Osteoarthritis problem
The problem of osteoarthritis in the Russian Federation is one of the most pressing, occupying a leading position among all diseases of the musculoskeletal system in terms of prevalence.
Epidemiological studies conducted over the past 3-5 years show that verified osteoarthritis by clinical and radiological manifestations is present in no less than 13% of the population of various ages, and its prevalence increases significantly in the elderly. This disease negatively affects performance, social activity, and self-care at home, significantly worsening the quality of life. Previously, osteoarthritis was called a degenerative disease; now, according to leading experts, it is a chronic inflammatory process that affects not only cartilage tissue, but also the joint capsule, tendons, ligaments, and subchondral bone. Of particular interest is damage to the shoulder joints, and it should be noted that the opinion on the etiopathogenesis and clinical manifestations of this pathology is ambiguous.
Currently, the definition of “humeroscapular periarthritis” is not used; in our study, in accordance with the modern classification, patients with the following nosology related to periarticular lesions of the shoulder joints were included:
- Tendinitis of the rotator cuff muscles and bicipital tendinitis M 75.2 ;
- Calcific tendinitis M 75.3 ;
- Subacromial (impigment) collision syndrome M 75.1 ;
- Retractile capsulitis M 75.0 ;
Purpose of the study: to evaluate the effectiveness, safety and tolerability of the drugs “Artradol” and “Artracam” in patients with periarticular lesions of the shoulder joints (humeral periarthritis).
Materials and methods: the study included 120 patients with periarticular lesions of the shoulder joints, namely:
- Rotator cuff tendinitis and bicipital tendinitis – 34 people
- Calcific tendinitis – 38 people
- Subacromial (impigment) impingement syndrome – 27 people
- Retractile capsulitis – 21 people
We observed over time 47 (39.17%) men and 73 (60.83%) women, whose average age was 54.5 ± 8.37 years in the range from 45 to 75 years. There were 32 (26.66%) working in observation groups. There are 11 (9.17%) unemployed people of working age, 77 (64.17%) pensioners.
In the first (control) observation group, no chondroprotective drugs were prescribed, including Artradol and Artracam.
In the second group, every other day Artradol was administered intramuscularly, the dry substance was dissolved in 1 ml of water for injection. The first three injections contained a dose of 0.1 g, starting with the fourth injection, the dose increased to 0.2 g.
In the third group, Artracam was prescribed as a chondroprotector; the contents of one sachet were dissolved by patients in 200 ml of water and taken orally once a day for 6 weeks.
In the fourth group, a combined prescription of “Artradol” and “Artracam” was carried out according to the scheme of alternating intramuscular administration of “Artradol” 0.2 mg and “Artracam” 1 sachet orally every other day.
In the study, 35 0.1 mg ampoules of Artradol and 20 sachets of Artracam were prescribed per course of treatment per patient.
The study included patients with periarticular lesions of the shoulder joints (diagnosis of glenohumeral periartitis according to the ACR criteria of 1987). They had radiographic stage II or III of osteoarthritis of the acromioclavicular joint according to Kellgren-Lawrence. All patients signed informed consent.
The initial exclusion criteria were patients with secondary gonarthrosis, infectious arthritis, systemic inflammatory diseases, gout, pseudogout, Paget's disease, intra-articular fractures, ochranosis, acromegaly, hemochromatosis, Wilson's disease, primary chondromatosis, chondrocalcinosis, concomitant severe diseases (uncontrolled arterial hypertension, unstable angina pectoris, cardiovascular failure, diabetes mellitus type 1. Severe liver and kidney diseases), with a stomach or duodenal ulcer within the last month, with bleeding or a tendency to bleeding, with a history of thrombophlebitis, pregnancy, lactation, as well as body mass index more than 40 kg/m2. Also, individuals included in the study were not required to undergo intra-articular injections of any drugs within 6 weeks before the start of the study. Patients with known hypersensitivity to chondroitin sulfate or glucosamine sulfate were excluded.
The observed patients had a pronounced need to take non-steroidal anti-inflammatory drugs (NSAIDs) (within 30 days over the last 3 months). At the beginning of the study, NSAIDs were not discontinued; patients continued taking this group of drugs in accordance with the individual presence of contraindications, followed by a dose reduction or discontinuation of NSAIDs based on their well-being. So, they took: Nimesulide in a daily dose of 200 mg in the form of sachets or Nise tablets, Ketoprofen intramuscularly 100 mg or 2 capsules (200 mg) per day, Meloxicam tablets or injections 15 mg per day, Ibuprofen 1200 mg-2400 mg in capsules per day, Airtal 1 tablet 2 times a day or 1 sachet 2 times a day, Naysilat 600 mg 2 times a day in the form of tablets, strictly 1 hour before meals, Ibuklin 1 tablet 3 times a day before meals or 2-3 hours after food without chewing.
