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Эффективность и безопасность разных лекарственных форм ацетилсалициловой кислоты
Воробьева Н.М. Эффективность и безопасность разных лекарственных форм ацетилсалициловой кислоты. Consilium Medicum. 2016; 18 (5): 82-88. DOI: 10.26442/2075-1753_2016.5.82-88
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Vorobyeva N.M. Efficacy and safety of various acetylsalicylic acid formulations. Consilium Medicum. 2016; 18 (5): 82–88. DOI: 10.26442/2075-1753_2016.5.82-88
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Аннотация
В обзорной статье обсуждаются вопросы эффективности и безопасности трех лекарственных форм ацетилсалициловой кислоты (АСК) – простой (не покрытой оболочкой, некишечнорастворимой), кишечнорастворимой и буферной. Подробно рассмотрены результаты нескольких отечественных клинических исследований, посвященных прямому сравнению кишечнорастворимой и буферной форм АСК. Показано, что лекарственная форма препарата может влиять как на эффективность, так и безопасность лечения. В частности, приводятся данные о том, что по сравнению с кишечнорастворимой АСК буферная форма обладает более выраженным антиагрегантным эффектом и в меньшей степени оказывает неблагоприятное воздействие на слизистую оболочку желудочно-кишечного тракта.
Ключевые слова: ацетилсалициловая кислота, лекарственная форма, эффективность, безопасность.
Ключевые слова: ацетилсалициловая кислота, лекарственная форма, эффективность, безопасность.
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The review article discusses the efficacy and safety of 3 different acetylsalicylic acid (ASA) formulations: a simple (uncoated, non-enteric coated), enteric coated and buffered formulations. We discussed in detail the results of several domestic clinical studies concerning the direct comparison of enteric coated and buffered formulations of ASA. It was shown that the dosage form of the drug can affect both the efficiency and safety of the treatment. In particular, we have shown the data that the buffered formulation has more significant antiplatelet effect and in a lesser degree damages the mucous membrane of the gastrointestinal tract in comparison with enteric coated ASA formulations.
Key words: acetylsalicylic acid, formulation, efficiency, safety.
Key words: acetylsalicylic acid, formulation, efficiency, safety.
Полный текст
Список литературы
1. Панченко Е.П., Добровольский А.. Тромбозы в кардиологии. Механизмы развития и возможности терапии. М.: Спорт и культура, 1999. / Panchenko E.P., Dobrovol'skii A.. Trombozy v kardiologii. Mekhanizmy razvitiia i vozmozhnosti terapii. M.: Sport i kul'tura, 1999. [in Russian]
2. Patrono C, Coller B, FitzGerald GA et al. Platelet-Active Drugs: The Relationships among dose, effectiveness, and side effects. The Seventh ACCP Conference of Antithrombotic and Thrombolytic Therapy 2004. Chest 2004; 126: 234s–264s.
3. Eikelboom JW, Hirsh J, Spencer FA et al. Antiplatelet Drugs. Antithrombotic therapy and prevention of thrombosis, 9th ACCP Evidence – based Clinical Practice Guidelines. Chest 2012; 141 (2): 89s–119s.
4. Antithrombotic Trialists’ Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002; 324: 71–86.
5. The Dutch TIA Trial Study Group. A comparison of two doses of aspirin (30 mg vs. 283 mg a day) in patients after a transient ischemic attack or minor ischemic stroke. N Engl J Med 1991; 325: 1261–6.
6. Taylor DW, Barnett HJM, Haynes RB et al. Low-dose and high-dose acetylsalicylic acid for patients undergoing carotid endarterectomy: randomised controlled trial. Lancet 1999; 353: 2179–83.
7. Mangano DT. Aspirin and mortality from coronary bypass surgery. N Engl J Med 2002; 347: 1309–17.
8. Pearson TA, Blair SN, Daniels SR et al. AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patient without Coronary or other Atherosclerotic Vascular Diseases. Circulation 2002; 106: 388–91.
9. Насонов Е.Л., Каратеев А.Е. Поражения желудка, связанные с приемом нестероидных противовоспалительных препаратов. Клин. медицина. 2000; 78 (3): 4–10. / Nasonov E.L., Karateev A.E. Porazheniia zheludka, sviazannye s priemom nesteroidnykh protivovospalitel'nykh preparatov. Klin. meditsina. 2000; 78 (3): 4–10. [in Russian]
10. Brooks PM, Day RO. Nonsteroidal antiinflammatory drugs – differences and similarities. N Engl J Med 1991; 324 (24): 1716–25.
