Нимесулид у пациентов с поясничной болью: эффективность и безопасность применения

1. CDC. National Ambulatory Medical Care Survey: 2010 Summary Tables. Table 9. www.cdc.gov/nchs/data/ahcd/namcs_summary/2010_namcs_ web_tables.pdf. Accessed March 29, 2016.
2. Davies C, Nitz A, Mattacola C et al. Practice patterns when treating patients with low back pain: a survey of physical therapists. Physiother Theor Pract 2014; 30 (6): 399–408.
3. American College of Radiology. ACR Appropriateness Criteria. Low back pain 2015. www.acr.org/~/media/ACR/Documents/AppCriteria/Diagnostic/LowBackPain.pdf. Accessed March 10, 2016.
4. Hoy D, March L, Brooks P et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis 2014; 73: 968–74.
5. Есин Р.Г., Есин О.Р., Ахмадеева Г.Д., Салихова Г.В. Боль в спине. Казань: Казанский полиграфкомбинат, 2010; с. 272. / Esin R.G., Esin O.R., Akhmadeeva G.D., Salikhova G.V. Bol' v spine. Kazan': Kazanskii poligrafkombinat, 2010; s. 272. [in Russian]
6. Dionne C, Dunn K, Croft P. Does back pain prevalence really decrease with increasing age? A systematic review Age Ageing 2006; 35: 229–34.
7. Williams J, Ng N, Peltzer K et al. Risk factors and disability associated with low back pain in older adults in low- and middle-income countries. Results from the WHO Study on Global AGEing and Adult Health (SAGE). PLoS One 2015; 10: e0127880.
8. Jacobs J, Hammerman-Rozenberg R, Cohen A, Stessman J. Chronic back pain among the elderly: prevalence, associations, and predictors. Spine 2006; 31: E203–E207.
9. Reid M, Williams C, Gill T. Back pain and decline in lower extremity physical function among community-dwelling older persons. J Gerontol A Biol Sci Med Sci 2005; 60: 793–7. 
10. Cayea D, Perera S, Weiner D. Chronic low back pain in older adults: what physicians know, what they think they know, and what they should be taught. J Am Geriatr Soc 2006; 54: 1772–77.
11. Moore N, Pollack C, Butkerait P. Adverse drug reactions and drug–drug interactions with over-the-counter NSAIDs. Ther Clin Risk Manag 2015; 11: 1061–75.
12. Hersh E, Moore P, Ross G. Over-the-counter analgesics and antipyretics: a critical assessment. Clin Ther 2000; 22 (5): 500–48.
13. Koffeman A, Valkhoff V, Celik S et al. High-risk use of over-the-counter non-steroidal anti-inflammatory drugs: a population-based cross-sectional study. Br J Gen Pract 2014; 64 (621): e191–e198.
14. Brattwall M, Turan I, Jakobsson J. Musculoskeletal pain: prescription of NSAID and weak opioid by primary health care physicians in Sweden 2004–2008 – a retrospective patient record review. Journal of Pain Research 2010; 3: 131–135.
15. Enthoven W, Roelofs P, Deyo R et al. Non-steroidal anti-inflammatory drugs for chronic low back pain. Cochrane Database Syst Rev 2016; 2: CD012087.
16. 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.
17. Omololu B, Alonge T, Ogunlade S, Aduroja O. Double blind clinical trial comparing the safety and efficacy of nimesulide (100mg) and diclofenac in osteoarthrosis of the hip and knee joints. West Afr J Med 2005; 24 (2): 128–33.
18. 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.
19. 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.
20. Шихкеримов Р.К. Применение нимесулида у пациентов с поясничной болью. Журн. неврологи и психиатрии им. С.С.Корсакова. 2016; 116 (5): 28–32. / Shikhkerimov R.K. Primenenie nimesulida u patsientov s poiasnichnoi bol'iu. Zhurn. nevrologi i psikhiatrii im. S.S.Korsakova. 2016; 116 (5): 28–32. [in Russian]
21. Goldstein J, Cryer B. Gastrointestinal injury associated with NSAID use: a case study and review of risk factors and preventative strategies. Drug Healthcare and Patient Safety 2015; 7: 31–41.
22. 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.
23. 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
24. 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]
25. 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.
26. 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.
27. Moodley I. Review of the cardiovascular safety of COXIBs compared to NSAIDS. Cardiovascular J оf Africa 2008; 19 (2): 102–6.
28. 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.
29. 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.
30. 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.
31. Bessone F. Non-steroidal anti-inflammatory drugs: What is the actual risk of liver damage? World J Gastroenterol 2010; 16 (45): 5651–61.
32. 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.
33. 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.
34. 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.
35. 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.
36. 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.
37. 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; Jul 11. DOI: 10.3892/ijmm.2016.2674. [Epub ahead of print]
38. 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.
39. 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.
40. 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.
41. Kshirsagar NA, Bachhav SS. Nimesulide controversy: a comparison of EU and Indian scenario. Int J Risk Saf Med 2013; 25 (4): 239–46.

