Применение низкомолекулярного гепарина Эниксум® в профилактике и лечении тромбозов в онкологии

Сомонова О.В., Елизарова А.Л., Матвеева И.И. Применение низкомолекулярного гепарина Эниксум® в профилактике и лечении тромбозов в онкологии. Современная Онкология. 2018; 20 (1): 29–34.

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Somonova O.V., Elizarova A.L., Matveeva I.I. The use of low molecular weight heparin Enixum® in the prevention and treatment of thrombosis in oncology. Journal of Modern Oncology. 2018; 20 (1): 29–34.

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Аннотация

Тромбоэмболические осложнения часто развиваются у пациентов с разными формами злокачественных новообразований, а возникновение тромбозов затрудняет противоопухолевое лечение и ухудшает показатели выживаемости больных. В современных исследованиях показано, что онкологическое заболевание повышает риск развития тромботических осложнений в 4–7 раз. Ведущую роль в патогенезе тромботических осложнений у больных злокачественными новообразованиями играют изменения системы гемостаза, вызываемые как самой опухолью, так и методами лечения. В настоящее время низкомолекулярные гепарины являются основными препаратами в профилактике и лечении тромботических осложнений у онкологических больных. Антикоагулянт прямого действия отечественного производства – Эниксум® (ЗАО ФармФирма «Сотекс», Россия, регистрационное удостоверение №ЛП-002330) по химической структуре представляет собой эноксапарин натрия, по фармакокинетическим и фармакодинамическим свойствам соответствует оригинальному препарату Клексан® (Санофи, Франция). Открытое сравнительное рандомизированное многоцентровое клиническое исследование на территории России (№ KI/0811-1/2) препаратов Эниксум® и Клексан® у пациентов с высоким риском развития тромботических/тромбоэмболических осложнений в послеоперационном периоде показало, что эффективность и безопасность препарата Эниксум® равнозначна эффективности и безопасности оригинального препарата Клексан®. Применение Эниксума для профилактики тромботических осложнений в послеоперационном периоде у онкогинекологических больных и терапии острых тромбозов и тромбоэмболии легочной артерии на разных этапах комплексного лечения доказало высокую эффективность и безопасность данного низкомолекулярного гепарина.

Ключевые слова: онкологические больные, тромботические осложнения, низкомолекулярные гепарины, Эниксум, эноксапарин натрия.

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Thromboembolic complications often develop in patients with various forms of malignant neoplasms, and the occurrence of thromboses complicates antitumor treatment and worsens the survival rates of patients. In modern studies it has been shown that oncological disease increases the risk of developing thrombotic complications 4–7 times. The leading role in the pathogenesis of thrombotic complications in patients with malignant neoplasms is played by changes in the hemostatic system, caused both by the tumor itself and by treatment methods. At present, low molecular weight heparins are the main drugs in the prevention and treatment of thrombotic complications in cancer patients. Anticoagulant of direct action of domestic production – Enixum® (Pharmfirma Soteks, Russia, registration certificate No. ЛП-002330) in chemical structure is sodium enoxaparin, according to pharmacokinetic and pharmacodynamic properties it corresponds to the original drug – Clexan® (Sanofi Winthrop Industry, France). An open comparative randomized multicenter clinical trial in Russia of the drug Enixum® and Clexan® in patients with a high risk of thrombotic/thromboembolic complications in the postoperative period showed that the efficacy and safety of the Enixum® product is equivalent to the efficacy and safety of the Clexan® drug. The use of Enixum® for the prevention of thrombotic complications in the postoperative period in oncogynecologic patients and in the treatment of acute thromboses and PE during various stages of complex treatment has proved the high efficacy and safety of this low molecular weight heparin.

Key words: oncological patients, thrombotic complications, low molecular weight heparins, Enixum® (sodium enoxaparin).

