Registro de ácido hialurónico intraarticular en el tratamiento de la osteoartritis de rodilla, en la Argentina. [Registry of intra-articular hyaluronic acid in the treatment of knee osteoarthritis in Argentina]
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Publicado:
may 2, 2019
Palabras clave:
Intraarticular, ácido hialurónico, rodilla, osteoartritis, intra-articular, hyaluronic acid, knee, arthrosis, osteoarthritis
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Resumen
Introducción: El ácido hialurónico intrarticular se suele utilizar para tratar la artrosis de rodilla. Nuestro objetivo fue analizar la efectividad y el uso del ácido hialurónico intrarticular en la práctica habitual.Materiales y Métodos: Cohorte retrospectiva observacional. Se evaluó a 1227 pacientes con artrosis de rodilla tratados con ácido hialurónico intrarticular 20 mg/2 ml/semana (76% 20 mg) y 40 mg/2 ml (24% 40 mg) según la práctica habitual. Seguimiento de 6 meses. Se evaluó la eficacia con la escala de Likert de 5 puntos y la proporción de respuesta ≥50%.Resultados: La mediana de aplicaciones fue de 5 (20 mg) y 3 (40 mg). El puntaje de Likert mejoró significativamente en ambos grupos a los 6 meses. La mediana del puntaje mejoró de 4 (media 3,77 ± 0,69) al inicio a 2 (media 1,99 ± 0,76) a los 6 meses con 20 mg (p <0,001) y de 4 (media 3,65 ± 0,65) a 2 (media 1,86 ± 0,72) con 40 mg (p <0,001). La proporción de respuesta ≥50% a los 6 meses fue del 61% y 66%, respectivamente. En el análisis multivariado, la tasa de respuesta ≥50% se asoció con un mayor puntaje inicial, edad más joven y menor duración de la enfermedad. Solo un paciente con 20 mg (0,1%) tuvo un episodio adverso severo (artritis séptica).Conclusión: Nuestro estudio en la práctica clínica común respalda la efectividad del ácido hialurónico intrarticular para tratar la artrosis de rodilla, con un beneficio clínico a los 6 meses de seguimiento. Abstract Background: Intra-articular treatment of knee osteoarthrosis (OA) with hyaluronic acid (IA-HA) is frequently used in Argentina, with different dosing forms and injection regimens. Our main objective was to provide real world data on the use and effectiveness of IA-HAMethods: In this observational retrospective cohort study we studied 1227 patients with knee osteoarthrosis treated with IA-HA 20mg/2ml weekly (76%-20mg group) and 40mg/2ml (24%-40mg group) according to usual practice intervals. Follow up was at 6 months and efficacy assessed by 5 point Likert scale and 50% or more response rate.Results: Median number of applications was 5 (20mg) and 3 (40mg). Both groups had a significant improvement in the Likert scale from baseline to 6 month. Median score improved from 4 (mean 3.77 ±0.69) at baseline to median of 2 (mean 1.99 ±0.76) at 6 months (20mg group, p <0.001) and from median of 4 (mean 3.65 ±0.65) to median 2 (mean 1.86 ±0.72) in the 40mg group, p <0.001. Proportion of patients with 50% or more 6 month response were 61% and 66% respectively. In the multivariate analysis, 50% response rate was associated with higher baseline score, younger age and shorter duration of disease. Only 1 patient in the 20mg group (0.1%) experienced a serious treatment related adverse event (septic arthritis) following injection.Conclusion: Our study in common clinical practice supports the effectiveness of IA-HA in step management of knee OA with clinical benefit observed at 6 month follow up. Key words: Intra-articular; hyaluronic acid; knee; arthrosis; osteoarthritis.
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Berenstein, M., Tacus, L., Kobrinsky, P., & Vaineras, D. (2019). Registro de ácido hialurónico intraarticular en el tratamiento de la osteoartritis de rodilla, en la Argentina. [Registry of intra-articular hyaluronic acid in the treatment of knee osteoarthritis in Argentina]. Revista De La Asociación Argentina De Ortopedia Y Traumatología, 84(2), 122-128. https://doi.org/10.15417/issn.1852-7434.2019.84.2.846
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Investigación Clínica
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1-Hussain SM, Neilly DW, Baliga S, Patil S, Meek R. Knee osteoarthritis: a review of management options. Scott Med J. 2016 Feb;61(1):7-16.
2-Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21.
3- Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69.
4-Altman RD, Manjoo A, Fierlinger A, Niazi F, Nicholls M. The mechanism of action for hyaluronic acid treatment in the osteoarthritic knee: a systematic review. BMC Musculoskelet Disord. 2015 Oct 26;16:321.
5-Nicholls MA, Fierlinger A, Niazi F, Bhandari M. The Disease-Modifying Effects of Hyaluronan in the Osteoarthritic Disease State. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Aug 11;10:1179544117723611.