11. Wallace JL, McKnight GW. The mucoid cap over superficial gastric damage in the rat. A high-pH microenvironment dissipated by nonsteroidal antiinflammatory drugs and endothelin. Gastroenterology 1990; 99 (2): 295–304.
12. Somasundaram S, Hayllar H, Rafi S et al. The biochemical basis of non-steroidal anti-inflammatory drug-induced damage to the gastrointestinal tract: a review and hypothesis. Scand J Gastroenterol 1995; 30 (4): 289–99.
13. Sagar KA, Smyth MR. A comparative bioavailability study of different aspirin formulations using on-line multidimensional chromatography. J Pharm Biomed Anal 1999; 21: 383–92.
14. Cox D, Maree AO, Dooley M et al. Effect of enteric coating on antiplatelet activity of low-dose aspirin in healthy volunteers. Stroke 2006; 37: 2153–8.
15. Pedersen A, FitzGerald G. Dose-related kinetics of aspirin. Presystemic acetylation of platelet cyclooxygenase. N Engl J Med 1984; 311: 1206–11.
16. Endo H, Hosono K, Inamori M et al. Incidence of small bowel injury induced by low-dose aspirin: a crossover study using capsule endoscopy in healthy volunteers. Digestion 2009; 79: 44–51.
17. Endo H, Sakaib E, Higurashib T. Differences in the severity of small bowel mucosal injury based on the type of aspirin as evaluated by capsule endoscopy. Dig Liver Dis 2012; 44: 833–8.
18. Hirata Y, Kataoka H, Shimura T et al. Incidence of gastrointestinal bleeding in patients with cardiovascular disease: buffered aspirin versus enteric-coated aspirin. Scand J Gastroenterol 2011; 46: 803–9.
19. Баркаган З.С., Котовщикова Е.Ф. Сравнительный анализ основных и побочных эффектов различных форм ацетилсалициловой кислоты. Клин. фармакология и терапия. 2004; 13 (3): 1–4. / Barkagan Z.S., Kotovshchikova E.F. Sravnitel'nyi analiz osnovnykh i pobochnykh effektov razlichnykh form atsetilsalitsilovoi kisloty. Klin. farmakologiia i terapiia. 2004; 13 (3): 1–4. [in Russian]
20. Верткин А.Л., Аристархова О.Ю., Адонина Е.В. и др. Безопасность и фармакоэкономическая эффективность применения различных препаратов ацетилсалициловой кислоты у пациентов с ИБС. Рус. мед. журн. 2009; 17 (9): 570–5. / Vertkin A.L., Aristarkhova O.Iu., Adonina E.V. i dr. Bezopasnost' i farmakoekonomicheskaia effektivnost' primeneniia razlichnykh preparatov atsetilsalitsilovoi kisloty u patsientov s IBS. Rus. med. zhurn. 2009; 17 (9): 570–5. [in Russian]
21. Яковенко Э.П., Краснолобова Л.П., Яковенко А.В. и др. Влияние препаратов ацетилсалициловой кислоты на морфофункциональное состояние слизистой оболочки желудка у кардиологических пациентов пожилого возраста. Сердце. 2013; 12 (3): 145–50. / Iakovenko E.P., Krasnolobova L.P., Iakovenko A.V. i dr. Vliianie preparatov atsetilsalitsilovoi kisloty na morfofunktsional'noe sostoianie slizistoi obolochki zheludka u kardiologicheskikh patsientov pozhilogo vozrasta. Serdtse. 2013; 12 (3): 145–50. [in Russian]
22. Ломакин Н.В., Русанова А.В., Бурячковская Л.И., Вершинина М.Г. Сравнение антиагрегантной эффективности разных форм ацетилсалициловой кислоты. Сердце. 2014; 78 (4): 206–14. / Lomakin N.V., Rusanova A.V., Buriachkovskaia L.I., Vershinina M.G. Sravnenie antiagregantnoi effektivnosti raznykh form atsetilsalitsilovoi kisloty. Serdtse. 2014; 78 (4): 206–14. [in Russian]
23. Takada M, Fujimoto M, Hosomi K. Difference in risk of gastrointestinal complications between users of enteric-coated and buffered low-dose aspirin. Int J Clin Pharmacol Ther 2014; 52 (3): 181–91.
