Результаты неинтервенционного клинического исследования «Колибри» по оценке эффективности и безопасности применения препарата АМБЕНЕ® БИО у пациентов с первичным и вторичным остеоартритом различной локализации

Abstract

Aim: to evaluate the efficacy and safety of therapy with AMBENE® BIO (in two courses for 48 weeks with a pause of 24 weeks) in patients with osteoarthritis of large and small joints of various localization. Patients and Methods: 118 patients with the established diagnosis of gonarthrosis or hand osteoarthritis of the hands were included in the study. Patients received AMBENE® BIO 1 ml once a day for 20 days according to the patient information leaflet. In gonarthrosis, intra-articular injection 1–2 ml into the target joint with an interval of 3–4 days during a course of 5–6 injections was prescribed. The therapy was conducted in two courses; the second course was conducted 6 months after. Before and after 30±7, 210±7 and 330±14 days from the treatment initiation, a comprehensive examination of patients was performed with an assessment of the pain severity on a 100 mm visual analog scale (VAS), the WOMAC index. The primary criterion for the analysis of efficacy was the degree of control over pain on movement, assessed by the subjects with the VAS 30±7 days after the treatment initiation (after the end of the first course in 10 days) versus the baseline. Results: initially, the pain on movement was 64.7 mm. After 30±7 days from the treatment initiation, the pain decreased to 41.6 mm (p < 0.05). Among patients with gonarthrosis, there was a significant positive trend on all scales of the WOMAC index (pain, stiffness, dysfunction, general indicator), and a significant decrease in pain was recorded on a 100 mm VAS, in particular, immediately after the end of the 20-day therapy course. Evaluation results of pain, stiffness and small joints function indicated that therapy with AMBENE® BIO had a significant positive effect in patients with hand osteoarthritis. No cases of severe adverse events were recorded. Conclusions: therapy with AMBENE®BIO in patients with osteoarthritis of small and large joints allows to achieve a statistically significant reduction in the pain syndrome severity and an improvement in the functional state of the joint in most patients. AMBENE®BIO therapy is characterized by a high safety profile and good tolerability. KEYWORDS: osteoarthritis, SYSADOA, chondroprotector, gonarthrosis, hand osteoarthritis, comorbidity. FOR CITATION: Feklistov A.Yu., Vorobieva L.D., Alekseeva O.G. et al. Results of a non-interventional study "Colibri" to evaluate the efficacy and safety of AMBENE® BIO in patients with primary and secondary osteoarthritis of various localization. Russian Medical Inquiry. 2022;6(3):126–132 (in Russ.). DOI: 10.32364/2587-6821-2022-6-3-126-132.