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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">farmaec</journal-id><journal-title-group><journal-title xml:lang="en">FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology</journal-title><trans-title-group xml:lang="ru"><trans-title>ФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2070-4909</issn><issn pub-type="epub">2070-4933</issn><publisher><publisher-name>IRBIS LLC</publisher-name></publisher></journal-meta><article-meta><article-id custom-type="elpub" pub-id-type="custom">farmaec-73</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>Russian Studies</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>Российские исследования</subject></subj-group></article-categories><title-group><article-title>MODELI NG CLINICAL AND ECONOMIC OUTCOMES OF TESTING FOR LTBI WITH T-SPOT.TB IN IMMUNOCOMPROMISED CHILDREN</article-title><trans-title-group xml:lang="ru"><trans-title>Клинико-экономическое моделирование результатов использования T-SPOT.TB у иммуноскомпрометированных детей</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Игнатьева</surname><given-names>В. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Ignatyeva</surname><given-names>V. I.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Авксентьева</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Avxentyeva</surname><given-names>M. V.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Омельяновский</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Omelyanovsky</surname><given-names>V. V.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хачатрян</surname><given-names>Г. Р.</given-names></name><name name-style="western" xml:lang="en"><surname>Khachatryan</surname><given-names>G. R.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">Российская академия народного хозяйства и государственной службы при Президенте РФ;&#13;
ГБОУ ВПО «Первый МГМУ имени И.М. Сеченова» Минздрава России, Москва<country>Россия</country></aff><aff xml:lang="en">The Russian Presedential Academy of National Economy and Public Administration;&#13;
The State Education Institution of Higher P rofessional Training The First Sechenov Moscow State Medical University under Ministry of Health of the Russian Federation<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru">Российская академия народного хозяйства и государственной службы при Президенте РФ<country>Россия</country></aff><aff xml:lang="en">The Russian Presedential Academy of National Economy and Public Administration<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2014</year></pub-date><pub-date pub-type="epub"><day>23</day><month>03</month><year>2015</year></pub-date><volume>7</volume><issue>3</issue><fpage>12</fpage><lpage>19</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Ignatyeva V.I., Avxentyeva M.V., Omelyanovsky V.V., Khachatryan G.R., 2015</copyright-statement><copyright-year>2015</copyright-year><copyright-holder xml:lang="ru">Игнатьева В.И., Авксентьева М.В., Омельяновский В.В., Хачатрян Г.Р.</copyright-holder><copyright-holder xml:lang="en">Ignatyeva V.I., Avxentyeva M.V., Omelyanovsky V.V., Khachatryan G.R.</copyright-holder><license license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.pharmacoeconomics.ru/jour/article/view/73">https://www.pharmacoeconomics.ru/jour/article/view/73</self-uri><abstract><p>weakening of immune status under the influence of some diseases or types of treatment could result in the activation of the present latent tuberculosis infection (LTBI). Recently it was suggested to use the immunoenzymometric interferon-gamma tests, T-SPOT.TB among them, but their costs are substantially higher than cost of the traditionally used tuberculin skin test (TST), thus the need for efficiency assessment arises. The aim of the study was to evaluate the cl inical and economic outcomes of testingfor LTBI with T-SPOT.TB in immunocompromised children. Methods: we develope d a model, forecasting the testing results, probable cases of tuberculosis activation and related costs for scenarios with alternative use of T-SPOT.TB and TST for diagnosing LTBI in immunocompromised children. Parameters for mo deling were derived from published data on sensitivity and specificity of tests and prevalence of LTBI in Russia. Costs were estimated from the position of overall government budget and included costs ofprim ary LTBI testing, additional testing to exclude active