Эффективность и безопасность применения нимесулида для лечения пациентов с дорсопатией
Эффективность и безопасность применения нимесулида для лечения пациентов с дорсопатией
Камчатнов П.Р., Казаков А.Ю., Чугунов А.В. Эффективность и безопасность применения нимесулида для лечения пациентов с дорсопатией. Consilium Medicum. 2016; 18 (9): 116–121. DOI: 10.26442/2075-1753_2016.9.116-121
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Kamchatnov P.R., Kazakov A.Yu., Chugunov A.V. Efficacy and safety of nimesulide for the treatment of patients with dorsopathy. Consilium Medicum. 2016; 18 (9): 116–121. DOI: 10.26442/2075-1753_2016.9.116-121
Эффективность и безопасность применения нимесулида для лечения пациентов с дорсопатией
Камчатнов П.Р., Казаков А.Ю., Чугунов А.В. Эффективность и безопасность применения нимесулида для лечения пациентов с дорсопатией. Consilium Medicum. 2016; 18 (9): 116–121. DOI: 10.26442/2075-1753_2016.9.116-121
________________________________________________
Kamchatnov P.R., Kazakov A.Yu., Chugunov A.V. Efficacy and safety of nimesulide for the treatment of patients with dorsopathy. Consilium Medicum. 2016; 18 (9): 116–121. DOI: 10.26442/2075-1753_2016.9.116-121
Поясничная боль – распространенный клинический синдром, характеризующийся высоким риском рецидивирования. Купирование интенсивного длительного болевого синдрома, терапия повторных осложнений ассоциированы с увеличением лекарственной нагрузки на организм и повышением риска развития нежелательных побочных эффектов. Правильный выбор лекарственного препарата, обеспечивающего максимальную эффективность при низком риске лекарственных осложнений, – важная составляющая успешной индивидуализированной терапии. Рассматриваются возможности применения нимесулида у пациентов с поясничной болью с учетом особенностей фармакологического профиля препарата.
Lumbar pain is a common clinical syndrome characterized by a high risk of recurrence. Relief of intense prolonged pain, recurrent complications of therapy is often associated with increased drug load on the body and an increased risk of unwanted side effects. The correct choice of drug, that can provide maximum efficiency at low risk of drug complications is an important component of a successful individualized therapy. The possibilities of use of nimesulide in patients with low back pain, taking into account features of the pharmacological profile of the drug, are discussed below.
Key words: back pain, nimesulide, side effects of treatment.
1. Alotti N, Bodó E, Gombocz K et al. Management of postoperative inflammatory response and pain with nimesulide after cardiac surgery. Orv Hetil 2003; 144 (48): 2353–7.
2. Binning A. Nimesulide in the treatment of postoperative pain: a double-blind, comparative study in patients undergoing arthroscopic knee surgery. Clin J Pain 2007; 23 (7): 565–70.
3. Omololu B, Alonge T, Ogunlade S, Aduroja O. Double blind clinical trial comparing the safety and efficacy of nimesulide (100 mg) and diclofenac in osteoarthrosis of the hip and knee joints. West Afr J Med 2005; 24 (2): 128–33.
4. Pohjolainen T, Jekunen A, Autio L, Vuorela H. Treatment of acute low back pain with the COX-2-selective anti-inflammatory drug nimesulide: results of a randomized, double-blind comparative trial versus ibuprofen. Spine 2000; 25 (12): 1579–85.
5. Ilic K, Sefik-Bukilica M, Jankovic S, Vujasinovic-Stupar N. Efficacy and safety of two generic copies of nimesulide in patients with low back pain or knee osteoarthritis. Reumatismo 2009; 61 (1): 27–33.
