Need For Non-steroidal Anti-inflammatory Drugs Research Articles

Complex therapy of musculoskeletal pain: the role of centrally acting muscle relaxants

Chronic pain is the main manifestation of musculoskeletal diseases (MSDs), leading to deterioration of quality of life and loss of ability to work. The importance of this problem is determined by the widespread prevalence of MSDs, osteoarthritis (OA), acute and chronic non-specific back pain (NBP), periarticular soft tissues lesions. Introduction of effective methods of treatment of musculoskeletal pain (MSP) into medical practice is one of the fundamental tasks of modern medicine.The pathogenesis of MSP includes mechanisms such as injury, inflammation, peripheral sensitization, biomechanical disorders, dysfunction of the nociceptive system and psychoemotional disorders. Painful muscle tension plays an important role in the development of MSP, especially in NBP. Given the complex pathogenesis of MSP, its treatment is based on the combined use of drugs with different mechanisms of action and nonpharmacological methods. Non-steroidal anti-inflammatory drugs (NSAIDs) have a central place in this context. However, they can cause serious adverse reactions (ARs), so when choosing NSAIDs, it is necessary to consider comorbid pathology and risk factors. One of the most acceptable NSAIDs with a pronounced analgesic effect and low incidence of ARs is aceclofenac, which is available in various dosage forms (tablets, sachets, topical cream for external use). This medication is characterized by proven efficacy and good tolerability.Centrally acting muscle relaxants (CM) play an important role in the treatment of MSP. They eliminate muscle spasm, enhance the effect of analgesics and reduce the need for NSAIDs. The effect of CM has been demonstrated in spasticity and NBP. However, the use of many drugs of this group can be associated with serious ARs, which limits their use.Tolperisone has the best combination of efficacy and favorable safety profile among CM. Its positive effect in the complex treatment of NBP has been confirmed in several well-organized, placebo-controlled trials. There are also studies demonstrating the efficacy of tolperisone in OA. An important advantage of this drug is virtually no sedative effect, and no negative impact on hemodynamics and on the ability to perform concentration-intensive work. Emergence of a new form of tolperisone – extended-release tablets (Mydocalm® Long 450 mg) – increases patient compliance with CM therapy and facilitates the physician's work.

Olokizumab in patients with inflammatory phenotype of osteoarthritis, treatment experience

Objective: to investigate the efficacy and safety of olokizumab (OKZ) in patients with knee osteoarthritis (OA) with synovitis, persistent pain and ineffectiveness of previous conservative therapy. Material and methods. The study included 15 patients with stage II–III knee OA who fulfilled the ACR criteria and had pain ≥50 mm on a visual analogue scale (VAS), synovitis and treatment failure. The age of patients ranged from 54 to 75 years; the duration of the disease was from 1 to 23 years. The duration of the study was 12 weeks, during which the patients received 3 subcutaneous injections of OKZ at a dose of 64 mg. The effectiveness of the treatment was assessed by the dynamics of pain intensity according to VAS, WOMAC and KOOS indices, the values of the DN4 questionnaire and the quality of life according to EQ-5D. In addition, the general assessment of the patient's health (GHA) according to VAS, the assessment of treatment efficacy by doctor and patient and the need for non-steroidal anti-inflammatory drugs (NSAIDs) were considered. All patients underwent laboratory testing. Results and discussion. During treatment, there was a significant decrease in pain intensity according to VAS, a statistically significant improvement in the KOOS and WOMAC indices (p<0.05), quality of life according to the EQ-5D questionnaire and GHA. Patients and doctors rated the treatment results very positively: an improvement or significant improvement was observed in 92.3% of cases. Adverse events were identified in 4 patients, which in 2 cases served as the reason for discontinuation of OKZ treatment and termination of participation in the study. During treatment with OKZ, a statistically significant decrease in CRP and ESR values, an increase in the concentration of interleukin 6 (p = 0.003), COMP (p = 0.03) and PIINP (p = 0.01) were observed. Conclusion. The results obtained suggest a significant symptomatic and anti-inflammatory effect of OKZ in patients with the inflammatory phenotype of OA.

