НОВОЕ НАПРАВЛЕНИЕ ЛОКАЛЬНОГО ЛЕЧЕНИЯ ОСТЕОАРТРОЗА КОЛЕННЫХ СУСТАВОВ

Abstract

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.