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Систематический обзор исследований безопасности и эффективности терапии лихорадки у детей и взрослых метамизолом натрия - Журнал Терапевтический архив №1 Поликлинические проблемы и организация медицинской помощи 2025
Систематический обзор исследований безопасности и эффективности терапии лихорадки у детей и взрослых метамизолом натрия
Малявин А.Г., Бабак С.Л., Заплатников А.Л., Булгакова В.А., Гарусова М.Ю., Илюхина М.Д. Систематический обзор исследований безопасности и эффективности терапии лихорадки у детей и взрослых метамизолом натрия. Терапевтический архив. 2025;97(1):71–79. DOI: 10.26442/00403660.2025.01.203101
© ООО «КОНСИЛИУМ МЕДИКУМ», 2025 г.
© ООО «КОНСИЛИУМ МЕДИКУМ», 2025 г.
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Аннотация
Цель. Систематический анализ существующих публикаций из доступных научных баз данных (PubMed, Cochrane, eLibrary) за период с 2018 по 2023 г. терапии лихорадки у детей и взрослых метамизолом натрия (МН).
Материалы и методы. Проведен систематический анализ научных публикаций по изучению эффективности и безопасности терапии лихорадки у взрослых и детей МН по сравнению с нестероидными противовоспалительными препаратами. В анализ включено 6 рандомизированных клинических исследований с участием 884 пациентов (101 взрослого и 783 детей).
Результаты. Во всех исследованиях продемонстрировано, что МН является эффективным средством купирования лихорадки у детей и взрослых при его кратковременном использовании. Эффективность МН по снижению температуры тела в диапазоне 1,5–6,0 ч после приема внутрь превосходит таковую от парацетамола, ибупрофена, ацетилсалициловой кислоты и не уступает по эффективности нимесулиду и пропацетамолу. Показано, что терапия лихорадки МН является более безопасной стратегией по сравнению с другими нестероидными противовоспалительными препаратами, поскольку не обладает клинически значимыми рисками раздражения слизистой оболочки желудка, развития желудочно-кишечных кровотечений и эрозий. Установлено, что терапевтические дозы МН не приводят к повышению артериального давления, а в ряде случаев способствуют гипотензивному эффекту, особенно при лихорадке у взрослых коморбидных пациентов с артериальной гипертензией.
Заключение. МН является эффективным средством для купирования лихорадки у детей и взрослых.
Ключевые слова: метамизол натрия, лихорадка, безопасность, жаропонижающие средства, антипиретический эффект, нестероидные противовоспалительные препараты
Materials and methods. A systematic review of scientific publications on the efficacy and safety of MS therapy for fever in adults and children compared to non-steroidal anti-inflammatory drugs was conducted. Six randomized clinical trials involving 884 patients (101 adults and 783 children) were included in the analysis.
Results. In all studies, MS has been demonstrated to be effective in reducing fever in both children and adults when used for short-term therapy. MS is superior to paracetamol, ibuprofen, acetylsalicylic acid and not inferior to nimesulide and propacetamol in terms of effectiveness in reducing body temperature between 1.5 and 6.0 hours after oral intake. It has been shown that treatment of fever with MS is a safer strategy compared to other non-steroidal anti-inflammatory drugs, as it has no clinically significant risks of gastric mucosal irritation, development of gastrointestinal bleeding and erosions. It has been established that therapeutic doses of MS do not lead to an increase in blood pressure, and in some cases contribute to hypotensive effect, especially in fever in adult comorbid patients with arterial hypertension.
Conclusion. MS is an effective treatment for fever in children and adults.
Keywords: metamizole sodium, fever, safety, antipyretic agents, antipyretic effect, nonsteroidal anti-inflammatory drugs
Материалы и методы. Проведен систематический анализ научных публикаций по изучению эффективности и безопасности терапии лихорадки у взрослых и детей МН по сравнению с нестероидными противовоспалительными препаратами. В анализ включено 6 рандомизированных клинических исследований с участием 884 пациентов (101 взрослого и 783 детей).
Результаты. Во всех исследованиях продемонстрировано, что МН является эффективным средством купирования лихорадки у детей и взрослых при его кратковременном использовании. Эффективность МН по снижению температуры тела в диапазоне 1,5–6,0 ч после приема внутрь превосходит таковую от парацетамола, ибупрофена, ацетилсалициловой кислоты и не уступает по эффективности нимесулиду и пропацетамолу. Показано, что терапия лихорадки МН является более безопасной стратегией по сравнению с другими нестероидными противовоспалительными препаратами, поскольку не обладает клинически значимыми рисками раздражения слизистой оболочки желудка, развития желудочно-кишечных кровотечений и эрозий. Установлено, что терапевтические дозы МН не приводят к повышению артериального давления, а в ряде случаев способствуют гипотензивному эффекту, особенно при лихорадке у взрослых коморбидных пациентов с артериальной гипертензией.
