Efficacy of combined use of glycosaminoglycan peptide complex for intramuscular administration and oral diacerein in osteoarthritis: evaluation according to an observational multicenter clinical trial
- 作者: Karateev A.E.1, Alekseeva L.I.1, Pogozheva E.Y.1, Amirdzhanova V.N.1, Filatova E.S.1, Nesterenko V.A.1, Lila A.M.1,2
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隶属关系:
- Nasonova Research Institute of Rheumatology
- Russian Medical Academy of Continuous Professional Education
- 期: 卷 93, 编号 5 (2021)
- 页面: 587-593
- 栏目: Original articles
- URL: https://bakhtiniada.ru/0040-3660/article/view/71513
- DOI: https://doi.org/10.26442/00403660.2021.05.200791
- ID: 71513
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Background. The combined use of intramuscular injection glycosaminoglycan peptide complex (GPC) and oral diacerein can increase the effectiveness of treatment of osteoarthritis (OA).
Aim. Compare the effectiveness of combination GPC + diacerein and GPC monotherapy in the treatment of OA in clinical practice.
Materials and methods. A retrospective evaluation of the results of a 12-week multicenter observational non-interventional study of the effectiveness of GPC (Rumalon®, a course of intramuscular injections 3 times a week, №25) in patients with moderate/severe OA (n=2955) requiring regular administration of nonsteroidal anti-inflammatory drugs (NSAIDs). The analysis identified a group of patients (n=414) who received GPC in combination with diacerein 100 mg/day (Diaflex Rompharm). The therapeutic effect was compared in the groups of GPC monotherapy (n=2541) and the combination of GPC with diacerein. These groups did not differ in average age (61.4±11.8 and 61.9±11.3 years), both were dominated by women (76.3 and 70.3%), there was approximately equal intensity of pain during movement and impaired joint function: 6.1±1.8/6.0±1.6 and 4.9±2.1/5.1±1.8 (according to the numerical rating scale 0–10). The dynamics of pain intensity, the need for NSAIDs, and the frequency of adverse events (AE) were compared 12 weeks after the start of treatment.
Results and discussion. In the majority of patients with OA – both on the background of GPC monotherapy and combined use of GPC and diacerein, there was a significant improvement. The number of patients with pain reduction ≥50% was 54.3 and 62.8% (p<0.001), NSAID administration was completely stopped in 66.7 and 77.5% (p<0.001), respectively. The effectiveness of the combination of GPC and diacerein was significantly higher than that of GPC monotherapy in OA of the knee joint, hip joint, and generalized OA. AE from the gastrointestinal tract was observed in 7.8 and 8.9%, arterial hypertension – in 6.3 and 4.6%, allergic reactions – in 0.3 and 0.5% of patients (not significant).
Conclusion. The application of the code of civil procedure is an effective treatment for OA. The combination of GPC and diacerein provides a more significant improvement than GPC monotherapy. GPC and diacerein (including in combination) are well tolerated and rarely cause AE.
作者简介
Andrei Karateev
Nasonova Research Institute of Rheumatology
编辑信件的主要联系方式.
Email: aekarat@yandex.ru
ORCID iD: 0000-0002-1391-0711
д.м.н., зав. лаб. патофизиологии боли и полиморфизма скелетно-мышечных заболеваний
俄罗斯联邦, MoscowLiudmila Alekseeva
Nasonova Research Institute of Rheumatology
Email: aekarat@yandex.ru
ORCID iD: 0000-0001-7017-0898
д-р мед. наук, зав. лаб. остеоартрита
俄罗斯联邦, MoscowElena Pogozheva
Nasonova Research Institute of Rheumatology
Email: aekarat@yandex.ru
ORCID iD: 0000-0001-5103-5447
канд. мед. наук, науч. сотр. лаб. патофизиологии боли и полиморфизма скелетно-мышечных заболеваний
俄罗斯联邦, MoscowVera Amirdzhanova
Nasonova Research Institute of Rheumatology
Email: aekarat@yandex.ru
ORCID iD: 0000-0001-5382-6357
д-р мед. наук, внештат. науч. сотр. лаб. патофизиологии боли и полиморфизма скелетно-мышечных заболеваний
俄罗斯联邦, MoscowEkaterina Filatova
Nasonova Research Institute of Rheumatology
Email: aekarat@yandex.ru
ORCID iD: 0000-0002-2475-8620
канд. мед. наук, науч. сотр. лаб. патофизиологии боли и полиморфизма скелетно-мышечных заболеваний
俄罗斯联邦, MoscowVadim Nesterenko
Nasonova Research Institute of Rheumatology
Email: aekarat@yandex.ru
ORCID iD: 0000-0002-7179-8174
мл. науч. сотр. лаб. патофизиологии боли и полиморфизма скелетно-мышечных заболеваний
俄罗斯联邦, MoscowAleksander Lila
Nasonova Research Institute of Rheumatology; Russian Medical Academy of Continuous Professional Education
Email: aekarat@yandex.ru
ORCID iD: 0000-0002-6068-3080
д-р мед. наук, проф., дир. ФГБНУ «НИИР им. В.А. Насоновой», зав. каф. ревматологии ФГБОУ ДПО РМАНПО
俄罗斯联邦, Moscow; Moscow参考
- Лила А.М., Алексеева Л.И., Таскина Е.А. Современные подходы к терапии остеоартрита с учетом обновленных международных рекомендаций. Русский медицинский журнал. 2019;3(11):48-52 [Lila AM, Alekseeva LI, Taskina EA. Modern approaches to the treatment of osteoarthritis taking into account the updated international recommendations. Russian Medical Journal. 2019;3(11):48-52 (in Russian)].