Outcomes of combined treatment of patients with acute lumbodynia

Introduction. Acute dorsalgia is a common reason to seek outpatient medical care in Russia. The clinical picture usually includes muscular-tonic and pain syndromes. The most common form of dorsalgia by localization is acute lumbar pain (lumbodynia).Aim. To evaluate the effectiveness of Spascuprel®, Traumeel S in the complex treatment of patients with acute lumbar pain in real-world clinical practice.Materials and methods. We conducted a non-interventional, prospective, observational study of 110 outpatients aged 26 to 65 years. Patients received a standard on-demand therapy with nonsteroidal anti-inflammatory drugs (NSAIDs). In addition, Group 1 received Spascuprel® and Traumeel® C, and Group 2 received centrally acting muscle relaxants. The effectiveness of treatment was assessed using the visual analogue scale (VAS) of pain intensity and the limitations of various activities in daily living were measured using the Roland – Morris questionnaire. Consideration was given to the exacerbation duration, the need for additional intake of NSAIDs, and the number of cases of pain exacerbation within 60 days from the start of participation in the observational study.Results. Under treatment, pain intensity showed statistically significant decreases in VAS scores (from 61.0 to 35.5 scores out of 100 according to VAS by Day 7 and to 19.5 scores by Day 14 of treatment in Group 1, from 61.2 to 41.1 and to 25.8 scores in Group 2, respectively (p < 0.05)). A more rapid decrease was observed in VAS pain intensity score from baseline in Group 1. Over 2-month observation period, group 1 had less exacerbations (p < 0.05) and fewer cases of need for additional intake of NSAIDs (p < 0.05). The frequency and severity of adverse events did not differ between two groups.Conclusion. A more rapid decrease in VAS pain intensity scores and reduction in the need for NSAIDs were noted in the group of patients with acute dorsalgia who used Traumeel® C and Spascuprel® in addition to standard NSAID therapy.

Topical therapy with Meloxicam for external use (Amelotex gel) for knee osteoarthritis in elderly patients

Introduction. Treatment of osteoarthritis (OA) in elderly patients remains an urgent issue due to the high prevalence of the disease, as well as the unsafety of the used drugs (nonsteroidal anti-inflammatory drugs (NSAIDs)) and their effect on the concomitant pathology of an elderly patient. Knee joints are most often affected in OA. In the complex therapy of the disease, topical remedies (ointments, gels, and patches), which do not have pronounced side effects, are widely used. Purpose of the study: to evaluate the effectiveness of Meloxicam for external use (MEU) (Amelotex gel) in the complex treatment of knee pain in elderly patients suf fering from OA. Material and methods. 57 elderly patients with knee OA of radiological stages II–III were examined. 30 patients of the study group used MEU for two weeks, in contrast to the control group (27 patients). The pain severity index according to the VAS at rest and walking, the WOMAC index of pain and function, positive results, and the need for NSAIDs were evaluated in dynamics. Results. The positive effect of the drug on the course of the disease has been demonstrated. In the group of the patients who used MEU in the complex OA treatment, a more significant decrease in the severity of joint pain and an improvement in the joint function was achieved, compared with the control group. After two weeks of treatment, the severity of walking pain according to the VAS and the WOMAC pain index in the study group decreased by 45 % and 50 %, respectively, and in the control group — by 32 % and 34 %, respectively (p ˂ 0.05). A greater number of elderly patients were able to stop taking unsafe NSAIDs due to the use of MEU. There were no side ef fects of the use of MEU. Conclusion. Meloxicam for external use is effective in osteoarthritis of the knee joints and does not cause side ef fects.

Modern possibilities of therapy of nonspecific pain in the lower back

Aim. To evaluate the effectiveness of combination therapy for low back pain (LBP) associated with spinal osteoarthritis (OA) using the Symptomatic Slow Acting Drugs for OsteoArthritis (SYSADOA) group drug Ambene® Bio.Materials and methods. The study included 30 patients with LBP aged 40 to 65 years. Various scales and questionnaires were used to assess the patients’ condition. All patients received Ambene® Bio 2.0 ml intramuscularly every other day for a total course of 10 injections. Some patients with severe pain continued to receive previously prescribed non-steroidal anti-inflammatory drugs (NSAIDs). After completing the course of treatment with Ambene® Bio, the overall effect of the therapy, changes in individual need for NSAIDs and the presence of adverse events were assessed.Results. All patients sought medical care due to exacerbation of chronic LBP. X-ray examination of the lumbosacral spine revealed degenerative-dystrophic changes in the vertebral-motor segments of the lumbar spine in all patients and in some patients – in the sacroiliac joints. The treatment showed positive dynamics in 27 (90 %) patients in the form of pain reduction not only in the lower back but also in peripheral joints. Of the 13 patients initially receiving NSAIDs, 7 (53.8 %) reduced the daily dose of the drug, and 3 (23.1 %) were able to stop taking NSAIDs. In 3 (23.1 %) cases, the initial NSAID dosage remained unchanged. Monotherapy with Ambene® Bio was received by 17 (56.7 %) patients. All patients expressed satisfaction with the treatment, of which 18 (60 %) rated the result as “excellent”, 7 (23.4 %) as “good” and 5 (16.6 %) as “satisfactory”.Conclusion. In all patients, therapy with Ambene® Bio, both in mono mode and in in combination with NSAIDs, had a positive effect, which was expressed in the reduction of the intensity of LBP on visual analog scale, improvement of peripheral joint function. In 7 (23.3 %) patients pain reduction was observed after the second injection of the drug (“the effect of the first dose”). In other cases the pain regressed later, but also within the course of treatment. All patients showed high adherence to therapy, which was explained by the rapid onset of the effect. The results of the study allow us to recommend Ambene® Bio for the treatment of LBP associated with spinal OA and within generalized OA, including patients with comorbid conditions.

