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Применение ацеклофенака (Аэртал) на ранних стадиях гонартроза
Применение ацеклофенака (Аэртал) на ранних стадиях гонартроза
Загородний Н.В., Ивашкин А.Н., Закирова А.Р., Скипенко Т.О. Consilium Medicum. 2016; 18 (8): 42–45. DOI: 10.26442/2075-1753_2016.8.42-45
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Аннотация
Цель данного исследования – оценка эффективности и безопасности применения препарата Аэртал® в лечении пациентов с гонартрозом на ранних стадиях. В группу исследования вошли пациенты с гонартрозом I–II стадии. Репрезентативная группа состояла из 80 пациентов (43 женщины и 37 мужчин), средний возраст составил 58 лет. Все исследуемые были рандомизированы на две группы консервативного лечения (A и B). Пациенты либо получали Аэртал® 100 мг 2 раза в день, либо диклофенак 75 мг 2 раза в день в течение 6 нед. Среднее значение по визуальной аналоговой шкале (ВАШ) для оценки интенсивности болевого синдрома в группе А составило 7,4, в группе Б – 7,6. После 6 нед консервативного лечения индекс ВАШ снизился до 3,8 в группе А и 5,4 – в группе B, показывая значительное снижение интенсивности боли. Значение индекса Western Ontario McMaster (WOMAC) в группе А 31,68±12,41 (>40), в группе В 36,17±10,32 (>40). Аналогичным образом индекс WOMAC снизился до 6,28 в группе А и 19,42 – в группе B, что показывает значительное снижение затруднений в повседневной физической деятельности, в том числе улучшение качества жизни пациентов.
Результаты данного исследования выявили более благоприятный профиль безопасности группы В (Аэртал®) по сравнению с группой A (диклофенак) на фоне практически равнозначной эффективности препаратов обеих групп. При этом Аэртал® обладает значительно лучшей желудочно-кишечной переносимостью, чем диклофенак. Исходя из представленных данных, можно констатировать, что ключевым моментом в выборе нестероидного противовоспалительного препарата врачом-ортопедом являются его высокая клиническая эффективность, безопасность, а также хорошая переносимость.
Ключевые слова: гонартроз, коленный сустав, ацеклофенак (Аэртал).
Результаты данного исследования выявили более благоприятный профиль безопасности группы В (Аэртал®) по сравнению с группой A (диклофенак) на фоне практически равнозначной эффективности препаратов обеих групп. При этом Аэртал® обладает значительно лучшей желудочно-кишечной переносимостью, чем диклофенак. Исходя из представленных данных, можно констатировать, что ключевым моментом в выборе нестероидного противовоспалительного препарата врачом-ортопедом являются его высокая клиническая эффективность, безопасность, а также хорошая переносимость.
Ключевые слова: гонартроз, коленный сустав, ацеклофенак (Аэртал).
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The purpose of this study was in the assessment of the efficacy and safety of Aertal® in patients with knee OA in its early stages. The study group consisted of patients with gonarthrosis stage I–II. Representative group consisted of 80 patients (43 women and 37 men), mean age was 58 years. All subjects were randomized to conservative treatment groups (A and B). Patients received either Aertal® 100 mg 2 times a day, or diclofenac 75 mg 2 times a day for 6 weeks. The average value of the visual analogue scale (VAS) for pain intensity estimates in group A was 7.4, group B – 7.6. After 6 weeks of conservative therapy VAS index fell to 3.8 in group A and 5,4 – in group B, showing a significant reduction in pain intensity. The Western Ontario McMaster (WOMAC) index in group A was 31,68±12,41 (>40), in the group B 36,17±10,32 (>40). Similarly, the WOMAC index fell to 6.28 in group A and to 19.42 – in group B, which shows a significant decrease of difficulty in daily physical activities, including improving the quality of life of patients.
The results of this study showed a favorable safety profile in the group B (Aertal®) compared with group A (diclofenac), against the background of almost equivalent efficacy of both groups. Thus Aertal® has much better gastrointestinal tolerability than diclofenac. Based on the data, it can be stated that the key issue in choosing NSAID orthopedic surgeon is its high clinical efficacy, safety, and well-tolerated.
