NEW DIRECTION IN LOCAL THERAPY OF OSTEOARTHRITIS OF THE KNEE JOINT

Study objective: to examine the comparative efficacy and tolerability of the Nanoplast forte therapeutic patch as compared with placebo patch with patients with osteoarthritis (OA) of the knee joint (KJ) in conditions of a prospective randomized multi-centered study approved by the local ethics committee.

Materials and methods.120 patients with OA of the KJ of the I to III radiographic stages according to Kellgren and Lаwrence take part in the study, 2 groups with 60 patients each compared in major clinical parameters. The primary efficacy criterion was relieving of pain in the target KJ (WOMAC index, section A) by ≥ 50 % as compared to the initial level. Assessment of B and C section of the WOMAC index in dynamics was performed in the course of the study. Visual and analogous scale (in mm) was used for general assessment separately by the patient and the doctor; daily assessment of pain intensity was performed by the patient. The total efficiency of the Nanoplast forte patch was studied on the 14th day separately by the doctor and the patient in accordance with the following grades: significant improvement; improvement; no effect; aggravation. The need for intake of nonsteroidal anti-inflammatory drugs (NSAIDs) was determined during the study as follows: daily dose, dose reduction or elimination of NSAIDs was determined due to the decrease in the intensity of pain. The patch was applied onto the target joint one a day at 12 o’clock (from 9 a. m. to 9 p. m.). Tolerability of the Nanoplast forte patch and the placebo patch was assessed in accordance with the frequency and manifestation of local and / or systemic undesired effects (from 1 to 3 points). The frequency of achievement of 50 % of pain decreasing (WOMAC index, section A) was evidently higher in the group of active Nanoplast forte patch than in the placebo group (38.2 as compared to 16.7 %, respectively; p = 0.013; Fisher exact criterion). Intensity of pain during walking was decreased only with the use of the active Nanoplast forte patch (p = 0.05; ANOVA two-factor analysis), and evident decreasing of pain was marked as quickly as on the 4th day of application. Due to the therapy, morning stiffness was evidently decreased and functional activity was increased in the main group. The general state of patients in accordance with their subjective assessment (p = 0.05) and with the doctor’s opinion (p = 0.01) was improved with statistic significance. Elimination and decreasing of the dose of NSAIDs took place evidently more frequently (p = 0.007; Fisher exact criterion) in the group of patients that applied active Nanoplast forte patch than in the placebo group. All patients completed the study in the active therapy group. No side effects associated with application of the Nanoplast forte patch were revealed. Due to application of the Nanoplast forte patch, 50 percent of patients eliminated or decreased the dose of previously prescribed NSAIDs, while only 25 % of patients did the same in the placebo group.

Conclusion. Nanoplast forte may be recommended as an efficient and safe method of local therapy of OA of the KJ.

1. Brand K.D., Doherty M., Lohmander L.S. (eds.). Osteoarthritis. Oxford: Oxford University Press, 1998.

2. Reginster J.Y. The prevalence and burder of arthritis. Rheumatology (Oxford) 2002;41 Supp 1:3–6.

3. Лыгина Е.В. Хондропротекторы в лечении остеоартроза. Современная ревматология 2012;(2):59–64. [Lygina E.V. Chondroprotectors in treatment of osteoarthritis. Sovremennaya revmatologiya = Modern Rheumatology 2012;(2):59–64. (In Russ.)].

4. Lawrence R.S., Helmick C.G., Arnett F.C. et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum 1998;41(5):778–99.

5. Фоломеева О.М., Лебедева Л.С., Ушакова М.А. Инвалидность, обусловленная ревматическими заболеваниями, среди жителей Российской Федерации. Научно-практическая ревматология 2001;(1):15–21 [Folomeyeva O.M., Lebedeva L.S., Ushakova M.A. Disability caused with rheumatic diseases among the population of the Russian Federation. Nauchnopracticheskaya revmatologiya = Scientific and ractical Rheumatology 2001;(1):15–21. (In Russ.)].

6. Эрдес Ш.Ф., Фоломеева О.М. Ревматические заболевания и инвалидность взрослого населения Российской Федерации. Научно-практическая ревматология 2007;(4):4–10. [Erdes Sh.F., Folomeyeva O.M. Rheumatic diseases and disability among the adult population of the Russian Federation. Nauchno-practicheskaya revmatologiya = Scientific and Practical Rheumatology 2007;(4):4–10. (In Russ.)].

7. Gore M., Tai K.S., Sadosky A. et al. Clinical comorbidities, treatment patterns, and direct medical costs of patients with osteoarthritis in usual care: a retrospective claims database analysis. J Med Econ 2011;14(4):497–507.

8. Насонов Е.Л., Каратеев А.Е. Симптоматическая терапия при ревматических заболеваниях. М., 2012. С. 53. [Nasonov E.L., Karateyev A.E. Symptomatic therapy with rheumatic diseases. Мoscow, 2012. P. 53. (In Russ.)].

9. Zhang W., Nuki G., Moskowitz R.W. et al. OARSI recommendations for the management of hip and knee osteoarthritis. Part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage 2010;18(4):476–99.

10. Ревматология. Клинические рекомендации. Под ред. Е.Л. Насонова. М.: ГЭОТАР-Медиа, 2010. 752 с. [Rheumatology. Clinical recommendations. Under revision of E.L. Nasonov. Moscow: GEOTAR-Media, 2010. 752 p. (In Russ.)].

11. Lin J., Zhang W., Jones A., Doherty М. Efficacy of topical non-steroidal antiinflammatory drugs in the treatment of osteoarthritis: meta-analysis of randomized controlled trials. BMJ 2004;329(7461):324–6.

12. Evans J.M., MacDonald T.M. Tolerability of topical NSAIDs in the elderly: do they really convey a safety advantage? Drugs Aging 1996;9(2):101–8 .

13. Ананьева Л.П., Панасюк Е.Ю., Денисов Л.Н., Кузин А.В. Боли в нижней части спины в практике ревматолога, локальная терапия Версатисом. Справочник поликлинического врача 2007;(9):43–6. [Ananiyeva L.P., Panasyuk E.Yu., Denisov L.N., Kuzin A.V. Pain in the lower back in the practice of a rheumatologist, local therapy with Versatis. Spravochnik poliklinicheskogo vracha = Reference Book of a Polyclinic Physician 2007;(9):43–6. (In Russ.)].