- Peat G, Thomas M. Osteoarthritis year in review 2020: epidemiology & therapy. Osteoarthritis Cartilage. 2021;29(2):180-9. doi: 10.1016/j.joca.2020.10.007
- Zhang Z, Huang C, Jiang Q, et al. Guidelines for the diagnosis and treatment of osteoarthritis in China (2019 edition). Ann Transl Med. 2020;8(19):1213. doi: 10.21037/atm-20-4665
- James SL, Abate D, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Lancet. 2018;392(10159):1789-858. doi: 10.1016/S0140-6736(18)32279-7
- Swain S, Sarmanova A, Mallen C, et al. Trends in incidence and prevalence of osteoarthritis in the United Kingdom: findings from the Clinical Practice Research Datalink (CPRD). Osteoarthritis Cartilage. 2020;28(6):792-801. doi: 10.1016/j.joca.2020.03.004
- Schmidt CO, Günther KP, Goronzy J, et al. Frequencies of musculoskeletal symptoms and disorders in the population-based German National Cohort (GNC). Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2020;63(4):415-25. doi: 10.1007/s00103-020-03110-1
- Галушко Е.А., Насонов Е.Л. Распространенность ревматических заболеваний в России. Альманах клинической медицины. 2018;46(1):32-9 [Galushko EA, Nasonov EL. Prevalence of rheumatic diseases in Russia. Almanac of Clinical Medicine. 2018;46(1):32-9 (in Russian)]. doi: 10.18786/2072-0505-2018-4-1-32-39.
- Mendy A, Park J, Vieira ER. Osteoarthritis and risk of mortality in the USA: a population-based cohort study. Int J Epidemiol. 2018;47(6):1821-9. doi: 10.1093/ije/dyy187
- Liu Q, Niu J, Li H, et al. Knee Symptomatic Osteoarthritis, Walking Disability, NSAIDs Use and All-cause Mortality: Population-based Wuchuan Osteoarthritis Study. Sci Rep. 2017;7(1):3309. doi: 10.1038/s41598-017-03110-3
- Hawker GA, Croxford R, Bierman AS, et al. All-cause mortality and serious cardiovascular events in people with hip and knee osteoarthritis: a population based cohort study. PLoS One. 2014;9(3):e91286. doi: 10.1371/journal.pone.0091286
- Collins JE, Katz JN, Dervan EE, Losina E. Trajectories and risk profiles of pain in persons with radiographic, symptomatic knee osteoarthritis: data from the osteoarthritis initiative. Osteoarthritis Cartilage. 2014;22(5):622-30. doi: 10.1016/j.joca.2014.03.009
- Dorais M, Martel-Pelletier J, Raynauld JP, et al. Impact of oral osteoarthritis therapy usage among other risk factors on knee replacement: a nested case-control study using the Osteoarthritis Initiative cohort. Arthritis Res Ther. 2018;20(1):172. doi: 10.1186/s13075-018-1656-2
- Chow YY, Chin KY. The Role of Inflammation in the Pathogenesis of Osteoarthritis. Mediators Inflamm. 2020;2020:8293921. doi: 10.1155/2020/8293921
- Bruyère O, Honvo G, Veronese N, et al. An updated algorithm recommendation for the management of knee osteoarthritis from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Semin Arthritis Rheum. 2019;49(3):337-50. doi: 10.1016/j.semarthrit.2019.04.008
- Алексеева Л.И., Таскина Е.А., Кашеварова Н.Г. Остеоартрит: эпидемиология, классификация, факторы риска и прогрессирования, клиника, диагностика, лечение. Современная ревматология. 2019;13(2):9-21 [Alekseeva LI, Taskina EA, Kashevarova NG. Osteoarthritis: epidemiology, classification, risk factors and progression, clinic, diagnosis, treatment. Modern Rheumatology. 2019;13(2):9-21 (in Russian)]. doi: 10.14412/1996-7012-2019-2-9-21
- Алексеева Л.И., Аникин С.Г., Зайцева Е.М., и др. Исследование эффективности, переносимости и безопасности препарата Хонрогард у пациентов с остеоартрозом. Фарматека. 2013;7(260):58-62 [Alekseeva LI, Anikin SG, Zaitseva EM, et al. Study of the efficacy, tolerability and safety of the drug Chondrogard in patients with osteoarthritis. Pharmateca. 2013;7(260):58-62 (in Russian)].