Evaluation of the impact of a course of therapy with an injectable form of chondroitin sulfate on the duration of remission and quality of life in patients with osteoarthritis

Ensuring a long-lasting effect of the therapy and its safety are important tasks in the treatment of patients with osteoarthritis (OA). Parenteral forms of chondroitin sulfate (CS) used for the background therapy of OA are characterized by proven efficacy and safety and, compared to oral forms, have greater bioavailability, faster onset of symptom-modifying effect and maintenance of more stable remission, which can significantly improve patients' quality of life.Objective: to evaluate the clinical efficacy and safety of two-month therapy with injectable CS and the duration of positive dynamics after the end of treatment in patients with knee OA (KOA).Material and methods. The open prospective observational study involved 35 patients (mainly women) aged 50–75 years with stage II–III KOA. All patients were prescribed intramuscular therapy with a CS solution (Mucosat® solution), with the first three injections of 1 ml, followed by 2 ml every second day (25 injections in total). Standard indices and questionnaires were used to assess the main clinical indicators at baseline and over time (14, 30, 60 days, 5 and 8 months after the start of treatment), as well as the results of ultrasound examination of the knee at baseline and at the end of treatment.Results and discussion. 14 days after the start of therapy, a statistically significant decrease in pain was observed applying the visual analogue scale (VAS), and after 2 months, 94% of patients had a significant decrease in knee pain according to VAS, Lequesne index and WOMAC index (total score and components). The KOOS parameters and quality of life according to EQ-5D-3L improved significantly. There was no pain or only minor pain (VAS ≤40 mm) in 54% of patients. The number of patients who had to take nonsteroidal anti-inflammatory drugs (NSAIDs) constantly fell threefold, while occasional use fell fivefold. The thickness of the synovial membrane of the knee joint and the number of patients with signs of synovitis decreased significantly. At 3 and 6 months after the end of therapy, most patients (60%) still had minor pain (≤40 mm according to VAS) and a significantly lower need for NSAIDs compared to baseline. The injectable CS was well tolerated and no adverse drug events were noted.Conclusion. We demonstrated both safety and efficacy and long-term maintenance of the clinical effect (6 months after the end of therapy) of injectable CS in the majority of OA patients, against the background of a low need for NSAIDs.

Substantiation of the method of local deep hypothermia for the relief of synovitis of the knee joint in patients with osteoarthritis

BACKGROUND: In patients with osteoarthritis, the long course of synovitis changes the nature of the inflammatory process, it becomes more resistant and resistant to a number of therapeutic techniques. In the arsenal of a practicing doctor, there are no reliable and affordable therapeutic methods that reliably provide relief of synovitis in the knee joint and objectively monitor the effectiveness of the therapy. Among the numerous methods of application in the treatment of diseases and injuries of the musculoskeletal system, low-molecular technologies with anti-inflammatory and analgesic effects are distinguished. One of these methods is local deep hypothermia.
 AIM: To substantiate the use of different low-temperature modes of local deep hypothermia in patients with knee osteoarthritis aggravated by synovitis, to study clinical efficacy and safety.
 MATERIALS AND METHODS: The study included 90 patients with osteoarthritis of the knee joints, burdened with synovitis. To determine the therapeutic parameters of local deep hypothermia, all patients were divided into three groups of 30 people. The effectiveness of the performed local deep hypothermia was assessed by the dynamics of the algofunctional Leken index, the intensity of joint pain on a 100-point Visual Analogue Scale (VAS) in millimeters and a decrease in the need for nonsteroidal anti-inflammatory drugs (NSAIDs).
 RESULTS: Technical and clinical parameters have been developed for carrying out the local deep hypothermia technique: area, cooling depth, rate of heat removal from the joint, duration of reproduction and number of procedures. Against the background of the performed local deep hypothermia, patients in three groups showed significant positive dynamics on the VAS and algofunctional Leken index, and in all three groups the difference between the initial and final values of these parameters was statistically significant (p 0.001). The use of local deep hypothermia allowed a significant part of patients to refuse to take NSAIDs, or to reduce the need to 50 mg and take episodically according to need. In our study, we did not record a recurrence of synovitis in all three groups during the first 3 months, which was 100%. After 12 months, the duration of remission in group I was 10.0%, in group II patients 73.3% and in group III patients 86.6%.
 CONCLUSION: Local deep hypothermia improves the effectiveness of synovitis treatment and can be recommended as an independent method for the treatment of patients with osteoarthritis of the knee aggravated by synovitis. The recommended local deep hypothermia exposure is 90 min, which allows for the longest period of remission of synovitis in the knee joint.

