Выбор препарата железа для парентерального введения при железодефицитной анемии
Выбор препарата железа для парентерального введения при железодефицитной анемии
Зырянов С.К., Байбулатова Е.А. Выбор препарата железа для парентерального введения при железодефицитной анемии. Терапевтический архив. 2024;96(4):407–418.
DOI: 10.26442/00403660.2024.04.202693
Zyryanov SK, Baybulatova EA. Selection of parenteral iron supplement for iron deficiency anemia: A review. Terapevticheskii Arkhiv (Ter. Arkh.). 2024;96(4):407–418. DOI: 10.26442/00403660.2024.04.202693
Выбор препарата железа для парентерального введения при железодефицитной анемии
Зырянов С.К., Байбулатова Е.А. Выбор препарата железа для парентерального введения при железодефицитной анемии. Терапевтический архив. 2024;96(4):407–418.
DOI: 10.26442/00403660.2024.04.202693
Zyryanov SK, Baybulatova EA. Selection of parenteral iron supplement for iron deficiency anemia: A review. Terapevticheskii Arkhiv (Ter. Arkh.). 2024;96(4):407–418. DOI: 10.26442/00403660.2024.04.202693
В статье рассмотрены лекарственные средства (ЛС) для лечения железодефицитных состояний и железодефицитной анемии, которой болеют около 30% мирового населения. Дефицит железа является важной причиной анемии, которая, в свою очередь, может спровоцировать госпитализацию и даже летальный исход. В ситуациях, когда имеется непереносимость или неэффективность пероральных форм препаратов железа, в целях быстрого его восполнения применяют препараты трехвалентного железа для внутривенного введения (ВВ). Приведенные ЛС представляют собой комплексы железа, состоящие из железогидроксидного ядра, окруженного углеводной оболочкой. Препараты железа для ВВ можно разделить на ЛС «старого» и «нового» поколений. Одним из наиболее изученных и популярных представителей «нового» поколения является железа карбоксимальтозат (ЖКМ). Результаты, полученные в клинических исследованиях, показали, что ЖКМ лучше и быстрее повышает концентрацию гемоглобина и пополняет запасы железа у пациентов, чем препараты «старого» поколения, а также имеет более благоприятный профиль безопасности. Большие дозы ЖКМ можно вводить за короткий период времени, что не только экономит ресурсы, но и повышает удовлетворенность больных. Введение больших доз железа при малом количестве инфузий в случае ЖКМ экономически более выгодно для всех подразделений медицинских учреждений, в связи с тем что значительно снижает общую стоимость медицинского обслуживания. ВВ препаратов железа играет важную роль в периоперационном лечении железодефицитной анемии, особенно в плановой хирургии. В настоящее время существует надежная доказательная база, которая подтверждает эффективность и безопасность внутривенных препаратов железа при хронической болезни почек, воспалительных заболеваниях кишечника, сердечной недостаточности, гинекологической и акушерской патологии, онкологических заболеваниях.
The article reviews medicinal products for the treatment of iron deficiency conditions and iron deficiency anemia, the prevalence of which is about 30% among the world population. Iron deficiency is a significant cause of anemia, which can lead to hospitalization and even death. In case of intolerance or ineffectiveness of oral formulations of iron supplements, if it is necessary to replenish the iron level quickly, trivalent iron formulations for intravenous administration are used. These supplements are iron complexes with an iron hydroxide core surrounded by a carbohydrate shell. Iron formulations for intravenous administration can be divided into drugs of the "old" and "new" generation. One of the most studied and popular representatives of the "new" generation is iron carboxymaltose (ICM). The results of clinical studies showed that ICM better and faster increases hemoglobin concentration and replenishes iron stores in patients compared to the "old" generation formulations and also has a more favorable safety profile. Large doses of ICM can be administered in a short time, saving resources and increasing patient satisfaction. The injection of large doses of iron with a small number of infusions in the case of ICM is more economically beneficial for all departments of medical institutions, as it significantly reduces the total cost of medical care. Intravenous iron plays an essential role in the perioperative treatment of iron deficiency anemia, especially in elective surgery. Currently, there is a reliable evidence base confirming the efficacy and safety of intravenous iron formulations in chronic kidney disease, inflammatory bowel disease, heart failure, gynecological and obstetric diseases, and cancer.
Keywords: iron deficiency, iron deficiency anemia, iron formulations for intravenous administration, iron carboxymaltose, efficacy, safety
1. Kumar A, Sharma E, Marley A, et al. Iron deficiency anaemia: pathophysiology, assessment, practical management. BMJ Open Gastroenterol. 2022;9(1).
DOI:10.1136/bmjgast-2021-000759
2. Peyrin-Biroulet L, Williet N, Cacoub P. Guidelines on the diagnosis and treatment of iron deficiency across indications: a systematic review. Am J Clin Nutr. 2015;102(6):1585-94. DOI:10.3945/ajcn.114.103366
3. Cappellini MD, Comin-Colet J, de Francisco A, et al. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017;92(10):1068-78. DOI:10.1002/ajh.24820
4. Warner MJ, Kamran MT. Iron Deficiency Anemia. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing, 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK448065. Accessed: 12.02.2024.