Заключение. МН является эффективным средством для купирования лихорадки у детей и взрослых.
Ключевые слова: метамизол натрия, лихорадка, безопасность, жаропонижающие средства, антипиретический эффект, нестероидные противовоспалительные препараты
________________________________________________
Materials and methods. A systematic review of scientific publications on the efficacy and safety of MS therapy for fever in adults and children compared to non-steroidal anti-inflammatory drugs was conducted. Six randomized clinical trials involving 884 patients (101 adults and 783 children) were included in the analysis.
Results. In all studies, MS has been demonstrated to be effective in reducing fever in both children and adults when used for short-term therapy. MS is superior to paracetamol, ibuprofen, acetylsalicylic acid and not inferior to nimesulide and propacetamol in terms of effectiveness in reducing body temperature between 1.5 and 6.0 hours after oral intake. It has been shown that treatment of fever with MS is a safer strategy compared to other non-steroidal anti-inflammatory drugs, as it has no clinically significant risks of gastric mucosal irritation, development of gastrointestinal bleeding and erosions. It has been established that therapeutic doses of MS do not lead to an increase in blood pressure, and in some cases contribute to hypotensive effect, especially in fever in adult comorbid patients with arterial hypertension.
Conclusion. MS is an effective treatment for fever in children and adults.
Keywords: metamizole sodium, fever, safety, antipyretic agents, antipyretic effect, nonsteroidal anti-inflammatory drugs
Полный текст
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3. Baranov AA, Namazova-Baranova LS, Lobzin YuV, et al. Modern approaches to the management of children with acute respiratory viral infection. Pediatric Pharmacology. 2023;20(2):162-74 (in Russian). DOI:10.15690/pf.v20i2.2539
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6. Mackowiak PA. Concepts of fever. Arch Intern Med. 1998;158(17):1870-81. DOI:10.1001/archinte.158.17.1870
7. Doman M, Thy M, Dessajan J, et al. Temperature control in sepsis. Front Med (Lausanne). 2023;10:1292468. DOI:10.3389/fmed.2023.1292468
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10. Plaisance KI, Mackowiak PA. Antipyretic therapy: Physiologic rationale, diagnostic implications, and clinical consequences. Archives of Internal Medicine. 2000;160(4):449-56. DOI:10.1001/archinte.160.4.449
11. Ghlichloo I, Gerriets V. Nonsteroidal anti-inflammatory drugs (NSAIDs). In: StatPearls Publishing, 2024. PMID:31613522
12. Mubarakshina OA. Topicality of nonsteroidal anti-inflammatory drugs in treatment of fever in children. Current Pediatrics. 2010;9(2):156-60 (in Russian).
13. Marushko YuV, Todyka YuI, Marushko YeYu. Clinical effectiveness and dose titration in pediatric practice. Zdorov'e Rebenka. 2016;1(69):41-7 (in Russian).
DOI: 10.22141/2224-0551.1.69.2016.73704
14. Zaitseva OV, Lokshina EE. The effectiveness and safety of analgesic antipyretics in pediatric care: Comparative aspects. Rossijskij Vestnik Perinatologii i Pediatrii. 2009;54(5):86-92 (in Russian).
15. Asfandiyarova NS, Philippov EV. The use of nonsteroidal anti-inflammatory drugs in polymorbid pathology. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(1):82-8 (in Russian).
DOI: 10.26442/00403660.2020.01.000480
16. Watkins PB, Kaplowitz N, Slattery JT, et al. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: A randomized controlled trial. JAMA. 2006;296(1):87-93. DOI:10.1001/jama.296.1.87
17. Andrade S, Bartels DB, Lange R, et al. Safety of metamizole: A systematic review of the literature. J Clin Pharm Ther. 2016;41(5):459-77. DOI:10.1111/jcpt.12422
18. European Medicines Agency. Assessment report: Referral under Article 31 of Directive 2001/83/EC metamizole-containing medicinal products. EMA/143912/2019. Available at: https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-chmp-assessment-repor.... Accessed: 26.11.2024.
19. Stromer W, Palladini M. Metamizole: A comprehensive approach to its benefit-risk profile. Evid Self Med. 2022;2(220153):1-4. DOI:10.52778/efsm.22.0153
20. Andrade SE, Martinez C, Walker AM. Comparative safety evaluation of non-narcotic analgesics. J Clin Epidemiol. 1998;51(12):1357-65. DOI:10.1016/s0895-4356(98)00076-6
21. Kötter T, da Costa BR, Fässler M, et al. Metamizole-associated adverse events: A systematic review and meta-analysis. PLoS One. 2015;10(4):e0122918. DOI:10.1371/journal.pone.0122918
22. European Medicines Agency. Metamizole-containing medicinal products article 107i referral – EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole. EMA/407900/2024. Available at: https://www.ema.europa.eu/en/documents/referral/metamizole-containing-medicinal-products-article-107.... Accessed: 20.09.2024.