Multicenter Longitudinal Observational Study Pharmaceuticals Alflutop in Russia (message 2)

Osteoarthritis (OA) is one of the most important medical and social problems due to the steady increase in morbidity and disability. Prevention, management of risk factors, and early treatment of OA are critical.Objective of the ISKRA study was to evaluate the efficacy of Alflutop in patients with OA of different locations and/or low back pain (LBP) with or without concomitant diseases.Material and methods. We selected 11,136 patients with OA of specific localizations aged 50 to 72 years. The duration of the study ranged from 20 to 31 days, and the number of visits was 2 (B1 and B2). Alflutop was prescribed 1 ml intramuscularly (IM) daily No. 20 or 2 ml IM every other day No. 10.The efficacy of therapy was determined by the time of onset of clinical effect (pain reduction, as assessed by the patient), the dynamics of pain intensity in the studied joint during movement and/or LBP according to the visual analogue scale (VAS), the assessment of quality of life according to the EQ-5D questionnaire and the patient's general health status (PGH) according to VAS. We assessed treatment adherence, need for nonsteroidal anti-inflammatory drugs (NSAIDs), satisfaction with treatment (based on VAS). The presence of comorbidities was also considered.Results and discussion. In hand OA (n=2776), a positive effect of therapy was observed in 98.6% of cases, according to patients' assessment. During the course of therapy, there was a significant decrease in pain on movement in the hands (according to VAS), improvement in PGH and quality of life (according to EQ-5D). Rapid development of the analgesic effect was seen on average at day 9.In hip OA (n=6666), a decrease in pain was noted in 83.3% of cases (<40 mm), improvement in PGH and quality of life in most patients, and a decrease in the need for NSAIDs in 64.9%.In the generalized form of OA (n=1694), significant clinical improvement was achieved in 97.1% of patients. A pain reduction ≥50% from baseline was noted in nearly 65% of cases.Elderly age, more severe radiographic manifestations of OA, low quality of life and compliance, and concomitant diseases were associated with a lower effect of therapy in hand and hip OA. In hand OA, high pain scores and worse PGH VAS scores also played a role. In hip OA, lower success was observed more often in women, and in hand OA — in men.In the generalized form of OA, lower satisfaction with pain management was associated with age, female sex, high body mass index, long history of OA, advanced radiographic stages, poorer quality of life and compliance, and comorbidity.Conclusion. The results of the use of Alflutop in hand and hip OA and generalized form of OA suggest the usefulness of its wide application in real clinical practice. Consideration and correction of the factors associated with less pronounced analgesic effect of the drug will improve the effectiveness of OA therapy.

Outcomes of the use of the glycosaminoglycan-peptide complex as monotherapy and in combination with diacerein for the treatment of knee osteoarthritis in real-world practice

Background. Slow-acting symptomatic agents (chondroprotectors) in osteoarthritis (OA) combined therapy is a promising approach.
 Aim. To compare the real-world results of combined therapy with glycosaminoglycan-peptide complex (GPC) and diacerein with GPC monotherapy in treating knee OA.
 Materials and methods. Statistical analysis of the data obtained during the observational, non-interventional study was conducted. The study group included 9190 patients with OA, 69.0% females, age 60.911.4, with moderate/severe pain (4 using a 010 numerical rating scale). Of these, 6199 received a combination of GPC (Rumalon, at least 20 intramuscular injections per course) + diacerein (Diaflex Rompharm) 100 mg/day, and 2991 patients received GPC monotherapy. The following indicators were evaluated: the change of pain during movement, at rest, and at night, the overall health assessment (using a 010 numerical rating scale), the number of patients with a pain reduction of 50% from the baseline, the patient's assessment of the treatment result using a 05 scale, a decrease in the need for non-steroidal anti-inflammatory drugs 2 months after the start of therapy.
 Results. The improvement of clinical indicators was more significant in patients who received a combination of GPC + diacerein, compared with GPC monotherapy: the decrease in pain during movement was 3.11.5 and 2.61.3, at rest 1 [0; 2] and 1 [0; 1], at night 2 [1; 4] and 2 [1; 3], the overall health assessment was 3.71.7 and 3.21.8, respectively (for all indicators p0.001). The percentage of patients with a 50% reduction in pain was 66.0 and 60.0% (p0.001), the assessment of treatment results was "good" or "excellent" in 62.1 and 42.9% (p0.001), a decrease in the need for non-steroidal anti-inflammatory drugs was reported in 60.9 and 57.1% (p=0.001) of patients, respectively.
 Conclusion. The therapeutic effect of the combination of GPC + diacerein in patients with OA is significantly higher than that of GPC monotherapy.

Alflutop Russian longitudinal multicentre observational study: preliminary results (message 1)

Evaluation of the effect of new drugs should be carried out in randomized controlled trials (RCTs), and observational studies (OSs) are carried out to confirm and refine the results obtained in RCTs, for example, to study the effectiveness of drugs in large groups of patients who were not included in RCTs or had comorbidities or older age.Objective: to evaluate the effectiveness of Alflutop (AF) via OS of patients with osteoarthritis (OA) of the knee and/or hip joints and/or low back pain (LBP) with or without comorbid diseases.Material and methods. A multicenter prospective cohort OS was conducted in 163 clinical centers in 58 cities of the Russian Federation and included 22,525 patients with OA and LBP who received AF as a part of a planned treatment prescribed by a doctor, or self-prescribed and purchased in a pharmacy. Pain, satisfaction with therapy, health assessment, need for non-steroidal anti-inflammatory drugs (NSAIDs), and quality of life were recorded using the EQ-5D questionnaire.Results and discussion. After one treatment course with AF, improvement was detected in 98% of cases, there was a rapid positive trend with a significant decrease in pain, the median time to clinical effect was 8 [5; 10] days. Assessment of general health status and satisfaction with therapy improved significantly. In 94.5% of patients, the daily requirement for NSAIDs decreased.Conclusion. The first results from the OS confirm the symptomatic effect of AF.