6. Шихкеримов Р.К. Применение нимесулида у пациентов с поясничной болью. Журн. неврологии и психиатрии им. С.С.Корсакова. 2016; 116 (5): 28–32. / Shikhkerimov R.K. Primenenie nimesulida u patsientov s poiasnichnoi bol'iu. Zhurn. nevrologii i psikhiatrii im. S.S.Korsakova. 2016; 116 (5): 28–32. [in Russian]
7. Figueiras A, Estany-Gestal A, Aguirre C et al. EMPHOGEN group. CYP2C9 variants as a risk modifier of NSAID-related gastrointestinal bleeding: a case-control study. Pharmacogenet Genomics 2016; 26 (2): 66–73.
8. Nagata N, Niikura R, Yamada A et al. Acute Middle Gastrointestinal Bleeding Risk Associated with NSAIDs, Antithrombotic Drugs, and PPIs: A Multicenter Case-Control Study. PLoS One 2016; 11 (3): e0151332; doi: 10.1371/journal.pone.0151332
9. Aminoshariae A, Kulild JC, Donaldson M. Short-term use of nonsteroidal anti-inflammatory drugs and adverse effects: An updated systematic review. J Am Dent Assoc 2016; 147 (2): 98–110; doi: 10.1016/j.adaj.2015.07.020
10. Vanderstraeten G, Lejeune TM, Piessevaux H et al. Gastrointestinal risk assessment in patients requiring non-steroidal anti-inflammatory drugs for osteoarthritis: The GIRANO study. J Rehabil Med 2016. Epub ahead of print; doi: 10.2340/16501977-2119
11. Каратеев А.Е., Алексеева Л.И., Братыгина Е.А., Аширова Т.Б. Оценка частоты развития побочных эффектов при длительном применении нимесулида в реальной клинической практике. РМЖ. 2009; 17 (21): 1466–72. / Karateev A.E., Alekseeva L.I., Bratygina E.A., Ashirova T.B. Otsenka chastoty razvitiia pobochnykh effektov pri dlitel'nom primenenii nimesulida v real'noi klinicheskoi praktike. RMZh. 2009; 17 (21): 1466–72. [in Russian]
12. Castellsague J, Pisa F, Rosolen V et al. Risk of upper gastrointestinal complications in a cohort of users of nimesulide and other nonsteroidal anti-inflammatory drugs in Friuli Venezia Giulia, Italy. Pharmacoepidemiol Drug Saf 2013; 22 (4): 365–75.
13. Rafaniello C, Ferrajolo C, Sullo M et al. Risk of gastrointestinal complications associated to NSAIDs, low-dose aspirin and their combinations: Results of a pharmacovigilance reporting system. Pharmacol Res 2016; 104: 108–14.
14. Grosser T, Fries S, Fitzgerald G. Biological basis for the cardiovascular consequences of Cox 2 inhibition: therapeutic challenges and opportunities. J Clin Invest 2006; 116: 4–15.
15. McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med 2011; 8 (9): e1001098; doi: 10.1371/journal.pmed.1001098
16. Olsen A, Fosbøl E, Lindhardsen J et al. Long-Term Cardiovascular Risk of NSAID Use According to Time Passed After First-Time Myocardial Infarction: A Nationwide Cohort Study. Circulation 2012; 126 (16): 1955–63.
17. Lapi F, Piccinni C, Simonetti M et al. Non-steroidal anti-inflammatory drugs and risk of cerebrovascular events in patients with osteoarthritis: a nested case-control study. Intern Emerg Med 2016; 11 (1): 49–59.
18. Rainsford K. Members of the Consensus Report Group on Nimesulide. Nimesulide – a multifactorial approach to inflammation and pain: scientific and clinical consensus. Curr Med Res Opin 2006; 22 (6): 1161–70.
19. Rainsford K. Current status of the therapeutic uses and actions of the preferential cyclo-oxygenase-2 NSAID, nimesulide. Inflammopharmacology 2006; 14 (3–4): 120–37.