23. European Medicines Agency. Metamizole Article-31 referral – Start of referral. EMA/338589/2018. Available at: https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-start-referral_en.pdf. Accessed: 20.09.2024.
24. Kaufman DW, Kelly JP, Jurgelon JM, et al. Drugs in the aetiology of agranulocytosis and aplastic anaemia. Eur J Haematol Suppl. 1996;60:23-30.
DOI:10.1111/j.1600-0609.1996.tb01641.x
25. Maluf E, Hamerschlak N, Cavalcanti AB, et al. Incidence and risk factors of aplastic anemia in Latin American countries: The LATIN case-control study. Haematologica. 2009;94(9):1220-6. DOI:10.3324/haematol.2008.002642
26. Mary JY, Guiguet M, Baumelou E. Drug use and aplastic anaemia: the French experience. French Cooperative Group for the Epidemiological Study of Aplastic Anaemia. Eur J Haematol Suppl. 1996;60:35-41. DOI:10.1111/j.1600-0609.1996.tb01643.x
27. Hamerschlak N, Maluf E, Biasi Cavalcanti A, et al. Incidence and risk factors for agranulocytosis in Latin American countries – the Latin Study: A multicenter study. Eur J Clin Pharmacol. 2008;64(9):921-9.
28. De Abajo FJ, Gil MJ, Bryant V, et al. Upper gastrointestinal bleeding associated with NSAIDs, other drugs and interactions: A nested case-control study in a new general practice database. Eur J Clin Pharmacol. 2013;69(3):691-701. DOI:10.1007/s00228-012-1386-3
29. Laporte JR, Carné X, Vidal X, et al. Upper gastrointestinal bleeding in relation to previous use of analgesics and non-steroidal anti-inflammatory drugs. Catalan Countries Study on Upper Gastrointestinal Bleeding. Lancet. 1991;337(8733):85-9. DOI:10.1016/0140-6736(91)90744-a
30. Lanas A, Serrano P, Bajador E, et al. Risk of upper gastrointestinal bleeding associated with non-aspirin cardiovascular drugs, analgesics and nonsteroidal anti-inflammatory drugs. Eur J Gastroenterol Hepatol. 2003;15(2):173-8. DOI:10.1097/00042737-200302000-00011
31. Laporte JR, Ibáñez L, Vidal X, et al. Upper gastrointestinal bleeding associated with the use of NSAIDs: Newer versus older agents. Drug Saf. 2004;27(6):411-20. DOI:10.2165/00002018-200427060-00005
32. Lanas A, García-Rodríguez LA, Arroyo MT, et al. Risk of upper gastrointestinal ulcer bleeding associated with selective cyclo-oxygenase-2 inhibitors, traditional non-aspirin non-teroidal anti-inflammatory drugs, aspirin and combinations. Gut. 2006;55(12):1731-8. DOI:10.1136/gut.2005.080754
33. Methley AM, Campbell S, Chew-Graham C, et al. PICO, PICOS and SPIDER: a comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews. BMC Health Services Research. 2014;14(1):579. DOI:10.1186/s12913-014-0579-0
34. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and elaboration. PLoS Med. 2009;6(7):e1000100. DOI:10.1371/journal.pmed.1000100
35. Reiner M, Massera E, Magni E. Nimesulide in the treatment of fever: A double-blind, crossover clinical trial. J Int Med Res. 1984;12(2):102-7. DOI:10.1177/030006058401200207
36. Ajgaonkar VS, Marathe SN, Virani AR. Dipyrone versus paracetamol: A double-blind study in typhoid fever. J Int Med Res. 1988;16(3):225-30. DOI:10.1177/030006058801600310
37. Wong A, Sibbald A, Ferrero F, et al. Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double-blind study. Clin Pediatr (Phila). 2001;40(6):313-24. DOI:10.1177/000992280104000602
38. Gozzoli V, Treggiari MM, Kleger GR, et al. Randomized trial of the effect of antipyresis by metamizol, propacetamol or external cooling on metabolism, hemodynamics and inflammatory response. Intensive Care Med. 2004;30(3):401-7. DOI:10.1007/s00134-003-2087-2
39. Prado J, Daza R, Chumbes O, et al. Antipyretic efficacy and tolerability of oral ibuprofen, oral dipyrone and intramuscular dipyrone in children: A randomized controlled trial. Sao Paulo Med J. 2006;124(3):135-40. DOI:10.1590/s1516-31802006000300005
40. Magni AM, Scheffer DK, Bruniera P. Antipyretic effect of ibuprofen and dipyrone in febrile children. J Pediatr (Rio J). 2011;87(1):36-42. DOI:10.2223/JPED.2060
41. Hoigné R, Zoppi M, Sollberger J, et al. Fall in systolic blood pressure due to metamizol (dipyrone, noramidopyrine, novaminsulfone). Results from the Comprehensive Hospital Drug Monitoring Berne (CHDMB). Agents Actions Suppl. 1986;19:189-95. PMID:3463177
42. Aronson JK. Meyler’s Side Effects of Analgesics and Anti-Inflammatory Drugs. 1st ed. The Netherlands: Elsevier Science, 2009.
