 (94%) of the 6M and 263 (91%) of the 12M patients had a favourable status at 3 years.(ABSTRACT TRUNCATED AT 400 WORDS)