5. Martens P. The Effect of Iron Deficiency on Cardiac Function and Structure in Heart Failure with Reduced Ejection Fraction. Card Fail Rev. 2022;8:e06. DOI:10.15420/cfr.2021.26
6. Evstatiev R, Marteau P, Iqbal T, et al. FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease. Gastroenterology. 2011;141(3):846-53.e1-2. DOI:10.1053/j.gastro.2011.06.005
7. Camaschella C, Nai A, Silvestri L. Iron metabolism and iron disorders revisited in the hepcidin era. Haematologica. 2020;105(2):260-72. DOI:10.3324/haematol.2019.232124
8. Geisser P, Burckhardt S. The pharmacokinetics and pharmacodynamics of iron preparations. Pharmaceutics. 2011;3(1):12-33. DOI:10.3390/pharmaceutics3010012
9. Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005;352(10):1011-23. DOI:10.1056/NEJMra041809
10. Железодефицитная анемия. Клинические рекомендации. 2021 г. Режим доступа: https://cr.minzdrav.gov.ru/schema/669_1. Ссылка активна на 12.02.2024 [Zhelezodefitsitnaia anemiia. Klinicheskie rekomendatsii. 2021 g. Available at: https://cr.minzdrav.gov.ru/schema/669_1. Accessed: 12.02.2024 (in Russian)].
11. Воробьев А.И., Аль-Ради Л.С., Андреева Н.Е., и др. Рациональная фармакотерапия заболеваний системы крови. Под общ. ред. А.И. Воробьева. М.: Литтерра, 2009 [Vorob'ev AI, Al'-Radi LS, Andreeva NE, et al. Ratsional'naia farmakoterapiia zabolevanii sistemy krovi. Pod obshch. red. AI Vorob'eva. Moscow: Litterra, 2009 (in Russian)].
12. Camaschella C. Iron deficiency. Blood. 2019;133(1):30-9. DOI:10.1182/blood-2018-05-815944
13. Cappellini MD, Musallam KM, Taher AT. Iron deficiency anaemia revisited. J Intern Med. 2020;287(2):153-70. DOI:10.1111/joim.13004
14. Polson MK, Bahrain H, Ogden JF, et al. Financial burden associated with discordance to intravenous iron therapies in US patients with iron deficiency anemia. J Manag Care Spec Pharm. 2023;29(7):818-24. DOI:10.18553/jmcp.2023.22407
15. Blumenstein I, Shanbhag S, Langguth P, et al. Newer formulations of intravenous iron: a review of their chemistry and key safety aspects – hypersensitivity, hypophosphatemia, and cardiovascular safety. Expert Opin Drug Saf. 2021;20(7):757-69. DOI:10.1080/14740338.2021.1912010
16. Auerbach M, Macdougall I. The available intravenous iron formulations: History, efficacy, and toxicology. Hemodial Int. 2017;21 Suppl. 1:S83-92. DOI:10.1111/hdi.12560
17. Jahn MR, Andreasen HB, Fütterer S, et al. A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Eur J Pharm Biopharm. 2011;78(3):480-91. DOI:10.1016/j.ejpb.2011.03.016
18. Koch TA, Myers J, Goodnough LT. Intravenous Iron Therapy in Patients with Iron Deficiency Anemia: Dosing Considerations. Anemia. 2015;2015:763576. DOI:10.1155/2015/763576
19. Kumar A, Brookes MJ. Iron Therapy in Inflammatory Bowel Disease. Nutrients. 2020;12(11). DOI:10.3390/nu12113478
20. Wang C, Graham DJ, Kane RC, et al. Comparative Risk of Anaphylactic Reactions Associated With Intravenous Iron Products. JAMA. 2015;314(19):2062-8. DOI:10.1001/jama.2015.15572
21. Dave CV, Brittenham GM, Carson JL, Setoguchi S. Risks for Anaphylaxis With Intravenous Iron Formulations: A Retrospective Cohort Study. Ann Intern Med. 2022;175(5):656-64. DOI:10.7326/M21-4009
22. Muñoz M, Gómez-Ramírez S, García-Erce JA. Intravenous iron in inflammatory bowel disease. World J Gastroenterol. 2009;15(37):4666-74. DOI:10.3748/wjg.15.4666
23. Kulnigg S, Stoinov S, Simanenkov V, et al. A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial. Am J Gastroenterol. 2008;103(5):1182-92. DOI:10.1111/j.1572-0241.2007.01744.x
24. Van Wyck DB, Martens MG, Seid MH, et al. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007;110(2 Pt. 1):267-78. DOI:10.1097/01.AOG.0000275286.03283.18
25. Van Wyck DB, Mangione A, Morrison J, et al. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009;49(12):2719-28. DOI:10.1111/j.1537-2995.2009.02327.x
26. Anker SD, Comin Colet J, Filippatos G, et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009;361(25):2436-48. DOI:10.1056/NEJMoa0908355
27. Rognoni C, Venturini S, Meregaglia M, et al. Efficacy and Safety of Ferric Carboxymaltose and Other Formulations in Iron-Deficient Patients: A Systematic Review and Network Meta-analysis of Randomised Controlled Trials. Clin Drug Investig. 2016;36(3):177-94. DOI:10.1007/s40261-015-0361-z
28. Danielson BG. Structure, chemistry, and pharmacokinetics of intravenous iron agents. J Am Soc Nephrol. 2004;15 Suppl. 2:S93-8. DOI:10.1097/01.ASN.0000143814.49713.C5
29. Bhandari S, Pereira DIA, Chappell HF, Drakesmith H. Intravenous Irons: From Basic Science to Clinical Practice. Pharmaceuticals (Basel). 2018;11(3). DOI:10.3390/ph11030082
30. Evans RW, Rafique R, Zarea A, et al. Nature of non-transferrin-bound iron: studies on iron citrate complexes and thalassemic sera. J Biol Inorg Chem. 2008;13(1):57-74. DOI:10.1007/s00775-007-0297-8
31. Horl WH, Macdougall IC, Rossert J, Schaefer RM. OPTA-therapy with iron and erythropoiesis-stimulating agents in chronic kidney disease. Nephrol Dial Transplant.