2. Herlihy JM, D’Acremont V, Hay Burgess DC, Hamer DH. Diagnosis and treatment of the febrile child. In: Black RE, Laxminarayan R, Temmerman M, Walker N, eds. Reproductive, maternal, newborn, and child health: Disease control priorities. 3rd ed. (Vol. 2). Washington (DC): The International Bank for Reconstruction and Development / The World Bank, 2016. Chapter 8. DOI:10.1596/978-1-4648-0348-2_ch8
3. Баранов А.А., Намазова-Баранова Л.С., Лобзин Ю.В., и др. Современные подходы к ведению детей с острой респираторной вирусной инфекцией. Педиатрическая фармакология. 2023;20(2):162-74 [Baranov AA, Namazova-Baranova LS, Lobzin YuV, et al. Modern approaches to the management of children with acute respiratory viral infection. Pediatric Pharmacology. 2023;20(2):162-74 (in Russian)]. DOI:10.15690/pf.v20i2.2539
4. Баранов А.А., Булгакова В.А., Вишнева Е.А., и др. Лихорадка у детей. Руководство для врачей. М.: ПедиатрЪ, 2021 [Baranov AA, Bulgakova VA, Vishneva EA, et al. Likhoradka u detei. Rukovodstvo dlia vrachei. Moscow: Pediatr", 2021 (in Russian)].
5. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506.
DOI:10.1016/S0140-6736(20)30183-5
6. Mackowiak PA. Concepts of fever. Arch Intern Med. 1998;158(17):1870-81. DOI:10.1001/archinte.158.17.1870
7. Doman M, Thy M, Dessajan J, et al. Temperature control in sepsis. Front Med (Lausanne). 2023;10:1292468. DOI:10.3389/fmed.2023.1292468
8. Таточенко В.К., Учайкин В.Ф. Лихорадка. Педиатрическая фармакология. 2006;3(3):43-4 [Tatochenko VK, Uchaikin VF. Fever. Pediatric Pharmacology. 2006;3(3):43-4 (in Russian)].
9. Дидковский Н.А., Танасова А.Н. Лихорадка. РМЖ. 2003;(4):189 [Didkovskij NA, Tanasova AN. Fever. Russian Medical Journal. 2003;(4):189 (in Russian)].
10. Plaisance KI, Mackowiak PA. Antipyretic therapy: Physiologic rationale, diagnostic implications, and clinical consequences. Archives of Internal Medicine. 2000;160(4):449-56. DOI:10.1001/archinte.160.4.449
11. Ghlichloo I, Gerriets V. Nonsteroidal anti-inflammatory drugs (NSAIDs). In: StatPearls Publishing, 2024. PMID:31613522
12. Мубаракшина О.А. Актуальность применения нестероидных противовоспалительных средств для лечения лихорадки у детей. Вопросы современной педиатрии. 2010;9(2):156-60 [Mubarakshina OA. Topicality of nonsteroidal anti-inflammatory drugs in treatment of fever in children. Current Pediatrics. 2010;9(2):156-60 (in Russian)].
13. Марушко Ю.В., Тодыка Ю.И., Марушко Е.Ю. Клиническая эффективность и подбор дозы ибупрофена в педиатрической практике. Здоровье ребенка. 2016;1(69):41-7 [Marushko YuV, Todyka YuI, Marushko YeYu. Clinical effectiveness and dose titration in pediatric practice. Zdorov'e Rebenka. 2016;1(69):41-7 (in Russian)].
DOI: 10.22141/2224-0551.1.69.2016.73704
14. Зайцева О.В., Локшина Э.Э. Сравнительные аспекты эффективности и безопасности анальгетиков-антипиретиков в педиатрии. Российский вестник перинатологии и педиатрии. 2009;54(5):86-92 [Zaitseva OV, Lokshina EE. The effectiveness and safety of analgesic antipyretics in pediatric care: Comparative aspects. Rossijskij Vestnik Perinatologii i Pediatrii. 2009;54(5):86-92 (in Russian)].