________________________________________________

1. CDC. National Ambulatory Medical Care Survey: 2010 Summary Tables. Table 9. www.cdc.gov/nchs/data/ahcd/namcs_summary/2010_namcs_ web_tables.pdf. Accessed March 29, 2016.
2. Davies C, Nitz A, Mattacola C et al. Practice patterns when treating patients with low back pain: a survey of physical therapists. Physiother Theor Pract 2014; 30 (6): 399–408.
3. American College of Radiology. ACR Appropriateness Criteria. Low back pain 2015. www.acr.org/~/media/ACR/Documents/AppCriteria/Diagnostic/LowBackPain.pdf. Accessed March 10, 2016.
4. Hoy D, March L, Brooks P et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis 2014; 73: 968–74.
5. Esin R.G., Esin O.R., Akhmadeeva G.D., Salikhova G.V. Bol' v spine. Kazan': Kazanskii poligrafkombinat, 2010; s. 272. [in Russian]
6. Dionne C, Dunn K, Croft P. Does back pain prevalence really decrease with increasing age? A systematic review Age Ageing 2006; 35: 229–34.
7. Williams J, Ng N, Peltzer K et al. Risk factors and disability associated with low back pain in older adults in low- and middle-income countries. Results from the WHO Study on Global AGEing and Adult Health (SAGE). PLoS One 2015; 10: e0127880.
8. Jacobs J, Hammerman-Rozenberg R, Cohen A, Stessman J. Chronic back pain among the elderly: prevalence, associations, and predictors. Spine 2006; 31: E203–E207.
9. Reid M, Williams C, Gill T. Back pain and decline in lower extremity physical function among community-dwelling older persons. J Gerontol A Biol Sci Med Sci 2005; 60: 793–7. 
10. Cayea D, Perera S, Weiner D. Chronic low back pain in older adults: what physicians know, what they think they know, and what they should be taught. J Am Geriatr Soc 2006; 54: 1772–77.
11. Moore N, Pollack C, Butkerait P. Adverse drug reactions and drug–drug interactions with over-the-counter NSAIDs. Ther Clin Risk Manag 2015; 11: 1061–75.
12. Hersh E, Moore P, Ross G. Over-the-counter analgesics and antipyretics: a critical assessment. Clin Ther 2000; 22 (5): 500–48.
13. Koffeman A, Valkhoff V, Celik S et al. High-risk use of over-the-counter non-steroidal anti-inflammatory drugs: a population-based cross-sectional study. Br J Gen Pract 2014; 64 (621): e191–e198.
14. Brattwall M, Turan I, Jakobsson J. Musculoskeletal pain: prescription of NSAID and weak opioid by primary health care physicians in Sweden 2004–2008 – a retrospective patient record review. Journal of Pain Research 2010; 3: 131–135.
15. Enthoven W, Roelofs P, Deyo R et al. Non-steroidal anti-inflammatory drugs for chronic low back pain. Cochrane Database Syst Rev 2016; 2: CD012087.
16. 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.
17. Omololu B, Alonge T, Ogunlade S, Aduroja O. Double blind clinical trial comparing the safety and efficacy of nimesulide (100mg) and diclofenac in osteoarthrosis of the hip and knee joints. West Afr J Med 2005; 24 (2): 128–33.
18. 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.
19. 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.
20. Shikhkerimov R.K. Primenenie nimesulida u patsientov s poiasnichnoi bol'iu. Zhurn. nevrologi i psikhiatrii im. S.S.Korsakova. 2016; 116 (5): 28–32. [in Russian]
21. Goldstein J, Cryer B. Gastrointestinal injury associated with NSAID use: a case study and review of risk factors and preventative strategies. Drug Healthcare and Patient Safety 2015; 7: 31–41.
22. 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.
23. 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
24. 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]
25. 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.
26. 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.
27. Moodley I. Review of the cardiovascular safety of COXIBs compared to NSAIDS. Cardiovascular J оf Africa 2008; 19 (2): 102–6.
28. 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.
29. 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.
30. 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.
31. Bessone F. Non-steroidal anti-inflammatory drugs: What is the actual risk of liver damage? World J Gastroenterol 2010; 16 (45): 5651–61.
32. 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.
33. 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.
34. 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.
35. 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.
36. 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.
37. 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; Jul 11. DOI: 10.3892/ijmm.2016.2674. [Epub ahead of print]
38. 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.
39. 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.
40. 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.
41. Kshirsagar NA, Bachhav SS. Nimesulide controversy: a comparison of EU and Indian scenario. Int J Risk Saf Med 2013; 25 (4): 239–46.

П.Р.Камчатнов*

ФГБОУ ВО Российский национальный исследовательский медицинский университет им. Н.И.Пирогова Минздрава России. 117997, Россия, Москва, ул. Островитянова, д. 1
*pavkam7@gmail.com

________________________________________________

P.R.Kamchatnov*

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