2007;22(Suppl. 3):2-6. DOI:10.1093/ndt/gfm014
32. Драпкина О.М., Авалуева Е.Б., Бакулин И.Г., и др. Ведение пациентов с железодефицитной анемией на этапе оказания первичной медико-санитарной помощи. Практическое руководство. М.: РОПНИЗ: Силицея-Полиграф, 2022 [Drapkina OM, Avalueva EB, Bakulin IG, et al. Vedenie patsientov s zhelezodefitsitnoi anemiei na etape okazaniia pervichnoi mediko-sanitarnoi pomoshchi. Prakticheskoe rukovodstvo. Moscow: ROPNIZ: Silitseia-Poligraf, 2022 (in Russian)].
33. Geisser P, Baer M, Schaub E. Structure/histotoxicity relationship of parenteral iron preparations. Arzneimittelforschung. 1992;42(12):1439-52.
34. Balakrishnan VS, Rao M, Kausz AT, et al. Physicochemical properties of ferumoxytol, a new intravenous iron preparation. Eur J Clin Invest. 2009;39(6):489-96.
DOI:10.1111/j.1365-2362.2009.02130.x
35. Beshara S, Sörensen J, Lubberink M, et al. Pharmacokinetics and red cell utilization of 52Fe/59Fe-labelled iron polymaltose in anaemic patients using positron emission tomography. Br J Haematol. 2003;120(5):853-9. DOI:10.1046/j.1365-2141.2003.03590.x
36. Miller JL. Iron deficiency anemia: a common and curable disease. Cold Spring Harb Perspect Med. 2013;3(7). DOI:10.1101/cshperspect.a011866
37. Auerbach M, Deloughery T. Single-dose intravenous iron for iron deficiency: a new paradigm. Hematology Am Soc Hematol Educ Program. 2016;2016(1):57-66. DOI:10.1182/asheducation-2016.1.57
38. Курилович Е.О., Волкова О.И., Попович Л.Д. Клинико-экономические аспекты применения парентеральных препаратов железа для коррекции дефицита железа и анемии у пациентов хирургического профиля. Главврач. 2020;12:44-55 [Kurilovich EO, Volkova OI, Popovich LD. Clinical and economic aspects of the use of parenteral iron preparations for the correction of iron deficiency and anemia in surgical patients. Chief Medical Officer. 2020;12:44-55 (in Russian)]. DOI:10.33920/med-03-2012-04
39. Gómez-Ramírez S, Shander A, Spahn DR, et al. Prevention and management of acute reactions to intravenous iron in surgical patients. Blood Transfus. 2019;17(2):137-45. DOI:10.2450/2018.0156-18
40. Macdougall IC, Bircher AJ, Eckardt KU, et al. Iron management in chronic kidney disease: conclusions from a "Kidney Disease: Improving Global Outcomes" (KDIGO) Controversies Conference. Kidney Int. 2016;89(1):28-39. DOI:10.1016/j.kint.2015.10.002
41. Avni T, Bieber A, Grossman A, et al. The safety of intravenous iron preparations: systematic review and meta-analysis. Mayo Clin Proc. 2015;90(1):12-23. DOI:10.1016/j.mayocp.2014.10.007
42. Elstrott B, Khan L, Olson S, et al. The role of iron repletion in adult iron deficiency anemia and other diseases. Eur J Haematol. 2020;104(3):153-61. DOI:10.1111/ejh.13345
43. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmén J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006;21(2):378-82. DOI:10.1093/ndt/gfi253
44. Arastu AH, Elstrott BK, Martens KL, et al. Analysis of Adverse Events and Intravenous Iron Infusion Formulations in Adults With and Without Prior Infusion Reactions. JAMA Netw Open. 2022;5(3):e224488. DOI:10.1001/jamanetworkopen.2022.4488
45. Rottembourg J, Kadri A, Leonard E, et al. Do two intravenous iron sucrose preparations have the same efficacy? Nephrol Dial Transplant. 2011;26(10):3262-7. DOI:10.1093/ndt/gfr024
46. Rottembourg J, Guerin A, Diaconita M, Kadri A. The Complete Study of the Switch from Iron-Sucrose Originator to Iron-Sucrose Similar and Vice Versa in Hemodialysis Patients. J Kidney. 2016;2(1):110. DOI:10.4172/2472-1220.1000110
47. Toblli JE, Cao G, Oliveri L, Angerosa M. Differences between original intravenous iron sucrose and iron sucrose similar preparations. Arzneimittelforschung. 2009;59(4):176-90. DOI:10.1055/s-0031-1296383
48. Toblli JE, Cao G, Oliveri L, Angerosa M. Evaluation of toxicity and oxidative stress induced by intravenous iron isomaltoside 1000 in a nonclinical model. Arzneimittelforschung. 2011;61(10):553-65. DOI:10.1055/s-0031-1300553
49. Toblli JE, Cao G, Oliveri L, Angerosa M. Assessment of the extent of oxidative stress induced by intravenous ferumoxytol, ferric carboxymaltose, iron sucrose and iron dextran in a nonclinical model. Arzneimittelforschung. 2011;61(7):399-410. DOI:10.1055/s-0031-1296218
50. WHO Guideline on Country Pharmaceutical Pricing Policies. Geneva: World Health Organization, 2013. Available at: https://www.ncbi.nlm.nih.gov/books/NBK258619. Accessed: 12.02.2024.