15. Асфандиярова Н.С., Филиппов Е.В. Использование нестероидных противовоспалительных препаратов при полиморбидной патологии. Терапевтический архив. 2020;92(1):82-8 [Asfandiyarova NS, Philippov EV. The use of nonsteroidal anti-inflammatory drugs in polymorbid pathology. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(1):82-8 (in Russian)]. DOI: 10.26442/00403660.2020.01.000480
16. Watkins PB, Kaplowitz N, Slattery JT, et al. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: A randomized controlled trial. JAMA. 2006;296(1):87-93. DOI:10.1001/jama.296.1.87
17. Andrade S, Bartels DB, Lange R, et al. Safety of metamizole: A systematic review of the literature. J Clin Pharm Ther. 2016;41(5):459-77. DOI:10.1111/jcpt.12422
18. European Medicines Agency. Assessment report: Referral under Article 31 of Directive 2001/83/EC metamizole-containing medicinal products. EMA/143912/2019. Available at: https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-chmp-assessment-repor.... Accessed: 26.11.2024.
19. Stromer W, Palladini M. Metamizole: A comprehensive approach to its benefit-risk profile. Evid Self Med. 2022;2(220153):1-4. DOI:10.52778/efsm.22.0153
20. Andrade SE, Martinez C, Walker AM. Comparative safety evaluation of non-narcotic analgesics. J Clin Epidemiol. 1998;51(12):1357-65. DOI:10.1016/s0895-4356(98)00076-6
21. Kötter T, da Costa BR, Fässler M, et al. Metamizole-associated adverse events: A systematic review and meta-analysis. PLoS One. 2015;10(4):e0122918. DOI:10.1371/journal.pone.0122918
22. European Medicines Agency. Metamizole-containing medicinal products article 107i referral – EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole. EMA/407900/2024. Available at: https://www.ema.europa.eu/en/documents/referral/metamizole-containing-medicinal-products-article-107.... Accessed: 20.09.2024.
23. European Medicines Agency. Metamizole Article-31 referral – Start of referral. EMA/338589/2018. Available at: https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-start-referral_en.pdf. Accessed: 20.09.2024.
24. Kaufman DW, Kelly JP, Jurgelon JM, et al. Drugs in the aetiology of agranulocytosis and aplastic anaemia. Eur J Haematol Suppl. 1996;60:23-30.
DOI:10.1111/j.1600-0609.1996.tb01641.x
25. Maluf E, Hamerschlak N, Cavalcanti AB, et al. Incidence and risk factors of aplastic anemia in Latin American countries: The LATIN case-control study. Haematologica. 2009;94(9):1220-6. DOI:10.3324/haematol.2008.002642
26. Mary JY, Guiguet M, Baumelou E. Drug use and aplastic anaemia: the French experience. French Cooperative Group for the Epidemiological Study of Aplastic Anaemia. Eur J Haematol Suppl. 1996;60:35-41. DOI:10.1111/j.1600-0609.1996.tb01643.x
27. Hamerschlak N, Maluf E, Biasi Cavalcanti A, et al. Incidence and risk factors for agranulocytosis in Latin American countries – the Latin Study: A multicenter study. Eur J Clin Pharmacol. 2008;64(9):921-9.
28. De Abajo FJ, Gil MJ, Bryant V, et al. Upper gastrointestinal bleeding associated with NSAIDs, other drugs and interactions: A nested case-control study in a new general practice database. Eur J Clin Pharmacol. 2013;69(3):691-701. DOI:10.1007/s00228-012-1386-3
29. Laporte JR, Carné X, Vidal X, et al. Upper gastrointestinal bleeding in relation to previous use of analgesics and non-steroidal anti-inflammatory drugs. Catalan Countries Study on Upper Gastrointestinal Bleeding. Lancet. 1991;337(8733):85-9. DOI:10.1016/0140-6736(91)90744-a
30. Lanas A, Serrano P, Bajador E, et al. Risk of upper gastrointestinal bleeding associated with non-aspirin cardiovascular drugs, analgesics and nonsteroidal anti-inflammatory drugs. Eur J Gastroenterol Hepatol. 2003;15(2):173-8. DOI:10.1097/00042737-200302000-00011
31. Laporte JR, Ibáñez L, Vidal X, et al. Upper gastrointestinal bleeding associated with the use of NSAIDs: Newer versus older agents. Drug Saf. 2004;27(6):411-20. DOI:10.2165/00002018-200427060-00005
32. Lanas A, García-Rodríguez LA, Arroyo MT, et al. Risk of upper gastrointestinal ulcer bleeding associated with selective cyclo-oxygenase-2 inhibitors, traditional non-aspirin non-teroidal anti-inflammatory drugs, aspirin and combinations. Gut. 2006;55(12):1731-8. DOI:10.1136/gut.2005.080754
