<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<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="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">pulmo</journal-id><journal-title-group><journal-title xml:lang="ru">Пульмонология</journal-title><trans-title-group xml:lang="en"><trans-title>PULMONOLOGIYA</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">0869-0189</issn><issn pub-type="epub">2541-9617</issn><publisher><publisher-name>Scientific and Practical Journal “PULMONOLOGIYA” LLC</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.18093/0869-0189-2014-0-4-5-12</article-id><article-id custom-type="elpub" pub-id-type="custom">pulmo-436</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="ru"><subject>ПЕРЕДОВАЯ СТАТЬЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>EDITORIAL</subject></subj-group></article-categories><title-group><article-title>Персонализированная терапия, основанная на генотипировании</article-title><trans-title-group xml:lang="en"><trans-title>Personalized genotyping!based therapy</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>Чучалин</surname><given-names>А. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Chuchalin</surname><given-names>A. G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>д. м. н., академик РАН, директор ФГБУ "НИИ пульмонологии" ФМБА России тел.\факс: (495) 4655264</p></bio><email xlink:type="simple">chuchalin@inbox.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБУ "НИИ пульмонологии" ФМБА России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Pulmonology Research Institute, Federal Medical and Biological Agency of Russia</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2014</year></pub-date><pub-date pub-type="epub"><day>28</day><month>08</month><year>2014</year></pub-date><volume>0</volume><issue>4</issue><fpage>5</fpage><lpage>12</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Чучалин А.Г., 2014</copyright-statement><copyright-year>2014</copyright-year><copyright-holder xml:lang="ru">Чучалин А.Г.</copyright-holder><copyright-holder xml:lang="en">Chuchalin A.G.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" 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://journal.pulmonology.ru/pulm/article/view/436">https://journal.pulmonology.ru/pulm/article/view/436</self-uri><abstract><p>Клиническая медицина постгеномного периода характеризуется развитием персонализированной терапии, в основу которой положен принцип генотипирования. Данный аналитический обзор посвящен клиническим исследованиям 2013 года, которые были одобрены FDA (Food and Drug Administration – Управление по контролю за продуктами и лекарствами, США), и включает 8 клинических исследований в области гематологии / онкологии, 3 – в области эндокринологии, по 2 клинических исследования в области гастроэнтерологии, инфекционных заболеваний, болезней органов дыхания, кардиологии, акушерства / гинекологии, неврологии и новых диагностических процедур и 1 клиническое исследование в области психиатрии. Проведенный анализ свидетельствует о дальнейшем развитии доказательной медицины, касающейся персонализированной терапии, основанной на генотипировании.</p></abstract><trans-abstract xml:lang="en"><p>In the postgenome era, clinical medicine is characterized by development of personalized genotypingbased approach to treatment. Clinical stud ies published in 2013–2014 and approved by FDA (Food and Drug Administration, USA) have been analyzed in this review. These include 8 clini cal studies on hematology / oncology, 3 clinical studies on endocrinology, 2 clinical studies on gastroenterology, infection diseases, respiratory dis eases, cardiology, gynecology / obstetrics, neurology and novel diagnostic procedures each and one clinical study on psychiatrics. The analysis demonstrated further development of evidencebased medicine that provided personalized genotypingbased therapy.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>персонализированная терапия</kwd><kwd>генотипирование</kwd><kwd>доказательная медицина</kwd><kwd>клинические исследования.</kwd></kwd-group><kwd-group xml:lang="en"><kwd>personalized therapy</kwd><kwd>genotyping</kwd><kwd>evidencebased medicine</kwd><kwd>clinical studies</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">Wang M.L., Rule S., Martin P. et al. Targeting BTK with ibrutinib in relapsed or refractory mantlecell lymphoma. N. Engl. J. Med. 2013; 369 (6): 507–516.</mixed-citation><mixed-citation xml:lang="en">Wang M.L., Rule S., Martin P. et al. Targeting BTK with ibrutinib in relapsed or refractory mantlecell lymphoma. N. Engl. J. Med. 2013; 369 (6): 507–516.</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Goede V., Fisher K., Busch R. et al. Obinutuzumab plus chlo rambucil in patients with CLL and coexisting conditions. N. Engl. J. Med. 2014; 370 (12): 1101–1110.