Кто или что влияет на оптимальный выбор пути введения лекарственных средств – это решение клинициста, пациента или государства?

Колбин А.С., Гомон Ю.М., Хохлова С.В. Кто или что влияет на оптимальный выбор пути введения лекарственных средств – это решение клинициста, пациента или государства? Новые и, казалось бы, неожиданные вопросы для российского здравоохранения. Современная Онкология. 2016; 18 (3): 12–18.

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Kolbin A.S., Gomon Yu.M., Khokhlova S.V. Who or what does influence the optimal choice of medication administration route? Is this the solution of clinician, patient or State? New and it should seem unexpected questions for Russian Health Care. Journal of Modern Oncology. 2016; 18 (3): 12–18.

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Аннотация

За последнее десятилетие в лекарственном лечении хронических заболеваний появились новые возможности, которые включают разный выбор режимов терапии, а также места ее проведения (амбулаторно, на дому, в стационаре). Информированность пациента о наличии альтернативных возможностей – важный фактор успешности терапии в плане ее приверженности пациентами и сохранения их качества жизни. Целью данного исследования явилось изучение факторов, влияющих на выбор пути введения лекарств, используемых при различных нозологиях. С этой целью в базе данных PubMed проведен анализ всех публикаций в период с 1990 по 2016 г., посвященных вопросам сравнения эффективности, безопасности, фармако-экономики, предпочтений пациентов при разных путях введения одного и того же лекарства. В результате анализа литературы был бесспорно доказан тот факт, что основными критериями выбора лекарств являются эффективность, безопасность, фармакоэкономические аспекты, а также предпочтения пациента. При этом последнее – важный фактор в достижении высокой приверженности терапии, повышении показателей эффективности медицинской технологии и улучшения качества жизни пациентов.

Ключевые слова: путь введения, эффективность, безопасность, предпочтения пациентов.

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New treatment options of chronic diseases, concerning the different selection of therapy regimens, as well as the system of drug administration (outpatiently, domiciliary, at hospital) started up over the last decade. The patient's awareness of the availability of treatment alternatives is an important benefit factor in terms of adherence of patients to treatment and preserving quality of life. The aim of this study was to examine the factors influencing the choice of medication administration route, used in case of various nosologies. In view of this we analyzed all publications in the PubMed database in the period of 1990 to 2016, concerning the comparison of efficacy, safety, pharmacoeconomic, patient preferences, in case of different medication administration route. As a result of the database analysis we incontestably proved that the basic criteria of medication selection were efficiency, safety, pharmacoeconomic aspects and patient preference. Patient preference is an important factor in achieving high adherence to treatment, increasing the efficiency of medical technology and enhancing quality of life.

Key words: administration route, efficiency, safety, patient preference.