Comparative evaluation of the efficacy and safety of intra-articular administration of hyaluronic acid and glucocorticoids in the complex therapy of osteoarthritis

Improving the treatment of knee (KN) osteoarthritis (OA) remains an urgent problem.Objective: to compare the efficacy and tolerability of intra-articular (i/a) administration of long-acting glucocorticoids (GCs) and Armaviscon®Forte and Armaviscon®Platinum hyaluronates in patients with knee OA.Material and methods. From November 2019 to April 2022, we examined and treated 60 patients (26 men and 34 women, mean age 41.32±3.71 years) suffering from primary KN OA. Study participants were randomly divided into three groups of 20 patients each. In the 1st group, a longacting GCs in combination with a local anesthetic was administered once i/a into the KN, in the 2nd – Armaviscon®Forte 2.3%, and in the 3rd – Armaviscon®Platinum 3%.Patients were examined at baseline, on the 14th and 60th day after a single injection of the drug. The intensity of pain was assessed on a visual analog scale (VAS), the Lequesne index, the KOOS, WOMAC, and EQ-5D questionnaires were used. When studying tolerability, the number of adverse reactions (ARs) was taken into account.Results. By the end of the observation period in the study groups, there was a decrease in the severity of pain and an increase in functionality with positive dynamics of the Lequesne and WOMAC indices. Both hyaluronic acid drugs had a positive effect on the functional state of the joints according to KOOS, improved the quality of life according to EQ-5D. The need for non-steroidal anti-inflammatory drugs in patients of the 2nd and 3rd groups decreased down to their complete cancellation. No adverse events requiring discontinuation of therapy have been reported. The advantage of i/a administration of hyaluronates in comparison with long-acting GCs was shown.Conclusion. In real clinical practice, in patients with symptomatic OA, i/a administration of hyaluronates allows obtaining more favorable results than the use of long-acting HA.

ЭФФЕКТИВНОСТЬ И БЕЗОПАСНОСТЬ СОЧЕТАННОГО ПРИМЕНЕНИЯ ПЕПТИДНОГО КОМПЛЕКСА И ДИАЦЕРЕИНА ПРИ ОСТЕОАРТРИТЕ КОЛЕННОГО СУСТАВА

As part of a prospective study, it was evaluated the efficacy and safety of the combined use of drugs from the group of symptomatic slow acting agents (SYSADOA): Diacerein and glycosaminoglycan peptide complex (GPC) in patients with knee osteoarthritis. The dynamics of pain according to Visual Analoguе Scale (VAS), need for non-steroidal anti-inflammatory drugs, the WOMAC index, EQ-5D score, and OMERACT-OARSI criterion, the presence of adverse events were analyzed, and the effect of Diacerein on the components of the metabolic syndrome was assessed. It was shown that the concomitant use of GPC and Diacerein demonstrated high efficiency and equivalent safety in comparison with the isolated use of GPC: a decrease in the pain intensity in the early stages of therapy, a decrease in the need for NSAIDs, a tendency to improve lipid and purine metabolism.

Місцеве застосування Мускомеду в лікуванні пацієнтів з остеоартрозом колінного суглоба

У статті наведені дані літератури та результати власного спостереження щодо ефективності та безпечності препарату Мускомед крем у лікуванні пацієнтів з остеоартрозом колінного суглоба. У дослідження включили 20 жінок (середній вік — 62 роки). Дизайн дослідження включав клініко-рентгенологічне обстеження хворих та анкетування за допомогою опитувальника WOMAC та візуально-аналогової шкали на початку лікування, через 7 та 14 діб застосування Мускомед крему. Мускомед крем застосовувався місцево як компонент фізіотерапевтичних процедур у складі комплексного консервативного лікування. Після завершення курсу лікування відмічалося вірогідне зменшення інтенсивності больового синдрому та зниження сумарного індексу WOMAC в пацієнтів із місцевим застосуванням Мускомед крему. Також спостерігалося більш виражене зменшення потреби в нестероїдних протизапальних препаратах у пацієнтів основної групи. Була продемонстрована безпечність та ефективність препарату Мускомед крем у лікуванні пацієнтів з остеоартрозом колінних суглобів, що проявлялося зменшенням вираженості больового синдрому та поліпшенням функціональної активності таких пацієнтів.

