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Objective: to evaluate the efficacy and safety of Alflutop therapy in elderly patients (75–90 years old) with knee osteoarthritis (OA) and multimorbidity based on the results of a prospective 6-year follow-up.Patients and methods. The study included 38 elderly women with knee OA (according to ACR criteria, 1986) stage II–III by Kellgren–Lawrence grading system, with pain ≥40 mm by visual analogue scale (VAS), who needed to take non-steroidal anti-inflammatory drugs (NSAIDs). Alflutop was administered as 1 ml intramuscular injections 20 consecutive days with a 6-month interval (12 courses). The effectiveness of therapy was assessed by VAS, WOMAC index and EQ-5D questionnaire. The safety of therapy was monitored throughout the observation period. The duration of the study was 6 years.Results and discussion. The full course of treatment with Alflutop was completed by 29 (76.3%) patients. Nine (23.7%) patients discontinued the study due to their inability to visit the treatment center (for reasons unrelated to the study).In elderly patients with knee OA, high level of multimorbidity was revealed, 5 comorbidities on average.There was a significant decrease in pain according to VAS (≥20%): by visit (V) 1 – in 76.3%, by V2 – in 71.0%, by V3 – in 68.4%, by V4 – in 63.1% and by V5 – in 55.2% of patients. By the 21st day of Alflutop therapy, a statistically significant decrease in the total WOMAC index (pConclusion. The results of a 6-year prospective study demonstrate the high efficacy of Alflutop in elderly patients with knee OA. The obtained data confirm the safety of long-term treatment with this drug in elderly patients with high multimorbidity, which makes it the first-line drug in the complex therapy of OA.

Objective: to evaluate the efficacy and safety of Alflutop (the bioactive concentrate from small sea fish) in patients aged 75 years and older with knee osteoarthritis (OA). Patients and methods. The investigation enrolled 38 patients aged 75 years and older with knee OA (according to the American College of Rheumatology (ACR) criteria, 1986), Kellgren–Lawrence grades II–III, ≥40 mm pain visual analogue scale (VAS), who required continuous non-steroidal anti-inflammatory drug (NSAID) use. All the patients received Alflutop in the standard regimen: a 1-ml intramuscular injection daily for 20 days. The dynamics of pain during movement was assessed using the VAS scale, the WOMAC, and the EQ-5D questionnaire. Comorbidity was determined according to the Charlson comorbidity index, polypharmacy, and the safety of therapy in all the patients. The investigation duration was 8 weeks.Results and discussion. On day 21 of Alflutop therapy, there was a statistically significant reduction in pain, stiffness, and functional insufficiency according to the WOMAC index (p< 0.001) and improvements in quality of life as shown by the EQ-5D questionnaire (p< 0.001); on day 56, the number of NSAID intake days decreased (p=0.005). The findings suggest that there is a high level of comorbidity in the majority (94.7%) of patients. The mean number of drugs taken was 5.0±1.5, which indicates the presence of polypharmacy. No serious or severe adverse events were recorded.Conclusion. The results of the investigation showed the statistically significant efficacy and safety of Alflutop in patients with knee OA in the elderly group.

Osteoarthritis (OA) is the most common joint disease. Searching for new treatment methods and regimens for OA is relevant.Objective: to evaluate the efficiency and safety of therapy with a symptomatic sustained-release drug (Alflutop) in combination with intra-articular hyaluronic acid (HA) injection versus monotherapy with HA in patients with knee OA in routine clinical practice.Patients and methods. A post-registration open-labeled prospective comparative randomized study was conducted to assess the results of treatment in 76 patients (31 men and 45 women; mean age, 49.3±8.5 years; body mass index, 28.4±0.8 kg/m2 ) in two clinical centers in Yekaterinburg and Perm. The patients were randomized into two equal groups, were homogeneous in terms of gender, the frequency of comorbidities, and vital signs (blood pressure, heart rate, and respiratory rate).Group 1 patients received Alflutop as 1-ml daily intramuscular injections (a total of 20 injections) + 2 ml of 1% intraarticular (IA) HA solution injections three times at 1-week intervals; Group 2 patients were given 2 ml of 1% intraarticular HA solution injections three times at 1-week intervals. As an additional therapy, the use of meloxicam 7.5–15 mg/day was permitted, and, if non-steroidal anti-inflammatory drugs were contraindicated, paracetamol 1–3 g/day might be used.Results and discussion. During treatment, both groups of patients showed improvement (compared to the baseline levels). At the same time, evaluating the intergroup values revealed clear differences: a more pronounced decrease in all WOMAC indicators in Group 1 patients: pain scores, 2 [1; 3] vs. 4 [2; 5] in Group 2 (pConclusion. The patients receiving the combination therapy with Alflutop + HA had the best treatment results in all the parameters assessed.

