The results of the use of hyaluronic acid «Sintesin» of various concentrations in patients with osteoarthritis of the knee joint of stage I–III in outpatient practice

   Introduction. Osteoarthritis (OA) of the knee joints is the most common joint disease affecting more than 80 % of people over 55 years of age. The priority method of treatment of knee joint OA is considered to be local injection therapy with the introduction of synovial fluid endoprostheses based on hyaluronic acid, included in the second stage of the ESCEO algorithm in 2019, as well as in the standard of specialized medical care for gonarthrosis (Order of the Ministry of Health No. 706n dated 10/27/2022). In world practice, joint fluid prostheses containing hyaluronic acid at a concentration of 10 mg/ml, 15 mg/ml, 23 mg/ml.

   The purpose of the study: to compare the effectiveness of the outpatient use of hyaluronic acid «Sintesin» 1 % - 2.0 ml, «Sintesin Plus» 1.5 % - 2.0 ml, «Sintesin Forte» 2.3 % - 3.0 ml (Bionoltra SA, Switzerland) together with the oral use of selective nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with osteoarthritis (OA) of the knee joint of stage I–III.

   Materials and methods. A comparative observational study of the efficacy and safety of injection therapy with the introduction of hyaluronic acid preparations included 120 patients with knee joint OA of the 1^st-3^rd stage who had not previously received treatment with the original drug «Sintesin» 1 % - 2.0 ml, «Sintesin Plus» 1.5 % - 2.0 ml, «Sintesin Forte» 2.3 % - 3.0 ml (Bionoltra SA, Switzerland). The selection of drugs for the treatment of patients with knee joint OA of the 1st-3rd stage was carried out in accordance with clinical recommendations for the treatment of osteoarthritis, taking into account the age and comorbidity of patients, as well as taking into account the accepted Consensus on the use of hyaluronic acid preparations (Congress of Orthobiology 2024). Celecoxib 200 mg per standard nonsteroidal anti-inflammatory drugs was selected the dosage is 200 mg / day for a period of 8 days to 1 month. Group A (30 people) – local administration of «Sintesin» 1 % - 2.0 hyaluronic acid by 3 injections into the joint – 1 time per week. Group B (30 people) – local administration of «Sintesin Plus» 1.5 % - 2.0 hyaluronic acid by 2 injections into the joint, 1 time per week. Group C (30 people) – local administration of «Sintesin Forte» 2.3 % - 3.0 – hyaluronic acid once. All patients were prescribed celecoxib 200–400 mg per day. Comparison group D (30 patients with stage I–III knee OA without synovitis) received only NSAIDs (celecoxib 200–400 mg per day). The duration of therapy with Celecoxib 200–400 mg per day in all groups ranged from 8 days to 1 month (according to indications, depending on the intensity of the pain syndrome). The total duration of follow-up was 6 months, the frequency of visits was 30, 90 and 180 days. The results were evaluated using standard examination methods., The pain level was assessed on a visual analog scale, based on the results of a patient survey, the WOMAC functional index and the Leken index were determined.

   Results. In group A (30 patients with stage I–III OA of the knee joint without synovitis, received intraarticular «Sintesin» 1 % - 2.0 3 injections into the joint – 1 time per week) – pain reduction was revealed on the 7^th day, NSAIDs were canceled on the 8^th day at stage I–II and on the 21^st a day at stage 3 (hereinafter NSAIDs – «on demand»). After 6 months, the pain in YOUR body decreased to 20–25 mm in OA of the knee joint of stage I–II and to 35–40 mm in stage III, a decrease in the Leken index after 6 months to 4 and 6–7 points, respectively. In group B (30 patients with stage I–III OA of the knee joint without synovitis, received intraarticular «Sintesin Plus» 1.5 % - 2.0 2 injections into the joint, 1 time per week) – pain reduction was revealed – NSAIDs were canceled on day 6 at stage 1–2, and on day 15 at stage 3 OA of the knee joint. Your pain decreased after 6 months to 20–25 mm in stage I–II knee joint OA and to 35–40 mm in stage III (NSAID was canceled after 14 days, then – «on demand»), a decrease in the Leken index after 6 months up to 4 and 5–6 points, respectively. In group C (30 patients with stage I–III OA of the knee joint without synovitis, received intraarticular «Synthesin Forte» 2.3 % - 3.0 once) – pain reduction was revealed on 3–4 days at stage 1–2 (NSAIDs were canceled on day 4) and on the 10^th day at stage 3 OA of the knee joint. Your pain decreased after 6 months to 15 mm in stage I–II knee joint OA and to 30 mm in stage III (NSAID was canceled after 10 days, then – «on demand»), the Leken index decreased after 6 months to 3 and 5 points, respectively. In group D (30 patients with stage I–III knee OA without synovitis, received only NSAIDs (celecoxib 200 mg per day). Pain reduction was revealed on the 10^th day (NSAID was canceled on the 11th day) at stage I–II and on the 25^th day at stage 3 (hereinafter NSAIDs – «on demand»). After 6 months, the pain in YOUR body decreased to 35 mm in OA of the knee joint of stage I–II and to 65 mm in stage III, a decrease in the Leken index after 6 months to 5–6 and 10–12 points, accordingly.

   Conclusions. 1. Preparations of hyaluronic acid «Sintesin» 1 % - 2.0, «Sintesin Plus» 1.5 % - 2.0, «Sintesin Forte» 2.3 % - 3.0 (produced by Bionoltra SA, Switzerland) – can be used as a safe and effective synovial fluid endoprosthesis in stage I–III OA of the knee joint with insufficient effect from chondroprotectors and NSAIDs. 2. It is recommended to use the identified advantages and possibilities of local injection therapy with hyaluronic acid «Sintesin» of various concentrations on an outpatient basis at all stages of knee joint OA. 3. Local injection therapy with hyaluronic acid «Sintesin» in combination with a short course of selective NSAIDs is recommended as the preferred treatment method in comparison with the appointment of only one selective NSAID.

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