20. Agúndez J, Lucena M, Martínez C et al. Assessment of nonsteroidal anti-inflammatory drug-induced hepatotoxicity. Expert Opin Drug Metab Toxicol 2011; 7 (7): 817–28.
21. Anelli M, Scioscia C, Grattagliano I, Lapadula G. Old and new antirheumatic drugs and the risk of hepatotoxicity. Ther Drug Monit 2012; 34 (6): 622–8.
22. Bessone F. Non-steroidal anti-inflammatory drugs: What is the actual risk of liver damage? World J Gastroenterol 2010; 16 (45): 5651–61.
23. Gulmez S, Larrey D, Pageaux G et al. Transplantation for acute liver failure in patients exposed to NSAIDs or paracetamol (acetaminophen): the multinational case-population SALT study. Drug Saf 2013; 36 (2): 135–44.
24. Donati M, Conforti A, Lenti M еt al. Risk of acute and serious liver injury associated to nimesulide and other NSAIDs: data from drug-induced liver injury case-control study in Italy. Br J Clin Pharmacol 2016; 82 (1): 238–48.
25. Magalhães R, Fonseca M, Brandão I, Caridade S. Autoimmune hepatitis unmasked by nimesulide. BMJ Case Rep 2016; 2016. pii: bcr2015212884.
26. Bernardes S, Nogueira A, Moreira E et al. Nimesulide-induced fatal acute liver failure in an elderly woman with metastatic biliary adenocarcinoma. A case report. Sao Paulo Med J 2015; 133 (4). http://dx.doi.org/10.1590/1516-3180.2013.7550003
27. Maruf A, O'Brien P. Inflammation-Enhanced Drug-Induced Liver Injury. Free Radic Biol Med 2014; 75 (Suppl. 1): S40.
28. Schmeltzer P, Kosinski A, Kleiner DE et al. Drug-Induced Liver Injury Network (DILIN). Liver injury from nonsteroidal anti-inflammatory drugs in the United States. Liver Int 2016; 36 (4): 603–9.
29. Tsujimoto S, Kishina M, Koda M, Yamamoto Y. Nimesulide, a cyclooxygenase-2 selective inhibitor, suppresses obesity-related non-alcoholic fatty liver disease and hepatic insulin resistance through the regulation of peroxisome proliferator-activated receptor g. Int J Mol Med 2016; doi: 10.3892/ijmm.2016.2674. [Epub ahead of print]
30. Demiryilmaz I, Turan M, Kisaoglu A et al. Protective effect of nimesulide against hepatic ischemia/reperfusion injury in rats: effects on oxidant/antioxidants, DNA mutation and COX-1/COX-2 levels. Pharmacol Rep 2014; 66 (4): 647–52.
31. Kress HG, Baltov A, Basiński A et al. Acute pain: a multifaceted challenge – the role of nimesulide. Curr Med Res Opin 2016; 32 (1): 23–36.
32. Franchi S, Heiman F, Visentin E, Sacerdote P. Survey on appropriateness of use of nimesulide in nine European countries. Drug Healthc Patient Saf 2015; 7: 51–5.
33. Kshirsagar NA, Bachhav SS. Nimesulide controversy: a comparison of EU and Indian scenario. Int J Risk Saf Med 2013; 25 (4): 239–46.
________________________________________________
1. Alotti N, Bodó E, Gombocz K et al. Management of postoperative inflammatory response and pain with nimesulide after cardiac surgery. Orv Hetil 2003; 144 (48): 2353–7.
2. Binning A. Nimesulide in the treatment of postoperative pain: a double-blind, comparative study in patients undergoing arthroscopic knee surgery. Clin J Pain 2007; 23 (7): 565–70.
3. Omololu B, Alonge T, Ogunlade S, Aduroja O. Double blind clinical trial comparing the safety and efficacy of nimesulide (100 mg) and diclofenac in osteoarthrosis of the hip and knee joints. West Afr J Med 2005; 24 (2): 128–33.