51. Rottembourg J. Are Iron Sucrose and Iron Sucrose Similar Equivalent? Analytical, Experimental and Clinical Determinations. Nutri Food Sci J. 2018;2(1):116.
52. Lee ES, Park BR, Kim JS, et al. Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Curr Med Res Opin. 2013;29(2):141-7. DOI:10.1185/03007995.2012.760444
53. EMA Reflection Paper on the Data Requirements for Intravenous Iron-Based Nano-Colloidal Products Developed with Reference to an Innovator Medicinal Product. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184922. Accessed: 12.02.2024.
54. Sharma N, Thiek JL, Natung T, Ahanthem SS. Comparative Study of Efficacy and Safety of Ferric Carboxymaltose Versus Iron Sucrose in Post-partum Anaemia. J Obstet Gynaecol India. 2017;67(4):253-7. DOI:10.1007/s13224-017-0971-x
55. Shin HW, Go DY, Lee SW, et al. Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for iron deficiency anemia in obstetric and gynecologic patients: A systematic review and meta-analysis. Medicine (Baltimore). 2021;100(20):e24571. DOI:10.1097/MD.0000000000024571
56. Naqash A, Ara R, Bader GN. Effectiveness and safety of ferric carboxymaltose compared to iron sucrose in women with iron deficiency anemia: phase IV clinical trials. BMC Womens Health. 2018;18(1):6. DOI:10.1186/s12905-017-0506-8
57. Jose A, Mahey R, Sharma JB, et al. Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial. BMC Pregnancy Childbirth. 2019;19(1):54. DOI:10.1186/s12884-019-2200-3
58. Christoph P, Schuller C, Studer H, et al. Intravenous iron treatment in pregnancy: comparison of high-dose ferric carboxymaltose vs. iron sucrose. J Perinat Med. 2012;40(5):469-74. DOI:10.1515/jpm-2011-0231
59. GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020;5(1):17-30. DOI:10.1016/S2468-1253(19)30333-4
60. Kulnigg S, Gasche C. Systematic review: managing anaemia in Crohn's disease. Aliment Pharmacol Ther. 2006;24(11-12):1507-23. DOI:10.1111/j.1365-2036.2006.03146.x
61. Aksan A, Schoepfer A, Juillerat P, et al. Iron Formulations for the Treatment of Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: A Cost-Effectiveness Analysis in Switzerland. Adv Ther. 2021;38(1):660-77. DOI:10.1007/s12325-020-01553-1
62. Губонина И.В., Щукина О.Б., Стуклов Н.И., и др. Анемия при воспалительных заболеваниях кишечника: подходы к диагностике, лечению и профилактике. Альманах клинической медицины. 2019:47(8):721-32 [Gubonina IV, Shchukina OB, Stuklov NI, et al. Anemia in inflammatory bowel diseases: the approaches to its diagnosis, treatment and prevention. Almanac of Clinical Medicine. 2019;47(8):721-32 (in Russian)]. DOI:10.18786/2072-0505-2019-47-078
63. Koduru P, Abraham BP. The role of ferric carboxymaltose in the treatment of iron deficiency anemia in patients with gastrointestinal disease. Therap Adv Gastroenterol.
