EFFICIENCY AND SAFETY OF CHEMOTHERAPY REGIMEN WITH SQ109 IN THOSE SUFFERING FROM MULTIPLE DRUG RESISTANT TUBERCULOSIS
The objective of the study: to assess efficiency and safety of SQ109 used within standard treatment regimens for multiple drug resistant tuberculosis (MDR TB)Subjects and Methods A multi-center, double, blind, randomized, placebo-controlled study was conducted in two parallel groups from September 2...
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Format: | Article |
Language: | Russian |
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New Terra Publishing House
2018-04-01
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Series: | Туберкулез и болезни лёгких |
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Online Access: | https://www.tibl-journal.com/jour/article/view/1098 |
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author | S. E. Borisov E. M. Bogorodskaya G. V. Volchenkov E. V. Kulchavenya A. O. Maryandyshev S. N. Skornyakov O. B. Talibov A. M. Tikhonov I. A. Vasilyeva |
author_facet | S. E. Borisov E. M. Bogorodskaya G. V. Volchenkov E. V. Kulchavenya A. O. Maryandyshev S. N. Skornyakov O. B. Talibov A. M. Tikhonov I. A. Vasilyeva |
author_sort | S. E. Borisov |
collection | DOAJ |
description | The objective of the study: to assess efficiency and safety of SQ109 used within standard treatment regimens for multiple drug resistant tuberculosis (MDR TB)Subjects and Methods A multi-center, double, blind, randomized, placebo-controlled study was conducted in two parallel groups from September 21, 2012 to September 30, 2016, in 6 research centers located in 5 cities of the Russian FederationMain results 1 Cessation of bacillary excretion confirmed by cultures on liquid media by the end of the 6th month of the intensive phase of chemotherapy in pulmonary MDR TB patients receiving SQ109 was observed confidently more often versus treatment regimens containing only existing anti-tuberculosis drugs: both for ITT population (610% versus 429%, p = 00412), and PP population (797% versus 614%, p = 00486) 2 There were no statistically significant differences in the achievement of sputum conversion between the groups, but by the end of the 8th week, the sputum converted in 52% of patients in the group treated with SQ109 versus 38% in the group taking a placebo The median time of bacillary excretion cessation confirmed by culture on liquid media in SQ109 group made 56 days, while in the placebo group it was 84 days 3 Use of SQ109 along with basic chemotherapy for pulmonary MDR TB did not result in the higher frequency of adverse events, worsening of their severity, development of new variants of adverse events compared to the basic anti-tuberculosis treatment of this group of patients in combination with placebo 4 Results of the study allow concluding that SQ109 is an effective drug, satisfactory tolerated (compatible with tolerability of placebo) being a part of integral etiotropic chemotherapy of pulmonary MDR TB patients |
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issn | 2075-1230 2542-1506 |
language | Russian |
last_indexed | 2024-03-12T03:30:03Z |
publishDate | 2018-04-01 |
publisher | New Terra Publishing House |
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series | Туберкулез и болезни лёгких |
spelling | doaj.art-95f3ca114ed944d7826a17058873f5b02023-09-03T13:29:15ZrusNew Terra Publishing HouseТуберкулез и болезни лёгких2075-12302542-15062018-04-0196361810.21292/2075-1230-2018-96-3-6-181098EFFICIENCY AND SAFETY OF CHEMOTHERAPY REGIMEN WITH SQ109 IN THOSE SUFFERING FROM MULTIPLE DRUG RESISTANT TUBERCULOSISS. E. Borisov0E. M. Bogorodskaya1G. V. Volchenkov2E. V. Kulchavenya3A. O. Maryandyshev4S. N. Skornyakov5O. B. Talibov6A. M. Tikhonov7I. A. Vasilyeva8ГБУЗ города Москвы «Московский городской научно-практический центр борьбы с туберкулезом Департамента здравоохранения города Москвы», МоскваГБУЗ города Москвы «Московский городской научно-практический центр