A controlled clinical trial of 3- and 5-month regimens in the treatment of sputum-positive pulmonary tuberculosis in South India.
Tuberculosis Research Centre; National Tuberculosis Institute.
American Review of Respiratory Diseases; 1986; 134; 27-33.
A controlled comparison of 3 short-course regimens was undertaken in patients with newly diagnosed, sputum-positive, pulmonary tuberculosis in South India. The regimens were: (1) R 3 : rifampicin plus streptomycin plus isoniazid plus pyrazinamide daily for 3 months; (2) R 5 :the same as regimen R 3 followed by streptomycin plus isoniazid plus pyrazinamide twice-weekly for 2 months; (3) Z 5 : the same as regimen R 5 but without rifampicin. The distribution of various pretreatment characteristics were similar in the 3 series. At the end of treatment, 6 patients (3 R 3 , 3 Z 5 ) of 694 (228 R 3 , 230 R 5 , 236 Z 5 ) with drug-sensitive organisms initially were classified as having an unfavourable response. By 24 months (21 months of follow-up for the R 3 regimen and 19 months for the R 5 and Z 5 regimens), a bacteriologic relapse requiring treatment occurred in 20% of 200 R 3 , 4% of 187 R 5 , and 13% of 199 Z 5 patients, the difference between the R 3 and R 5 series being highly significant (p=0.00001). Considering patients with cultures initially resistant to isoniazid, 4 of 57 in the R 3 and R 5 series combined had an unfavourable response to treatment compared with 13 of 26 in the Z 5 series (p<0.00010). Of the 4 patients with an unfavourable response in the R 3 and R 5 series combined resistance to rifampin emerged in 2. Complaints of arthralgia were made by 45% of the R 3 and R 5 patients combined and 70% of the Z 5 patients
(p <0.00001). However, chemotherapy was modified in only 5 and 12%, respectively. Jaundice occurred in 7% of the R 3 and R 5 patients and 1% of the Z 5 patients (p<0.00001).
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