Нимесулид является нестероидным противовоспалительным препаратом (НПВП), эффективным в лечении целого ряда заболеваний, сопровождающихся воспалением и болью, в том числе и острой болью при первичной дисменорее. Нимесулид стал доступен на рынке с 1985 г. По степени селективности в отношении изоформ циклооксигеназы (ЦОГ) нимесулид относится к препаратам, ингибирующим преимущественно ЦОГ-2. В статье приводятся данные по эффективности и безопасности применения нимесулида.
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) effective in treating a variety of diseases associated with inflammation and pain, including acute pain in primary dysmenorrhea. Nimesulide is now available on the market since 1985. According to the degree of selectivity to the isoforms of cyclooxygenase (COX) nimesulide refers to drugs which inhibit predominantly COX-2. The article presents data on the efficacy and safety of nimesulide.
Key words: non-steroidal anti-inflammatory drug nimesulide, efficiency, safety.
1. European Medicines Agency Summary of Product Characteristics. Annex III to the Commision Decision on Article 31 referral for nimesulide-containing medicinal products. [Accessed July 28, 2014]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Nimesulide/human_referra.... Updated January 20, 2012.
2. 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.
3. Warner TD, Giuliano F, Vojnovic I et al. Nonsteroid drug selectivities for cyclo-oxygenase-1 rather than cyclooxygenase-2 are associated with human gastrointestinal toxicity: a full in vitro analysis. Proc Natl Acad Sci USA 1999; 96: 7563–8.
4. Shah AA, Thjodleifsson B, Murray FE et al. Selective inhibition of COX-2 in humans is associated with less gastrointestinal injury: a comparison of nimesulide and naproxen. Gut 2001; 48: 339–46.
5. Bennett A, Tavares IA. COX-2 inhibitors compared and contrasted. Exp Opin Pharmacother 2001; 2: 1859–76.
6. Rainsford KD and 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: 1161–70.
7. Bennet А, Villa G. Nimesulid: an NSAID that preferentially inhibits COX-2, and has various unique pharmacological activities. Exp Opin Pharmacother 2000; 1: 277–6.
8. Tassorelli C, Greco R, Sandrin IG, Nappi G. Central components of the analgesic/antihyperalgesic effect of nimesulide: studies in animal models of pain and hyperalgesia. Drugs 2003; 63 (Suppl. 1): 9–22.
9. 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 (PhilaPa 1976) 2000; 25 (12): 1579–85.
10. Konstantinovic L, Kahjun Z, Milovanovic A et al. Acute low back pain with radiculopathy: a double – blind, randomized, placebo-controlled study. Photomed Laser Surg 2010; 28 (4): 555–60.
11. Duffy T, Belton O, Bresnihan B et al. Inhibition of PGE2 production by nimesulide compared with diclofenac in the acutely inflamed joint of patients with arthritis. Drugs 2003; 63 (Suppl. 1): 31–6.
12. Bianchi M, Broggini M. A randomised, double-blind, clinical trial comparing the efficacy of nimesulide, celecoxib and rofecoxib in osteoarthritis of the knee. Drugs 2003; 63 (Suppl. 1): 37–46.
13. Bianchi M, Ferrario P, Balzarini P et al. Plasma and synovial fluid concentrations of nimesulide and its main metabolite after a single or repeated oral administration in patients with knee osteoarthritis. J Int Med Res 2006; 34: 348–54.
14. Чухловина М.Л. Использование препарата Найз (нимесулид) при лечении цервикогенной головной боли. Препарати та технології. 2009; 1 (57): 53–5. / Chukhlovina M.L. Ispol'zovanie preparata Naiz (nimesulid) pri lechenii tservikogennoi golovnoi boli. Preparati ta tekhnologії. 2009; 1 (57): 53–5. [in Russian]
15. Котова О.В. Назначение нестероидных противовоспалительных препаратов: соотношение эффективность/безопасность. Consilium Medicum. 2012; 14 (1): 79–82. / Kotova O.V. Naznachenie nesteroidnykh protivovospalitel'nykh preparatov: sootnoshenie effektivnost'/bezopasnost'. Consilium Medicum. 2012; 14 (1): 79–82. [in Russian]
16. Котова О.В., Акарачкова Е.С. Острые болевые синдромы в неврологической практике. Эффективная фармакотерапия. 2014; 31: 40–5. / Kotova O.V., Akarachkova E.S. Ostrye bolevye sindromy v nevrologicheskoi praktike. Effektivnaia farmakoterapiia. 2014; 31: 40–5. [in Russian]
17. Lanas A. A review of the gastrointestinal safety data gastroenterologist's perspective. Rheumatology 2010; 49 (Suppl. 2): 3–10.