2. Patrono C, Coller B, FitzGerald GA et al. Platelet-Active Drugs: The Relationships among dose, effectiveness, and side effects. The Seventh ACCP Conference of Antithrombotic and Thrombolytic Therapy 2004. Chest 2004; 126: 234s–264s.
3. Eikelboom JW, Hirsh J, Spencer FA et al. Antiplatelet Drugs. Antithrombotic therapy and prevention of thrombosis, 9th ACCP Evidence – based Clinical Practice Guidelines. Chest 2012; 141 (2): 89s–119s.
4. Antithrombotic Trialists’ Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002; 324: 71–86.
5. The Dutch TIA Trial Study Group. A comparison of two doses of aspirin (30 mg vs. 283 mg a day) in patients after a transient ischemic attack or minor ischemic stroke. N Engl J Med 1991; 325: 1261–6.
6. Taylor DW, Barnett HJM, Haynes RB et al. Low-dose and high-dose acetylsalicylic acid for patients undergoing carotid endarterectomy: randomised controlled trial. Lancet 1999; 353: 2179–83.
7. Mangano DT. Aspirin and mortality from coronary bypass surgery. N Engl J Med 2002; 347: 1309–17.
8. Pearson TA, Blair SN, Daniels SR et al. AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patient without Coronary or other Atherosclerotic Vascular Diseases. Circulation 2002; 106: 388–91.
9. Насонов Е.Л., Каратеев А.Е. Поражения желудка, связанные с приемом нестероидных противовоспалительных препаратов. Клин. медицина. 2000; 78 (3): 4–10. / Nasonov E.L., Karateev A.E. Porazheniia zheludka, sviazannye s priemom nesteroidnykh protivovospalitel'nykh preparatov. Klin. meditsina. 2000; 78 (3): 4–10. [in Russian]
10. Brooks PM, Day RO. Nonsteroidal antiinflammatory drugs – differences and similarities. N Engl J Med 1991; 324 (24): 1716–25.
11. Wallace JL, McKnight GW. The mucoid cap over superficial gastric damage in the rat. A high-pH microenvironment dissipated by nonsteroidal antiinflammatory drugs and endothelin. Gastroenterology 1990; 99 (2): 295–304.
12. Somasundaram S, Hayllar H, Rafi S et al. The biochemical basis of non-steroidal anti-inflammatory drug-induced damage to the gastrointestinal tract: a review and hypothesis. Scand J Gastroenterol 1995; 30 (4): 289–99.
13. Sagar KA, Smyth MR. A comparative bioavailability study of different aspirin formulations using on-line multidimensional chromatography. J Pharm Biomed Anal 1999; 21: 383–92.
14. Cox D, Maree AO, Dooley M et al. Effect of enteric coating on antiplatelet activity of low-dose aspirin in healthy volunteers. Stroke 2006; 37: 2153–8.
15. Pedersen A, FitzGerald G. Dose-related kinetics of aspirin. Presystemic acetylation of platelet cyclooxygenase. N Engl J Med 1984; 311: 1206–11.
16. Endo H, Hosono K, Inamori M et al. Incidence of small bowel injury induced by low-dose aspirin: a crossover study using capsule endoscopy in healthy volunteers. Digestion 2009; 79: 44–51.
17. Endo H, Sakaib E, Higurashib T. Differences in the severity of small bowel mucosal injury based on the type of aspirin as evaluated by capsule endoscopy. Dig Liver Dis 2012; 44: 833–8.
18. Hirata Y, Kataoka H, Shimura T et al. Incidence of gastrointestinal bleeding in patients with cardiovascular disease: buffered aspirin versus enteric-coated aspirin. Scand J Gastroenterol 2011; 46: 803–9.
