Under the programme condition, 3 regimens of ethambutol plus morphazinamide plus kanamycin and ethambutol plus morphazinmide plus rifampicin are being compared in the management of patients at Health Centres with pulmonary tuberculosis whose first-lire chemotherapy has failed. A total of 1,017 patients with sputum positive pulmonary tuberculosis, who had previously been treated with first-line drugs for more than one year but not with the drugs under study, were allocated at random to: EMK(1) ethambutol (24 months) plus morphazinamide (24 months) plus kanamycin (6
months) daily; EMK(2) ethambutol (24 months) plus morphazinamide (12 months) plus kanamycin (6 months) daily: EMK(3) ethambutol (12 months) plus morphazinamide (24 months) plus kanamycin (6 months) daily; and EMR ethambutol (12 months) plus morphazinamide (12 months) plus rifampicin(12 months) daily. There were 869 patients (214 EMK(1), 226 EMK(2), 215 EMK(3), 214 EMR) in the main comparison. Of 869 patients admitted to the study, 751 (86%) completed 1 year’s treatment, 118 (14%) patients terminated their treatment prematurely before 1 year. As assessed at 12 months, a bacteriologically favourable response was achieved in 41% of 182 EMK(1), 43% of 195 EMK(2), 39% of 182 EMK(3) and 70% of 192 EMR. EMR regimen wart significantly better than three EMK regimens. Bacteriological relapse rate calculated by Life Table method, in the second year of treatment was 13% in EMK(1), 22% in EMK(2), 20% in EMK(3) and 10% in EMR. The radiographic improvement was, on the whole, not significant. Adverse reactions were uncommon, 38 interrupted temporarily and 11 terminated their treatment completely due to adverse reactions.
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