Efficacy of a combined drug containing ferrous fumarate and folic acid in anemia in the second trimester of pregnancy: results of a multicenter study
- Авторлар: Pavlovich S.1, Melikhov O.2,3, Khodzhaeva Z.1, Muminova K.1, Sakalo V.1, Gorodnova E.1, Abashova E.4, Yarmolinskaya M.4, Chulkov V.5, Nazipova Z.6, Savelyeva I.7, Andreeva M.8, Kudlai Y.8, Enkova E.9, Zaripova A.10
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Мекемелер:
- Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia
- Scientific Society “League for Promoting Clinical Trials”
- Institute of Clinical Research
- D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
- City Center for Hemostatic Pathology
- Republican Clinical Hospital, Ministry of Health of the Republic of Tatarstan
- Omsk State Medical University, Ministry of Health of Russia
- Kuban State Medical University, Ministry of Health of Russia
- Voronezh City Clinical Polyclinic No. 1
- Nurmed Medical Center
- Шығарылым: № 2 (2023)
- Беттер: 108-116
- Бөлім: Exchange of Experience
- URL: https://journals.rcsi.science/0300-9092/article/view/258666
- DOI: https://doi.org/10.18565/aig.2023.51
- ID: 258666
Дәйексөз келтіру
Аннотация
Objective: To evaluate the effect of ferrous fumarate/folic acid (FF/FA) on the clinical and laboratory signs of anemia in pregnant women in the second trimester.
Materials and methods: The investigation enrolled 160 women at 14 to 20 weeks’ gestation who were diagnosed with anemia and were prescribed FF/FA.
Results: The use of FF/FA caused a significant improvement in clinical and biochemical blood test results reflecting the severity of anemia: an increase in Hb, Ht, RBC, MCV, MCH, MCHC, serum iron, and ferritin, a decrease in the frequency of microcytosis and serum latent iron-binding capacity. After 3 months of therapy, the total study population displayed an increase in mean values of HgB from 102.0 to 117.0 g/l, ferritin from 46.2 to 55.9 µg/l, serum iron from 12.02 to 20.49 µmol/l. The proportion of patients without anemia was 77% (118/153); that with mild and moderate anemia were 20% (31/153), and 2% (3/153), respectively, which shows a significant improvement compared to that at the start of therapy. In the group with iron deficiency anemia (IDA), (Hb<110 g/l, ferritin<30 µg/l), Hb increased from an average of 103.3 to 109.8 g/l, ferritin from 14.4 to 24.3 µg/l, serum iron from 11.87 to 20.53 µmol/l. After 3 months, mild and moderate IDA was present in 30% (28/93) and 3% (3/93) patients, respectively.
Conclusion. The findings are comparable with international and Russian data and can conclude that FF/FA is an effective and safe way to correct IDA in pregnant women and is suitable for long-term use.
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##article.viewOnOriginalSite##Авторлар туралы
Stanislav Pavlovich
Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia
Email: s_pavlovich@oparina4.ru
ORCID iD: 0000-0002-1313-7079
PhD, Academic Secretary; Professor, Department of Obstetrics, Gynecology, Perinatology and Reproductology
Ресей, MoscowOleg Melikhov
Scientific Society “League for Promoting Clinical Trials”; Institute of Clinical Research
Хат алмасуға жауапты Автор.
Email: melikhov.oleg@gmail.com
ORCID iD: 0000-0001-9442-7707
PhD, Director; Chairman
Ресей, Moscow; MoscowZulfiya Khodzhaeva
Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia
Email: zkhodjaeva@mail.ru
ORCID iD: 0000-0001-8159-3714
Dr. Med. Sci., Professor, Deputy Director of Obstetrics Institute, Professor at the Department of Obstetrics, Gynecology, Perinatology of the Department of Professional Education
Ресей, MoscowKamilla Muminova
Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia
Email: kamika91@mail.ru
ORCID iD: 0000-0003-2708-4366
PhD, Researcher at the High Risk Pregnancy Department
Ресей, MoscowViktoriya Sakalo
Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia
Email: v_sakalo@oparina4.ru
ORCID iD: 0000-0002-5870-4655
PhD, Junior Researcher at the Department of Pregnancy Pathology, Institute of Obstetrics, doctor at the 1st Obstetric Department of Pregnancy Pathology
Ресей, MoscowElena Gorodnova
Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia
Email: e_gorodnova@oparina4.ru
ORCID iD: 0000-0003-3993-7629
Scopus Author ID: 6508176604
PhD, MPH (Master of Public Health), Head of Scientific & Clinical Center
Ресей, MoscowElena Abashova
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