4. Pohjolainen T, Jekunen A, Autio L, Vuorela H. Treatment of acute low back pain with the COX-2-selective anti-inflammatory drug nimesulide: results of a randomized, double-blind comparative trial versus ibuprofen. Spine 2000; 25 (12): 1579–85.
5. Ilic K, Sefik-Bukilica M, Jankovic S, Vujasinovic-Stupar N. Efficacy and safety of two generic copies of nimesulide in patients with low back pain or knee osteoarthritis. Reumatismo 2009; 61 (1): 27–33.
6. Shikhkerimov R.K. Primenenie nimesulida u patsientov s poiasnichnoi bol'iu. Zhurn. nevrologii i psikhiatrii im. S.S.Korsakova. 2016; 116 (5): 28–32. [in Russian]
7. Figueiras A, Estany-Gestal A, Aguirre C et al. EMPHOGEN group. CYP2C9 variants as a risk modifier of NSAID-related gastrointestinal bleeding: a case-control study. Pharmacogenet Genomics 2016; 26 (2): 66–73.
8. Nagata N, Niikura R, Yamada A et al. Acute Middle Gastrointestinal Bleeding Risk Associated with NSAIDs, Antithrombotic Drugs, and PPIs: A Multicenter Case-Control Study. PLoS One 2016; 11 (3): e0151332; doi: 10.1371/journal.pone.0151332
9. Aminoshariae A, Kulild JC, Donaldson M. Short-term use of nonsteroidal anti-inflammatory drugs and adverse effects: An updated systematic review. J Am Dent Assoc 2016; 147 (2): 98–110; doi: 10.1016/j.adaj.2015.07.020
10. Vanderstraeten G, Lejeune TM, Piessevaux H et al. Gastrointestinal risk assessment in patients requiring non-steroidal anti-inflammatory drugs for osteoarthritis: The GIRANO study. J Rehabil Med 2016. Epub ahead of print; doi: 10.2340/16501977-2119
11. Karateev A.E., Alekseeva L.I., Bratygina E.A., Ashirova T.B. Otsenka chastoty razvitiia pobochnykh effektov pri dlitel'nom primenenii nimesulida v real'noi klinicheskoi praktike. RMZh. 2009; 17 (21): 1466–72. [in Russian]
12. Castellsague J, Pisa F, Rosolen V et al. Risk of upper gastrointestinal complications in a cohort of users of nimesulide and other nonsteroidal anti-inflammatory drugs in Friuli Venezia Giulia, Italy. Pharmacoepidemiol Drug Saf 2013; 22 (4): 365–75.
13. Rafaniello C, Ferrajolo C, Sullo M et al. Risk of gastrointestinal complications associated to NSAIDs, low-dose aspirin and their combinations: Results of a pharmacovigilance reporting system. Pharmacol Res 2016; 104: 108–14.
14. Grosser T, Fries S, Fitzgerald G. Biological basis for the cardiovascular consequences of Cox 2 inhibition: therapeutic challenges and opportunities. J Clin Invest 2006; 116: 4–15.
15. McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med 2011; 8 (9): e1001098; doi: 10.1371/journal.pmed.1001098
16. Olsen A, Fosbøl E, Lindhardsen J et al. Long-Term Cardiovascular Risk of NSAID Use According to Time Passed After First-Time Myocardial Infarction: A Nationwide Cohort Study. Circulation 2012; 126 (16): 1955–63.
17. Lapi F, Piccinni C, Simonetti M et al. Non-steroidal anti-inflammatory drugs and risk of cerebrovascular events in patients with osteoarthritis: a nested case-control study. Intern Emerg Med 2016; 11 (1): 49–59.
18. Rainsford K. Members of the Consensus Report Group on Nimesulide. Nimesulide – a multifactorial approach to inflammation and pain: scientific and clinical consensus. Curr Med Res Opin 2006; 22 (6): 1161–70.
