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<article 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" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" article-type="research-article" dtd-version="1.2" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">Russian Journal of Allergy</journal-id><journal-title-group><journal-title xml:lang="en">Russian Journal of Allergy</journal-title><trans-title-group xml:lang="ru"><trans-title>Российский Аллергологический Журнал</trans-title></trans-title-group></journal-title-group><issn publication-format="print">1810-8830</issn><issn publication-format="electronic">2686-682X</issn><publisher><publisher-name xml:lang="en">Publishing House ABV Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">160</article-id><article-id pub-id-type="doi">10.36691/RJA160</article-id><article-categories><subj-group subj-group-type="toc-heading" xml:lang="en"><subject>Articles</subject></subj-group><subj-group subj-group-type="toc-heading" xml:lang="ru"><subject>Статьи</subject></subj-group><subj-group subj-group-type="article-type"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title xml:lang="en">Subcutaneous immunoglobulin for treatment of patients with primary immunodeficiencies: review of the literature and personal experience</article-title><trans-title-group xml:lang="ru"><trans-title>Заместительная терапия с подкожным введением иммуноглобулина в лечении больных с первичными иммунодефицитами: собственный опыт и обзор литературы</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Rodina</surname><given-names>Y A</given-names></name><name xml:lang="ru"><surname>Родина</surname><given-names>Юлия Александровна</given-names></name></name-alternatives><bio xml:lang="ru"><p>врач отделения иммунологии.</p></bio><email>rodina.julija@rambler.ru</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Abramova</surname><given-names>I N</given-names></name><name xml:lang="ru"><surname>Абрамова</surname><given-names>Ирина Николаевна</given-names></name></name-alternatives><bio xml:lang="ru"><p>врач отделения иммунологии</p></bio><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Shcherbina</surname><given-names>A Yu</given-names></name><name xml:lang="ru"><surname>Щербина</surname><given-names>Анна Юрьевна</given-names></name></name-alternatives><bio xml:lang="ru"><p>Институт гематологии, иммунологии и клеточных технологий НМИЦ ДГОИ им. Д. Рогачева, доктор медицинских наук, профессор, заместитель директора.</p></bio><xref ref-type="aff" rid="aff1"/></contrib></contrib-group><aff-alternatives id="aff1"><aff><institution xml:lang="en">Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology, Ministry of Health of the Russian Federation</institution></aff><aff><institution xml:lang="ru">ФГБУ «Национальный медицинский исследовательский центр детской гематологии, онкологии, иммунологии им. Д. Рогачева» Минздрава России</institution></aff></aff-alternatives><pub-date date-type="pub" iso-8601-date="2018-04-15" publication-format="electronic"><day>15</day><month>04</month><year>2018</year></pub-date><volume>15</volume><issue>2</issue><issue-title xml:lang="en">VOL 15, NO2 (2018)</issue-title><issue-title xml:lang="ru">ТОМ 15, №2 (2018)</issue-title><fpage>29</fpage><lpage>36</lpage><history><date date-type="received" iso-8601-date="2020-03-10"><day>10</day><month>03</month><year>2020</year></date></history><permissions><copyright-statement xml:lang="en">Copyright ©; 2018, Pharmarus Print Media</copyright-statement><copyright-statement xml:lang="ru">Copyright ©; 2018, Фармарус Принт Медиа</copyright-statement><copyright-year>2018</copyright-year><copyright-holder xml:lang="en">Pharmarus Print Media</copyright-holder><copyright-holder xml:lang="ru">Фармарус Принт Медиа</copyright-holder><ali:free_to_read