2016;9(1):76-85. DOI:10.1177/1756283X15616577
64. Aksan A, Işık H, Radeke HH, et al. Systematic review with network meta-analysis: comparative efficacy and tolerability of different intravenous iron formulations for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2017;45(10):1303-18. DOI:10.1111/apt.14043
65. Gordon M, Sinopoulou V, Iheozor-Ejiofor Z, et al. Interventions for treating iron deficiency anaemia in inflammatory bowel disease. Cochrane Database Syst Rev. 2021;1(1):CD013529. DOI:10.1002/14651858.CD013529.pub2
66. Volkova N, Arab L. Evidence-based systematic literature review of hemoglobin/hematocrit and all-cause mortality in dialysis patients. Am J Kidney Dis. 2006;47(1):24-36. DOI:10.1053/j.ajkd.2005.09.007
67. Locatelli F, de Francisco A, Deray G, et al. Mortality and cardiovascular morbidity associated with haemoglobin levels: a pooled analysis of randomised controlled trials. Nephron Clin Pract. 2014;128(3-4):323-32. DOI:10.1159/000366478
68. Drozdz M, Weigert A, Silva F, et al. Achievement of renal anemia KDIGO targets by two different clinical strategies – a European hemodialysis multicenter analysis. BMC Nephrol. 2019;20(1):5. DOI:10.1186/s12882-018-1196-7
69. Hofman JMG, Eisenga MF, Diepenbroek A, et al. Switching iron sucrose to ferric carboxymaltose associates to better control of iron status in hemodialysis patients. BMC Nephrol. 2018;19(1):242. DOI:10.1186/s12882-018-1045-8
70. Macdougall IC, Bock AH, Carrera F, et al. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014;29(11):2075-84. DOI:10.1093/ndt/gfu201
71. Righini M, Dalmastri V, Capelli I, et al. Intravenous Iron Replacement Therapy Improves Cardiovascular Outcomes in Hemodialysis Patients. In Vivo. 2021;35(3):1617-24. DOI:10.21873/invivo.12419
72. Хроническая сердечная недостаточность. Клинические рекомендации 2020. Российский кардиологический журнал. 2020;25(11):4083 [2020 Clinical practice guidelines for Chronic heart failure. Russian Journal of Cardiology. 2020;25(11):4083 (in Russian)]. DOI:10.15829/1560-4071-2020-4083
73. Мареев Ю.В., Гиляревский С.Р., Беграмбекова Ю.Л., и др. Согласованное мнение экспертов по поводу лечения дефицита железа у стабильных и декомпенсированных больных хронической сердечной недостаточностью. Кардиология. 2021;61(4):73-8 [Mareev YuV, Gilarevsky SR, Begrambekova YuL, et al. Expert consensus regarding treatment of iron deficiency in stable and decompensated patients with heart failure. Kardiologiia. 2021;61(4):73-8 (in Russian)]. DOI:10.18087/cardio.2021.4.n1639
74. McDonagh TA, Metra M, Adamo M, et al. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023;44(37):3627-39. DOI:10.1093/eurheartj/ehad195
75. Кобалава Ж.Д., Сафарова А.Ф., Лапшин А.А. Влияние терапии внутривенным карбоксимальтозатом железа на динамику показателей неинвазивной миокардиальной работы левого желудочка у пациентов с хронической сердечной недостаточностью с низкой фракцией выброса. Российский кардиологический журнал. 2023;28(1):87-94 [Kobalava ZhD, Safarova AF, Lapshin AA. Influence of intravenous ferric carboxymaltose on non-invasive parameters of left ventricular myocardial work in patients with heart failure with reduced ejection fraction. Russian Journal of Cardiology. 2023;28(1):87-94 (in Russian)]. DOI:10.15829/1560-4071-2023-5310
76. Ponikowski P, Kirwan BA, Anker SD, et al. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet. 2020;396(10266):1895-904. DOI:10.1016/S0140-6736(20)32339-4
77. Виноградова Н.Г., Чесникова А.И. Железодефицитные состояния при сердечно-сосудистых заболеваниях: влияние на прогноз и особенности коррекции. Южно-Российский журнал терапевтической практики. 2023;4(1):7-18 [Vinogradova NG, Chesnikova AI. Iron deficiency states in cardiovascular diseases: impact on prognosis and features of correction. South Russian Journal of Therapeutic Practice. 2023;4(1):7-18 (in Russian)]. DOI:10.21886/2712-8156-2023-4-1-7-18
________________________________________________
1. Kumar A, Sharma E, Marley A, et al. Iron deficiency anaemia: pathophysiology, assessment, practical management. BMJ Open Gastroenterol. 2022;9(1).
DOI:10.1136/bmjgast-2021-000759
2. Peyrin-Biroulet L, Williet N, Cacoub P. Guidelines on the diagnosis and treatment of iron deficiency across indications: a systematic review. Am J Clin Nutr. 2015;102(6):1585-94. DOI:10.3945/ajcn.114.103366
3. Cappellini MD, Comin-Colet J, de Francisco A, et al. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017;92(10):1068-78. DOI:10.1002/ajh.24820
4. Warner MJ, Kamran MT. Iron Deficiency Anemia. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing, 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK448065. Accessed: 12.02.2024.
5. Martens P. The Effect of Iron Deficiency on Cardiac Function and Structure in Heart Failure with Reduced Ejection Fraction. Card Fail Rev. 2022;8:e06. DOI:10.15420/cfr.2021.26
6. Evstatiev R, Marteau P, Iqbal T, et al. FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease. Gastroenterology. 2011;141(3):846-53.e1-2. DOI:10.1053/j.gastro.2011.06.005
7. Camaschella C, Nai A, Silvestri L. Iron metabolism and iron disorders revisited in the hepcidin era. Haematologica. 2020;105(2):260-72. DOI:10.3324/haematol.2019.232124
8. Geisser P, Burckhardt S. The pharmacokinetics and pharmacodynamics of iron preparations. Pharmaceutics. 2011;3(1):12-33. DOI:10.3390/pharmaceutics3010012
9. Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005;352(10):1011-23. DOI:10.1056/NEJMra041809
10. Zhelezodefitsitnaia anemiia. Klinicheskie rekomendatsii. 2021 g. Available at: https://cr.minzdrav.gov.ru/schema/669_1. Accessed: 12.02.2024 (in Russian).
11. Vorob'ev AI, Al'-Radi LS, Andreeva NE, et al. Ratsional'naia farmakoterapiia zabolevanii sistemy krovi. Pod obshch. red. AI Vorob'eva. Moscow: Litterra, 2009 (in Russian).