tuberculosis in case of positive result, preventive chemotherapy and costs of treatment for cases of tuberculosis activation. Results: there would be 20 tr ue positive and 80 true negative tests in the cohort of 100 patients if the test's sensivity and specificity were 100% and prevalence of LTBI was 20%. When testing with TST 100 immunocompromised children we expected that there would be 40 positi ve tests (among them 7 true positive, meaning that only 7 out of20 children with LTBI would be found in the developed model), and 3 cases of tuberculosis activation. When using T-SPOT.TB in the same cohort there were 19 positive tests in the developed model (14 out of 20 LTBI cases detected), tuberculosis activation was possible in 2 cases. The total costs per cohort were 1.71 mln RUR. in case of TST testing (including primary testing costs – 7,900 RUR) and 1.07 mln RUR for scenario with T-SPOT.TB testing (including primary testing costs – 250,000 RUR). Conclusions: The use of T-SPOT.TB for LTBI detection in immunocompromised children is efficient, as additional costs for primary testing could be compensated by the following decrease of costs related to additional testing and preventive chemotherapy.</p></abstract><trans-abstract xml:lang="ru"><p>снижение иммунного статуса организма под влиянием ряда заболеваний или используемых методов лечения может привести к активации имеющейся у данного пациента латентной туберкулезной инфекции (ЛТБИ). В последнее время для диагностики ЛТБИ предлагается использовать иммуноферментные гамма-интерфероновые тесты, одним из которых является T-SPOT.TB, однако их стоимость значительно выше стоимости традиционно использовавшейся ранее реакции Манту, что определяет необходимость оценки экономической целесообразности их применения. Цель – провести клинико-экономическую оценку использования T-SPOT.TB для диагностики ЛТБИ у иммуноскомпрометированных детей. Материалы и методы: построена модель, позволяющая прогнозировать результаты тестирования, вероятные случаи активации туберкулезного процесса и ассоциированные с ними затраты в случае альтернативного использования T-SPOT.TB и реакции Манту для диагностики ЛТБИ у иммуноскомпрометированных детей. Моделирование проводилось на основании опубликованных данных о чувствительности и специфичности сравниваемых тестов, а также распространенности ЛТБИ в РФ. С позиции государства оценивались затраты на тестирование, дополнительное обследование для исключения активного туберкулезного процесса и превентивную терапию у всех детей с положительными результатами тестов, а также затраты на лечение случаев активации туберкулезного процесса. Результаты: у 100 обследованных при распространенности ЛТБИ 20% и использовании идеального теста со 100%-ной чувствительностью и специфичностью было бы получено 20 истинно положительных и 80 истинно отрицательных результатов. При использовании реакции Манту для диагностики ЛТБИ у 100 иммуноскомпрометированных детей ожидается 40 положительных результатов (из них истинно положительных семь, то есть в исследуемой модели было выявлено семь случаев ЛТБИ из имеющихся 20), а активация туберкулезного процесса может произойти в трех случаях. При использовании T-SPOT.TB в этой же когорте положительные результаты в исследуемой модели были получены у 19 детей (выявлено 14 случаев ЛТБИ из 20), активация туберкулезного процесса вероятна в двух случаях. Итоговые затраты на всю когорту составят 1,71 млн руб. при использовании реакции Манту (в т.ч. затраты на тестирование – 7,9 тыс. руб.) и 1,07 млн руб. при использовании T-SPOT.TB (в т.ч. затраты на тестирование – 250 тыс. руб.). Заключение: использование T-SPOT.TB для диагностики ЛТБИ у иммуноскомпрометированных детей является экономически целесообразным, так как дополнительные затраты на тестирование могут быть компенсированы последующим сокращением затрат на дополнительные обследования и превентивную химиотерапию.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>ЛТБИ</kwd><kwd>T-SPOT.TB</kwd><kwd>реакция Манту</kwd><kwd>иммуно- скомпрометированные дети</kwd></kwd-group><kwd-group xml:lang="en"><kwd>LTBI</kwd><kwd>T-SPOT.TB</kwd><kwd>TST</kwd><kwd>immunocompromised children</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Александрова Е.Н. и др. Интерпретация комплексной когортной оценки результатов туберкулинодиагностики. Проблемы туберкулеза и болезней легких. 2008; 7: 23-26.