tibljТуберкулез и болезни легкихTuberculosis and Lung Diseases2075-12302542-1506Медицинские знания и технологии10.21292/2075-1230-2018-96-3-6-18tiblj-1098Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ РЕЖИМА ХИМИОТЕРАПИИ, ВКЛЮЧАЮЩЕГО ПРЕПАРАТ SQ109, У БОЛЬНЫХ ТУБЕРКУЛЕЗОМ ЛЕГКИХ С МНОЖЕСТВЕННОЙ ЛЕКАРСТВЕННОЙ УСТОЙЧИВОСТЬЮ ВОЗБУДИТЕЛЯEFFICIENCY AND SAFETY OF CHEMOTHERAPY REGIMEN WITH SQ109 IN THOSE SUFFERING FROM MULTIPLE DRUG RESISTANT TUBERCULOSISБорисовС. Е.BorisovS. E.

доктор медицинских наук, профессор, заместитель директора по научно-клинической работе

Doctor of Medical Sciences, Professor, Deputy Director for Research

sebarsik@gmail.comБогородскаяЕ. М.BogorodskayaE. M.

доктор медицинских наук, директор

Doctor of Medical Sciences, Director

mnpcbtdir2012@yandex.ruВолченковГ. В.VolchenkovG. V.

главный врач

Center for Specialized of Phthisiopulmonary Care, Vladimir Chief Doctor

root@tubdisp.elcom.ruКульчавеняЕ. В.KulchavenyaE. V.

доктор медицинских наук, профессор, главный научный сотрудник

Doctor of Medical Sciences, Professor, Chief Researcher

urotub@yandex.ruМарьяндышевА. О.MaryandyshevA. O.

доктор медицинских наук, член-корреспондент РАН, заведующий кафедрой фтизиопульмонологии, профессор

Doctor of Medical Sciences, C orrespondent Member of RAS, Head of Phthisiopulmonology Department, Professor

maryandyshev@gmail.comСкорняков С. Н.SkornyakovS. N.

доктор медицинских наук, профессор, директор

Doctor of Medical Sciences, Professor, Director

sns@nm.ruТалибов О. Б.TalibovO. B.

кафедра терапии, клинической фармакологии и скорой медицинской помощи

Therapy, Clinical Pharmacology and Emergency Care Unit

oleg.talibov@gmail.comТихоновА. М.TikhonovA. M.

врач-фтизиатр 1-го терапевтического отделения

Phthisiologist of the 1st Therapy Department

alex13ft@bk.ruВасильеваИ. А.VasilyevaI. A.

доктор медицинских наук, профессор, директор

Doctor of Medical Sciences, Professor, Director

ГБУЗ города Москвы «Московский городской научно-практический центр борьбы с туберкулезом Департамента здравоохранения города Москвы», МоскваРоссияMoscow Municipal Scientific Practical Center of Tuberculosis Control, MoscowRussian FederationГУЗ Владимирской области «Областной противотуберкулезный диспансер», г. ВладимирРоссияVladimir Regional TB Dispensary, VladimirRussian FederationФГБУ «Новосибирский НИИ туберкулеза» МЗ РФ, г. НовосибирскРоссияNovosibirsk Tuberculosis Research Institute, NovosibirskRussian FederationГУЗ «Архангельский областной клинический противотуберкулезный диспансер», г. АрхангельскРоссияArkhangelsk Regional Clinical TB Dispensary, ArkhangelskRussian FederationФГБУ «Национальный медицинский исследовательский центр фтизиопульмонологии и инфекционных заболеваний» МЗ РФ, МоскваРоссияNational Medical Research Center of Phthisiopulmonology and Infectious Diseases, MoscowRussian FederationГОУ ВПО «Московский государственный медико-стоматологический университет им. А. И. Евдокимова» МЗ РФ, МоскваРоссияA. I. Yevdokimov State Medical Stomatological University, MoscowRussian FederationФГБНУ «Центральный НИИ туберкулеза», МоскваРоссияCentral Tuberculosis Research Institute, MoscowRussian FederationФГБУ «Национальный медицинский исследовательский центр фтизиопульмонологии и инфекционных заболеваний» МЗ РФ, МоскваРоссияNational Medical Research Center of Phthisiopulmonology and Infectious Diseases, MoscowRussian Federation201802042018963618Copyright © Борисов С.Е., Богородская Е.М., Волченков Г.В., Кульчавеня Е.В., Марьяндышев А.О., Скорняков  С.Н., Талибов  О.Б., Тихонов А.М., Васильева И.А., 20182018Борисов С.Е., Богородская Е.М., Волченков Г.В., Кульчавеня Е.В., Марьяндышев А.О., Скорняков  С.Н., Талибов  О.Б., Тихонов А.М., Васильева И.А.Borisov S.E., Bogorodskaya E.M., Volchenkov G.V., Kulchavenya E.V., Maryandyshev A.O., Skornyakov S.N., Talibov O.B., Tikhonov A.M., Vasilyeva I.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.tibl-journal.com/jour/article/view/1098Цель исследования

Цель исследования: определение эффективности и безопасности препарата SQ109 в составе стандартных схем лечения, используемых при туберкулезе легких с множественной лекарственной устойчивостью M. tuberculosis (МЛУ МБТ)

Материалы и методы

Материалы и методы. Многоцентровое, двойное, слепое, рандомизированное плацебо-контролируемое исследование в двух параллельных группах проведено с 31 октября 2012 г по 30 сентября 2016 г в 6 исследовательских центрах, расположенных в  пяти городах РоссийскойФедерации

Основные результаты

Основные результаты. 1 Прекращение бактериовыделения, подтвержденное посевами мокроты на жидких средах, к концу 6-го мес интенсивной фазы химиотерапии у больных туберкулезом легких с МЛУ МБТ при режиме лечения, включающем препарат SQ109, отмечено достоверно чаще, чем при режиме, содержащем только существующие противотуберкулезные препараты: как для популяции ITT (61,0% против 42,9%, p = 0,0412), так для популяции PP (79,7% против 61,4%, p = 0,0486) 2 Статистически значимых различий в сроках достижения прекращения бактериовыделения между группами не выявлено, но к концу 8-й нед лечения отмечена негативация мокроты у 52% больных группы SQ109 при 38% в группе плацебо Медиана срока прекращения бактериовыделания при исследовании на жидких средах в группе SQ109 составила 56 дней, а в группе плацебо – 84 дня 3 Применение препарата SQ109 на фоне базовой химиотерапии туберкулеза легких с МЛУ МБТ не привело ни к росту частоты нежелательных явлений, ни к увеличению степени их тяжести, ни к появлению новых вариантов нежелательных явлений в сравнении с базисной противотуберкулезной терапией данной группы больных в сочетании с плацебо 4 Результаты исследования позволяют сделать вывод об эффективности и удовлетворительной переносимости (сопоставимой с переносимостью плацебо) препарата SQ109 в составе комплексной этиотропной химиотерапии больных туберкулезом легких с МЛУ МБТ

 

 

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 Federation

Main 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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The authors declare that there are no conflicts of interest present.