Какие факторы влияют на эффективность длительной анальгетической терапии при остеоартрите? Анализ данных многоцентрового 3-месячного исследования ПАРАЦЕЛЬС
Какие факторы влияют на эффективность длительной анальгетической терапии при остеоартрите? Анализ данных многоцентрового 3-месячного исследования ПАРАЦЕЛЬС
Каратеев А.Е., Лила А.М., Погожева Е.Ю. и др. Какие факторы влияют на эффективность длительной анальгетической терапии при остеоартрите? Анализ данных многоцентрового 3-месячного исследования ПАРАЦЕЛЬС. Терапевтический архив. 2019; 91 (5): 68–75. DOI: 10.26442/00403660.2019.05.000233
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Karateev A.E., Lila A.M., Pogozheva E.Yu., et al. What factors affect the effectiveness of long-term analgesic therapy for osteoarthritis? Data analysis of the multi-center 3-month PARACELSUS study. Therapeutic Archive. 2019; 91 (5): 68–75. DOI: 10.26442/00403660.2019.05.000233
Какие факторы влияют на эффективность длительной анальгетической терапии при остеоартрите? Анализ данных многоцентрового 3-месячного исследования ПАРАЦЕЛЬС
Каратеев А.Е., Лила А.М., Погожева Е.Ю. и др. Какие факторы влияют на эффективность длительной анальгетической терапии при остеоартрите? Анализ данных многоцентрового 3-месячного исследования ПАРАЦЕЛЬС. Терапевтический архив. 2019; 91 (5): 68–75. DOI: 10.26442/00403660.2019.05.000233
________________________________________________
Karateev A.E., Lila A.M., Pogozheva E.Yu., et al. What factors affect the effectiveness of long-term analgesic therapy for osteoarthritis? Data analysis of the multi-center 3-month PARACELSUS study. Therapeutic Archive. 2019; 91 (5): 68–75. DOI: 10.26442/00403660.2019.05.000233
При лечении остеоартрита (ОА) следует учитывать факторы, которые могут влиять на эффективность терапии. Цель исследования: определение факторов, влияющих на эффективность длительной анальгетической терапии при ОА. Материалы и методы. В исследование включены 6448 больных (70,9% женщины и 29,1% мужчины), среднего возраста 57,8±10,2 года, с выраженной болью [≥40 мм по визуальной аналоговой шкале]. Все пациенты получали препарат неомыляемых соединений авакадо и сои (НСАС) 300 мг/сут. Для купирования боли в начале и в ходе исследования применялся препарат кетопрофен лизиновая соль (КЛС) 320 мг/сут. Критерием эффективности являлось снижение боли ≥50% и удовлетворенность лечением ≥4 по 5-балльной шкале. Оценивалось влияние ряда факторов на результат лечения. Результаты. За 3 мес лечения боль снизилась с 63,7±12,0 до 14,2±11,7 мм. Оценили результат как «хороший» или «превосходный» 81,7% больных. Нежелательные реакции отмечались редко. Суммарно хороший ответ на терапию отмечен у 87,4% больных. Пол, индекс массы тела ≥30 кг/м2, сахарный диабет 2-го типа, плохой эффект нестероидных противовоспалительных препаратов и медленнодействующих противовоспалительных средств в анамнезе не влияли на результат. Эффект был меньше у лиц ≥65 лет [отношение шансов (ОШ) 0,418; 95% доверительный интервал (ДИ) 0,342–0,509, р<0,001], с рентгенологической стадией ≥2 по Kellgren–Lawrence (ОШ 0,556; 95% ДИ 0,298–0,738, р<0,001), с болью в покое (ОШ 0,690; 95% ДИ 0,596–0,800, р<0,001), синовитом (ОШ 0,778; 95% ДИ 0,673–0,900, p=0,001), болью в области энтезисов (ОШ 0,846; 95% ДИ 0,616–0,957, p=0,032), а также при наличии дескрипторов центральной сенситизации (ЦС; ОШ 0,530; 95% ДИ 0,458–0,613, р<0,001). Заключение. Комбинация НСАС и КЛС позволяет добиться успешного контроля боли при ОА. Ряд факторов: возраст ≥65 лет, рентгенологическая стадия ОА ≥2, боль в покое, синовит, боль в области энтезисов и наличие дескрипторов ЦС ассоциируются с худшим результатом лечения.
