Русский
Evaluation of the effectiveness of the new anti-tuberculosis drug thiozonide in patients with pulmonary tuberculosis with multi- and extensive drug resistance of Mycobacterium tuberculosis
DOI: https://dx.doi.org/10.18565/pharmateca.2023.14.112-117
A.Y. Savchenko, G.V.Ramenskaya, V.G. Kukes, N.V. Shilova
1) I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia; 2) Federal State Institution of Science «Scientific Center of Biomedical Technology of the Federal Medical-Biological Agency of Russia», Svetlye Gory Village, Krasnogorsk District, Moscow region, Russia; 3) Clinical Pharmacology Branch Federal State Institution of Science «Scientific Center of Biomedical Technology of the Federal Medical-Biological Agency of Russia», Moscow, Russia; 4) GEN-LAB ltd, Moscow, Russia
Objective. Evaluation of the effectiveness of the drug tiozonide included in a comprehensive treatment regimen for patients diagnosed with multidrug-resistant (MDR-TB) or extensive drug-resistant (XDR-TB) pulmonary tuberculosis.
Methods. Evaluation of the safety and efficacy of tiozonide in 160 patients diagnosed with MDR-TB or XDR-TB who were treated as inpatients or outpatients in a multicenter clinical trial, against standard antituberculosis chemotherapy in patients diagnosed with multidrug-resistant or extensive drug-resistant pulmonary tuberculosis. As the main criterion for the effectiveness of combination treatment of patients with MDR and XDR tuberculosis using various doses of the drug thiozonide compared with placebo, the dynamics of the quantitative content of Mycobacterium tuberculosis (MBT) in the sputum of patients, determined by bacterioscopic and bacteriological methods, was assessed.
Results. Analysis of the results of bacterioscopic studies showed a significant decrease in bacterial excretion in patients during long-term treatment in the tiozonide treatment groups. It was most pronounced when taking 400 mg and amounted to 93% at the 10th visit (84th day of treatment) compared to the baseline indicator. Analysis of the results of bacteriological studies, as well as sputum bacterioscopy, showed a significant increase in the rate of decline in bacteriological test indicators in patients taking thiozonide. This reduction was most pronounced in the 400 mg group and amounted to 2 points or 95% at the last 10th visit compared to the pre-treatment value of 2.1 points. Treatment in this group resulted in the absence of MBT in the sputum of most patients.
Conclusion. The results of the evaluation of the effectiveness of the drug thiozonide in the complex therapy of patients with MDR- and XDR-TB demonstrated that the use of thiozonide in doses of 400 and 600 mg ensured the achievement of a complex primary endpoint compared with placebo in relation to the dynamics of MBT content in sputum according to the bacterioscopic and bacteriological methods. The data obtained allow to justify the sample size and treatment regimen for the third phase study of the drug thiozonide.
Methods. Evaluation of the safety and efficacy of tiozonide in 160 patients diagnosed with MDR-TB or XDR-TB who were treated as inpatients or outpatients in a multicenter clinical trial, against standard antituberculosis chemotherapy in patients diagnosed with multidrug-resistant or extensive drug-resistant pulmonary tuberculosis. As the main criterion for the effectiveness of combination treatment of patients with MDR and XDR tuberculosis using various doses of the drug thiozonide compared with placebo, the dynamics of the quantitative content of Mycobacterium tuberculosis (MBT) in the sputum of patients, determined by bacterioscopic and bacteriological methods, was assessed.
Results. Analysis of the results of bacterioscopic studies showed a significant decrease in bacterial excretion in patients during long-term treatment in the tiozonide treatment groups. It was most pronounced when taking 400 mg and amounted to 93% at the 10th visit (84th day of treatment) compared to the baseline indicator. Analysis of the results of bacteriological studies, as well as sputum bacterioscopy, showed a significant increase in the rate of decline in bacteriological test indicators in patients taking thiozonide. This reduction was most pronounced in the 400 mg group and amounted to 2 points or 95% at the last 10th visit compared to the pre-treatment value of 2.1 points. Treatment in this group resulted in the absence of MBT in the sputum of most patients.
Conclusion. The results of the evaluation of the effectiveness of the drug thiozonide in the complex therapy of patients with MDR- and XDR-TB demonstrated that the use of thiozonide in doses of 400 and 600 mg ensured the achievement of a complex primary endpoint compared with placebo in relation to the dynamics of MBT content in sputum according to the bacterioscopic and bacteriological methods. The data obtained allow to justify the sample size and treatment regimen for the third phase study of the drug thiozonide.
Keywords: microbiological assessment of sputum, sputum microscopy, extensive drug resistance of Mycobacterium tuberculosis, multi-drug resistance of Mycobacterium tuberculosis, thiozonide, tuberculosis
About the Autors
Corresponding author: Natalya V. Shilova, Cand. Sci. (Med.), Director of GEN-LAB ltd, Moscow, Russia; nvshilova@gmail.com
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