33. Methley AM, Campbell S, Chew-Graham C, et al. PICO, PICOS and SPIDER: a comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews. BMC Health Services Research. 2014;14(1):579. DOI:10.1186/s12913-014-0579-0
34. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and elaboration. PLoS Med. 2009;6(7):e1000100. DOI:10.1371/journal.pmed.1000100
35. Reiner M, Massera E, Magni E. Nimesulide in the treatment of fever: A double-blind, crossover clinical trial. J Int Med Res. 1984;12(2):102-7. DOI:10.1177/030006058401200207
36. Ajgaonkar VS, Marathe SN, Virani AR. Dipyrone versus paracetamol: A double-blind study in typhoid fever. J Int Med Res. 1988;16(3):225-30. DOI:10.1177/030006058801600310
37. Wong A, Sibbald A, Ferrero F, et al. Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double-blind study. Clin Pediatr (Phila). 2001;40(6):313-24. DOI:10.1177/000992280104000602
38. Gozzoli V, Treggiari MM, Kleger GR, et al. Randomized trial of the effect of antipyresis by metamizol, propacetamol or external cooling on metabolism, hemodynamics and inflammatory response. Intensive Care Med. 2004;30(3):401-7. DOI:10.1007/s00134-003-2087-2
39. Prado J, Daza R, Chumbes O, et al. Antipyretic efficacy and tolerability of oral ibuprofen, oral dipyrone and intramuscular dipyrone in children: A randomized controlled trial. Sao Paulo Med J. 2006;124(3):135-40. DOI:10.1590/s1516-31802006000300005
40. Magni AM, Scheffer DK, Bruniera P. Antipyretic effect of ibuprofen and dipyrone in febrile children. J Pediatr (Rio J). 2011;87(1):36-42. DOI:10.2223/JPED.2060
41. Hoigné R, Zoppi M, Sollberger J, et al. Fall in systolic blood pressure due to metamizol (dipyrone, noramidopyrine, novaminsulfone). Results from the Comprehensive Hospital Drug Monitoring Berne (CHDMB). Agents Actions Suppl. 1986;19:189-95. PMID:3463177
42. Aronson JK. Meyler’s Side Effects of Analgesics and Anti-Inflammatory Drugs. 1st ed. The Netherlands: Elsevier Science, 2009.
________________________________________________
2. Herlihy JM, D’Acremont V, Hay Burgess DC, Hamer DH. Diagnosis and treatment of the febrile child. In: Black RE, Laxminarayan R, Temmerman M, Walker N, eds. Reproductive, maternal, newborn, and child health: Disease control priorities. 3rd ed. (Vol. 2). Washington (DC): The International Bank for Reconstruction and Development / The World Bank, 2016. Chapter 8. DOI:10.1596/978-1-4648-0348-2_ch8
3. Baranov AA, Namazova-Baranova LS, Lobzin YuV, et al. Modern approaches to the management of children with acute respiratory viral infection. Pediatric Pharmacology. 2023;20(2):162-74 (in Russian). DOI:10.15690/pf.v20i2.2539
4. Baranov AA, Bulgakova VA, Vishneva EA, et al. Likhoradka u detei. Rukovodstvo dlia vrachei. Moscow: Pediatr", 2021 (in Russian).
5. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497-506.
DOI:10.1016/S0140-6736(20)30183-5
6. Mackowiak PA. Concepts of fever. Arch Intern Med. 1998;158(17):1870-81. DOI:10.1001/archinte.158.17.1870
7. Doman M, Thy M, Dessajan J, et al. Temperature control in sepsis. Front Med (Lausanne). 2023;10:1292468. DOI:10.3389/fmed.2023.1292468
8. Tatochenko VK, Uchaikin VF. Fever. Pediatric Pharmacology. 2006;3(3):43-4 (in Russian).
9. Didkovskij NA, Tanasova AN. Fever. Russian Medical Journal. 2003;(4):189 (in Russian).
10. Plaisance KI, Mackowiak PA. Antipyretic therapy: Physiologic rationale, diagnostic implications, and clinical consequences. Archives of Internal Medicine. 2000;160(4):449-56. DOI:10.1001/archinte.160.4.449
11. Ghlichloo I, Gerriets V. Nonsteroidal anti-inflammatory drugs (NSAIDs). In: StatPearls Publishing, 2024. PMID:31613522
12. Mubarakshina OA. Topicality of nonsteroidal anti-inflammatory drugs in treatment of fever in children. Current Pediatrics. 2010;9(2):156-60 (in Russian).
13. Marushko YuV, Todyka YuI, Marushko YeYu. Clinical effectiveness and dose titration in pediatric practice. Zdorov'e Rebenka. 2016;1(69):41-7 (in Russian).
DOI: 10.22141/2224-0551.1.69.2016.73704
14. Zaitseva OV, Lokshina EE. The effectiveness and safety of analgesic antipyretics in pediatric care: Comparative aspects. Rossijskij Vestnik Perinatologii i Pediatrii. 2009;54(5):86-92 (in Russian).