Treatment of knee joint osteoarthritis in overweight women in outpatient practice

Objectives: evaluation of the clinical efficacy and safety of the healthy joints maintaining compound Artroflex®in knee osteoarthritis (OA) in postmenopausal overweight women in outpatient clinical practice.Patients and methods. An open, prospective observational single-center post-marketing study included 30 postmenopausal women 50–75 years old (mean age 62.3±6.3 years) with knee OA. Patient body mass index (BMI) was >25 (mean body weight 85.3±15.3 kg). Radiographically confirmed primary gonarthrosis stage II according to Kellgren–Lawrence was detected in 26 (87.0%) patients, stage III – in 4 (13.0%). The duration of knee OA ranged from 1 to 21 years (average 7.8±6.1 years).Artroflex®was prescribed 1 capsule 2 times a day for 3 months. During three visits (baseline, after 1 and 3 months), the need for analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) and the occurrence of adverse reactions (AR) were determined. Health status and pain level were also assessed using a visual analogue scale (VAS), the severity of pain and stiffness, limited function according to the WOMAC questionnaire, fatigue/fatigue according to the FACIT scale, the Charlson comorbidity index, satisfaction of the doctor with the results of treatment using the IMOS scale, and satisfaction of the patient with using the IMPSS scale.Results and discussion. A statistically significant decrease in the pain score according to the VAS, an improvement in health status, and the WOMAC index were found in the overwhelming number of patients, regardless of BMI. 90% of women noted decrease in fatigue/fatigue on the FACIT scale, and 93% of patients reported satisfaction with treatment, regardless of the Charlson comorbidity index. The need for NSAIDs after one month of use of the Artroflex®compound decreased by 7%, after 3 months – by 23%. A negative feedback was found between the baseline indicator of health status and the assessment of the effectiveness of therapy. No serious ARs were identified during the study.Conclusion. Feasibility of using the Artroflex®compound in real clinical practice in patients with knee OA and excessive body mass has been shown.

Therapeutic niche of hyaluronic acid derivatives in osteoarthritis

Osteoarthritis (OA) is a widespread disease of synovial joints, the treatment of which determines a significant number of tactical and strategic directions. Currently, there is experience in the local use of so-called synovial fluid (SF) prostheses, which are viscoelastic substances that improve the cushioning properties of the native intra-articular environment. The overwhelming majority of viscoelastic additives are represented by hyaluronic acid (HA) derivatives, a natural component of SF, whose biological role consists in maintaining the rheological properties of fluid and the presence of anti-inflammatory, anti-nociceptive and chondro-protective properties. In the development of HA drugs, the main goals are the sustained and controlled release of therapeutic doses of the drug, taking into account the choice of carrier, drug molecule and target articular tissue. Assessing the quality and physiological feasibility of introducing a particular viscoelastic drug into the joint involves determining the so-called crossover frequency - the point of intersection of the viscosity modulus G’ and the elastic modulus G” (G’/G”), which reflects changes in the viscoelastic properties of the SF with increasing load frequency when transitioning from walking to running. Physiological range of frequencies out of the majority of investigated medical products corresponds to a single one, among which there are also variants of domestic production. Numerous studies of local application of some HA drugs in patients with OA confirm their effectiveness and safety, in particular, reduction of pain syndrome, reduction of the need for nonsteroidal anti-inflammatory drugs, improvement of the quality of life. However, unfortunately, most HA drugs available on the market have not undergone full-fledged clinical trials, so there is a need to study the comparative effectiveness of drugs of this group approved for use and determine their place in the treatment of OA with different variants of the course.

The efficacy and safety of glycosaminoglycan-peptide complex in patients with knee osteoarthritis and comorbidity: a multicenter prospective study

Objective: to evaluate the efficacy and safety of glycosaminoglycan-peptide complex (GPC, Rumalon) used in patients with knee osteoarthritis (OA) and comorbidities (hypertension and/or type 2 diabetes mellitus (T2DM).Patients and methods: A 10-month multicenter (13 centers from 10 subjects of the Russian Federation) prospective study included 179 patients with Stages II–III primary tibiofemoral knee OA and comorbidity, a walking pain intensity of ≥40 mm on a visual analogue scale (VAS), and a need for nonsteroidal anti-inflammatory drugs (for at least 30 days in the previous 3 months). The efficiency of treatment was evaluated from the changes in VAS scores for knee pain intensity during walking, the overall WOMAC score and scores of its individual indicators, laboratory parameters, and ultrasound data. All the patients received 2 cycles of GPC treatment with 25 injections, by following the manufacturer's instructions.Results and discussion. Even at 2 months after starting the treatment, there was a statistically significant reduction in pain during walking from 60 (50–69) to 40 (27–53.5) mm on the VAS (p< 0.05), which persisted during the follow-up period. A similar pattern was found when assessing the WOMAC index and its components. The drug demonstrated an anti-inflammatory effect: a decrease in the number of patients with synovitis from 55.7 to 39.2% (p=0.02), the level of high-sensitivity C-reactive protein (hsCRP) from 3.2 (1.3–6.2) to 2.6 (1.2–5.7) mg/l (p< 0.05). GPC was ascertained to have a safety profile.Conclusion. The data of this study confirm the good therapeutic effect and safety of GPC Rumalon in knee OA patients with hypertension and/or T2DM. The drug is shown to have a rapid analgesic and anti-inflammatory effect, as well as a positive influence on all clinical manifestations of OA.