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1. Trousseau A. Phlegmasia Alba Dolens. Lectures on clinical medicine, delivered at the Hotel-Dieu. Paris, London: New Sydenham Society, 1872.
2. Agnelli G, Verso M. Management of venous thromboembolism in patients with cancer. J Thromb Haemost 2011; 9 (Suppl. 1): 316–24.
3. Geerts WH, Pineo GF, Heit JA et al. Prevention of venous thromboembolism. The Seventh ACCR Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126 (Suppl.): 338S–400S.
4. Kakkar AK, Haas S, Walsh D et al. Prevention of perioperative venous thromboembolism: outcome after cancer and non-cancer surgery (abstract). Thromb Haemost 2001; 86 (Suppl.): 0c1732.
5. Barsam SJ, Patel R, Arya. Anticoagulation for prevention and treatment of cancer-related venous thromboembolism. Br J Haematol 2013; 161 (Iss. 6): 764–77.
6. Amin C, Mackman N, Key NC. Microparticles and cancer. Pathophysiol Haemost Thromb 2008; 36: 177–83.
7. Magnus N, D’Asti E, Meehan B et al. Oncogenes and the coagulation system – forses that modulate dormant and aggressive states in cancer. Thromb Res 2014; 133 (Suppl. 2): S1–S9.
8. Lee AY. The roles of anticoagulants in patients with cancer. Thromb Res 2010; 125 (Suppl. 2): S8–S11.
9. Levine MN, Lee AY, Kakkar AK. Thrombosis and cancer. American Society of Clinical Oncology, 41 Annual Meeting, 2005; p. 748–77.
10. Hirsh J, Warkentin TE, Shaughnessy SG et al. Heparin and low molecular weight heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy and safety. Chest 2001; 119 (Suppl. 1): 64S–94S.
11. Hirsh J, Anand SS, Halperin JL, Fuster V. Guide to Anticoagulant therapy: Heparin. A Statement for healthcare Professionals from the American Heart Association. Curculation 2001; 103 (24): 2994–3018. PubMed PMID: 11413093.
12. Mismetti P, Laporte S, Darmon JY et al. Meta-analysis of low-molecular- weight heparin in the prevention pf venous thromboembolism in general surgery. Br J Surg 2001; 88: 913–30.
13. Lyman GH, Bohlke K, Khorana AA et al. Venous thromboembolism prophylaxis and treatment in patients with cancer: ASCO clinical Practice Guideline Update 2014. J Clin Oncol 2015; 33: 654–6.
14. Kuderer NM, Lyman GH. Guidelines for treatment and prevention of venous thromboembolism among patients with cancer. Thromb Res 2014; 133 (Suppl. 2): S122–S127.
15. Mandala M. Management of venous thromboembolism in cancer patients. ESMO Clinical Practice Guidelines. Ann Oncol 2011; 22 (Suppl. 6): vi85–vi92.
16. Kearon C, Akl EA, Ornelas J et al. Antithrombotic therapy for VTE disease. Chest 2016; 149 (2): 315–52.
17. Rossiiskie klinicheskie rekomendatsii po diagnostike, lecheniiu i profilaktike venoznykh tromboembolicheskikh oslozhnenii (VTEO). Flebologiia. 2015; 4 (2): 2–52. [in Russian]
18. Guyatt GH, Akl EA, Growther M et al. Executive Summary. Antithrombotic therapy and Prevention of Thrombosis, 9th ed: ACCP evidence-based clinical practice guidelines. Chest 2012; 141 (Suppl. 2): 7S–47S.
19. Watson HG, Keeling DM, Laffan M et al. Guedeline on aspects of cancer-related venous thrombosis. British J Haematology 2015; 170 (Iss. 5): 640–8.
20. Lee AY, Levine MN, Baker MD et al. Low-Molecular-Weight Heparin versus a Coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. New Eng J Med 2003; 349: 146–53.
21. Kearon C, Akl EA, Comerota AJ et al. Antithrombotic therapy for VTE disease: Antithrombotic therapy and prevention of thrombosis, 9th ed. American College of Chest Physicians Evidence – Based Clinical Practice Guidelines. Chest 2012; 141 (2): 419S–430S.

Авторы

О.В.Сомонова*, А.Л.Елизарова, И.И.Матвеева

ФГБУ «Национальный медицинский исследовательский центр онкологии им. Н.Н.Блохина» Минздрава России. 115478, Россия, Москва, Каширское ш., д. 23
*somonova@mail.ru

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O.V.Somonova*, A.L.Elizarova, I.I.Matveeva

N.N.Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation. 115478, Russian Federation, Moscow, Kashirskoe sh., d. 23
*somonova@mail.ru

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