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CLINICAL TRIAL
COMPARATIVE STUDY
CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
Comparison of the effectiveness of WHO short-course chemotherapy and standard Russian antituberculous regimens in Tomsk, western Siberia.
Lancet 2001 August 12
BACKGROUND: There has been a resurgence of tuberculosis in Russia in the past decade. Traditional Russian services for treatment of tuberculosis are very different from those in the west. We aimed to compare the effects of WHO short-course chemotherapy with standard Russian antituberculous regimens.
METHODS: New tuberculosis patients aged 18 years or older were included in a trial and systematically allocated to traditional Russian tuberculosis treatments or WHO short-course chemotherapy in the two largest tuberculosis diagnostic and treatment centres of Tomsk Oblast, western Siberia. Standard WHO tuberculosis outcomes and rates of sputum conversion were used as primary outcomes. Analyses were by intention-to-treat.
FINDINGS: 646 new cases were enrolled into the trial, of which 356 patients were given Russian tuberculosis treatment (155 smear positive) and 290 were given WHO short-course chemotherapy (155 smear positive). There was no statistical difference between the proportion cured or completing treatment (63% for both groups [difference in proportion=0%, 95% CI -11 to 11%]); or dying (short-course chemotherapy, 8% vs Russian, 11% [difference in proportion=-3%, 95% CI -9 to 4%]). There was no statistical difference with respect to sputum conversion rate at 6 months (91% vs 85% [difference in proportion=6%, 95% CI -2 to 13%]). Overall, outcomes were worse among patients with multidrug resistant isolates than non-resistant isolates.
INTERPRETATIONS: WHO short-course chemotherapy treatment for tuberculosis can work well in Russia.
METHODS: New tuberculosis patients aged 18 years or older were included in a trial and systematically allocated to traditional Russian tuberculosis treatments or WHO short-course chemotherapy in the two largest tuberculosis diagnostic and treatment centres of Tomsk Oblast, western Siberia. Standard WHO tuberculosis outcomes and rates of sputum conversion were used as primary outcomes. Analyses were by intention-to-treat.
FINDINGS: 646 new cases were enrolled into the trial, of which 356 patients were given Russian tuberculosis treatment (155 smear positive) and 290 were given WHO short-course chemotherapy (155 smear positive). There was no statistical difference between the proportion cured or completing treatment (63% for both groups [difference in proportion=0%, 95% CI -11 to 11%]); or dying (short-course chemotherapy, 8% vs Russian, 11% [difference in proportion=-3%, 95% CI -9 to 4%]). There was no statistical difference with respect to sputum conversion rate at 6 months (91% vs 85% [difference in proportion=6%, 95% CI -2 to 13%]). Overall, outcomes were worse among patients with multidrug resistant isolates than non-resistant isolates.
INTERPRETATIONS: WHO short-course chemotherapy treatment for tuberculosis can work well in Russia.
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