Комбинированная терапия гиалуронатом натрия и хондроитина сульфатом при остеоартрите коленного сустава

Study Objective: To assess the efficiency and safety of intraarticular combination therapy with sodium hyaluronate and chondroitin sulfate (Hyalurom СS) in patients with knee osteoarthritis (OS). Materials and Methods. The 6-month study enrolled 79 patients with primary knee OA stage II–III (Kellgren и Lawrence), with pain intensity of at least 40 mm, using a visual analogue scale. Mean age was 60.3 ± 8.7 years; mean body mass index was 29.2 ± 4.7 kg/m2, and duration of disease of 6 (3–10) years. Therapy efficiency and safety were assessed on the basis of pain dynamics, constrained movements, joint functionality, patient health, quality of life, and daily need in non-steroidal anti-inflammatory drugs. Study Results. Initial pain was 62 (55–72) mm. After intraarticular injection of the drug, knee pain was statistically less severe, and in a week, it was 41 (32–51) mm, in a month — 28 (20–42) mm, in 3 months — 22 (14–37) mm, and in 6 months — 20 (14–42) mm (р < 0.0001). The same pattern was identified when the total knee functionality points were determined: 1,125 (899–1540) mm — initial value, 821 (556–1119) mm — in a week, 627 (401–874) mm — in a month, 554 (310–750) mm — in 3 months, and 552 (309–837) mm — in 6 months of follow-up (p < 0.0001). The same pattern was true for the assessment of all components of the index. Pain: 268 (189–312) mm, 161 (91–206) mm, 121 (63–165) mm, 102 (48–163) mm, 91 (48–171) mm, respectively (p < 0.0001); constrained movements: 101 (59–130) mm, 66 (30–92) mm, 51 (24-68) mm, 41 (18-60) mm, 40 (20-61) mm, respectively (p < 0.0001); impaired functionality: 802 (647–1095) mm, 587 (405-798) mm, 457 (277-683) mm, 396 (220-586) mm, 402 (191-638) mm, respectively (p < 0.0001). Statistically significant improvement in the quality of life and overall health condition was noted throughout the entire follow-up period: 0.52 (-0.02–0.59) mm and 0.69 (0.59–0.80) mm, р < 0.0001; 48 (30–60) mm and 72 (60–80) mm, р < 0.0001. The therapy led to reduction in the need for non-steroidal anti-inflammatory drugs: in a week, they were discontinued by 39.2% of patients; in a month — by 72.2% of patients, in 3 months — 73.4%, and in 6 months — 54.4% of patients. When the therapy efficiency was assessed by the patient and physician, “significant improvement” and “improvement” were recorded in a majority of cases. Adverse events associated with increased pain and/or swollen knee were noted in 8 (10.1%) patients. Conclusion. The results show good long-term effect from Hyalurom СS therapy. We recorded statistically significant reduction in pain, less constrained movements, rarer need in non-steroidal anti-inflammatory drugs, improved quality of life and joint functionality. The drug possesses a good safety profile and can be recommended for wide clinical application. Keywords: knee osteoarthritis, hyaluronic acid, chondroitin sulfate.

Evaluation of the efficacy and safety of a combination of chondroitin sulfate and glucosamine sulfate for knee and hip osteoarthritis in real clinical practice

A combination of chondroitin and glucosamine is widely used in clinical practice as both a symptomatic and structure-modifying agent for the treatment of osteoarthritis (OA). The emergence of new drugs based on this combination substantially expands treatment options for OA therapy.Objective: to evaluate the efficacy and safety of Artroflex® that is a combination of chondroitin sulfate 400 mg and glucosamine sulfate 500 mg (CS + GS) to support joint health in patients with knee and/or hip OA.Patients and methods. When implementing an open observational research program, the results of using the CS + GS complex were assessed in 644 OA patients (74.7% women) (mean age, 58.0±14.6 years) who experienced moderate/severe pain and required to continuously take non-steroidal anti-inflammatory drugs (NSAIDs). The CS + GS complex was prescribed in a dose of 2 capsules per day for 3 months. The investigators estimated changes in pain on movement by a 0 to 10 verbal pain scale, general health (GH) by a 0–10 visual analogue scale), the Lequesne index, the need for NSAIDs, and patient satisfaction with treatment and its tolerance.Results and discussion. After 3-month therapy, there were decreases in pain intensity by 49.2±16.8%, GH scores by 45.6±18.1%, the Lequesne index from 9.0 [6.0; 13.0] to 5.0 [3.0; 9.0]; less than half (45.2%) of the patients still needed for NSAIDs. 82.2% of patients were satisfied or completely satisfied with treatment results; 89.6% reported good treatment tolerance.Adverse events (apparently associated with NSAID use) were recorded in 2.2% of cases. There were no serious complications that required CS + GS treatment discontinuation or hospitalization.Conclusion. The findings have indicated that Artroflex® used to support joint health is an effective agent that controls OA symptoms and has a good safety level.