12. Camaschella C. Iron deficiency. Blood. 2019;133(1):30-9. DOI:10.1182/blood-2018-05-815944
13. Cappellini MD, Musallam KM, Taher AT. Iron deficiency anaemia revisited. J Intern Med. 2020;287(2):153-70. DOI:10.1111/joim.13004
14. Polson MK, Bahrain H, Ogden JF, et al. Financial burden associated with discordance to intravenous iron therapies in US patients with iron deficiency anemia. J Manag Care Spec Pharm. 2023;29(7):818-24. DOI:10.18553/jmcp.2023.22407
15. Blumenstein I, Shanbhag S, Langguth P, et al. Newer formulations of intravenous iron: a review of their chemistry and key safety aspects – hypersensitivity, hypophosphatemia, and cardiovascular safety. Expert Opin Drug Saf. 2021;20(7):757-69. DOI:10.1080/14740338.2021.1912010
16. Auerbach M, Macdougall I. The available intravenous iron formulations: History, efficacy, and toxicology. Hemodial Int. 2017;21 Suppl. 1:S83-92. DOI:10.1111/hdi.12560
17. Jahn MR, Andreasen HB, Fütterer S, et al. A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Eur J Pharm Biopharm. 2011;78(3):480-91. DOI:10.1016/j.ejpb.2011.03.016
18. Koch TA, Myers J, Goodnough LT. Intravenous Iron Therapy in Patients with Iron Deficiency Anemia: Dosing Considerations. Anemia. 2015;2015:763576. DOI:10.1155/2015/763576
19. Kumar A, Brookes MJ. Iron Therapy in Inflammatory Bowel Disease. Nutrients. 2020;12(11). DOI:10.3390/nu12113478
20. Wang C, Graham DJ, Kane RC, et al. Comparative Risk of Anaphylactic Reactions Associated With Intravenous Iron Products. JAMA. 2015;314(19):2062-8. DOI:10.1001/jama.2015.15572
21. Dave CV, Brittenham GM, Carson JL, Setoguchi S. Risks for Anaphylaxis With Intravenous Iron Formulations: A Retrospective Cohort Study. Ann Intern Med. 2022;175(5):656-64. DOI:10.7326/M21-4009
22. Muñoz M, Gómez-Ramírez S, García-Erce JA. Intravenous iron in inflammatory bowel disease. World J Gastroenterol. 2009;15(37):4666-74. DOI:10.3748/wjg.15.4666
23. Kulnigg S, Stoinov S, Simanenkov V, et al. A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial. Am J Gastroenterol. 2008;103(5):1182-92. DOI:10.1111/j.1572-0241.2007.01744.x
24. Van Wyck DB, Martens MG, Seid MH, et al. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007;110(2 Pt. 1):267-78. DOI:10.1097/01.AOG.0000275286.03283.18
25. Van Wyck DB, Mangione A, Morrison J, et al. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009;49(12):2719-28. DOI:10.1111/j.1537-2995.2009.02327.x
26. Anker SD, Comin Colet J, Filippatos G, et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009;361(25):2436-48. DOI:10.1056/NEJMoa0908355
27. Rognoni C, Venturini S, Meregaglia M, et al. Efficacy and Safety of Ferric Carboxymaltose and Other Formulations in Iron-Deficient Patients: A Systematic Review and Network Meta-analysis of Randomised Controlled Trials. Clin Drug Investig. 2016;36(3):177-94. DOI:10.1007/s40261-015-0361-z
28. Danielson BG. Structure, chemistry, and pharmacokinetics of intravenous iron agents. J Am Soc Nephrol. 2004;15 Suppl. 2:S93-8. DOI:10.1097/01.ASN.0000143814.49713.C5
29. Bhandari S, Pereira DIA, Chappell HF, Drakesmith H. Intravenous Irons: From Basic Science to Clinical Practice. Pharmaceuticals (Basel). 2018;11(3). DOI:10.3390/ph11030082
30. Evans RW, Rafique R, Zarea A, et al. Nature of non-transferrin-bound iron: studies on iron citrate complexes and thalassemic sera. J Biol Inorg Chem. 2008;13(1):57-74. DOI:10.1007/s00775-007-0297-8
31. Horl WH, Macdougall IC, Rossert J, Schaefer RM. OPTA-therapy with iron and erythropoiesis-stimulating agents in chronic kidney disease. Nephrol Dial Transplant.
2007;22(Suppl. 3):2-6. DOI:10.1093/ndt/gfm014
32. Drapkina OM, Avalueva EB, Bakulin IG, et al. Vedenie patsientov s zhelezodefitsitnoi anemiei na etape okazaniia pervichnoi mediko-sanitarnoi pomoshchi. Prakticheskoe rukovodstvo. Moscow: ROPNIZ: Silitseia-Poligraf, 2022 (in Russian).
33. Geisser P, Baer M, Schaub E. Structure/histotoxicity relationship of parenteral iron preparations. Arzneimittelforschung. 1992;42(12):1439-52.
34. Balakrishnan VS, Rao M, Kausz AT, et al. Physicochemical properties of ferumoxytol, a new intravenous iron preparation. Eur J Clin Invest. 2009;39(6):489-96.
