Split-drug regimens for the treatment of patients with sputum smear-positive pulmonary tuberculosis – a unique approach

Tuberculosis Research Centre , Chennai (2004) Split-drug regimens for the treatment of patients with sputum smear-positive pulmonary tuberculosis – a unique approach. Tropical Medicine and International Health, 9 (5). pp. 551-558. ISSN Print: 1360-2276; Online: 1365-3156

PDF 200403.pdf - Published Version Restricted to Registered users only Download (90kB) | Request a copy

Abstract

objective To evaluate the efficacy of split-drug regimens for treatment of patients with sputum smear-positive pulmonary tuberculosis in south India. design Randomized controlled clinical trial where eligible patients were randomly allocated to: (i) 2RE3HZ3(alt)/4RH2 (split I): rifampicin plus ethambutol given on one day and isoniazid plus pyrazinamide the next day for first 2 months followed by rifampicin plus isoniazid twice weekly for 4 months, or (ii) 3RE3HZ3(alt)/3RH2 (split II): similar to regimen 1, except duration was 3 months in each phase, or (iii) 2REHZ3/4RH2 (control): rifampicin, isoniazid, ethambutol and pyrazinamide, given thrice weekly for 2 months followed by isoniazid and rifampicin twice weekly for 4 months. All patients were followed up clinically and bacteriologically every month up to 2 years and every 6 months for up to 5 years. results A favourable response (cultures negative for Mycobacterium tuberculosis during the last 2 months of treatment) was observed in 91% of 407 patients in split I, 94% of 415 in split II and 89% of 418 in the control regimen. Ninety-one per cent of 370 patients in split I, 93% of 389 in split II and 90% of 370 in control regimens had quiescent disease at the end of 60 months. Gastrointestinal symptoms were more frequent under the control regimen (P ¼ 0.01). conclusion Split-drug regimens were as effective as the control regimen in terms of favourable response at the end of treatment and quiescent disease at 5 years, and caused fewer gastrointestinal side-effects.

Item Type:	Article
Additional Information:	Study Paper
Uncontrolled Keywords:	pulmonary tuberculosis, split drug regimens, controlled clinical trial
Subjects:	Tuberculosis > Clinical Research
Divisions:	Clinical Research
Depositing User:	Dr. Rathinasabapati R
Date Deposited:	19 Nov 2013 07:52
Last Modified:	09 Mar 2016 10:38
URI:	http://eprints.nirt.res.in/id/eprint/639

Actions (login required)

View Item