Study of chemotherapy regimens of 5 and 7 months duration and the role of corticosteroids in the treatment of sputum-positive patients with pulmonary tuberculosis in South India

Tuberculosis Research Centre , Madras (1983) Study of chemotherapy regimens of 5 and 7 months duration and the role of corticosteroids in the treatment of sputum-positive patients with pulmonary tuberculosis in South India. Tubercle, 64 (2). pp. 73-91. ISSN 0041-3879

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Abstract

A controlled clinical trial of 3 short-course chemotherapy regimens was undertaken in patients with bacteriologically positive, newly diagnosed pulmonary tuberculosis. The patients were allocated at random to receive one of 3 regimens: rifampicin, streptomycin, isoniazid and pyrazinamide daily for 2 months, followed by streptomycin, isoniazid and pyrazinamide twice weekly for 3 months (R/5) or for 5 months (R/7), and the same regimen as R/7 but without rifampicin (Z/7). Further, half the patients in each series, selected at random, were prescribed daily prednisolone for the first 8 weeks. Of the 509 patients admitted to this phase of the trial, 390 had pre-treatment sputum cultures sensitive to isoniazid and streptomycin. At 2 months, in 92 % of R/5 and R/7 patients (combined) and in 72% of Z/7 patients all cultures were negative (P<0.00001). All 390 patients had a favourable response at the end of chemotherapy. At follow up for 24 months from the time of admission a bacteriological relapse requiring retreatment was observed in 5.4 % of R/5, 0.0 % of R/7 and 3.9 % of Z/7 patients. The differences between R/7 and each of the other 2 series were significant (P < 0.03). Including a second phase of the study to increase the numbers in the Z/7 series, a total of 269 patients with drug-sensitive sputum cultures received the Z/7 regimen. All of them had a favourable response to treatment and only 2.6 % had a bacteriological relapse requiring retreatment. These results demonstrate that in patients with drug-sensitive cultures, good results can be achieved with a shortcourse regimen that does not include rifampicin. Among patients with sputum cultures resistant to both isoniazid and streptomycin, 6 of 23 in the R/5 and R/7 series had an unfavourable response to treatment, compared with 13 of 16 in the Z/7 series (P<0.01). These results demonstrate that in patients with drug-resistant cultures, short course regimens that do not include rifampicin may be unsatisfactory. Prednisolone given for the first 8 weeks did not influence the speed of sputum conversion or the response to chemotherapy in patients with drug-sensitive cultures and it had no effect on the rate of bacteriological relapse. However, in patients with cultures resistant to streptomycin and isoniazid the response to chemotherapy was less favourable in those who had taken prednisolone than in those who had not. Thus, 4 of 12 receiving prednisolone in the R/5 and R/7 series had an unfavourable response compared with 2 of 11 not receiving it (P>0.2), and all of 10 and 3 of 6, respectively, in the Z/7 series (P =0.04). The most common adverse drug reaction was arthralgia, which was complained of by 24 % of patients in the R/5 and R/7 series and 46 % in the Z/7 series (P<0.001) ; all except 5 continued their normal activities without any interruption or modification of the regimen. Hepatitis occurred in 17 (2.5 %) patients.

Item Type:	Article
Subjects:	Tuberculosis > Clinical Research Tuberculosis > Epidemiological Research
Divisions:	Clinical Research
Depositing User:	Dr. Rathinasabapati R
Date Deposited:	06 Aug 2013 10:42
Last Modified:	16 Mar 2016 05:24
URI:	http://eprints.nirt.res.in/id/eprint/167

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