6-Hiramitsu T, Yasuda T, Ito H, Shimizu M, Julovi SM, Kakinuma T, Akiyoshi M, Yoshida M, Nakamura T. Intercellular adhesion molecule-1 mediates the inhibitory effects of hyaluronan on interleukin-1beta-induced matrix metalloproteinase production in rheumatoid synovial fibroblasts via down-regulation of NF-kappaB and p38. Rheumatology (Oxford). 2006 Jul;45(7):824-32.
7-Lindqvist U, Tolmachev V, Kairemo K, Aström G, Jonsson E, Lundqvist H. Elimination of stabilised hyaluronan from the knee joint in healthy men. Clin Pharmacokinet. 2002;41(8):603-13.
8-Strand, V., McIntyre, L. F., Beach, W. R., Miller, L. E. & Block, J. E. Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials. J Pain Res 8, 217–228 (2015).
9-Rutjes, A. W., Juni, P., da, C. B. R., Trelle, S., Nuesch, E. & Reichenbach, S. Viscosupplementation for osteoarthritis of the knee: a systematic review and meta-analysis. Ann. Intern. Med.157, 180–191 (2012).
10-Miller, L. E. & Block, J. E. US-Approved IA-HA Injections are Safe and Effective in Patients with Knee Osteoarthritis: Systematic Review and Meta-Analysis of Randomized, Saline-Controlled Trials. Clin Med Insights Arthritis Musculoskelet Disord 6, 57–63 (2013).
11-Lo, G. H., LaValley, M., McAlindon, T. & Felson, D. T. IA-HA in treatment of knee osteoarthritis: a meta-analysis. JAMA 290, 3115–3121 (2003).
12-Wang, C. T., Lin, J., Chang, C. J., Lin, Y. T. & Hou, S. M. Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. A meta-analysis of randomized controlled trials. J Bone Joint Surg Am 86-A, 538–545 (2004).
13-Arrich, J., Piribauer, F., Mad, P., Schmid, D., Klaushofer, K. & Mullner, M. IA-HA for the treatment of osteoarthritis of the knee: systematic review and meta-analysis. CMAJ 172, 1039–1043 (2005).
14-Bellamy, N. et al. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev doi: 10.1002/14651858.CD005321.pub2 (2006).
15-Altman RD, Farrokhyar F, Fierlinger A, Niazi F, Rosen J. Analysis for Prognostic Factors from a Database for the IA-HA (Euflexxa) Treatment for Osteoarthritis of the Knee. Cartilage. 2016 Jul;7(3):229-37.
16-Bowman EN, Hallock JD, Throckmorton TW, Azar FM. Hyaluronic acid injections for osteoarthritis of the knee: predictors of successful treatment. Int Orthop. 2018 Jan 3. doi: 10.1007/s00264-017-3731-8.
17-Altman RD, Bedi A, Karlsson J, Sancheti P, Schemitsch E. Product Differences in IA-HAs for Osteoarthritis of the Knee. Am J Sports Med. 2016 Aug;44(8):2158-65.
18-Colen, S., van den Bekerom, M. P., Mulier, M. & Haverkamp, D.Hyaluronic acid in the treatment of knee osteoarthritis: a systematic review and meta-analysis with emphasis on the efficacy of different products. BioDrugs 26, 257–268 (2012).
19-Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542.
20-Sun SF, Hsu CW, Lin HS, Liou IH, Chen YH, Hung CL. Comparison of Single Intra-Articular Injection of Novel Hyaluronan (HYA-JOINT Plus) with Synvisc-One for Knee Osteoarthritis: A Randomized, Controlled, Double-Blind Trial of Efficacy and Safety. J Bone Joint Surg Am. 2017 Mar 15;99(6):462-471.
21- Conrozier T, Eymard F, Afif N, Balblanc JC, Legré-Boyer V, Chevalier X; Happyvisc Study Group. Safety and efficacy of intra-articular injections of a combination of hyaluronic acid and mannitol (HAnOX-M) in patients with symptomatic knee osteoarthritis: Results of a double-blind, controlled, multicenter, randomized trial. Knee. 2016 Oct;23(5):842-8.
22- Bruyère O, Cooper C, Pelletier JP, Maheu E, Rannou F, Branco J, Luisa Brandi M, Kanis JA, Altman RD, Hochberg MC, Martel-Pelletier J, Reginster JY. 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.
2-Lespasio MJ, Piuzzi NS, Husni ME, Muschler GF, Guarino A, Mont MA. Knee Osteoarthritis: A Primer. Perm J. 2017;21.
3- Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69.
4-Altman RD, Manjoo A, Fierlinger A, Niazi F, Nicholls M. The mechanism of action for hyaluronic acid treatment in the osteoarthritic knee: a systematic review. BMC Musculoskelet Disord. 2015 Oct 26;16:321.
5-Nicholls MA, Fierlinger A, Niazi F, Bhandari M. The Disease-Modifying Effects of Hyaluronan in the Osteoarthritic Disease State. Clin Med Insights Arthritis Musculoskelet Disord. 2017 Aug 11;10:1179544117723611.