Assessing the need for NSAIDs, we emphasize that 97.5% of the patients included in the study took NSAIDs regularly. As mentioned above, the personalized selection of NSAIDs was controlled, taking into account contraindications and predicted unwanted side effects. The optimal dose of NSAIDs was selected, since in more than 13.33% it was unreasonably overestimated or underestimated.
During the therapy period, intra-articular injections of glucocorticoids, hyaluronic acid preparations and any other drugs were not performed. Also excluded from the list of prescriptions were drugs that have chondroprotective properties, such as anticoagulants, antiplatelet agents, fibrinolytics, and physiotherapy procedures were not performed.
Patients included in the study suffered from comorbid diseases. We identified 58 patients with verified nosologies, which accounted for 48.3% of all examined. Note that hypertension was diagnosed in 51 (42.5%), spondyloarthrosis of the thoracic and lumbosacral spine - in 29 (24.2%), atherosclerosis - in 21 (17.5%), discirculatory encephalopathy 2 - in 4 (3.3%), coronary heart disease – in 3 (2.5%), chronic obstructive bronchitis – 2 (1.6%), chronic cholecystitis outside the acute stage – 2 (1.6%), duodenal ulcer (history of exacerbations 1 and 2 years ago, respectively) - 2 (1.6%), chronic pyelonephritis, chronic renal failure stage I - 1 (0.8%), type 2 diabetes mellitus in the compensated stage - 1 (0. 8%). In 62 patients, comorbid conditions were not diagnosed, which amounted to 51.6%.
Patients were prescribed supportive pharmacotherapy for concomitant pathology: diuretics in combination with ACE inhibitors, as well as beta-blockers for the treatment of hypertension, NSAIDs and chondroprotectors for the treatment of spondyloarthrosis, statins for the correction of dyslipidemia, nootropics for patients with dyscirculatory encephalopathy, choleretic drugs and hepatoprotectors - for patients with chronic cholecystitis, proton pump inhibitors - for patients with peptic ulcer disease. Treatment of comorbid conditions was coordinated with specialists in the profile of concomitant pathology.
In the observed patients, initially, using a visual analog scale (VAS, mm), pain at night in bed, pain while sitting or lying down, pain in an upright position, pain when moving the upper limbs (active and passive) and pain on palpation were determined.
Table 1 Initial parameters of pain syndrome in observed patients (n=120)
Characteristics of pain syndrome | YOUR, mm |
Pain in bed at night | 41,5±3,82 |
Pain while sitting and lying down | 43,2±4,03 |
Pain in an upright position | 45,4±4,12 |
Pain with active movements of the upper limbs | 46,3±4,67 |
Pain with passive movements of the upper limbs | 49,7±5,11 |
Pain on palpation | 53,9±4,96 |
Table 2 Initial severity of pain syndrome in observation groups
Characteristics of pain syndrome | 1st group | 2nd group | 3rd group | 4th group |
Pain in bed at night | 41,5±3,82 | 41,2±2,63 | 40,6±3,15 | 41,2±3,87 |
Pain while sitting and lying down | 43,2±4,03 | 44,3±3,84 | 42,3±2,90 | 43,8±3,97 |
Pain in an upright position | 45,4±4,12 | 46,2±3,76 | 45,7±3,42 | 45,8±3,52 |
Pain with active movements of the upper limbs | 46,3±4,67 | 47,1±4,85 | 46,4±4,71 | 46,7±4,72 |
Pain with passive movements of the upper limbs | 49,7±5,11 | 50,2±4,98 | 49,8±5,09 | 50,1±5,13 |
Pain on palpation | 53,9±4,96 | 54,6±4,87 | 54,2±4,93 | 54,4±4,63 |
Table 3 Initial parameters of the WOMAC questionnaire in observed patients (n=120)
Sections of the WOMAC Questionnaire | Points (average values) |
Section A. Pain | 43,8±4,09 |
Section B. Stiffness | 26,2±3,91 |
Section B. Difficulties in daily activities | 53,52±4,87 |
Table 4 Initial expression of WOMAC questionnaire parameters in observation groups
1st group | 2nd group | 3rd group | 4th group | |
Section A. Pain | 42,6±3,57 | 43,5±4,01 | 44,8±4,16 | 44,5±3,94 |
Section B. Stiffness | 25,4±3,25 | 26,7±3,84 | 28,3±4,06 | 27,9±4,11 |
Section B. Difficulties in daily activities | 52,5±4,62 | 54,1±4,48 | 55,3±4,69 | 53,6±4,37 |
Initially, statistically significant differences in the parameters presented in table. 2 and table. 4 were not observed in the observation groups.