DOI:10.1111/j.1365-2362.2009.02130.x
35. Beshara S, Sörensen J, Lubberink M, et al. Pharmacokinetics and red cell utilization of 52Fe/59Fe-labelled iron polymaltose in anaemic patients using positron emission tomography. Br J Haematol. 2003;120(5):853-9. DOI:10.1046/j.1365-2141.2003.03590.x
36. Miller JL. Iron deficiency anemia: a common and curable disease. Cold Spring Harb Perspect Med. 2013;3(7). DOI:10.1101/cshperspect.a011866
37. Auerbach M, Deloughery T. Single-dose intravenous iron for iron deficiency: a new paradigm. Hematology Am Soc Hematol Educ Program. 2016;2016(1):57-66. DOI:10.1182/asheducation-2016.1.57
38. Kurilovich EO, Volkova OI, Popovich LD. Clinical and economic aspects of the use of parenteral iron preparations for the correction of iron deficiency and anemia in surgical patients. Chief Medical Officer. 2020;12:44-55 (in Russian). DOI:10.33920/med-03-2012-04
39. Gómez-Ramírez S, Shander A, Spahn DR, et al. Prevention and management of acute reactions to intravenous iron in surgical patients. Blood Transfus. 2019;17(2):137-45. DOI:10.2450/2018.0156-18
40. Macdougall IC, Bircher AJ, Eckardt KU, et al. Iron management in chronic kidney disease: conclusions from a "Kidney Disease: Improving Global Outcomes" (KDIGO) Controversies Conference. Kidney Int. 2016;89(1):28-39. DOI:10.1016/j.kint.2015.10.002
41. Avni T, Bieber A, Grossman A, et al. The safety of intravenous iron preparations: systematic review and meta-analysis. Mayo Clin Proc. 2015;90(1):12-23. DOI:10.1016/j.mayocp.2014.10.007
42. Elstrott B, Khan L, Olson S, et al. The role of iron repletion in adult iron deficiency anemia and other diseases. Eur J Haematol. 2020;104(3):153-61. DOI:10.1111/ejh.13345
43. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmén J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006;21(2):378-82. DOI:10.1093/ndt/gfi253
44. Arastu AH, Elstrott BK, Martens KL, et al. Analysis of Adverse Events and Intravenous Iron Infusion Formulations in Adults With and Without Prior Infusion Reactions. JAMA Netw Open. 2022;5(3):e224488. DOI:10.1001/jamanetworkopen.2022.4488
45. Rottembourg J, Kadri A, Leonard E, et al. Do two intravenous iron sucrose preparations have the same efficacy? Nephrol Dial Transplant. 2011;26(10):3262-7. DOI:10.1093/ndt/gfr024
46. Rottembourg J, Guerin A, Diaconita M, Kadri A. The Complete Study of the Switch from Iron-Sucrose Originator to Iron-Sucrose Similar and Vice Versa in Hemodialysis Patients. J Kidney. 2016;2(1):110. DOI:10.4172/2472-1220.1000110
47. Toblli JE, Cao G, Oliveri L, Angerosa M. Differences between original intravenous iron sucrose and iron sucrose similar preparations. Arzneimittelforschung. 2009;59(4):176-90. DOI:10.1055/s-0031-1296383
48. Toblli JE, Cao G, Oliveri L, Angerosa M. Evaluation of toxicity and oxidative stress induced by intravenous iron isomaltoside 1000 in a nonclinical model. Arzneimittelforschung. 2011;61(10):553-65. DOI:10.1055/s-0031-1300553
49. Toblli JE, Cao G, Oliveri L, Angerosa M. Assessment of the extent of oxidative stress induced by intravenous ferumoxytol, ferric carboxymaltose, iron sucrose and iron dextran in a nonclinical model. Arzneimittelforschung. 2011;61(7):399-410. DOI:10.1055/s-0031-1296218
50. WHO Guideline on Country Pharmaceutical Pricing Policies. Geneva: World Health Organization, 2013. Available at: https://www.ncbi.nlm.nih.gov/books/NBK258619. Accessed: 12.02.2024.
51. Rottembourg J. Are Iron Sucrose and Iron Sucrose Similar Equivalent? Analytical, Experimental and Clinical Determinations. Nutri Food Sci J. 2018;2(1):116.
52. Lee ES, Park BR, Kim JS, et al. Comparison of adverse event profile of intravenous iron sucrose and iron sucrose similar in postpartum and gynecologic operative patients. Curr Med Res Opin. 2013;29(2):141-7. DOI:10.1185/03007995.2012.760444
53. EMA Reflection Paper on the Data Requirements for Intravenous Iron-Based Nano-Colloidal Products Developed with Reference to an Innovator Medicinal Product. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184922. Accessed: 12.02.2024.