Key words: arthrosis, knee joint, aceclofenac (Aertal).
The results of this study showed a favorable safety profile in the group B (Aertal®) compared with group A (diclofenac), against the background of almost equivalent efficacy of both groups. Thus Aertal® has much better gastrointestinal tolerability than diclofenac. Based on the data, it can be stated that the key issue in choosing NSAID orthopedic surgeon is its high clinical efficacy, safety, and well-tolerated.
Key words: arthrosis, knee joint, aceclofenac (Aertal).
Полный текст
Список литературы
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2. Ogata Y, Mabuchi Y, Yoshida M et al. Purified Human Synovium Mesenchymal Stem Cells as a Good Resource for Cartilage Regeneration. PLoS ONE 2015; 10 (6).
3. Matsukura Y, Muneta T, Tsuji K et al. Mouse synovial mesenchymal stem cells increase in yield with knee inflammation. J Orthop Res 2015; 33: 246–53.
4. Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage 2013; 21: 16–21. doi: 10.1016/j.joca.2012.11.012.
5. Jakobsen RB, Engebretsen L, Slauterbeck JR. An Analysis of the Quality of Cartilage Repair Studies. J Bone Joint Surg Am 2014; 87 (10): 2232–9.
6. Anthony J. Ferretti, DO. Osteoarthritis of the Knee: Pill, Needle, or Knife. MHSA Primary Care 2015 LECOM Summer CME.
7. Lanas A, Ferrandez A. NSAID-induced gastrointestinal damage: current clinical management and recommendations for prevention. Chin J Dig Dis 2006; 7 (3): 127–33.
8. Ward DE, Veys EM, Bowdker JM, Roma J. Comparison of aceclofenac with diclofenac in the treatment of osteoarthrosis. Clin Rheumatol 1995; 14: 656–62.
9. Somashekar PL, Sanjay Pai PN, Gopalkrishna Rao. Synthesis and Characterization of Specified Impurities of Aceclofenac. Chem Sci Trans 2013; 2 (3): 813–20.
10. Brandt KD. The mechanism of action of nonsteroidal anti–inflammatory drugs. J Rheum 1991; 18: 120–1.
11. Chichasova N.V. Lechenie osteoartroza: vliianie na khriashchevuiu tkan' razlichnykh protivovospalitel'nykh preparatov. Rus. med. zhurn. 2005; 13 (8): 539–43. [in Russian]
12. Hаskinsson EC, Irani M, Murray F. A large prospective open-label, multi-centre SAMM study, comparing the safety of aceclofenac with diclofenac in patients with rheumatic disease. Eur J Rheumatol Inflam 2000; 17: 1–7.
13. Dooley M, Spencer CM, Dunn CJ et al. Aceclofenac. A reappraisal of its use in the management of pain and rheumatic disease. Drugs 2001; 61 (9): 1351–78.
14. Pasero G, Ruju G, Macolongo R et al. Aceclofenac versus naproхen in the treatment of ankylosing spondylitis: a double-blend, controlled study. Curr Nher Res 1994; 55: 833–42.
15. Perez Busquiner M, Calero E, Rodriguez M et al. Comparison of aceclofenac with piroxicam in the treatment of osteosrthrosis. Clin Rheumatol 1997; 16: 154–9.
16. Ward DE, Veys EM, Bowdler JM, Roma J. Comparison of aceclofenac with diclofenac in the treatment of osteoarthritis. Clin Rheumatol 1995; 14 (6): 656–62.
17. Lemmel EM, Leeb B, De Bast J, Aslanidis S. Patient and physician satisfaction with aceclofenac: results of the European Observational Cohort Study (experience with aceclofenac for inflammatory pain in daily practice). Aceclofenac is the treatment of choice for patients and physicians in the management of inflammatory pain. Curr Med Res Opin 2002; 18 (3): 146–53.
2. Ogata Y, Mabuchi Y, Yoshida M et al. Purified Human Synovium Mesenchymal Stem Cells as a Good Resource for Cartilage Regeneration. PLoS ONE 2015; 10 (6).