15. Asfandiyarova NS, Philippov EV. The use of nonsteroidal anti-inflammatory drugs in polymorbid pathology. Terapevticheskii Arkhiv (Ter. Arkh.). 2020;92(1):82-8 (in Russian).
DOI: 10.26442/00403660.2020.01.000480
16. Watkins PB, Kaplowitz N, Slattery JT, et al. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: A randomized controlled trial. JAMA. 2006;296(1):87-93. DOI:10.1001/jama.296.1.87
17. Andrade S, Bartels DB, Lange R, et al. Safety of metamizole: A systematic review of the literature. J Clin Pharm Ther. 2016;41(5):459-77. DOI:10.1111/jcpt.12422
18. European Medicines Agency. Assessment report: Referral under Article 31 of Directive 2001/83/EC metamizole-containing medicinal products. EMA/143912/2019. Available at: https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-chmp-assessment-repor.... Accessed: 26.11.2024.
19. Stromer W, Palladini M. Metamizole: A comprehensive approach to its benefit-risk profile. Evid Self Med. 2022;2(220153):1-4. DOI:10.52778/efsm.22.0153
20. Andrade SE, Martinez C, Walker AM. Comparative safety evaluation of non-narcotic analgesics. J Clin Epidemiol. 1998;51(12):1357-65. DOI:10.1016/s0895-4356(98)00076-6
21. Kötter T, da Costa BR, Fässler M, et al. Metamizole-associated adverse events: A systematic review and meta-analysis. PLoS One. 2015;10(4):e0122918. DOI:10.1371/journal.pone.0122918
22. European Medicines Agency. Metamizole-containing medicinal products article 107i referral – EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole. EMA/407900/2024. Available at: https://www.ema.europa.eu/en/documents/referral/metamizole-containing-medicinal-products-article-107.... Accessed: 20.09.2024.
23. European Medicines Agency. Metamizole Article-31 referral – Start of referral. EMA/338589/2018. Available at: https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-start-referral_en.pdf. Accessed: 20.09.2024.
24. Kaufman DW, Kelly JP, Jurgelon JM, et al. Drugs in the aetiology of agranulocytosis and aplastic anaemia. Eur J Haematol Suppl. 1996;60:23-30.
DOI:10.1111/j.1600-0609.1996.tb01641.x
25. Maluf E, Hamerschlak N, Cavalcanti AB, et al. Incidence and risk factors of aplastic anemia in Latin American countries: The LATIN case-control study. Haematologica. 2009;94(9):1220-6. DOI:10.3324/haematol.2008.002642
26. Mary JY, Guiguet M, Baumelou E. Drug use and aplastic anaemia: the French experience. French Cooperative Group for the Epidemiological Study of Aplastic Anaemia. Eur J Haematol Suppl. 1996;60:35-41. DOI:10.1111/j.1600-0609.1996.tb01643.x
27. Hamerschlak N, Maluf E, Biasi Cavalcanti A, et al. Incidence and risk factors for agranulocytosis in Latin American countries – the Latin Study: A multicenter study. Eur J Clin Pharmacol. 2008;64(9):921-9.
28. De Abajo FJ, Gil MJ, Bryant V, et al. Upper gastrointestinal bleeding associated with NSAIDs, other drugs and interactions: A nested case-control study in a new general practice database. Eur J Clin Pharmacol. 2013;69(3):691-701. DOI:10.1007/s00228-012-1386-3
29. Laporte JR, Carné X, Vidal X, et al. Upper gastrointestinal bleeding in relation to previous use of analgesics and non-steroidal anti-inflammatory drugs. Catalan Countries Study on Upper Gastrointestinal Bleeding. Lancet. 1991;337(8733):85-9. DOI:10.1016/0140-6736(91)90744-a
30. Lanas A, Serrano P, Bajador E, et al. Risk of upper gastrointestinal bleeding associated with non-aspirin cardiovascular drugs, analgesics and nonsteroidal anti-inflammatory drugs. Eur J Gastroenterol Hepatol. 2003;15(2):173-8. DOI:10.1097/00042737-200302000-00011
31. Laporte JR, Ibáñez L, Vidal X, et al. Upper gastrointestinal bleeding associated with the use of NSAIDs: Newer versus older agents. Drug Saf. 2004;27(6):411-20. DOI:10.2165/00002018-200427060-00005
32. Lanas A, García-Rodríguez LA, Arroyo MT, et al. Risk of upper gastrointestinal ulcer bleeding associated with selective cyclo-oxygenase-2 inhibitors, traditional non-aspirin non-teroidal anti-inflammatory drugs, aspirin and combinations. Gut. 2006;55(12):1731-8. DOI:10.1136/gut.2005.080754
33. Methley AM, Campbell S, Chew-Graham C, et al. PICO, PICOS and SPIDER: a comparison study of specificity and sensitivity in three search tools for qualitative systematic reviews. BMC Health Services Research. 2014;14(1):579. DOI:10.1186/s12913-014-0579-0
34. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and elaboration. PLoS Med. 2009;6(7):e1000100. DOI:10.1371/journal.pmed.1000100
35. Reiner M, Massera E, Magni E. Nimesulide in the treatment of fever: A double-blind, crossover clinical trial. J Int Med Res. 1984;12(2):102-7. DOI:10.1177/030006058401200207
36. Ajgaonkar VS, Marathe SN, Virani AR. Dipyrone versus paracetamol: A double-blind study in typhoid fever. J Int Med Res. 1988;16(3):225-30. DOI:10.1177/030006058801600310
37. Wong A, Sibbald A, Ferrero F, et al. Antipyretic effects of dipyrone versus ibuprofen versus acetaminophen in children: Results of a multinational, randomized, modified double-blind study. Clin Pediatr (Phila). 2001;40(6):313-24. DOI:10.1177/000992280104000602
38. Gozzoli V, Treggiari MM, Kleger GR, et al. Randomized trial of the effect of antipyresis by metamizol, propacetamol or external cooling on metabolism, hemodynamics and inflammatory response. Intensive Care Med. 2004;30(3):401-7. DOI:10.1007/s00134-003-2087-2
39. Prado J, Daza R, Chumbes O, et al. Antipyretic efficacy and tolerability of oral ibuprofen, oral dipyrone and intramuscular dipyrone in children: A randomized controlled trial. Sao Paulo Med J. 2006;124(3):135-40. DOI:10.1590/s1516-31802006000300005
40. Magni AM, Scheffer DK, Bruniera P. Antipyretic effect of ibuprofen and dipyrone in febrile children. J Pediatr (Rio J). 2011;87(1):36-42. DOI:10.2223/JPED.2060
41. Hoigné R, Zoppi M, Sollberger J, et al. Fall in systolic blood pressure due to metamizol (dipyrone, noramidopyrine, novaminsulfone). Results from the Comprehensive Hospital Drug Monitoring Berne (CHDMB). Agents Actions Suppl. 1986;19:189-95. PMID:3463177
42. Aronson JK. Meyler’s Side Effects of Analgesics and Anti-Inflammatory Drugs. 1st ed. The Netherlands: Elsevier Science, 2009.
Авторы
А.Г. Малявин1, С.Л. Бабак2, А.Л. Заплатников3, В.А. Булгакова4,5, М.Ю. Гарусова*6, М.Д. Илюхина7
1ФГБОУ ВО «Российский университет медицины» Минздрава России, Москва, Россия;
2Научно-образовательный институт клинической медицины им. Н.А. Семашко Российского университета медицины Минздрава России, Москва, Россия;
3ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
4ФГБНУ «Российский научный центр хирургии им. акад. Б.В. Петровского», Москва, Россия;
5ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России (Пироговский Университет), Москва, Россия;
6ООО «Опелла Хелскеа», Москва, Россия;
7ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*marina.garusova@sanofi.com
1Russian University of Medicine, Moscow, Russia;
2Semashko Research Institute of Clinical Medicine of the Russian University of Medicine, Moscow, Russia;
3Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
4Petrovsky National Research Center of Surgery, Moscow, Russia;
5Pirogov Russian National Research Medical University (Pirogov University), Moscow, Russia;
6Opella Healthcare LLC, Moscow, Russia;
7Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*marina.garusova@sanofi.com
1ФГБОУ ВО «Российский университет медицины» Минздрава России, Москва, Россия;
2Научно-образовательный институт клинической медицины им. Н.А. Семашко Российского университета медицины Минздрава России, Москва, Россия;
3ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, Москва, Россия;
4ФГБНУ «Российский научный центр хирургии им. акад. Б.В. Петровского», Москва, Россия;
5ФГАОУ ВО «Российский национальный исследовательский медицинский университет им. Н.И. Пирогова» Минздрава России (Пироговский Университет), Москва, Россия;
6ООО «Опелла Хелскеа», Москва, Россия;
7ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*marina.garusova@sanofi.com
________________________________________________
1Russian University of Medicine, Moscow, Russia;
2Semashko Research Institute of Clinical Medicine of the Russian University of Medicine, Moscow, Russia;
3Russian Medical Academy of Continuous Professional Education, Moscow, Russia;
4Petrovsky National Research Center of Surgery, Moscow, Russia;
5Pirogov Russian National Research Medical University (Pirogov University), Moscow, Russia;
6Opella Healthcare LLC, Moscow, Russia;
7Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*marina.garusova@sanofi.com
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