</mixed-citation><mixed-citation xml:lang="en">Aleksandrova E.N. i dr. Problemy tuberkuleza i boleznei legkikh. 2008; 7: 23-26.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Педиатрия: национальное руководство: в 2 т. М. 2009; 2: 1024 с.</mixed-citation><mixed-citation xml:lang="en">Pediatrics: national leadership in 2 volumes [Pediatriya: natsional'noe rukovodstvo: v 2 t.]. Moscow. 2009; 2: 1024 s.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">По становление Правительства Российской Федерации от 18 октября 2013 г. N 932 г. Москва «О программе государственных гарантий бе сплатного оказания гражданам медицинской помощи на 2014 год и на плановый период 2015 и 2016 годов». http://www.rg.ru/2013/10/22/medpomosch-site-dok.html.</mixed-citation><mixed-citation xml:lang="en">Resolution of the Government of the Russian Federation dated October 18, 2013 N 932 Moscow «About the state guarantees the free provision of medical care to citizens in 2014 and the planned period 2015 and 2016» [Postanovlenie Pravitel'stva Rossiiskoi Federatsii ot 18 oktyabrya 2013 g. N 932 g. Moskva «O programme gosudarstvennykh garantii besplatnogo okazaniya grazhdanam meditsinskoi pomoshchi na 2014 god i na planovyi period 2015 i 2016 godov». http://www.rg.ru/2013/10/22/medpomosch-site-dok.html.]</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Ситуация по туберкулезу и работе противотуберкулезной службы Российской Федерации в 2012 году. http://www.mednet.ru/images/stories/files/CMT/2012_tvs_rossiya.pdf)</mixed-citation><mixed-citation xml:lang="en">The situation of tuberculosis and TB service work of the Russian Federation in 2012 [Situatsiya po tuberkulezu i rabote protivotuberkuleznoi sluzhby Rossiiskoi Federatsii v 2012 godu.] http://www.mednet.ru/images/stories/files/CMT/2012_tvs_rossiya.pdf)</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Тарифы на услуги. http://www.mgfoms.ru/?page_id=5198. 15.02.2014.</mixed-citation><mixed-citation xml:lang="en">Fees for services [Tarify na uslugi]. http://www.mgfoms. ru/?page_id=5198. 15.02.2014.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Ayieko J., Abuogi L., Simchowitz B., Bukusi E.A., Smith A.H., Reingold A. Efficacy of isoniazid prophylactic therapy in prevention of tuberculosis in children: a meta-analysis. BMC Infect Dis. 2014 Feb 20; 14: 91. doi: 10.1186/1471-2334-14-91. PubMed PMID: 24555539; PubMed Central PMCID: PMC3936889.</mixed-citation><mixed-citation xml:lang="en">Ayieko J., Abuogi L., Simchowitz B., Bukusi E.A., Smith A.H.,Reingold A. Efficacy of isoniazid prophylactic therapy in prevention of tuberculosis in children: a meta-analysis. BMC Infect Dis. 2014 Feb 20;14: 91. doi: 10.1186/1471-2334-14-91. PubMed PMID: 24555539; PubMed Central PMCID: PMC3936889.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Cattamanchi et al. Interferon-gamma release assays for the diagnosis of latent tuberculosis infection in HIV-infected individuals – A systematic review and meta-analysis. J. Acquir Immune Defic Syndr. 2011 March; 56 (3): 230-238.</mixed-citation><mixed-citation xml:lang="en">Cattamanchi et al. Interferon-gamma release assays for the diagnosis of latent tuberculosis infection in HIV-infected individuals – A systematic review and meta-analysis. J. Acquir Immune Defic Syndr. 2011 March; 56 (3): 230-238.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Centers for Disease Control and Prevention. [Title]. MMWR. 2010; 59 (No. RR-5).</mixed-citation><mixed-citation xml:lang="en">Centers for Disease Control and Prevention. [Title]. MMWR. 2010; 59 (No. RR-5).</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Centers for Disease Control and Prevention. [Title]. MMWR. 2010; 59 (No. RR-5).</mixed-citation><mixed-citation xml:lang="en">Centers for Disease Control and Prevention. [Title]. MMWR. 2010; 59 (No. RR-5).</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Clinical diagnosis and management of tuberculosis, and measures for its prevention and control. Clinical guidelines, CG117 – Issued: March 2011. http://www.nice.org.uk/guidance/index.jsp?action=byID&amp;o=13422.</mixed-citation><mixed-citation xml:lang="en">Clinical diagnosis and management of tuberculosis, and measures for its prevention and control. Clinical guidelines, CG117 – Issued: March 2011. http://www.nice.org.uk/guidance/index.jsp?action=byID&amp;o=13422.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Global tuberculosis Report 2013. WHO. http://apps.who.int/iris/bitstream/10665/91355/1/9789241564656_eng.pdf?ua=1.