xmlns:ali="http://www.niso.org/schemas/ali/1.0/" start_date="2020-12-15"/></permissions><self-uri xlink:href="https://rusalljournal.ru/raj/article/view/160">https://rusalljournal.ru/raj/article/view/160</self-uri><abstract xml:lang="en"><p>Substitution with normal human immunoglobulin is a golden standard of primary immunodeficiencies therapy. Subcutaneous immunoglobulins, especially delivered via «rpid push» method are gaining popularity among patients and treating physician since at home infusions allow to reduce treatment costs and increase patients’ quality of life. Here we report first Russian experience of subcutaneous infusion of Gamunex®-C immunoglobulin, in four patients with primary immunodeficiencies, performed by their parents via «rapid push» method at home. No systemic reactions have been reported, Gamunex®-C treatment prevented severe infections and allowed adequate average serum IgG levels (10,1 g/l while on subcutaneous infusions in comparison with 8,5 g/l while on intravenous immunoglobulin).</p></abstract><trans-abstract xml:lang="ru"><p>Заместительная терапия нормальным человеческим иммуноглобулином является «золотым стандартом» лечения пациентов с первичными иммунодефицитами. Все большей популярностью у врачей и пациентов пользуется подкожное введение препарата иммуноглобулина (ПКИГ), в частности с использованием метода rapid push, что позволяет сократить расходы на ведение пациентов и улучшить их качество жизни за счет проведения терапии на дому. Мы сообщаем о первом российском опыте подкожного введения препарата Гамунекс®-С у четырех пациентов с первичным иммунодефицитом, проводимого родственниками пациентов в домашних условиях. Подкожное введение иммуноглобулина не сопровождалось системными реакциями, позволило поддерживать адекватный уровень иммуноглобулина G в сыворотке крови (10,1 г/л на фоне терапии ПКИГ по сравнению с 8,5 г/л на фоне предшествующей внутривенной заместительной терапии) и предотвратить развитие тяжелых инфекций.</p></trans-abstract><kwd-group xml:lang="en"><kwd>subcutaneous immunoglobulin</kwd><kwd>Gamunex®-C</kwd><kwd>primary immunodeficiency</kwd><kwd>IgG trough level</kwd><kwd>rapid push method</kwd><kwd>complications</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>подкожный иммуноглобулин</kwd><kwd>Гамунекс®-С</kwd><kwd>первичные иммунодефициты</kwd><kwd>сывороточный уровень IgG</kwd><kwd>метод «rapid push»</kwd><kwd>осложнения</kwd></kwd-group></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><mixed-citation>Bruton OC. Agammaglobulinemia. Pediatrics. 1952; 9: 722-728. DOI: 10.1016/b978-012448510-5.50111-4.</mixed-citation></ref><ref id="B2"><label>2.</label><mixed-citation>Berger M. A history of immunoglobulin therapy, from the Harvard crash program to monoclonal antibodies. Curr Allergy Asthma Rep. 2002; 2: 368-378. DOI: 10.1007/s11882-002-0069-z.</mixed-citation></ref><ref id="B3"><label>3.</label><mixed-citation>Кузьменко НБ, Щербина А.Ю. Классификация первичных иммунодефицитов как отражение современных представлений об их патогенезе и терапевтических подходах. Российский журнал детской гематологии и онкологии. 2017; (3): 51-57</mixed-citation></ref><ref id="B4"><label>4.</label><mixed-citation>Hinman J., Tullis JL, Saravis CA, Pennell RB. Intravenous use of plasmin treated immunoglobulin G. I. Preliminary report on tolerance by immunologically deficient patients. Vox Sang. 1967; 13: 85-90.</mixed-citation></ref><ref id="B5"><label>5.</label><mixed-citation>Щербина А., Косачева Т., Румянцев А. Внутривенный иммуноглобулин в педиатрической практике. Вопросы современной педиатрии. 2010; (9): 114-118</mixed-citation></ref><ref id="B6"><label>6.</label><mixed-citation>Berger M., Cupps TR, Fauci AS. Immunoglobulin replacement therapy by slow subcutaneous infusion. Ann Intern Med. 1980; 93: 55-56. DOI: 10.7326/0003-4819-93-1-55.