3. Matsukura Y, Muneta T, Tsuji K et al. Mouse synovial mesenchymal stem cells increase in yield with knee inflammation. J Orthop Res 2015; 33: 246–53.
4. Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage 2013; 21: 16–21. doi: 10.1016/j.joca.2012.11.012.
5. Jakobsen RB, Engebretsen L, Slauterbeck JR. An Analysis of the Quality of Cartilage Repair Studies. J Bone Joint Surg Am 2014; 87 (10): 2232–9.
6. Anthony J. Ferretti, DO. Osteoarthritis of the Knee: Pill, Needle, or Knife. MHSA Primary Care 2015 LECOM Summer CME.
7. Lanas A, Ferrandez A. NSAID-induced gastrointestinal damage: current clinical management and recommendations for prevention. Chin J Dig Dis 2006; 7 (3): 127–33.
8. Ward DE, Veys EM, Bowdker JM, Roma J. Comparison of aceclofenac with diclofenac in the treatment of osteoarthrosis. Clin Rheumatol 1995; 14: 656–62.
9. Somashekar PL, Sanjay Pai PN, Gopalkrishna Rao. Synthesis and Characterization of Specified Impurities of Aceclofenac. Chem Sci Trans 2013; 2 (3): 813–20.
10. Brandt KD. The mechanism of action of nonsteroidal anti–inflammatory drugs. J Rheum 1991; 18: 120–1.
11. Чичасова Н.В. Лечение остеоартроза: влияние на хрящевую ткань различных противовоспалительных препаратов. Рус. мед. журн. 2005; 13 (8): 539–43. /
Chichasova N.V. Lechenie osteoartroza: vliianie na khriashchevuiu tkan' razlichnykh protivovospalitel'nykh preparatov. Rus. med. zhurn. 2005; 13 (8): 539–43. [in Russian]
12. Hаskinsson EC, Irani M, Murray F. A large prospective open-label, multi-centre SAMM study, comparing the safety of aceclofenac with diclofenac in patients with rheumatic disease. Eur J Rheumatol Inflam 2000; 17: 1–7.
13. Dooley M, Spencer CM, Dunn CJ et al. Aceclofenac. A reappraisal of its use in the management of pain and rheumatic disease. Drugs 2001; 61 (9): 1351–78.
14. Pasero G, Ruju G, Macolongo R et al. Aceclofenac versus naproхen in the treatment of ankylosing spondylitis: a double-blend, controlled study. Curr Nher Res 1994; 55: 833–42.
15. Perez Busquiner M, Calero E, Rodriguez M et al. Comparison of aceclofenac with piroxicam in the treatment of osteosrthrosis. Clin Rheumatol 1997; 16: 154–9.
16. Ward DE, Veys EM, Bowdler JM, Roma J. Comparison of aceclofenac with diclofenac in the treatment of osteoarthritis. Clin Rheumatol 1995; 14 (6): 656–62.
17. Lemmel EM, Leeb B, De Bast J, Aslanidis S. Patient and physician satisfaction with aceclofenac: results of the European Observational Cohort Study (experience with aceclofenac for inflammatory pain in daily practice). Aceclofenac is the treatment of choice for patients and physicians in the management of inflammatory pain. Curr Med Res Opin 2002; 18 (3): 146–53.
________________________________________________
2. Ogata Y, Mabuchi Y, Yoshida M et al. Purified Human Synovium Mesenchymal Stem Cells as a Good Resource for Cartilage Regeneration. PLoS ONE 2015; 10 (6).
3. Matsukura Y, Muneta T, Tsuji K et al. Mouse synovial mesenchymal stem cells increase in yield with knee inflammation. J Orthop Res 2015; 33: 246–53.
4. Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage 2013; 21: 16–21. doi: 10.1016/j.joca.2012.11.012.
5. Jakobsen RB, Engebretsen L, Slauterbeck JR. An Analysis of the Quality of Cartilage Repair Studies. J Bone Joint Surg Am 2014; 87 (10): 2232–9.