Currently, with osteoarthritis (OA), numerous over-the-counter and prescription drugs are used, as well as biologically active additives (BAA). Significant market share in Russia are: chondroitin sulfate, glycosaminoglycan-peptide complex and Alflutop. The purpose of the article is to compare the clinical recommendations of the professional communities of doctors of the Russian Federation, countries of Europe, Great Britain, the USA, Canada, Australia on approaches to chondroprotective therapy/SYSADOA for osteoarthritis using the example of chondroitin sulfate, glycosamine glycan-peptide complex and Alflutop. Materials and methods : The analysis included 11 clinical recommendations (guideline) from 2008 to 2019 on the management of patients with OA. Results : The glycosaminoglycan-peptide complex (Rumalon) and Alflutop were recommended by the Russian Scientific Medical Society of Therapists (RNMOT), but are not mentioned in the recommendations of several Russian professional communities. In the European recommendations, the glycosaminoglycan-peptide complex and the drug Alflutop are not considered. Chondroitin sulfate to reduce the symptoms of OA is recommended by 5 professional guideline. With the exception of Russian recommendations, the listed professional communities recommend the use of chondroitin sulfate only as a “pharmaceutical quality drug”. Conclusion : It is advisable to agree on Russian recommendations on the use of the drugs in question. At the level of foreign and Russian professional communities, particular attention is required to analysis of data on the use of chondroitin sulfate, taking into account the quality of production, the composition of active substances and bioavailability, the quantitative content of active substances and the quality of substances. It is necessary to systematize the products with a separate assessment of the effectiveness of registered medicines, biologically active additives of pharmaceutical quality and low-quality products with minimal bioavailability.

Introduction: the article describes the most common variants of paraarticular tissue pathology (PTP) - enthesitis of the upper and lower extremities, back. The issues of enthesitis etiology, pathogenesis, clinic presentation, diagnosis, differential diagnosis are considered. The historical background, technique and mechanism of action of perifocal syringe injections are presented.Objective of the study: evaluate the clinical efficacy of perifocal syringe injection of Alflutop in patients with enthesitis of the upper and lower extremities and back.Materials and methods of the study:76 patients with shoulder joint enthesitis (30 patients), epicondylitis (10), back pain (14), trochanteritis (13), anseritis of the knee joints (9) received treatment with perifocal injections of Alflutop as a course of 5 injections with an interval of 1 injection every 2 -3 days. We evaluated general well-being, local pain at rest, during palpation and movement, range of motion. The diagnosis was established clinically, and using the results of x-ray examination, ultrasound, MRI.The results of treatment: significant outcomes in patients, which included improved well-being, reduced pain, increased range of motion. 69 of 76 patients demonstrated significant improvement and improvement - the effectiveness of therapy was 90.8% with high tolerability of the drug.

The paper discusses the etiology, pathogenesis, pathomorphology and pathophysiology of osteoarthritis of large joints from the perspective of evidencebased medicine. The processes occurring in the tissues of the joints during the development of the pathological process at various stages are described in detail; the features of diagnosis and treatment in sports medicine are described in detail. The characteristic of drugs used to treat osteoarthritis is described, with a description of the positive effect and negative effect on particular organs and systems. A preparation Alflutop was comprehensively analysed regarding its effectiveness in terms of safety and impact on the development of the pathological process. It was shown that Alflutop is a drug of choice in the treatment of joint destruction.

The article presents the results of a study of the effect of prolonged Alflutop therapy on the arthrosonographic changes in knee joints (sizes of articular cartilage, joint space width, severity of osteophytic disease, local inflammation activity) in patients with gonarthritis. The treatment was prescribed to patients in the early stages of the disease and repeated by regular courses. It was found that prolonged therapy with Alflutop slows down the articular cartilage degradation, the progression of structural changes in knee joints, the local inflammation activity (according to arthrosonography), which reduces the symptoms of osteoarthritis and improves the patient’s quality of life.

The article presents the results of a study investigating the effect of prolonged treatment with Alflutop (5-year follow-up) on the radiographic progression of knee osteoarthritis (narrowing of the height of the X-ray articular cavity, osteophytosis, worsening of the radiographic stage of the pathological process). Medication was prescribed to 64 patients (mean age of 47.4 ± 11.6 years) at the early stages of the disease and was carried out by repeated courses. The comparison group consisted of 140 patients (mean age of 46.7 ± 10.4 years). It was noted that long-term treatment with Alflutop slows the progression of structural changes of the knee, which certainly has a positive effect on symptoms of osteoarthritis, the quality of life of patients.