борьбы с туберкулезом Департамента здравоохранения города Москвы», МоскваГУЗ Владимирской области «Областной противотуберкулезный диспансер», г. ВладимирФГБУ «Новосибирский НИИ туберкулеза» МЗ РФ, г. НовосибирскГУЗ «Архангельский областной клинический противотуберкулезный диспансер», г. АрхангельскФГБУ «Национальный медицинский исследовательский центр фтизиопульмонологии и инфекционных заболеваний» МЗ РФ, МоскваГОУ ВПО «Московский государственный медико-стоматологический университет им. А. И. Евдокимова» МЗ РФ, МоскваФГБНУ «Центральный НИИ туберкулеза», МоскваФГБУ «Национальный медицинский исследовательский центр фтизиопульмонологии и инфекционных заболеваний» МЗ РФ, МоскваThe objective of the study: to assess efficiency and safety of SQ109 used within standard treatment regimens for multiple drug resistant tuberculosis (MDR TB)Subjects and Methods A multi-center, double, blind, randomized, placebo-controlled study was conducted in two parallel groups from September 21, 2012 to September 30, 2016, in 6 research centers located in 5 cities of the Russian FederationMain results 1 Cessation of bacillary excretion confirmed by cultures on liquid media by the end of the 6th month of the intensive phase of chemotherapy in pulmonary MDR TB patients receiving SQ109 was observed confidently more often versus treatment regimens containing only existing anti-tuberculosis drugs: both for ITT population (610% versus 429%, p = 00412), and PP population (797% versus 614%, p = 00486) 2 There were no statistically significant differences in the achievement of sputum conversion between the groups, but by the end of the 8th week, the sputum converted in 52% of patients in the group treated with SQ109 versus 38% in the group taking a placebo The median time of bacillary excretion cessation confirmed by culture on liquid media in SQ109 group made 56 days, while in the placebo group it was 84 days 3 Use of SQ109 along with basic chemotherapy for pulmonary MDR TB did not result in the higher frequency of adverse events, worsening of their severity, development of new variants of adverse events compared to the basic anti-tuberculosis treatment of this group of patients in combination with placebo 4 Results of the study allow concluding that SQ109 is an effective drug, satisfactory tolerated (compatible with tolerability of placebo) being a part of integral etiotropic chemotherapy of pulmonary MDR TB patientshttps://www.tibl-journal.com/jour/article/view/1098препарат sq109туберкулез легкихмножественная лекарственная устойчивость m. tuberculosis |
spellingShingle | S. E. Borisov E. M. Bogorodskaya G. V. Volchenkov E. V. Kulchavenya A. O. Maryandyshev S. N. Skornyakov O. B. Talibov A. M. Tikhonov I. A. Vasilyeva EFFICIENCY AND SAFETY OF CHEMOTHERAPY REGIMEN WITH SQ109 IN THOSE SUFFERING FROM MULTIPLE DRUG RESISTANT TUBERCULOSIS Туберкулез и болезни лёгких препарат sq109 туберкулез легких множественная лекарственная устойчивость m. tuberculosis |
title | EFFICIENCY AND SAFETY OF CHEMOTHERAPY REGIMEN WITH SQ109 IN THOSE SUFFERING FROM MULTIPLE DRUG RESISTANT TUBERCULOSIS |
title_full | EFFICIENCY AND SAFETY OF CHEMOTHERAPY REGIMEN WITH SQ109 IN THOSE SUFFERING FROM MULTIPLE DRUG RESISTANT TUBERCULOSIS |
title_fullStr | EFFICIENCY AND SAFETY OF CHEMOTHERAPY REGIMEN WITH SQ109 IN THOSE SUFFERING FROM MULTIPLE DRUG RESISTANT TUBERCULOSIS |
title_full_unstemmed | EFFICIENCY AND SAFETY OF CHEMOTHERAPY REGIMEN WITH SQ109 IN THOSE SUFFERING FROM MULTIPLE DRUG RESISTANT TUBERCULOSIS |
title_short | EFFICIENCY AND SAFETY OF CHEMOTHERAPY REGIMEN WITH SQ109 IN THOSE SUFFERING FROM MULTIPLE DRUG RESISTANT TUBERCULOSIS |
title_sort | efficiency and safety of chemotherapy regimen with sq109 in those suffering from multiple drug resistant tuberculosis |
topic | препарат sq109 туберкулез легких множественная лекарственная устойчивость m. tuberculosis |
url | https://www.tibl-journal.com/jour/article/view/1098 |
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