There are factors that can affect the effectiveness of treatment of osteoarthritis (OA). Aim to identify factors affecting the effectiveness of long-term analgesic therapy in OA. Materials and methods. The study included 6448 patients (70.9% female and 29.1% male), middle age 57.8±10.2 years, with severe pain [≥40 mm on the visual analog scale]. All patients received the preparation of avocado-soybean unsaponifiables (ASU) 300 mg/day. For pain relief at the beginning and during the study, the drug Ketoprofen lysine salt (KLS) 320 mg/day was used. The efficiency criterion was pain reduction ≥50% and satisfaction with treatment ≥4 on a 5-point scale. The influence of a number of factors on the result of treatment was evaluated. Results. For 3 months of treatment, the pain decreased from 63.7±12.0 to 14.2±11.7 mm VAS. The result was evaluated as "good" or "excellent" 81.7% of patients. Adverse reactions were rare. In total, a good response to therapy was noted in 87.4% of patients. Gender, body mass index ≥30 kg/m2, type 2 diabetes mellitus, poor effect of non-steroidal anti-inflammatory drugs (NSAIDs) and Symptomatic Slow-Acting Drugs in Osteoarthritis (SYSADOA) in history did not affect the result. The effect was lower in persons >65 years [odds ratio (OR) 0.418; 95% confidence interval (CI) 0.342–0.509, p<0.001], with radiological stage >2 by Kellgren–Lawrence (OR 0.556; 95% CI 0.298–0.738, p<0.001), with pain at rest (OR 0.690; 95% CI 0.596–0.800, p<0.001), synovitis (OR 0.778; 95% CI 0.673–0.900, p=0.001), pain in the enthesis region (OR 0.846; 95% CI 0.616–0.957, p=0.032), and also in the presence of central sensitization descriptors (CS; OR 0.530; 95% CI 0.458–0.613, p<0.001). Conclusion. The combination of ASU and NSAID (KLS) allows for successful control of pain in OA. Factors such as age >65 years, stage OA of K/L >2, pain at rest, synovitis, pain in the region of enthesis and the presence of CS descriptors associated with the worst treatment outcome.
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13. Fidelix T, Soares B, Trevisani V. Diacerein for osteoarthritis. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005117.
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1. Rossijskie klinicheskie rekomendacii. Revmatologiya. Pod red. EL. Nasonova. Moscow: GEOTAR-Media, 2017: 446 s. (In Russ.). ISBN 978-5-9704-4261-6
2. Murray CJ, Barber RM, Foreman KJ, et al. Global, regional, and national disability-adjusted life years (DALYs) for 306 diseases and injuries and healthy life expectancy (HALE) for 188 countries, 1990-2013: quantifying the epidemiological transition. Lancet. 2015 Nov 28;386(10009):2145-91. doi: 10.1016/S0140-6736(15)61340-X Epub 2015 Aug 28
3. Balabanova RM, Erdes ShF. Rasprostranennost` revmaticheskix zabolevaniĭ v Rossii v 2012–2013 gg. Nauchno-prakticheskaya revmatologiya. 2015;53(2):120-4 (In Russ.).
4. Folomeeva OM, Galushko EA, Erdes ShF. Rasprostranennost revmaticheskix zabolevaniĭ v populyaciyax vzroslogo naseleniya Rossii i SShA. Nauchno-prakticheskaya revmatologiya. 2008;46(4):4-13 (In Russ.).