The main clinical manifestations of osteoarthritis (OA) are a painful articular syndrome of varying intensity accompanied by loss of functionality and impaired quality of life. The pathogenetic links of the degradation are related to violations of the hyaline cartilage structure. Collagen defects are practically not restored, worsening the dysfunction of joints. Alflutop is the cartilage protector, including chondroitin sulfate. In the literature its symptom - and the structure-modifying effect is shown. In the study we conducted in 60 patients the dynamics of painful articular syndrome, functional features and the quality of life of patients in case of complex treatment with alflutop were studied.

Objective. To assess alflutop clinical efficacy and safety during long-term course treatment of knee osteoarthritis. Methods. 51 pts with definite knee osteoarthritis of I-III stage according to Kellgren-Lawrence classification were included in an open controlled study. 20 pts received 6 intra-articular injections of alflutop 2 ml with subsequent intramuscular treatment during 3 months. Such courses were repeated 6 months apart for 2 years. 31 pts of control group received nonsteroidal anti-inflammatory drugs (NSAID) only. Pain on visual analog scale, Leken functional score, changes of NSAID treatment and radiological picture were used for assessment of efficacy. Clinical examination was performed before and after every treatment course and 3 months after the last course. Results. Every alflutop treatment course provided significant stepwise decrease of pain with improvement of mobility, reduction of NSAID requirement and absence of osteoarthritis radiological progression. Doctor and pts clinical efficacy and safety assessment coincided. Conclusion. Alflutop is an effective drug for knee osteoarthritis treatment. It has anti-inflammatory and probably chondroprotective activity with good safety.

Objective: to evaluate the symptom- and structure-modifying effect of alflutop versus placebo (PL) in patients with knee osteoarthrosis (OA).Subjects and methods. The trial enrolled 90 patients with knee OA (ACR criteria and Kellgren–Lawrence Stages II–III) and pain on walking ≥ 40 mm on a visual analogue scale (VAS) who signed their informed consent. The patients were randomly assigned to two groups: 1) 45 patients who received alflutop as 1-ml intramuscular injections for a 20-day cycle at a 6-month interval for 2 years (a total of 4 cycles during 2 years); 2) 45 patients who were given PL (isotonic sodium chloride) injections following the same pattern. As concomitant therapy ibuprofen was used in a dose of 600–1200 mg/day. The efficiency of treatment was evaluated using the OMERACT-OARSI criteria, changes in the three scales WOMAC, EQ-5D, pain and general health status (GHS) on VAS; 15-m walking time, and therapeutic efficiency assessment by the physician and patient. At the beginning and at the end of the investigation, knee joint X-ray and magnetic resonance imaging were performed and the time course of changes in the level of biochemical markers (CTX-II and COMP) was determined to evaluate the structure-modifying effect of alflutop. Adverse reactions were recorded at each visit. A Statistica 10.0 data package was used for statistical analysis.Results. At the end of the trial, the use of aflutop versus PL showed a significant pain reduction in an intent-to-treat population (p=0.003). Analysis of a per protocol population indicated that the pain reduction was more marked in the aflutop group. WOMAC showed that the differences between the groups in the absolute value of pain intensity reduction were significant. A significance stiffness reduction was seen in the alflutop group at Visit 3; no significant decrease was found in the PL group (p < 0.001). Improvements in joint function and reduction in joint WOMAC index were noted in the alflutop group after the first cycle of therapy and these remained throughout the follow-up (p = 0.001). At Visit 6, significantly better quality of life was observed only in the alflutop group (p = 0.0045). Analysis of the GHS scale revealed that the differences between the groups were significant (p = 0.03). In the alflutop and PL groups, the therapy respondents were 73 and 40%, (p = 0.001). Among the alflutop-treated patients, 79% reduced the daily dose of nonsteroidal anti-inflammatory drugs (NSAIDs) and 21% completely discontinued using them. In the PL group, only 23% needed daily lower intake of NSAIDs.Conclusion. The double-blind randomized placebo-controlled trial established the symptom-modifying effect of alflutop in patients with knee OA.

The paper presents the results of studying the impact of long-term treatment with theraflex (a 3-year follow-up) or alflutop (a 5-year follow-up) in patients with knee osteoarthosis. Both drugs have been shown to exert a positive effect on the symptoms of the disease. It has been concluded that theraflex affects more actively the pathogenic mechanisms in the progression of gonarthrosis.

Summary Aljlutup is an effective and well tolerable drug which not only decreases pains and other clinical manifestations of secondary synovitis but also has positive effect on the structure of articular cartilage.