</mixed-citation><mixed-citation xml:lang="en">Goede V., Fisher K., Busch R. et al. Obinutuzumab plus chlo rambucil in patients with CLL and coexisting conditions. N. Engl. J. Med. 2014; 370 (12): 1101–1110.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Sequist L.V., Chih'Hsin Yang J., O' Byrne K. et al. Phase 111 study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR muta tions. J. Clin. Oncol. 2013; 31 (27): 3327–3334.</mixed-citation><mixed-citation xml:lang="en">Sequist L.V., Chih'Hsin Yang J., O' Byrne K. et al. Phase 111 study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR muta tions. J. Clin. Oncol. 2013; 31 (27): 3327–3334.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Flaherty K.T., Infante J.R., Daud A. et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 muta tion. N. Engl. J. Med. 2012; 367 (18): 1694–1703.</mixed-citation><mixed-citation xml:lang="en">Flaherty K.T., Infante J.R., Daud A. et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 muta tion. N. Engl. J. Med. 2012; 367 (18): 1694–1703.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Flaherty K.T., Robert C., Hersey P. et al. Improved survival with MEK inhibition in BRAFmutated melanoma. N. Engl. J. Med. 2012; 367 (2): 107–114.</mixed-citation><mixed-citation xml:lang="en">Flaherty K.T., Robert C., Hersey P. et al. Improved survival with MEK inhibition in BRAFmutated melanoma. N. Engl. J. Med. 2012; 367 (2): 107–114.</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Verrna S., Miles D., Gianni L. et al. Trastuzumab emtansine for HER2positive advanced breast cancer. N. Engl. J. Med. 2012; 367 (19): 1783–1791.</mixed-citation><mixed-citation xml:lang="en">Verrna S., Miles D., Gianni L. et al. Trastuzumab emtansine for HER2positive advanced breast cancer. N. Engl. J. Med. 2012; 367 (19): 1783–1791.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Wallace A.M., Han L.K., Povoski S.P. et al. Comparative evaluation of [(99m)tc]tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two phase 3 tri als. Ann. Surg. Oncol. 2013; 20 (8): 2590–2599.</mixed-citation><mixed-citation xml:lang="en">Wallace A.M., Han L.K., Povoski S.P. et al. Comparative evaluation of [(99m)tc]tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two phase 3 tri als. Ann. Surg. Oncol. 2013; 20 (8): 2590–2599.</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Parker C., Nilsson S., Heinrich D. et al. Alpha emmiter radi um223 and survival in metastatic prostate cancer. N. Engl. J. Med. 2013; 369 (3): 213–223.</mixed-citation><mixed-citation xml:lang="en">Parker C., Nilsson S., Heinrich D. et al. Alpha emmiter radi um223 and survival in metastatic prostate cancer. N. Engl. J. Med. 2013; 369 (3): 213–223.</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">ClinicalTrials.gov.number, NCTO1106352 .</mixed-citation><mixed-citation xml:lang="en">ClinicalTrials.gov.number, NCTO1106352 .</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Richardson P.G., Siegel D.S., Vij R. et al. Pomalidomide alone or in combination with lowdose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study. Blood. 2014; 123: 18–26.</mixed-citation><mixed-citation xml:lang="en">Richardson P.G., Siegel D.S., Vij R. et al. Pomalidomide alone or in combination with lowdose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study. Blood. 2014; 123: 18–26.</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">DeFronzo R.A., Burant C.F., Fleck P. et al. Efficacy and tol erability of the DPP4 inhibitor alogliptin combined with pioglitazone, in metformintreated patients with type 2 dia betes. J. Clin. Endocrinol. Metab. 2012; 97 (5): 1615–1622.</mixed-citation><mixed-citation xml:lang="en">DeFronzo R.A., Burant C.F., Fleck P. et al. Efficacy and tol erability of the DPP4 inhibitor alogliptin combined with pioglitazone, in metformintreated patients with type 2 dia betes. J. Clin. Endocrinol. Metab. 2012; 97 (5): 1615–1622.</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Nauck M.A., Ellis G.C., Fleck P.R. et al. Efficacy and safety of adding the dipeptidyl peptidase4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inade quately controlled with metformin monotherapy: a multi centre randomised, duobleblind, placebocontrolled study. J. Clin. Pract. 2009; 63 (1): 46–55.</mixed-citation><mixed-citation xml:lang="en">Nauck M.A., Ellis G.C., Fleck P.R. et al. Efficacy and safety of adding the dipeptidyl peptidase4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inade quately controlled with metformin monotherapy: a multi centre randomised, duobleblind, placebocontrolled study. J. Clin. Pract. 2009; 63 (1): 46–55.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">DeFronzo R.A., Fleck P., Wilson C. et al. Efficacy and safety of the dipeptidyl peptidase4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control. Diabet. Care. 2008; 31 (12): 2315–2317.