5. "Arthritis-Related Statistics: Prevalence of Arthritis in the United States". Centers for Disease Control and Prevention, US Department of Health and Human Services. 9 November 2016. На сайте: https://www.cdc.gov/ arthritis/data_statistics/arthritis-related-stats.htm
6. Pfuntner A, Wier LM, Stocks C. Most Frequent Conditions in U.S. Hospitals, 2011: Statistical Brief #162. Source Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006-2013 Sep.
7. McAlindon TE, Bannuru RR, Sullivan MC, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003 Epub 2014 Jan 24
8. Bruyère O, Cooper C, Pelletier JP, et al. A consensus statement on the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) algorithm for the management of knee osteoarthritis-From evidence-based medicine to the real-life setting. Semin Arthritis Rheum. 2016 Feb;45(4 Suppl):S3-11. doi:10.1016/j.semarthrit.20 15.11.010 Epub 2015 Dec 2
9. Robinson WH, Lepus CM, Wang Q, et al. Low-grade inflammation as a key mediator of the pathogenesis of osteoarthritis. Nat Rev Rheumatol. 2016 Oct;12(10):580-92. doi: 10.1038/nrrheum.2016.136 Epub 2016 Aug 19
10. Mathiessen A, Conaghan PG. Synovitis in osteoarthritis: current understanding with therapeutic implications. Arthritis Res Ther. 2017 Feb 2;19(1):18. doi: 10.1186/s13075-017-1229-9
11. Towheed T, Maxwell L, Anastassiades T, et al. Glucosamine therapy for treating osteoarthritis. Cochrane Database Syst Rev. 2005 Apr 18;(2): CD002946.
12. Reichenbach S, Sterchi R, Scherer M, et al. Meta-analysis: chondroitin for osteoarthritis of the knee or hip. Ann Intern Med. 2007;146(8):580-90.
13. Fidelix T, Soares B, Trevisani V. Diacerein for osteoarthritis. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD005117.
14. Clegg DO, Reda DJ, Harris CL, et al. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med. 2006 Feb 23;354(8):795-808.
15. Moore R, Moore O, Derry S, et al. Responder analysis for pain relief and numbers needed to treat in a meta-analysis of etoricoxib osteoarthritis trials: bridging a gap between clinical trials and clinical practice. Ann Rheum Dis. 2010;69:374-9.
16. Sarzi-Puttini P, Atzeni F, Lanata L, et al. Pain and ketoprofen: what is its role in clinical practice? Reumatismo. 2010;62(3):172-88.
17. Le Loet X. Safety of ketoprofen in the elderly: a prospective study on 20,000 patients. Scand J Rheumatol Suppl. 1989;83:21-7.
18. Sarzi-Puttini P, Atzeni F, Lanata L, Bagnasco M. Efficacy of ketoprofen vs. ibuprofen and diclofenac: a systematic review of the literature and meta-analysis. Clin Exp Rheumatol. 2013 Sep-Oct;31(5):731-8. Epub 2013 May 17
19. Karateev AE, Zhuravleva MV, Alekseev VV i dr. Effektivnost kombinacii lekarstvenny`x form ketoprofena lizinovoĭ soli (Artrozilen®) u pacientov s myshechno-skeletnoj bolyu v klinicheskoj praktike: Issledovanie KULON (Ketoprofen: udovletvorennost lecheniem i ocenka nezhelatelnyx yavleniĭ). Klinicheskaya farmakologiya i terapiya. 2013;22(4):22-30 (In Russ.).
20. Cameron M, Chrubasik S. Oral herbal therapies for treating osteoarthritis. Cochrane Database Syst Rev. 2014 May 22;(5):CD002947. doi: 10.1002/1 4651858.CD002947.pub2
21. Christensen R, Bartels E, Astrup A, Bliddal H. Symptomatic efficacy of avocado-soybean unsaponifiables (ASU) in osteoarthritis (OA) patients: a meta-analysis of randomized controlled trials. Osteoarthritis Cartilage. 2008;16(4):399-408.
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