18. Rostom A, Muir R, Dube C et al. Prevention of NSAID-related upper gastrointestinal toxicity: a meta-analysis of traditional NSAIDs with gastroprotection and COX-2 inhibitors. Drug Health Patient Saf 2009; 1: 47–71.
19. Conforti A, Leone R, Moretti U et al. Adverse drug reactions related to the use of NSAIDs with a focus on nimesulide: results of spontaneous reporting from a Northern Italian area. Drug Saf 2001; 24: 16.
20. 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.
21. Traversa G, Bianchi C, DaCas R et al. Cohort study of hepatotoxity associated with nimesulide and other non-steroidal anti-inflammatory drugs. DMJ 2003; 327: 18–22.
22. European Medicines Evalutionagency. Committee for Proprietary Medical Products. CPMP/1724/04. htpp/www.emea.eu.int.
23. Davis R, Brogden RN. Nimesulide. An update of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs 1994; 48: 431–54.
24. Boelsterli U. Nimesulide and hepatic adverse еffects: roles of reactive metabolites and hostfactors. Int J Clin Pract 2002; 128: 30–6.
25. Kriegel W, Korff K, Ehrlich J et al. Double-blind study comparing the long-term efficacy of the COX-2 inhibitor nimesulide and naproxen in patients with osteoarthritis. Int J Clin Pract 2001; 55 (8): 510–14.
26. 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.
27. Котова О.В.Вопросы безопасности длительной терапии нимесулидом. Фарматека. 2013; 9 (262): 54–8. / Kotova O.V.Voprosy bezopasnosti dlitel'noi terapii nimesulidom. Farmateka. 2013; 9 (262): 54–8. [in Russian]
28. Котова О.В. Остеоартроз: вопросы диагностики и лечения. Consilium Medicum. 2013; 15 (9): 45–9. / Kotova O.V. Osteoartroz: voprosy diagnostiki i lecheniia. Consilium Medicum. 2013; 15 (9): 45–9. [in Russian]
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1. European Medicines Agency Summary of Product Characteristics. Annex III to the Commision Decision on Article 31 referral for nimesulide-containing medicinal products. [Accessed July 28, 2014]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Nimesulide/human_referra.... Updated January 20, 2012.
2. 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.
3. Warner TD, Giuliano F, Vojnovic I et al. Nonsteroid drug selectivities for cyclo-oxygenase-1 rather than cyclooxygenase-2 are associated with human gastrointestinal toxicity: a full in vitro analysis. Proc Natl Acad Sci USA 1999; 96: 7563–8.
4. Shah AA, Thjodleifsson B, Murray FE et al. Selective inhibition of COX-2 in humans is associated with less gastrointestinal injury: a comparison of nimesulide and naproxen. Gut 2001; 48: 339–46.
5. Bennett A, Tavares IA. COX-2 inhibitors compared and contrasted. Exp Opin Pharmacother 2001; 2: 1859–76.
6. Rainsford KD and 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: 1161–70.
7. Bennet А, Villa G. Nimesulid: an NSAID that preferentially inhibits COX-2, and has various unique pharmacological activities. Exp Opin Pharmacother 2000; 1: 277–6.
8. Tassorelli C, Greco R, Sandrin IG, Nappi G. Central components of the analgesic/antihyperalgesic effect of nimesulide: studies in animal models of pain and hyperalgesia. Drugs 2003; 63 (Suppl. 1): 9–22.