19. Баркаган З.С., Котовщикова Е.Ф. Сравнительный анализ основных и побочных эффектов различных форм ацетилсалициловой кислоты. Клин. фармакология и терапия. 2004; 13 (3): 1–4. / Barkagan Z.S., Kotovshchikova E.F. Sravnitel'nyi analiz osnovnykh i pobochnykh effektov razlichnykh form atsetilsalitsilovoi kisloty. Klin. farmakologiia i terapiia. 2004; 13 (3): 1–4. [in Russian]
20. Верткин А.Л., Аристархова О.Ю., Адонина Е.В. и др. Безопасность и фармакоэкономическая эффективность применения различных препаратов ацетилсалициловой кислоты у пациентов с ИБС. Рус. мед. журн. 2009; 17 (9): 570–5. / Vertkin A.L., Aristarkhova O.Iu., Adonina E.V. i dr. Bezopasnost' i farmakoekonomicheskaia effektivnost' primeneniia razlichnykh preparatov atsetilsalitsilovoi kisloty u patsientov s IBS. Rus. med. zhurn. 2009; 17 (9): 570–5. [in Russian]
21. Яковенко Э.П., Краснолобова Л.П., Яковенко А.В. и др. Влияние препаратов ацетилсалициловой кислоты на морфофункциональное состояние слизистой оболочки желудка у кардиологических пациентов пожилого возраста. Сердце. 2013; 12 (3): 145–50. / Iakovenko E.P., Krasnolobova L.P., Iakovenko A.V. i dr. Vliianie preparatov atsetilsalitsilovoi kisloty na morfofunktsional'noe sostoianie slizistoi obolochki zheludka u kardiologicheskikh patsientov pozhilogo vozrasta. Serdtse. 2013; 12 (3): 145–50. [in Russian]
22. Ломакин Н.В., Русанова А.В., Бурячковская Л.И., Вершинина М.Г. Сравнение антиагрегантной эффективности разных форм ацетилсалициловой кислоты. Сердце. 2014; 78 (4): 206–14. / Lomakin N.V., Rusanova A.V., Buriachkovskaia L.I., Vershinina M.G. Sravnenie antiagregantnoi effektivnosti raznykh form atsetilsalitsilovoi kisloty. Serdtse. 2014; 78 (4): 206–14. [in Russian]
23. Takada M, Fujimoto M, Hosomi K. Difference in risk of gastrointestinal complications between users of enteric-coated and buffered low-dose aspirin. Int J Clin Pharmacol Ther 2014; 52 (3): 181–91.
________________________________________________
1. Panchenko E.P., Dobrovol'skii A.. Trombozy v kardiologii. Mekhanizmy razvitiia i vozmozhnosti terapii. M.: Sport i kul'tura, 1999. [in Russian]
2. Patrono C, Coller B, FitzGerald GA et al. Platelet-Active Drugs: The Relationships among dose, effectiveness, and side effects. The Seventh ACCP Conference of Antithrombotic and Thrombolytic Therapy 2004. Chest 2004; 126: 234s–264s.
3. Eikelboom JW, Hirsh J, Spencer FA et al. Antiplatelet Drugs. Antithrombotic therapy and prevention of thrombosis, 9th ACCP Evidence – based Clinical Practice Guidelines. Chest 2012; 141 (2): 89s–119s.
4. Antithrombotic Trialists’ Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002; 324: 71–86.
5. The Dutch TIA Trial Study Group. A comparison of two doses of aspirin (30 mg vs. 283 mg a day) in patients after a transient ischemic attack or minor ischemic stroke. N Engl J Med 1991; 325: 1261–6.
6. Taylor DW, Barnett HJM, Haynes RB et al. Low-dose and high-dose acetylsalicylic acid for patients undergoing carotid endarterectomy: randomised controlled trial. Lancet 1999; 353: 2179–83.
7. Mangano DT. Aspirin and mortality from coronary bypass surgery. N Engl J Med 2002; 347: 1309–17.
8. Pearson TA, Blair SN, Daniels SR et al. AHA Guidelines for Primary Prevention of Cardiovascular Disease and Stroke: 2002 Update: Consensus Panel Guide to Comprehensive Risk Reduction for Adult Patient without Coronary or other Atherosclerotic Vascular Diseases. Circulation 2002; 106: 388–91.
9. Nasonov E.L., Karateev A.E. Porazheniia zheludka, sviazannye s priemom nesteroidnykh protivovospalitel'nykh preparatov. Klin. meditsina. 2000; 78 (3): 4–10. [in Russian]
10. Brooks PM, Day RO. Nonsteroidal antiinflammatory drugs – differences and similarities. N Engl J Med 1991; 324 (24): 1716–25.