6. Anthony J. Ferretti, DO. Osteoarthritis of the Knee: Pill, Needle, or Knife. MHSA Primary Care 2015 LECOM Summer CME.
7. Lanas A, Ferrandez A. NSAID-induced gastrointestinal damage: current clinical management and recommendations for prevention. Chin J Dig Dis 2006; 7 (3): 127–33.
8. Ward DE, Veys EM, Bowdker JM, Roma J. Comparison of aceclofenac with diclofenac in the treatment of osteoarthrosis. Clin Rheumatol 1995; 14: 656–62.
9. Somashekar PL, Sanjay Pai PN, Gopalkrishna Rao. Synthesis and Characterization of Specified Impurities of Aceclofenac. Chem Sci Trans 2013; 2 (3): 813–20.
10. Brandt KD. The mechanism of action of nonsteroidal anti–inflammatory drugs. J Rheum 1991; 18: 120–1.
11. Chichasova N.V. Lechenie osteoartroza: vliianie na khriashchevuiu tkan' razlichnykh protivovospalitel'nykh preparatov. Rus. med. zhurn. 2005; 13 (8): 539–43. [in Russian]
12. Hаskinsson EC, Irani M, Murray F. A large prospective open-label, multi-centre SAMM study, comparing the safety of aceclofenac with diclofenac in patients with rheumatic disease. Eur J Rheumatol Inflam 2000; 17: 1–7.
13. Dooley M, Spencer CM, Dunn CJ et al. Aceclofenac. A reappraisal of its use in the management of pain and rheumatic disease. Drugs 2001; 61 (9): 1351–78.
14. Pasero G, Ruju G, Macolongo R et al. Aceclofenac versus naproхen in the treatment of ankylosing spondylitis: a double-blend, controlled study. Curr Nher Res 1994; 55: 833–42.
15. Perez Busquiner M, Calero E, Rodriguez M et al. Comparison of aceclofenac with piroxicam in the treatment of osteosrthrosis. Clin Rheumatol 1997; 16: 154–9.
16. Ward DE, Veys EM, Bowdler JM, Roma J. Comparison of aceclofenac with diclofenac in the treatment of osteoarthritis. Clin Rheumatol 1995; 14 (6): 656–62.
17. Lemmel EM, Leeb B, De Bast J, Aslanidis S. Patient and physician satisfaction with aceclofenac: results of the European Observational Cohort Study (experience with aceclofenac for inflammatory pain in daily practice). Aceclofenac is the treatment of choice for patients and physicians in the management of inflammatory pain. Curr Med Res Opin 2002; 18 (3): 146–53.
Авторы
Н.В.Загородний, А.Н.Ивашкин, А.Р.Закирова*, Т.О.Скипенко
ФГАОУ ВО Российский университет дружбы народов. 117198, Россия, Москва, ул. Миклухо-Маклая, д. 6;
ГБУЗ Городская клиническая больница №31 Департамента здравоохранения г. Москвы. 119415, Россия, Москва, ул. Лобачевского, д. 42
*arthro@mail.ru
ФГАОУ ВО Российский университет дружбы народов. 117198, Россия, Москва, ул. Миклухо-Маклая, д. 6;
ГБУЗ Городская клиническая больница №31 Департамента здравоохранения г. Москвы. 119415, Россия, Москва, ул. Лобачевского, д. 42
*arthro@mail.ru
________________________________________________
N.V.Zagorodniy, A.N.Ivashkin, A.R.Zakirova*, T.О.Skipenko
People’s Friendship University of Russia. 117198, Russian Federation, Moscow, ul. Miklukho-Maklaya, d. 6;
City Clinical Hospital №31 of the Department of Health of Moscow. 119415, Russian Federation, Moscow, ul. Lobachevskogo, d. 42
*arthro@mail.ru
People’s Friendship University of Russia. 117198, Russian Federation, Moscow, ul. Miklukho-Maklaya, d. 6;
City Clinical Hospital №31 of the Department of Health of Moscow. 119415, Russian Federation, Moscow, ul. Lobachevskogo, d. 42
*arthro@mail.ru
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