</mixed-citation><mixed-citation xml:lang="en">Global tuberculosis Report 2013. WHO. http://apps.who.int/iris/bitstream/10665/91355/1/9789241564656_eng.pdf?ua=1.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Kakkar F., Allen U.D., Ling D., Pai M., Kitai I.C. Canadian Paediatric Society, Infectious Diseases and Immunization Committee. Tuberculosis in children: New diagnostic blood tests. Paediatr Child Health. 2010; 15 (8): 529-533.</mixed-citation><mixed-citation xml:lang="en">Kakkar F., Allen U.D., Ling D., Pai M., Kitai I.C. Canadian Paediatric Society, Infectious Diseases and Immunization Committee. Tuberculosis in children: New diagnostic blood tests. Paediatr Child Health. 2010; 15 (8): 529-533.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Liebeschuetz S., Bamber S., Ewer K., Deeks J., Pathan A.A., Lalvani A. Diagnosis of tuberculosis in South African children with a T-cell- based assay: a prospective cohort study. Lancet. 2004; 364: 2196-203.</mixed-citation><mixed-citation xml:lang="en">Liebeschuetz S., Bamber S., Ewer K., Deeks J., Pathan A.A., Lalvani A. Diagnosis of tuberculosis in South African children with a T-cell- based assay: a prospective cohort study. Lancet. 2004; 364:2196-203.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Mandalakas A.M., Detjen A.K., Hesseling A.C., Benedetti A., Menzies D. Interferon-gamma release assays and childhood tuberculosis: systematic review and meta-analysis. Int J Tuberc Lung Dis. 15 (8): 1018-1032.</mixed-citation><mixed-citation xml:lang="en">Mandalakas A.M., Detjen A.K., Hesseling A.C., Benedetti A., Menzies D. Interferon-gamma release assays and childhood tuberculosis: systematic review and meta-analysis. Int J Tuberc Lung Dis. 15 (8): 1018-1032.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Marais B.J., Gie R.P., Schaaf H.S. et al. The natural history of childhood intra-thoracic tuberculosis: a critical review of literature from the pre-chemotherapy era. International Journal of Tuberculosis and Lung Disease. 2004; 8 (4): 535-539.</mixed-citation><mixed-citation xml:lang="en">Marais B.J., Gie R.P., Schaaf H.S. et al. The natural history of childhood intra-thoracic tuberculosis: a critical review of literature from the pre-chemotherapy era. International Journal of Tuberculosis and Lung Disease. 2004; 8 (4): 535-539.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Pai M., Zwerling A., Menzies D. Systematic review: T-cell-based assays for the diagnosis of latent tuberculosis infection – an update. Ann Intern Med. 2008; 149:177-184.</mixed-citation><mixed-citation xml:lang="en">Pai M., Zwerling A., Menzies D. Systematic review: T-cell-based assays for the diagnosis of latent tuberculosis infection – an update. Ann Intern Med. 2008; 149:177-184.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Pooran et al. Different screening strategies (single or dual) for the diagnosis of suspected latent tuberculosis: a cost effectiveness analysis. BMC Pulmonary Medicine. 2010; 10: 7.</mixed-citation><mixed-citation xml:lang="en">Pooran et al. Different screening strategies (single or dual) for the diagnosis of suspected latent tuberculosis: a cost effectiveness analysis. BMC Pulmonary Medicine. 2010; 10: 7.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Red book. Report of the committee on infectious diseases. http://aapredbook.aappublications.org 15.02.2014.</mixed-citation><mixed-citation xml:lang="en">Red book. Report of the committee on infectious diseases. http://aapredbook.aappublications.org 15.02.2014.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Report of the Tenth Meeting WHO STRATEGIC AND TECHNICAL ADVISORY GROUP FOR TUBERCULOSIS (STAG-TB). 27-29 September 2010.</mixed-citation><mixed-citation xml:lang="en">Report of the Tenth Meeting WHO Strategic and technical advisory group for tuserculosis (STAG-TB). 27-29 September 2010.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">Trehan I., Meinzen-Derr J.K., Jamison L., Staat M.A. Tuberculosis Screening in Internationally Adopted Children: The Need for Initial and Repeat Testing Pediatrics 2008; 122; e7.</mixed-citation><mixed-citation xml:lang="en">Trehan I., Meinzen-Derr J.K., Jamison L., Staat M.A. Tuberculosis Screening in Internationally Adopted Children: The Need for Initial and Repeat Testing Pediatrics 2008; 122; e7.</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
