A controlled clinical trial of 3-and 5- month regimens in the treatment of sputum-positive pulmonary tuberculosis in South India

Tuberculosis Research Centre , Madras and National Tuberculosis Institute, Bangalore (2007) A controlled clinical trial of 3-and 5- month regimens in the treatment of sputum-positive pulmonary tuberculosis in South India. American Review of Respiratory Diseases, 134 (1). pp. 27-33. ISSN 0003-0805

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Abstract

A controlled compartson of 3 short-eourse regimens was undertaken In patlents with newly diagnosed, sputum-positive, pulmonary tuberculosis In SOuth India. The regimens were: (1) R3: rltampln plus streptomycin plus laonlll%ld plus pyrazinamide dally for 3 months; (2) R5: the same 8S regimen A3 followed by streptomycin plus Isonlezld plus pyrazinamide twice weekly for 2 months; (3) Z5: the same as regimen R5 but without rlfampln. The dlstrlbutlons ofvarlous pretreetment char& c1erlstlca were similar In the 3 series. At the end of treatment, 6 patients (3 R3, 3 Z5) of 694 (228 R3, 230 R5, 236 ZS) with drug-aenaltlve organlsmslnltlally were classified aa h!lYlng un unf!lYorable response. By 24 months (21 months of follow-up for the R3 regimen and 19 months for the R5 and ZS regimens), e bacteriologic relapse requiring treatment occurred In 20% of 200 R3, 4% of 187 R5, snd 13%of 199Z5 patients, the difference between the R311nd R5 series being highly significant (p = 0.00001). Considering patients with c.ultllres Initially resistant to laonlazld, 4 of 57 In the R3 and R5 series combined had an unfavorable responsa to tAlatment compared with 13 of 26 In the Z5 series (p <0.0001). Of the 4 patients with an untallorable response In the R3 and RS series combined, resistance to rllampln emerged In 2. Complaints of arthralgia were made by 45'11l of the R3 and AS patients combined and 70% ot the Z5 patients (p <: 0.00001). However, chemotherapy wes modified In only 5 and 12%, respectively. Jaundice occurred In 7% of the R3 and R5 patients and 1% of the ZS patients (p < 0.00001).

Item Type:	Article
Additional Information:	Study-13
Subjects:	Tuberculosis > Clinical Research
Divisions:	Clinical Research
Depositing User:	Dr. Rathinasabapati R
Date Deposited:	09 Jan 2014 09:49
Last Modified:	31 Mar 2021 04:33
URI:	http://eprints.nirt.res.in/id/eprint/819

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