19. Rainsford K. Current status of the therapeutic uses and actions of the preferential cyclo-oxygenase-2 NSAID, nimesulide. Inflammopharmacology 2006; 14 (3–4): 120–37.
20. Agúndez J, Lucena M, Martínez C et al. Assessment of nonsteroidal anti-inflammatory drug-induced hepatotoxicity. Expert Opin Drug Metab Toxicol 2011; 7 (7): 817–28.
21. Anelli M, Scioscia C, Grattagliano I, Lapadula G. Old and new antirheumatic drugs and the risk of hepatotoxicity. Ther Drug Monit 2012; 34 (6): 622–8.
22. Bessone F. Non-steroidal anti-inflammatory drugs: What is the actual risk of liver damage? World J Gastroenterol 2010; 16 (45): 5651–61.
23. Gulmez S, Larrey D, Pageaux G et al. Transplantation for acute liver failure in patients exposed to NSAIDs or paracetamol (acetaminophen): the multinational case-population SALT study. Drug Saf 2013; 36 (2): 135–44.
24. Donati M, Conforti A, Lenti M еt al. Risk of acute and serious liver injury associated to nimesulide and other NSAIDs: data from drug-induced liver injury case-control study in Italy. Br J Clin Pharmacol 2016; 82 (1): 238–48.
25. Magalhães R, Fonseca M, Brandão I, Caridade S. Autoimmune hepatitis unmasked by nimesulide. BMJ Case Rep 2016; 2016. pii: bcr2015212884.
26. Bernardes S, Nogueira A, Moreira E et al. Nimesulide-induced fatal acute liver failure in an elderly woman with metastatic biliary adenocarcinoma. A case report. Sao Paulo Med J 2015; 133 (4). http://dx.doi.org/10.1590/1516-3180.2013.7550003
27. Maruf A, O'Brien P. Inflammation-Enhanced Drug-Induced Liver Injury. Free Radic Biol Med 2014; 75 (Suppl. 1): S40.
28. Schmeltzer P, Kosinski A, Kleiner DE et al. Drug-Induced Liver Injury Network (DILIN). Liver injury from nonsteroidal anti-inflammatory drugs in the United States. Liver Int 2016; 36 (4): 603–9.
29. Tsujimoto S, Kishina M, Koda M, Yamamoto Y. Nimesulide, a cyclooxygenase-2 selective inhibitor, suppresses obesity-related non-alcoholic fatty liver disease and hepatic insulin resistance through the regulation of peroxisome proliferator-activated receptor g. Int J Mol Med 2016; doi: 10.3892/ijmm.2016.2674. [Epub ahead of print]
30. Demiryilmaz I, Turan M, Kisaoglu A et al. Protective effect of nimesulide against hepatic ischemia/reperfusion injury in rats: effects on oxidant/antioxidants, DNA mutation and COX-1/COX-2 levels. Pharmacol Rep 2014; 66 (4): 647–52.
31. Kress HG, Baltov A, Basiński A et al. Acute pain: a multifaceted challenge – the role of nimesulide. Curr Med Res Opin 2016; 32 (1): 23–36.
32. Franchi S, Heiman F, Visentin E, Sacerdote P. Survey on appropriateness of use of nimesulide in nine European countries. Drug Healthc Patient Saf 2015; 7: 51–5.
33. Kshirsagar NA, Bachhav SS. Nimesulide controversy: a comparison of EU and Indian scenario. Int J Risk Saf Med 2013; 25 (4): 239–46.
Авторы
П.Р.Камчатнов*, А.Ю.Казаков, А.В.Чугунов
ФГБОУ ВО Российский национальный исследовательский медицинский университет им. Н.И.Пирогова Минздрава России. 117997, Россия, Москва, ул. Островитянова, д. 1
*pavkam7@gmail.com
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P.R.Kamchatnov*, A.Yu.Kazakov, A.V.Chugunov
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
*pavkam7@gmail.com