Experience with chondroitin sulfate in the combination therapy of lower back pain

Standard treatment for lower back pain (LBP) includes the use of nonsteroidal anti-inflammatory drugs (NSAIDs). Objective : to determine the magnitude of the effect of injectable chondroitin sulfate (CS) as part of combination therapy for LBP on the intensity of pain syndrome. Patients and methods . The investigation was conducted in August 2019 to February 2020. A total of 60 patients (23 men and 37 women) aged 36 to 66 years (mean age, 48.65±8.72 years) with non-specific LBP were followed up. The patients were divided into two equal groups. A study group (n=30) took a NSAID (meloxicam) 7.5 mg twice daily for 7—10 days and intramuscular (i.m.) CS every other day in accordance with the scheme: the first three injections at a dose of 1 ml (100 mg) on days 1, 3, and 5; if this was well tolerable, a dose of 2 ml (200 mg) from the 4th injection (on day 7). A control group (n=30) used meloxicam 7.5 mg twice daily for 7—10 days. Changes in the patients' status were evaluated at baseline and 10, 20, and 50 days after therapy. The authors used a numerical rating scale (NRS) to determine the intensity of pain (at rest, during walking, during palpation), as well as the Oswestry functional status scale (OFSS). Adverse events (AEs) were evaluated. Results and discussion . In the study group, there was a decreased need for NSAIDs on day 7 of therapy, whereas in the control group, there were no dosage regimen changes through the treatment cycle. The intensity of pain syndrome according to the NRS decreased by 89.8% in the study group and by 68.3% in the control group; that according to OFSS reduced by 95.5% in the study group and by 86.6% in the control group (p<0.05). The use of i.m. CS injections in the combination therapy of LBP increases the efficiency of treatment, can reduce the dose of NSAIDs and improve the functional capabilities of the patients with pain syndrome. The safety of CS was confirmed by the absence of AEs throughout the follow-up period. Conclusion . The investigation has demonstrated that the use of i.m. CS injections in the combination therapy of LBP can improve treatment outcomes.

Evaluation of the efficacy and safety of injectable glycosaminoglycan-peptide complex (GPC) in patients with osteoarthritis: a multicenter observational study GLADIOLUS (GPC in the treatment of osteoarthritis: a follow-up study of pain relief and local symptom reduction)

Glycosaminoglycan-peptide complex (GPC) is a popular injectable extended-release symptomatic agent (ERSA) in Russia for the treatment of osteoarthritis (OA). To date, no large-scale studies of GPC used in real clinical practice have been conducted in our country.Objective: to evaluate the efficacy and safety of GPC in the treatment of OA in real clinical practice.Patients and methods. A multicenter observational non-interventional study was performed to evaluate the efficacy of GPC (Rumalon® , a cycle of intramuscular injections thrice weekly; a total of 25 injections). A study group consisted of 2,955 patients (75.4% female) aged 61.4±11.8 years) with knee and hip OA, and generalized OA (GOA) with the previous inefficacy of oral ERSAs, moderate/severe pain, and the need for regular use of nonsteroidal anti-inflammatory drugs (NSAIDs). 414 (14%) patients received a GPC and diacerein combination 100 mg/day. The investigators assessed the dynamics of pain during movement and at rest, functional disorders (on a numeric rating scale (NRS) of 0–10), as well as the need for NSAIDs at 12 weeks after starting the GPC cycle.Results and discussion. 98.5% of the patients completed their GPC treatment cycle. The therapy decreased the intensity of pain at rest from 4 [3; 5] to 1 [0; 2] and during movement from 6 [5; 7] to 2 [1; 3] and reduced the severity of functional disorders from 5 [4; 6] to 1 [0; 3]. The number of patients with a good response to therapy (a≥50% decrease in symptom severity) for pain at rest and during movement was 55.6 and 53.5%, respectively; and for functional disorders was 50.8%. 68.1% of patients stopped taking NSAIDs. The GPC and diacerein combination was more effective than GPC monotherapy: the number of patients with a ≥50% decrease in movement pain was 62.8 and 54.3%, respectively (p <0.001). GPC was well tolerated. During treatment, there were skin allergic reactions (0.3%), moderate injection-site pain (0.37%), and adverse reactions (ARs) related to the gastrointestinal tract (8%) and cardiovascular system (6%) (which were likely to be caused by NSAIDs). There were no serious ARs that were life-threatening and required hospitalization.Conclusion. GPC allows successful control of the main symptoms of knee and hip OA and GOA, by reducing pain, and those of functional disorders, and the need for NSAIDs. The GPC and diacerein combination is more effective than GPC monotherapy. GPC therapy is well tolerated and very rarely causes ARs.