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Список литературы

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1. https://rg.ru/2011/11/23/zdorovie-dok.html
2. Stoner KL, Harder H, Fallowfield LJ et al. Intravenous versus Subcutaneous Drug Administration. Which Do Patients Prefer? A Systematic Review. Patient 2015; 8: 145–53.
3. Postanovlenie Pravitel'stva RF ot 28 oktiabria 2015 g. № 1154 "O poriadke opredeleniia vzaimozameniaemosti lekarstvennykh preparatov dlia meditsinskogo primeneniia". www.rlsnet.ru/Files/na/1154.pdf / [in Russian]
4. Prikaz FAS Rossii ot 28.04.2010 N 220 (red. ot 23.11.2015) "Ob utverzhdenii Poriadka provedeniia analiza sostoianiia konkurentsii na tovarnom rynke". http:// www.consultant.ru/document/cons_doc_LAW_ 103446/ [in Russian]
5. Federal'nyi Zakon №135 «O zashchite konkurentsii" ot 26.07.2006 v redaktsii ot 04.07.2016. http://www.consultant.ru/document/ cons_doc_LAW_61763 [in Russian]
6. Jin J et al. The optimal choice of medication administration route regarding intravenous, intramuscular, and subcutaneous injection. Patient preference and adherence 2015: 9; 923–42.
7. Kukes V.G. Klinicheskaia farmakologiia. M: GEOTAR-Media, 2015. [in Russian]
8. Arthur J, Atkinson Jr, Darrell R. Abernethy etc. Principles of Clinical Pharmacology; Academic Press, 2006.
9. Osnovnye poniatiia v otsenke meditsinskikh tekhnologii: metod. posobie. Pod red. Kolbina A.S., Zyrianova S.K., Belousova D.Iu. M.: Izdatel'stvo OKI, 2013. [in Russian]
10. PaPadmitriou K et al. The socio-economical impact of intravenous (IV) versus subcutaneous (SC) administration of trastuzumab: future prospectives. Facts Views Vis Obgyn 2015; 7 (3): 176–80.
11. Ismael G et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncology. 2012; 13 (9): 869–78.
12. Jackisch C et al. Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study. Ann Oncolog 2015; 26; 320–5.
13. Lui J et al. Intravenous Versus Subcutaneous Anti-TNF-Alpha Agents for Crohn’s Disease: A Comparison of Effectiveness and Safety. J Manag Care Spec Pharm 2015; 21 (7): 559–66.
14. Mystakidou K et al. Oral versus intravenous ibandronic acid: a comparison for metastatic bone disease. J Cancer Res Clin Oncol 2008; 134 (12); 1303–10.
15. Pivot X, Gligorov J, Müller V et al. Pref Her Study Group. Patients' preferences for subcutaneous trastuzumab versus conventional intravenousinfusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol 2014; 25 (10): 1979–87.
16. http://www.rlsnet.ru/tn_index_id_2581.htm
17. http://www.rlsnet.ru/tn_index_id_4539.htm
18. Shah DK, Missmer SA, Correia KF et al. Pharmacokinetics of human chorionic gonadotropin injection in obese and normal-weight women. J Clin Endocrinol Metab 2014; 99 (4): 1314–21.
19. Nisbet AC. Intramuscular gluteal injections in the increasingly obese population: retrospective study. BMJ 2006; 332 (7542): 637–8.
20. Zaybak A, Gunes UY, Tamsel S et al. Does obesity prevent the needle from reaching muscle in intramuscular injections? J Adv Nurs 2007; 58 (6): 552–6.
21. WHO Library Cataloguing-in-Publication Data: WHO model formulary for children 2010. Based on the second model list of essential medicines for children 2009.
22. Miller A, Hancock F. Sequential therapy for significant infection: a comparison of the efficacy, safety profile and cost of intravenous cefuroxime followed by oral cefuroxime axetil versus cefotaxime. In: Abstracts of the 7th ECCMID, Vienna, Austria, 1995, 128.
23. Sylwestrzak G et al. Considering patient preferences when selecting anti-tumor necrosis factor therapeutic options. American Health Drug Benefits 2014; 7 (2): 71–81.
24. Lewiecki EM et al. Adherence to and gastrointestinal tolerability of monthly oral or quarterly intravenous ibandronate therapy in women with previous intolerance to oral bisphosphonates: a 12-month open-label, prospective evaluation. Clin Ther 2008; 30 (4): 605–21.
25. Zhang J et al. Trends in the Use of Biologic Agents Among Rheumatoid Arthritis Patients Enrolled in the US Medicare Program. Arthritis Care Res 2013;
65 (11): 1743–51.
26. Kamimura T, Miyamoto T, Yokota N et al. High incidence and severity of injection site reactions in the first cycle compared with subsequent cycles of subcutaneous bortezomib. Int J Hematol 2013; 98 (6): 694–701.
27. Simons FE, Gu X, Simons KJ. Epinephrine absorption in adults: intramuscular versus subcutaneous injection. J Allergy Clin Immunol 2001; 108 (5): 871–3.
28. Kagan L, Turner MR, Balu-Iyer SV et al. Subcutaneous absorption of monoclonal antibodies: role of dose, site of injection, and injection volume on rituximab pharmacokinetics in rats. Pharm Res 2012; 29 (2): 490–9.
29. Weiss LG et al. The efficacy of once weekly compared with 2 or 3 times weekly subcutaneous epoetin-β: results from a randomized controlled multicentre trial. Nephrol Dial Transplant 2000; 15: 2014–9.
30. Wasserman RL, Melamed I, Stein MR et al; IGSC, 10% with rHuPH20 Study Group. Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. J Allergy Clin Immunol 2012; 130 (4): 951–7.e11.
31. Pezzarossa A, Taddei F, Cimicchi MC et al. Perioperative management of diabetic subjects. Subcutaneous versus intravenous insulin administration during glucose-potassium infusion. Diabetes Care 1988; 11 (1): 52–8.
32. http://www.rlsnet.ru/tn_index_id_5689.htm
33. http://www.rlsnet.ru/tn_index_id_3026.htm
34. Rachina S.A. i dr. Analiz antibakterial'noi terapii gospitalizirovannykh patsientov s vnebol'nichnoi pnevmoniei v razlichnykh regionakh RF: uroki mnogotsentrovogo farmakoepidemiologicheskogo issledovaniia. Klin. farmakologiia i antimikrob. khimioterapiia. 2009; 11 (1): 66–78. [in Russian]
35. De Cock E et al. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Medicine 2016; 5 (3): 389–97.
36. De Cock E et al. Time Savings with rituximab subcutaneous injection versus rituximab intravenous infusion: a time and motion study in eight countries. PLoS One 2016; 11 (6): e0157957.
37. Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm 1990; 47: 533–43.
38. Pharmaceutical Care – Policies and Practices for a Safer, More Responsible and Cost-effective Health System is published by the Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM). Ed. Dr S. Keitel Page layout and cover: EDQM European Directorate for the Quality of Medicines & HealthCare (EDQM). Printed on acid-free paper at the Council of Europe. 62 р.
39. Willeke P et al. Patient/rheumatologist evaluation of infusion treatment for rheumatoid arthritis. Z Rheumatol 2011; 70 (3): 232–4.
40. Greenapple R. Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a Survey of Payers and Providers. Am Health Drug Benefits 2012; 5 (2): 83–92.

Авторы

А.С.Колбин*1,2, Ю.М.Гомон1, С.В.Хохлова3

1 ФГБОУ ВО Первый Санкт-Петербургский государственный медицинский университет им. И.П.Павлова Минздрава России. 197022, Россия, Санкт-Петербург, ул. Льва Толстого, д. 6/8;
2 ФГБОУ ВПО Санкт-Петербургский государственный университет. 199034, Санкт-Петербург, Университетская наб. д. 7/9;
3 ФГБУ Российский онкологический научный центр им. Н.Н.Блохина Минздрава России. 115478, Россия, Москва, Каширское ш., д. 23
*аlex.kolbin@mail.ru

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A.S.Kolbin*1,2, Yu.M.Gomon1, S.V.Khokhlova3

1 I.M.Pavlov First Saint Petersburg State Medical University of the Ministry of Health of the Russian Federation. 197022, Russian Federation, Saint Petersburg, ul. L'va Tolstogo, d. 6/8;
2 Saint Petersburg State University. 199034, Russian Federation, Saint Petersburg, Universitetskaia nab., d. 7/9;
3 N.N.Blokhin Russian Cancer Research Center of the Ministry of Health of the Russian Federation. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23
*аlex.kolbin@mail.ru

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