Email: abashova@yandex.ru
ORCID iD: 0000-0003-2399-3108
SPIN-код: 2133-0310
PhD, Senior Researcher, Department of Gynecology and Endocrinology
Ресей, Saint PetersburgMaria Yarmolinskaya
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
Email: m.yarmolinskaya@gmail.com
ORCID iD: 0000-0002-6551-4147
SPIN-код: 3686-3605
Professor of RAS, Dr. Med. Sci., Professor, Head of the Department of Gynecology and Endocrinology, Head of Center “Diagnostics and treatment of endometriosis”; Professor at the Department of Obstetrics and Gynecology
Ресей, Saint PetersburgVasilii Chulkov
City Center for Hemostatic Pathology
Email: vschulkov@rambler.ru
ORCID iD: 0000-0002-0952-6856
Dr. Med. Sci., Professor at the Department of Faculty Therapy
Ресей, ChelyabinskZulfira Nazipova
Republican Clinical Hospital, Ministry of Health of the Republic of Tatarstan
Email: zulfira93@mail.ru
ORCID iD: 0009-0002-3591-522X
hematologist
Ресей, KazanIrina Savelyeva
Omsk State Medical University, Ministry of Health of Russia
Email: saveljeva_iv_omsk@mail.ru
ORCID iD: 0000-0001-9342-7342
Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology No. 1
Ресей, OmskMargarita Andreeva
Kuban State Medical University, Ministry of Health of Russia
Email: andreeva_md@mail.ru
ORCID iD: 0000-0002-6524-3965
Dr. Med. Sci., Associate Professor, Professor at the Department of Obstetrics, Gynecology and Perinatology, Faculty of Postgraduate Education
Ресей, KrasnodarYulia Kudlai
Kuban State Medical University, Ministry of Health of Russia
Email: kudlai.j@yandex.ru
ORCID iD: 0000-0002-3192-7170
student of the Faculty of Pediatrics
Ресей, KrasnodarElena Enkova
Voronezh City Clinical Polyclinic No. 1
Email: enkova@bk.ru
ORCID iD: 0000-0001-8885-1587
Dr. Med. Sci., Professor, Head of the Department of Obstetrics and Gynecology No. 2
Ресей, VoronezhAliya Zaripova
Nurmed Medical Center
Email: zaripovaash@yandex.ru
ORCID iD: 0000-0002-2701-319X
postgraduate student of the Department of Obstetrics and Gynecology named after V.S. Gruzdev; Chief Physician, obstetrician-gynecologist, ultrasound diagnostics doctor
Ресей, KazanӘдебиет тізімі
- WHO. Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity. World Health Organization; 2011. Available at: https://apps.who.int/iris/handle/10665/85839]
- Ministry of Health of the Russian Federation. Iron deficiency anemia. Clinical guidelines. Мoscow; 2021. (in Russian).
- Pavord S., Daru J., Prasannan N., Robinson S., Stanworth S., Girling J.; BBSH Committee. UK guidelines on the management of iron deficiency in pregnancy. Br. J. Haematol. 2020; 188(6): 819-30. https://dx.doi.org/10.1111/bjh.16221.
- WHO. WHO Global Anaemia estimates, 2021 Edition. WHO Global health observatory. 2022. Available at: https:// www.who.int/data/gho/data/themes/topics/anaemia_in_women_and_children
- Jung J., Rahman M.M., Rahman M.S., Swe K.T., Islam M.R., Rahman M.O., Akter S. Effects of hemoglobin levels during pregnancy on adverse maternal and infant outcomes: a systematic review and meta-analysis. Ann. N. Y. Acad. Sci. 2019; 1450: 69-82. https://dx.doi.org/10.1111/nyas.14112.
- Masukume G., Khashan A.S., Kenny L.C., Baker P.N., Nelson G. SCOPE Consortium. Risk factors and birth outcomes of anaemia in early pregnancy in a nulliparous cohort. PLoS One. 2015; 10(4): e0122729. 10.1371/ journal.pone.0122729.
- Christian P., Mullany L.C., Hurley K.M., Katz J., Black R.E. Nutrition and maternal, neonatal, and child health. Semin. Perinatol. 2015; 39(5): 361-72. https://dx.doi.org/10.1053/j.semperi.2015.06.009.
- Expert council resolution on prevention and treatment of iron deficiency anemia in pregnant women. Obstetrics and Gynecology. 2020; (4): 230-2. https://dx.doi.org/10.18565/aig.2020.4.230-232.
- WHO. WHO guidelines on prenatal care for a positive pregnancy experience. 2017. 196p. Available at: https://www.who.int/ru/publications/i/item/9789241549912 (in Russian).
- Wang L., Mei Z., Li H., Zhang Y., Liu J., Serdula M.K. Modifying effects of maternal Hb concentration on infant birth weight in women receiving prenatal iron-containing supplements: a randomised controlled trial. Br. J. Nutr. 2016; 115(4): 644-9. https://dx.doi.org/10.1017/S0007114515004870.
- Korotkikh I.N., Litvinenko O.V. Iron deficiencies in pregnancy and their pharmacotherapy. Russian Journal of Woman and Child Health. 2019; 2(4): 292-5. (in Russian). https://dx.doi.org/10.32364/ 2618-8430-2019-2-4-292-295.