11. Wallace JL, McKnight GW. The mucoid cap over superficial gastric damage in the rat. A high-pH microenvironment dissipated by nonsteroidal antiinflammatory drugs and endothelin. Gastroenterology 1990; 99 (2): 295–304.
12. Somasundaram S, Hayllar H, Rafi S et al. The biochemical basis of non-steroidal anti-inflammatory drug-induced damage to the gastrointestinal tract: a review and hypothesis. Scand J Gastroenterol 1995; 30 (4): 289–99.
13. Sagar KA, Smyth MR. A comparative bioavailability study of different aspirin formulations using on-line multidimensional chromatography. J Pharm Biomed Anal 1999; 21: 383–92.
14. Cox D, Maree AO, Dooley M et al. Effect of enteric coating on antiplatelet activity of low-dose aspirin in healthy volunteers. Stroke 2006; 37: 2153–8.
15. Pedersen A, FitzGerald G. Dose-related kinetics of aspirin. Presystemic acetylation of platelet cyclooxygenase. N Engl J Med 1984; 311: 1206–11.
16. Endo H, Hosono K, Inamori M et al. Incidence of small bowel injury induced by low-dose aspirin: a crossover study using capsule endoscopy in healthy volunteers. Digestion 2009; 79: 44–51.
17. Endo H, Sakaib E, Higurashib T. Differences in the severity of small bowel mucosal injury based on the type of aspirin as evaluated by capsule endoscopy. Dig Liver Dis 2012; 44: 833–8.
18. Hirata Y, Kataoka H, Shimura T et al. Incidence of gastrointestinal bleeding in patients with cardiovascular disease: buffered aspirin versus enteric-coated aspirin. Scand J Gastroenterol 2011; 46: 803–9.
19. Barkagan Z.S., Kotovshchikova E.F. Sravnitel'nyi analiz osnovnykh i pobochnykh effektov razlichnykh form atsetilsalitsilovoi kisloty. Klin. farmakologiia i terapiia. 2004; 13 (3): 1–4. [in Russian]
20. Vertkin A.L., Aristarkhova O.Iu., Adonina E.V. i dr. Bezopasnost' i farmakoekonomicheskaia effektivnost' primeneniia razlichnykh preparatov atsetilsalitsilovoi kisloty u patsientov s IBS. Rus. med. zhurn. 2009; 17 (9): 570–5. [in Russian]
21. Iakovenko E.P., Krasnolobova L.P., Iakovenko A.V. i dr. Vliianie preparatov atsetilsalitsilovoi kisloty na morfofunktsional'noe sostoianie slizistoi obolochki zheludka u kardiologicheskikh patsientov pozhilogo vozrasta. Serdtse. 2013; 12 (3): 145–50. [in Russian]
22. Lomakin N.V., Rusanova A.V., Buriachkovskaia L.I., Vershinina M.G. Sravnenie antiagregantnoi effektivnosti raznykh form atsetilsalitsilovoi kisloty. Serdtse. 2014; 78 (4): 206–14. [in Russian]
23. Takada M, Fujimoto M, Hosomi K. Difference in risk of gastrointestinal complications between users of enteric-coated and buffered low-dose aspirin. Int J Clin Pharmacol Ther 2014; 52 (3): 181–91.
Авторы
Н.М.Воробьева
ГБОУ ВПО Российский национальный исследовательский медицинский университет им. Н.И.Пирогова Минздрава России. 117997, Россия, Москва, ул. Островитянова, д. 1
natalyavorobjeva@mail.ru
ГБОУ ВПО Российский национальный исследовательский медицинский университет им. Н.И.Пирогова Минздрава России. 117997, Россия, Москва, ул. Островитянова, д. 1
natalyavorobjeva@mail.ru
________________________________________________
N.M.Vorobyeva
N.I.Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation. 117997, Russian Federation, Moscow, ul. Ostrovitianova, d. 1
natalyavorobjeva@mail.ru
N.I.Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation. 117997, Russian Federation, Moscow, ul. Ostrovitianova, d. 1
natalyavorobjeva@mail.ru
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