</mixed-citation></ref><ref id="B7"><label>7.</label><mixed-citation>Pierce CR, Jain N. Risks associated with the use of intravenous immunoglobulin. Transfus Med Rev. 2003; 17: 241-254.</mixed-citation></ref><ref id="B8"><label>8.</label><mixed-citation>Simon EM, Summers SM. Vascular Access Complications: An Emergency Medicine Approach. Emerg Med Clin North Am. 2017; 35: 771-788.</mixed-citation></ref><ref id="B9"><label>9.</label><mixed-citation>Lederman HM, Roifman CM, Lavi S., Gelfand EW. Corticosteroids for prevention of adverse reactions to intravenous immune serum globulin infusions in hypogammaglobulinemic patients. Am J. Med. 1986; 81: 443-446. DOI: 10.1016/0002-9343(86)90296-2.</mixed-citation></ref><ref id="B10"><label>10.</label><mixed-citation>Gardulf A., Hammarstrom L., Edvard Smith CI. Home treatment of hypogammaglobulinemia with subcutaneous gammaglobulin by rapid infusion. Lancet. 1991; 338: 162-166. DOI: 10.1016/0140-6736(91)90147-h.</mixed-citation></ref><ref id="B11"><label>11.</label><mixed-citation>Stiehm ER, Casillas AM, Finkelstein JZ, Gallagher KT, Groncy PM, Kobayashi RH et al. Slow subcutaneous human intravenous immunoglobulin in the treatment of antibody immunodeficiency: use of an old method with a new product. J. Allergy Clin Immunol. 1998; 101: 848-849. DOI: 10.1016/s0091-6749(98)70314-8.</mixed-citation></ref><ref id="B12"><label>12.</label><mixed-citation>Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol. 2004; 112: 1-7. DOI: 10.1016/j.clim.2004.02.002.</mixed-citation></ref><ref id="B13"><label>13.</label><mixed-citation>Gardulf A., Nicolay U., Asensio O., Bernatowska E., Böck Beatriz A., Carvalho C. et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies - a prospective, multi-national study. J. Clin Immunol. 2006; 26: 177-185. DOI: 10.1007/s10875-006-9002-x.</mixed-citation></ref><ref id="B14"><label>14.</label><mixed-citation>Skoda-Smith S., Torgerson TR, Ochs HD. Subcutaneous immunoglobulin replacement therapy in the treatment of patients with primary immunodeficiency disease. Ther Clin Risk Manag. 2010; 6: 1-10. DOI: 10.2147/tcrm.s4353.</mixed-citation></ref><ref id="B15"><label>15.</label><mixed-citation>Grunebaum E., Levy Y., Shoenfeld Y. Novel aspects of hy-pogammaglobulinemic states: subcutaneous immunoglobulin treatment. Isr Med Assoc J. 2002; 4: 288-289. DOI: 10.1002/art.10363.</mixed-citation></ref><ref id="B16"><label>16.</label><mixed-citation>Mankarous M., Lee M., Fischer S., Pyun KH, Ochs HD, Oxelius VA et al. The half-lives of IgG subclasses and specifi antibodies in patients with primary immunodeficiency who are receiving intravenously administered immunoglobulin. J. Lab Clin Med. 1988: 112: 634-640. DOI: 10.1016/s0140-6736(86)92826-6.</mixed-citation></ref><ref id="B17"><label>17.</label><mixed-citation>Bonilla FA. Pharmacokinetics of immunoglobulin administered via intravenous or subcutaneous routes. Immunol Allergy Clin N. Am. 2008; 28: 803-819. DOI: 10.1016/j.iac.2008.06.006.</mixed-citation></ref><ref id="B18"><label>18.</label><mixed-citation>Gardulf A., Nicolay U., Math D., Asensio O., Bernatowska E., Böck A. et al. Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG infusions at home. J. Allergy Clin Immunol. 2004; 114: 936-942. DOI: 10.1016/j.jaci.2004.06.053.</mixed-citation></ref><ref id="B19"><label>19.</label><mixed-citation>Moore ML, Quinn JM. Subcutaneous immunoglobulin replacement therapy for primary antibody deficiency: advancements into the 21st century. Ann Allergy Asthma Immunol. 2008; 101: 114-121.</mixed-citation></ref><ref id="B20"><label>20.</label><mixed-citation>Orange JS, Hossny EM, Weiler CR, Ballow M., Berger M., Bonilla FA et al. Use of intravenous immunoglobulin in human disease; a review of the evidence by members of the primary immunodeficiency committee of the AAAAI. J. Allergy Clin Immunol. 