</mixed-citation><mixed-citation xml:lang="en">DeFronzo R.A., Fleck P., Wilson C. et al. Efficacy and safety of the dipeptidyl peptidase4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control. Diabet. Care. 2008; 31 (12): 2315–2317.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Lavalle'Gonzalez F.J., Januszewicz A., Davidson J. et al. Efficacy ahd safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on back ground metformin monotherapy: a randomised trial. Diabetologia. 2013; 56 (12): 2582–2592.</mixed-citation><mixed-citation xml:lang="en">Lavalle'Gonzalez F.J., Januszewicz A., Davidson J. et al. Efficacy ahd safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on back ground metformin monotherapy: a randomised trial. Diabetologia. 2013; 56 (12): 2582–2592.</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Gane E.J., Stedman C.A., Hyland R.H. et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N. Engl. J. Med. 2014; 368: 34–44.</mixed-citation><mixed-citation xml:lang="en">Gane E.J., Stedman C.A., Hyland R.H. et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N. Engl. J. Med. 2014; 368: 34–44.</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Walmsley S.L., Antela A., Clumeck N. et al. Dolutegravir plus abacavirlamivudine for the treatment of HIV1 infection. N. Engl. J. Med. 2013; 369 (19): 1807–1818.</mixed-citation><mixed-citation xml:lang="en">Walmsley S.L., Antela A., Clumeck N. et al. Dolutegravir plus abacavirlamivudine for the treatment of HIV1 infection. N. Engl. J. Med. 2013; 369 (19): 1807–1818.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">Donohue J.F., Maleki'Yazdi M.R., Kilbride S. et al. Efficacy and safety of oncedaily umeclidinium / vilanterol 42,5 /25 mcg in COPD. Respir. Med. 2013; 107 (10): 1538–1546.</mixed-citation><mixed-citation xml:lang="en">Donohue J.F., Maleki'Yazdi M.R., Kilbride S. et al. Efficacy and safety of oncedaily umeclidinium / vilanterol 42,5 /25 mcg in COPD. Respir. Med. 2013; 107 (10): 1538–1546.</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Kerwin E.M., Scott'Wilson C., Sanford L. et al. A random ized trial of fluticasone / furoate / vilanterol (50 / 25 mcg; 100 / 25 mcg) on lung function in COPD. Respir. Med. 2013; 107: 560–569.</mixed-citation><mixed-citation xml:lang="en">Kerwin E.M., Scott'Wilson C., Sanford L. et al. A random ized trial of fluticasone / furoate / vilanterol (50 / 25 mcg; 100 / 25 mcg) on lung function in COPD. Respir. Med. 2013; 107: 560–569.</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Pulido T., Adzerkho I., Channick R.N. et al. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N. Engl. J. Med. 2013; 369: 809–818.</mixed-citation><mixed-citation xml:lang="en">Pulido T., Adzerkho I., Channick R.N. et al. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N. Engl. J. Med. 2013; 369: 809–818.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">Ghofrani H.'A., D'Armini A.M., Grimminger F. et al. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N. Engl. J. Med. 2013, 369, 319–329.</mixed-citation><mixed-citation xml:lang="en">Ghofrani H.'A., D'Armini A.M., Grimminger F. et al. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N. Engl. J. Med. 2013, 369, 319–329.</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">Elger C., Halasz P., Maia J. et al. Efficacy and safety of esli carbazepine acetate as adjunctive treatment in adults with refractory partial – onset seizures. A randomized, double blind, placebocontrolled, parallelgroup phase III study. Epilepsia. 2009; 50 (3): 453–464.</mixed-citation><mixed-citation xml:lang="en">Elger C., Halasz P., Maia J. et al. Efficacy and safety of esli carbazepine acetate as adjunctive treatment in adults with refractory partial – onset seizures. A randomized, double blind, placebocontrolled, parallelgroup phase III study. Epilepsia. 2009; 50 (3): 453–464.</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">Fox R.J., Miller D.H., Phillips T. et al. Placebocontrolled phase 3 study of oral BG12 or glatiramer in multiple scle rosis. N. Engl. J. Med. 2012; 367 (12): 1087–1097.</mixed-citation><mixed-citation xml:lang="en">Fox R.J., Miller D.H., Phillips T. et al. Placebocontrolled phase 3 study of oral BG12 or glatiramer in multiple scle rosis. N. Engl. J. Med. 2012; 367 (12): 1087–1097.</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">Gold R., Kappos L., Arnold D.L. et al. Placebocontrolled phase 3 study of oral BG12 for relapsing multiple sclerosis. N. Engl. J. Med. 2012; 367 (12): 1098–1107.</mixed-citation><mixed-citation xml:lang="en">Gold R., Kappos L., Arnold D.L. et al. Placebocontrolled phase 3 study of oral BG12 for relapsing multiple sclerosis. N. Engl. J. Med. 2012; 367 (12): 1098–1107.</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>