54. Sharma N, Thiek JL, Natung T, Ahanthem SS. Comparative Study of Efficacy and Safety of Ferric Carboxymaltose Versus Iron Sucrose in Post-partum Anaemia. J Obstet Gynaecol India. 2017;67(4):253-7. DOI:10.1007/s13224-017-0971-x
55. Shin HW, Go DY, Lee SW, et al. Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for iron deficiency anemia in obstetric and gynecologic patients: A systematic review and meta-analysis. Medicine (Baltimore). 2021;100(20):e24571. DOI:10.1097/MD.0000000000024571
56. Naqash A, Ara R, Bader GN. Effectiveness and safety of ferric carboxymaltose compared to iron sucrose in women with iron deficiency anemia: phase IV clinical trials. BMC Womens Health. 2018;18(1):6. DOI:10.1186/s12905-017-0506-8
57. Jose A, Mahey R, Sharma JB, et al. Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial. BMC Pregnancy Childbirth. 2019;19(1):54. DOI:10.1186/s12884-019-2200-3
58. Christoph P, Schuller C, Studer H, et al. Intravenous iron treatment in pregnancy: comparison of high-dose ferric carboxymaltose vs. iron sucrose. J Perinat Med. 2012;40(5):469-74. DOI:10.1515/jpm-2011-0231
59. GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020;5(1):17-30. DOI:10.1016/S2468-1253(19)30333-4
60. Kulnigg S, Gasche C. Systematic review: managing anaemia in Crohn's disease. Aliment Pharmacol Ther. 2006;24(11-12):1507-23. DOI:10.1111/j.1365-2036.2006.03146.x
61. Aksan A, Schoepfer A, Juillerat P, et al. Iron Formulations for the Treatment of Iron Deficiency Anemia in Patients with Inflammatory Bowel Disease: A Cost-Effectiveness Analysis in Switzerland. Adv Ther. 2021;38(1):660-77. DOI:10.1007/s12325-020-01553-1
62. Gubonina IV, Shchukina OB, Stuklov NI, et al. Anemia in inflammatory bowel diseases: the approaches to its diagnosis, treatment and prevention. Almanac of Clinical Medicine. 2019;47(8):721-32 (in Russian). DOI:10.18786/2072-0505-2019-47-078
63. Koduru P, Abraham BP. The role of ferric carboxymaltose in the treatment of iron deficiency anemia in patients with gastrointestinal disease. Therap Adv Gastroenterol.
2016;9(1):76-85. DOI:10.1177/1756283X15616577
64. Aksan A, Işık H, Radeke HH, et al. Systematic review with network meta-analysis: comparative efficacy and tolerability of different intravenous iron formulations for the treatment of iron deficiency anaemia in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2017;45(10):1303-18. DOI:10.1111/apt.14043
65. Gordon M, Sinopoulou V, Iheozor-Ejiofor Z, et al. Interventions for treating iron deficiency anaemia in inflammatory bowel disease. Cochrane Database Syst Rev. 2021;1(1):CD013529. DOI:10.1002/14651858.CD013529.pub2
66. Volkova N, Arab L. Evidence-based systematic literature review of hemoglobin/hematocrit and all-cause mortality in dialysis patients. Am J Kidney Dis. 2006;47(1):24-36. DOI:10.1053/j.ajkd.2005.09.007
67. Locatelli F, de Francisco A, Deray G, et al. Mortality and cardiovascular morbidity associated with haemoglobin levels: a pooled analysis of randomised controlled trials. Nephron Clin Pract. 2014;128(3-4):323-32. DOI:10.1159/000366478
68. Drozdz M, Weigert A, Silva F, et al. Achievement of renal anemia KDIGO targets by two different clinical strategies – a European hemodialysis multicenter analysis. BMC Nephrol. 2019;20(1):5. DOI:10.1186/s12882-018-1196-7
69. Hofman JMG, Eisenga MF, Diepenbroek A, et al. Switching iron sucrose to ferric carboxymaltose associates to better control of iron status in hemodialysis patients. BMC Nephrol. 2018;19(1):242. DOI:10.1186/s12882-018-1045-8
70. Macdougall IC, Bock AH, Carrera F, et al. FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia. Nephrol Dial Transplant. 2014;29(11):2075-84. DOI:10.1093/ndt/gfu201
71. Righini M, Dalmastri V, Capelli I, et al. Intravenous Iron Replacement Therapy Improves Cardiovascular Outcomes in Hemodialysis Patients. In Vivo. 2021;35(3):1617-24. DOI:10.21873/invivo.12419
72. 2020 Clinical practice guidelines for Chronic heart failure. Russian Journal of Cardiology. 2020;25(11):4083 (in Russian). DOI:10.15829/1560-4071-2020-4083
73. Mareev YuV, Gilarevsky SR, Begrambekova YuL, et al. Expert consensus regarding treatment of iron deficiency in stable and decompensated patients with heart failure. Kardiologiia. 2021;61(4):73-8 (in Russian). DOI:10.18087/cardio.2021.4.n1639
74. McDonagh TA, Metra M, Adamo M, et al. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023;44(37):3627-39. DOI:10.1093/eurheartj/ehad195
75. Kobalava ZhD, Safarova AF, Lapshin AA. Influence of intravenous ferric carboxymaltose on non-invasive parameters of left ventricular myocardial work in patients with heart failure with reduced ejection fraction. Russian Journal of Cardiology. 2023;28(1):87-94 (in Russian). DOI:10.15829/1560-4071-2023-5310
76. Ponikowski P, Kirwan BA, Anker SD, et al. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial. Lancet. 2020;396(10266):1895-904. DOI:10.1016/S0140-6736(20)32339-4
77. Vinogradova NG, Chesnikova AI. Iron deficiency states in cardiovascular diseases: impact on prognosis and features of correction. South Russian Journal of Therapeutic Practice. 2023;4(1):7-18 (in Russian). DOI:10.21886/2712-8156-2023-4-1-7-18
Авторы
С.К. Зырянов, Е.А. Байбулатова*
ФГАОУ ВО «Российский университет дружбы народов им. Патриса Лумумбы», Москва, Россия
*baybulatova-ea@rudn.ru
________________________________________________
Sergey K. Zyryanov, Elena A. Baybulatova*
Patrice Lumumba Peoples' Friendship University of Russia, Moscow, Russia
*baybulatova-ea@rudn.ru