2006; 117: S525-S553. DOI: 10.1016/j.jaci.2006.01.015.</mixed-citation></ref><ref id="B21"><label>21.</label><mixed-citation>GardulfA, Borte M., Ochs HD, Nicolay U., Althaus AH, Böck A. et al. Prognostic factors for health-related quality of life in adults and children with primary antibody deficienciency receiving SCIg home therapy. Clin Immunol. 2008; 126: 81-88. DOI: 10.1016/j.clim.2007.06.009.</mixed-citation></ref><ref id="B22"><label>22.</label><mixed-citation>Fasth A., Nystrom J. Quality of life and health-care resource utilization among children with primary immunodeficiency receiving home treatment with subcutaneous human immunoglobulin. J. Clin Immunol. 2008; 28: 370-378. DOI: 10.1007/s10875-008-9180-9.</mixed-citation></ref><ref id="B23"><label>23.</label><mixed-citation>Abolhassani H., Sadaghiani MS, Aghamohammadi A., Ochs HD, Rezaei N. Home-based subcutaneous immunoglobulin versus hospital-based intravenous immunoglobulin in treatment of primary antibody deficiencies: systematic review and meta analysis. Clin Immunol. 2016; 166-167: 103-104. DOI: 10.1007/s10875-012-9720-1.</mixed-citation></ref><ref id="B24"><label>24.</label><mixed-citation>Dams ETM, van der Meer JWM. Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies. Lancet. 1995; 345: 864. DOI: 10.1016/s0140-6736(95)93002-7.</mixed-citation></ref><ref id="B25"><label>25.</label><mixed-citation>Ochs HD, Gupta S., Kiessling P., Nicolay U., Berger M., Althaus A. et al. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency disease. J. Clin Immunol. 2006; 26: 265-273. DOI: 10.1007/s10875-006-9021-7.</mixed-citation></ref><ref id="B26"><label>26.</label><mixed-citation>Chapel HM, Spickett GP, Ericson D., Engl W., Eibl MM, Bjorkander J. et al. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J. Clin Immunol. 2000; 20: 94-100. DOI: 10.1023/a:1006678312925.</mixed-citation></ref><ref id="B27"><label>27.</label><mixed-citation>Abghari PF, Poowuttikul P., Secord E. Pneumococcal Antibody Titers: A Comparison of Patients Receiving Intravenous Immunoglobulin Versus Subcutaneous Immunoglobulin. Glob Pediatr Health. 2017. DOI: 10.1177/2333794X16689639.</mixed-citation></ref><ref id="B28"><label>28.</label><mixed-citation>Compagno N., Cinetto F., Semenzato G., Agostini C. Subcutaneous immunoglobulin in lymphoproliferative disorders and rituximab-related secondary hypogammaglobulinemia: a single-center experience in 61 patients. Haematologica. 2014; 99(6): 1101-1106. DOI: 10.3324/haematol.2013.101261.</mixed-citation></ref><ref id="B29"><label>29.</label><mixed-citation>Schaik IN, Bril V., van Geloven N., Hartung HP, Lewis RA, Sobue G. et al. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018; 17: 35-46. DOI: 10.1016/j.jns.2017.08.225.</mixed-citation></ref><ref id="B30"><label>30.</label><mixed-citation>Beecher G., Anderson D., Siddiqi ZA. Subcutaneous immunoglobulin in myasthenia gravis exacerbation: A prospective, open-label trial. Neurology. 2017; 89: 1135-1141. DOI: 10.1212/wnl.0000000000004365.</mixed-citation></ref><ref id="B31"><label>31.</label><mixed-citation>Yamazaki-Nakashimada MA, Saez-de-Ocariz M., Maldona-do-Colin G., Garcia-Romero MT Subcutaneous immunoglobulin for the treatment of deep morphoea in a child. Clin Exp Dermatol. 2017. DOI: 10.1111/ced.13352.</mixed-citation></ref><ref id="B32"><label>32.</label><mixed-citation>Bourque PR, Pringle CE, Cameron W., Cowan J., Chardon JW. Subcutaneous Immunoglobulin Therapy in the Chronic Management of Myasthenia Gravis: A Retrospective Cohort Study. PLoS One. 2016; 11: e0159993. DOI: 10.1371/journal.pone.0159993.</mixed-citation></ref><ref id="B33"><label>33.</label><mixed-citation>Spadaro G., Pecoraro A., De Renzo A., Della Pepa R., Genovese A. Intravenous versus subcutaneous immunoglobulin replacement in secondary hypogammaglobulinemia. Clin Immunol. 