- Gromova O.A., Torshin I.Yu., Tetruashvili N.K., Gogoleva I.V. Systematic analysis of ferrous protein succinilate pharmacological properties. Effective Pharmacotherapy. 2018; (13): 20-9. (in Russian).
- Wahyuwibowo J., Aziz A., Safitri E., Minidian F., Zulaikhah S.T. Iron-folate supplementation during pregnancy for prevent oxidative stress in pregnant rats: Level of MDA, Creatinine, Glucose, Erythrocite, Blood Pressure, Body Weight and Number of Offspring. Pharmacog. J. 2020; 12(1): 186-91. https://dx.doi.org/10.5530/pj.2020.12.28.
- Cawley S., Mullaney L., McKeating A., Farren M., McCartney D., Turner M.J. An analysis of folic acid supplementation in women presenting for antenatal care. J. Public Health (Oxf.). 2016; 38(1): 122-9. https://dx.doi.org/10.1093/pubmed/fdv019.
- Stamm R.A., Houghton L.A. Nutrient intake values for folate during pregnancy and lactation vary widely around the world. Nutrients. 2013; 5(10): 3920-47. https://dx.doi.org/10.3390/nu5103920.
- Roche M.L., Samson K.L.I., Green T.J., Karakochuk C.D., Martinez H. Perspective: weekly iron and folic acid supplementation (WIFAS): a critical review and rationale for inclusion in the essential medicines list to accelerate anemia and neural tube defects reduction. Adv. Nutr. 2021; 12(2): 334-42. https://dx.doi.org/10.1093/advances/nmaa169.
- O'Malley E.G., Cawley S., Kennedy R.A.K., Reynolds C.M.E., Molloy A., Turner M.J. Maternal anaemia and folate intake in early pregnancy. J. Public Health (Oxf.). 2018; 40(3): e296-e302. https://dx.doi.org/10.1093/pubmed/ fdy013.
- Gromova O.A., Torshin I.Yu., Tetruashvili N.K., Pavlovich S.V. Systematic analysis of molecular synergy between folic acid and ferrous fumarate in iron deficiency anemia. Obstetrics and Gynecology. 2022; (12): 178-86. (in Russian). https://dx.doi.org/10.18565/ aig.2022.301.
- Giblin T.J. Jr, Lee J.F., Rattigan J.P. Ferrous fumarate: a well-tolerated oral iron preparation. Clin. Med. (Northfield). 1962; 69: 2258-60.
- Yismaw A.E., Tulu H.B., Kassie F.Y., Araya B.M. Iron-folic acid adherence and associated factors among pregnant women attending antenatal care at Metema District, Northwest Ethiopia. Front. Public Health. 2022; 10: 978084. https://dx.doi.org/10.3389/fpubh.2022.978084.
- Kirilyuk A.A. Iron-containing medicines: from clinical pharmacology to pharmaceutical assistance (report 1). Bulletin of Pharmacy. 2020; (3): 81-97. (in Russian).
- Torshin I.Iu., Gromova O.A., Limanova O.A., Grishina T.R., Bashmakova N.V., Kerimkulova N.V., Serova O.F., Kraposhina T.P., Kosenko I.M. A meta-analysis of clinical studies on the use of iron fumarate for the prevention and treatment of iron deficiency anemia in pregnant women. Gynecology. 2015; 17(5): 24-31. (in Russian).
- Declaration of Helsinki of the World Medical Association. Adopted at the 18th WMA General Assembly, Helsinki, Finland, June 1964, amended at the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. (in Russian).
- National Standard of the Russian Federation GOST R 52379-2005 "Good Clinical Practice". (in Russian).
- Russian Society of Obstetricians and Gynecologists, V.I. Kulakov Scientific Center for Obstetrics, Gynecology and Perinatology. Federal Clinical Guidelines of the Ministry of Health of Russia. Diagnosis, prevention and treatment of iron deficiency conditions in pregnant and postpartum women. 2013. 26p. (in Russian).
- Mehta B.C. Ineffectiveness of iron polymaltose in treatment of iron deficiency anemia. J. Assoc. Physicians India. 2003; 51: 419-21.
- Ruiz-Argüelles G.J., Díaz-Hernández A., Manzano C., Ruiz-Delgado G.J. Ineffectiveness of oral iron hydroxide polymaltose in iron-deficiency anemia. Hematology. 2007; 12(3): 255-6. https://dx.doi.org/10.1080/10245330701214160.
- Gilgen D., Mascie-Taylor C.G. The effect of weekly iron supplementation on anaemia and on iron deficiency among female tea pluckers in Bangladesh. J. Hum. Nutr. Diet. 2001; 14(3): 185-90. https://dx.doi.org/10.1046/ j.1365-277x.2001.00291.x.
- Baev O.R. Prevention and treatment of iron deficiency conditions during pregnancy: use of combination of iron and folic acid. Pharmateca. 2011; (13): 47-52. (in Russian).