Abstract | BACKGROUND: METHODS: We retrospectively analysed the data on patients assigned to the control regimen (2H (3)R(3)Z(3)E(3)/4H(3)R(3)) in two clinical trials during 2001-06 at the National Institute for Research in Tuberculosis, Chennai, India. RESULTS: Of the 268 patients treated with this regimen, data for efficacy analysis were available for 249. At the end of treatment, of 249 patients, 238 (96%) had a favourable status. Treatment failure occurred in the remaining 11: 7 in whom the organisms were initially drug-susceptible and 4 with initial drug resistance. Of the 238 patients who had a favourable status at the end of treatment, 14 (6%) had recurrence of tuberculosis during the following 24 months. In the intention-to-treat analysis, 245 (94%) of 262 patients had a favourable status at the end of treatment. Of the 28 patients with initial drug resistance, 24 (86%) had a favourable outcome. Only 4 of these 24 patients were found to have recurrence of tuberculosis in 2 years of follow-up. Among the 221 patients initially infected with drug-susceptible organisms, drug resistance did not develop in any of the 7 patients in whom the treatment failed or the 10 who had recurrence of tuberculosis. Further, 5 of the 7 patients in whom the treatment failed continued to excrete drug-susceptible bacilli at 6 months. Adverse drug reactions were observed in 38 (14%) of the 262 patients. Only 3 (1.1%) needed a modification in the treatment. CONCLUSION:
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Authors | V V Banu Rekha, K Rajaram, A S Kripasankar, R Parthasarathy, K C Umapathy, I Sheikh, N Selvakumar, M Victor, C Niruparani, R Sridhar, M S Jawahar |
Journal | The National medical journal of India
(Natl Med J India)
2012 Jul-Aug
Vol. 25
Issue 4
Pg. 196-200
ISSN: 0970-258X [Print] India |
PMID | 23278775
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | Copyright 2012, NMJI. |
Chemical References |
- Antitubercular Agents
- Pyrazinamide
- Ethambutol
- Isoniazid
- Rifampin
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Topics |
- Adult
- Antitubercular Agents
(administration & dosage, adverse effects, therapeutic use)
- Drug Resistance, Bacterial
- Drug Therapy, Combination
- Ethambutol
(therapeutic use)
- Female
- Humans
- Intention to Treat Analysis
- Isoniazid
(therapeutic use)
- Male
- Pyrazinamide
(therapeutic use)
- Recurrence
- Rifampin
(therapeutic use)
- Sputum
(microbiology)
- Treatment Outcome
- Tuberculosis
(drug therapy)
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