- Имаметдинова Г.Р., Чичасова Н.В. Хондроитина сульфат при заболеваниях опорно-двигательного аппарата: эффективность и безопасность с позиций доказательной медицины. Русский медицинский журнал. 2016;24(22):1481-8 [Imametdinova GR, Chichasova NV. Chondroitin sulfate in diseases of the musculoskeletal system: efficacy and safety from the standpoint of evidence-based medicine. Russian Medical Journal. 2016;24(22):1481-8 (in Russian)].
- Шостак Н.А., Правдюк Н.Г., Клименко А.А., и др. Остеоартрит и ассоциированная патология – клинико-патогенетические взаимосвязи. Русский медицинский журнал. 2019;11(II):44-7 [Shostak NA, Pravdyuk NG, Klimenko AA, et al. Osteoarthritis and associated pathology-clinical and pathogenetic relationships. Russian Medical Journal. 2019;11(II):44-7 (in Russian)].
- Каратеев А.Е. Гликозаминогликан-пептидный комплекс при лечении остеоартрита коленного и тазобедренного суставов: из прошлого в будущее. Научно-практическая ревматология. 2020;58(1):91-6 [Karateev AE. Glycosaminoglycan peptide complex in the treatment of osteoarthritis of the knee and hip joints: from the past to the future. Scientific and practical rheumatology. 2020;58(1):91-6 (in Russian)]. doi: 10.14412/1995-4484-2020-91-96
- Honvo G, Reginster JY, Rabenda V, et al. Safety of Symptomatic Slow-Acting Drugs for Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis. Drugs Aging. 2019;36(Suppl. 1):65-99. doi: 10.1007/s40266-019-00662-z
- Алексеева Л.И., Каратеев А.Е., Погожева Е.Ю., и др. Оценка эффективности и безопасности инъекционной формы гликозаминогликан-пептидного комплекса у пациентов с остеоартритом: многоцентровое наблюдательное исследование ГЛАДИОЛУС (ГПК при Лечении остеоАртрита: Динамическое Исследование Обезболивания и Локального Уменьшения Симптомов). Современная ревматология. 2020;14(2):76-83 [Alekseeva LI, Karateev AE, Pogozheva EYu, et al. Evaluation of the efficacy and safety of the injectable form of the glycosaminoglycan-peptide complex in patients with osteoarthritis: A multicenter observational study of GLADIOLUS. Modern Rheumatology. 2020;14(2):76-83 (in Russian)]. doi: 10.14412/1996-7012-2020-2-76-83
- De Oliveira PG, Termini L, Durigon EL, et al. Diacerein: A potential multi-target therapeutic drug for COVID-19. Med Hypotheses. 2020;144:109920. doi: 10.1016/j.mehy.2020.109920
- Steinecker-Frohnwieser B, Kaltenegger H, Weigl L, et al. Pharmacological treatment with diacerein combined with mechanical stimulation affects the expression of growth factors in human chondrocytes. Biochem Biophys Rep. 2017;11:154-60. doi: 10.1016/j.bbrep.2017.06.006
- Jaillon P. Controlled randomized clinical trials. Bull Acad Natl Med. 2007;191(4-5):739-56.
- Nahin RL, Boineau R, Khalsa PS, et al. Evidence-Based Evaluation of Complementary Health Approaches for Pain Management in the United States. Mayo Clin Proc. 2016;91(9):1292-306. doi: 10.1016/j.mayocp.2016.06.007
- Garattini S, Bertele V. Benefits, benefits, once more benefits... with no risk? Stop overlooking the harms of medicines. Eur J Clin Pharmacol. 2018;74(3):373-5. doi: 10.1007/s00228-017-2378-0
- Zhu X, Wu D, Sang L, et al. Comparative effectiveness of glucosamine, chondroitin, acetaminophen or celecoxib for the treatment of knee and/or hip osteoarthritis: a network meta-analysis. Clin Exp Rheumatol. 2018;36(4):595-602.
- Wandel S, Jüni P, Tendal B, et al. Effects of glucosamine, chondroitin, or placebo in patients with osteoarthritis of hip or knee: network meta-analysis. BMJ. 2010;341:c4675. doi: 10.1136/bmj.c4675
- Kongtharvonskul J, Woratanarat P, McEvoy M, et al. Efficacy of glucosamine plus diacerein versus monotherapy of glucosamine: a double-blind, parallel randomized clinical trial. Arthritis Res Ther. 2016;18(1):233. doi: 10.1186/s13075-016-1124-9
- Lubis AMT, Siagian C, Wonggokusuma E, et al. Comparison of Glucosamine-Chondroitin Sulfate with and without Methylsulfonylmethane in Grade I-II Knee Osteoarthritis: A Double Blind Randomized Controlled Trial. Acta Med Indones. 2017;49(2):105-11.
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