9. 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 (PhilaPa 1976) 2000; 25 (12): 1579–85.
10. Konstantinovic L, Kahjun Z, Milovanovic A et al. Acute low back pain with radiculopathy: a double – blind, randomized, placebo-controlled study. Photomed Laser Surg 2010; 28 (4): 555–60.
11. Duffy T, Belton O, Bresnihan B et al. Inhibition of PGE2 production by nimesulide compared with diclofenac in the acutely inflamed joint of patients with arthritis. Drugs 2003; 63 (Suppl. 1): 31–6.
12. Bianchi M, Broggini M. A randomised, double-blind, clinical trial comparing the efficacy of nimesulide, celecoxib and rofecoxib in osteoarthritis of the knee. Drugs 2003; 63 (Suppl. 1): 37–46.
13. Bianchi M, Ferrario P, Balzarini P et al. Plasma and synovial fluid concentrations of nimesulide and its main metabolite after a single or repeated oral administration in patients with knee osteoarthritis. J Int Med Res 2006; 34: 348–54.
14. Chukhlovina M.L. Ispol'zovanie preparata Naiz (nimesulid) pri lechenii tservikogennoi golovnoi boli. Preparati ta tekhnologії. 2009; 1 (57): 53–5. [in Russian]
15. Kotova O.V. Naznachenie nesteroidnykh protivovospalitel'nykh preparatov: sootnoshenie effektivnost'/bezopasnost'. Consilium Medicum. 2012; 14 (1): 79–82. [in Russian]
16. Kotova O.V., Akarachkova E.S. Ostrye bolevye sindromy v nevrologicheskoi praktike. Effektivnaia farmakoterapiia. 2014; 31: 40–5. [in Russian]
17. Lanas A. A review of the gastrointestinal safety data gastroenterologist's perspective. Rheumatology 2010; 49 (Suppl. 2): 3–10.
18. Rostom A, Muir R, Dube C et al. Prevention of NSAID-related upper gastrointestinal toxicity: a meta-analysis of traditional NSAIDs with gastroprotection and COX-2 inhibitors. Drug Health Patient Saf 2009; 1: 47–71.
19. Conforti A, Leone R, Moretti U et al. Adverse drug reactions related to the use of NSAIDs with a focus on nimesulide: results of spontaneous reporting from a Northern Italian area. Drug Saf 2001; 24: 16.
20. 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.
21. Traversa G, Bianchi C, DaCas R et al. Cohort study of hepatotoxity associated with nimesulide and other non-steroidal anti-inflammatory drugs. DMJ 2003; 327: 18–22.
22. European Medicines Evalutionagency. Committee for Proprietary Medical Products. CPMP/1724/04. htpp/www.emea.eu.int.
23. Davis R, Brogden RN. Nimesulide. An update of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy. Drugs 1994; 48: 431–54.
24. Boelsterli U. Nimesulide and hepatic adverse еffects: roles of reactive metabolites and hostfactors. Int J Clin Pract 2002; 128: 30–6.
25. Kriegel W, Korff K, Ehrlich J et al. Double-blind study comparing the long-term efficacy of the COX-2 inhibitor nimesulide and naproxen in patients with osteoarthritis. Int J Clin Pract 2001; 55 (8): 510–14.
26. 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.
27. Kotova O.V.Voprosy bezopasnosti dlitel'noi terapii nimesulidom. Farmateka. 2013; 9 (262): 54–8. [in Russian]
28. Kotova O.V. Osteoartroz: voprosy diagnostiki i lecheniia. Consilium Medicum. 2013; 15 (9): 45–9. [in Russian]
Авторы
О.В.Котова*, Е.С.Акарачкова
ГБОУ ВПО Первый Московский государственный медицинский университет им. И.М.Сеченова Минздрава России. 119991, Россия, Москва, ул. Трубецкая, д. 8, стр. 2
*ol_kotova@mail.ru
________________________________________________
O.V.Kotova*, E.S.Akarachkova
I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation. 119991, Russian Federation, Moscow, ul. Trubetskaia, d. 8, str. 2
*ol_kotova@mail.ru