2016; 166-167: 103-4. DOI: 10.1016/j.clim.2016.04.001.</mixed-citation></ref><ref id="B34"><label>34.</label><mixed-citation>Kankakee, IL: CSL Behring; 2015. Hizentra [prescribing information]</mixed-citation></ref><ref id="B35"><label>35.</label><mixed-citation>Kobrynski L. Subcutaneous immunoglobulin therapy: a new option for patients with primary immunodeficiency diseases. Biologics. 2012; 6: 277-287. DOI: 10.2147/btt.s25188.</mixed-citation></ref><ref id="B36"><label>36.</label><mixed-citation>Krishnarajah G., Lehmann JK, Ellman B., Bhak RH, DerSark-issian M., Leader D. Jr, Bullinger AL, Sheng Duh M. Evaluating dose ratio of subcutaneous to intravenous immunoglobulin therapy among patients with primary immunodeficiency disease switching to 20% subcutaneous immunoglobulin therapy. Am J. Manag Care. 2016; 22: 475-481.</mixed-citation></ref><ref id="B37"><label>37.</label><mixed-citation>Gardulf A. Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs 2007; 21: 105-116. DOI: 10.2165/00063030-200721020-00005.</mixed-citation></ref><ref id="B38"><label>38.</label><mixed-citation>Misbah S., Sturzenegger MH, Borte M., Shapiro RS, Wasser-man RL, Berger M., Ochs HD. Subcutaneous immunoglobulin: opportunities and outlook. Clin Exp Immunol. 2009; 158 Suppl 1: 51-9. DOI: 10.1111/j.1365-2249.2009.04027.x.</mixed-citation></ref><ref id="B39"><label>39.</label><mixed-citation>Shapiro R. Subcutaneous immunoglobulin therapy by rapid push is preferred to infusion by pump: a retrospective analysis. J. Clin Immunol. 2010; 30: 301-307. DOI: 10.1007/s10875-009-9352-2.</mixed-citation></ref><ref id="B40"><label>40.</label><mixed-citation>Shapiro RS. Subcutaneous immunoglobulin: rapid push vs infusion pump in pediatrics. Pediatr Allergy Immunol. 2013; 24: 49-53. DOI: 10.1111/pai.12026.</mixed-citation></ref><ref id="B41"><label>41.</label><mixed-citation>Martin A., Lavoie L., Goetghebeur M., Schellenberg R. Economic benefits of subcutaneous rapid push versus intravenous immunoglobulin infusion therapy in adult patients with primary immune deficiency. Transfus Med. 2013; 23: 55-60. DOI: 10.1111/j.1365-3148.2012.01201.x.</mixed-citation></ref><ref id="B42"><label>42.</label><mixed-citation>https://m.youtube.com/watch?v=vxZIlpefWxo. Или поиск в youtube.com по ключевым словам: «Введение иммуноглобулина методом rapid push», «Подкожный путь введения иммуноглобулинов». Или https://drive.google.com/file/d/0BxHccTKpyjzSa0JkR2t5Zk53MU0/view.</mixed-citation></ref><ref id="B43"><label>43.</label><mixed-citation>Ballow M., Wasserman RL, Jolles S., Chapel H., Berger M., Misbah SA. Assessment of Local Adverse Reactions to Subcutaneous Immunoglobulin (SCIG) in Clinical Trials. J. Clin Immunol. 2017; 37: 517-518. DOI: 10.1007/s10875-017-0410-x.</mixed-citation></ref><ref id="B44"><label>44.</label><mixed-citation>Roifman CM, Schroeder H., Berger M., Sorensen R., Ballow M., Buckley RH et al. Comparison ofthe efficacy of IGIV-C, 10% (caprylate/chromatography) and IGIV-SD, 10% as replacement therapy in primary immune deficiency. A randomized double-blind trial.I. Int Immunopharmacol. 2003; 3: 1325-1333. DOI: 10.1016/s1567-5769(03)00134-6.</mixed-citation></ref><ref id="B45"><label>45.</label><mixed-citation>Bonilla FA. Intravenous and subcutaneous immunoglobulin G. replacement therapy. Allergy Asthma Proc. 2016; 37: 426-431. DOI: 10.2500/aap.2016.37.3987.</mixed-citation></ref><ref id="B46"><label>46.</label><mixed-citation>Wasserman RL, Irani AM, Tracy J., Tsoukas C., Stark D., Levy R. et al. Pharmacokinetics and safety of subcutaneous immune globulin (human), 10% caprylate/chromatography purified in patients with primary immunodeficiency disease. Clin Exp Immunol. 2010; 161: 518-526. DOI: 10.1111/j.1365-2249.2010.04195.x.</mixed-citation></ref></ref-list></back></article>