6-Hiramitsu T, Yasuda T, Ito H, Shimizu M, Julovi SM, Kakinuma T, Akiyoshi M, Yoshida M, Nakamura T. Intercellular adhesion molecule-1 mediates the inhibitory effects of hyaluronan on interleukin-1beta-induced matrix metalloproteinase production in rheumatoid synovial fibroblasts via down-regulation of NF-kappaB and p38. Rheumatology (Oxford). 2006 Jul;45(7):824-32.
7-Lindqvist U, Tolmachev V, Kairemo K, Aström G, Jonsson E, Lundqvist H. Elimination of stabilised hyaluronan from the knee joint in healthy men. Clin Pharmacokinet. 2002;41(8):603-13.
8-Strand, V., McIntyre, L. F., Beach, W. R., Miller, L. E. & Block, J. E. Safety and efficacy of US-approved viscosupplements for knee osteoarthritis: a systematic review and meta-analysis of randomized, saline-controlled trials. J Pain Res 8, 217–228 (2015).
9-Rutjes, A. W., Juni, P., da, C. B. R., Trelle, S., Nuesch, E. & Reichenbach, S. Viscosupplementation for osteoarthritis of the knee: a systematic review and meta-analysis. Ann. Intern. Med.157, 180–191 (2012).
10-Miller, L. E. & Block, J. E. US-Approved IA-HA Injections are Safe and Effective in Patients with Knee Osteoarthritis: Systematic Review and Meta-Analysis of Randomized, Saline-Controlled Trials. Clin Med Insights Arthritis Musculoskelet Disord 6, 57–63 (2013).
11-Lo, G. H., LaValley, M., McAlindon, T. & Felson, D. T. IA-HA in treatment of knee osteoarthritis: a meta-analysis. JAMA 290, 3115–3121 (2003).
12-Wang, C. T., Lin, J., Chang, C. J., Lin, Y. T. & Hou, S. M. Therapeutic effects of hyaluronic acid on osteoarthritis of the knee. A meta-analysis of randomized controlled trials. J Bone Joint Surg Am 86-A, 538–545 (2004).
13-Arrich, J., Piribauer, F., Mad, P., Schmid, D., Klaushofer, K. & Mullner, M. IA-HA for the treatment of osteoarthritis of the knee: systematic review and meta-analysis. CMAJ 172, 1039–1043 (2005).
14-Bellamy, N. et al. Viscosupplementation for the treatment of osteoarthritis of the knee. Cochrane Database Syst Rev doi: 10.1002/14651858.CD005321.pub2 (2006).
15-Altman RD, Farrokhyar F, Fierlinger A, Niazi F, Rosen J. Analysis for Prognostic Factors from a Database for the IA-HA (Euflexxa) Treatment for Osteoarthritis of the Knee. Cartilage. 2016 Jul;7(3):229-37.
16-Bowman EN, Hallock JD, Throckmorton TW, Azar FM. Hyaluronic acid injections for osteoarthritis of the knee: predictors of successful treatment. Int Orthop. 2018 Jan 3. doi: 10.1007/s00264-017-3731-8.
17-Altman RD, Bedi A, Karlsson J, Sancheti P, Schemitsch E. Product Differences in IA-HAs for Osteoarthritis of the Knee. Am J Sports Med. 2016 Aug;44(8):2158-65.
18-Colen, S., van den Bekerom, M. P., Mulier, M. & Haverkamp, D.Hyaluronic acid in the treatment of knee osteoarthritis: a systematic review and meta-analysis with emphasis on the efficacy of different products. BioDrugs 26, 257–268 (2012).
19-Concoff A, Sancheti P, Niazi F, Shaw P, Rosen J. The efficacy of multiple versus single hyaluronic acid injections: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Dec 21;18(1):542.
20-Sun SF, Hsu CW, Lin HS, Liou IH, Chen YH, Hung CL. Comparison of Single Intra-Articular Injection of Novel Hyaluronan (HYA-JOINT Plus) with Synvisc-One for Knee Osteoarthritis: A Randomized, Controlled, Double-Blind Trial of Efficacy and Safety. J Bone Joint Surg Am. 2017 Mar 15;99(6):462-471.
21- Conrozier T, Eymard F, Afif N, Balblanc JC, Legré-Boyer V, Chevalier X; Happyvisc Study Group. Safety and efficacy of intra-articular injections of a combination of hyaluronic acid and mannitol (HAnOX-M) in patients with symptomatic knee osteoarthritis: Results of a double-blind, controlled, multicenter, randomized trial. Knee. 2016 Oct;23(5):842-8.
22- Bruyère O, Cooper C, Pelletier JP, Maheu E, Rannou F, Branco J, Luisa Brandi M, Kanis JA, Altman RD, Hochberg MC, Martel-Pelletier J, Reginster JY. 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.