To quantitatively assess coordination in the observation groups, we conducted the “Get Up and Walk” test, which determined the ability to get up from a chair without support within an estimated time in seconds, as well as on a numerical rating scale (NRS) in points.
Table 5 Initial parameters of the “Get up and go” test in observation groups
1st group | 2nd group | 3rd group | 4th group | |
Inability to get up from a chair without support (sec) | 9,1±3,71 | 8,9±4,24 | 8,1±3,55 | 9,0±4,05 |
Inability to get up from a chair without support (CHS points) | 9,2±3,83 | 8,5±3,96 | 8,0±3,37 | 8,8±3,67 |
Safety assessment was carried out according to the following indicators: frequency and nature of adverse events that developed during the observation period, their relationship with the study drug (no connection, unlikely, possible, probable, definite, unknown).
An adverse event was considered to be any medical event that occurred to the patient during participation in the study, regardless of connection with the therapy. The criterion for early exclusion of a patient from their study was the development of serious adverse events (events leading to death, threatening the patient’s life, and also requiring surgical intervention and additional therapy). All cases of adverse events were recorded in the study chart and primary documentation, and were also sent to the study sponsor.
During the study, blood test parameters were monitored: clinical (hemoglobin, leukocytes, ESR) and biochemical (AST, ALT), urine analysis.
During the open study, patients were excluded according to the following criteria: ineffectiveness of therapy for the underlying disease - persistence or worsening of pain requiring treatment adjustment, serious adverse events, refusal to participate in the study, as well as violation of the protocol.
Artradol lyophilisate for the preparation of solution for intramuscular administration 100 mg, 10 ampoules
Registration Certificate Holder
INKAMFARM (Russia)
Dosage form
Medicine - Artradol® (Artradol)
Description
Lyophilisate for preparing a solution for intramuscular administration
white or white with a yellowish tint porous mass compacted into a tablet.
1 amp.
chondroitin sulfate sodium 100 mg
Ampoules with a capacity of 2 ml (5) - plastic trays (2) - cardboard packs. Ampoules with a capacity of 2 ml (10) - cardboard holders (1) - cardboard packs.
Indications
Degenerative-dystrophic diseases of the joints and spine (osteoarthrosis of peripheral joints, intervertebral osteoarthrosis and osteochondrosis), to accelerate the formation of callus in fractures.
Contraindications for use
Hypersensitivity to chondroitin sulfate, tendency to bleeding, thrombophlebitis; for intramuscular administration and oral administration - children under 18 years of age, pregnancy, breastfeeding; for intra-articular injection - the presence of active inflammatory and infectious processes in the joint, the presence of active skin disease and skin infection in the area of the intended injection.
Carefully
Simultaneous use with direct anticoagulants.
pharmachologic effect
The agent that affects phosphorus-calcium metabolism in cartilage tissue is a high-molecular mucopolysaccharide. It has chondrostimulating, regenerating, anti-inflammatory and analgesic effects. Chondroitin sulfate is involved in the construction of the main substance of cartilage and bone tissue. It has chondroprotective properties, enhances metabolic processes in hyaline and fibrous cartilage, subchondral bone; inhibits enzymes that cause degradation (destruction) of articular cartilage; stimulates the production of proteoglycans by chondrocytes. Helps reduce the release of inflammatory mediators and pain factors into the synovial fluid, suppresses the secretion of leukotrienes and prostaglandins. Slows down bone resorption and reduces calcium loss, accelerates bone tissue restoration processes. Chondroitin sulfate slows the progression of osteoarthritis and osteochondrosis. Promotes the restoration of the joint capsule and cartilaginous surfaces of the joints, prevents the collapse of connective tissue, and normalizes the production of joint fluid.
Possessing structural similarity to heparin, it can potentially prevent the formation of fibrin thrombi in the synovial and subchondral microvasculature.
Drug interactions
The effect of indirect anticoagulants, antiplatelet agents, and fibrinolytics may be enhanced, which requires more frequent monitoring of blood coagulation parameters when used together.
Dosage regimen
Orally for adults - 1.5-1 g 2 times a day.
IM - 100 mg chondroitin sodium sulfate every other day. If well tolerated, the dose is increased to 200 mg, starting with the fourth injection. The course of treatment is 25-30 injections. If necessary, repeated courses of treatment are possible after 6 months.
For intra-articular administration, a single dose is 200 mg. Frequency and duration of use - according to a special scheme.
Side effect
Allergic reactions: uncommon - skin itching, erythema, urticaria, dermatitis, angioedema.
From the digestive system: often - diarrhea, abdominal pain, nausea; frequency unknown - vomiting.
Local reactions: pain and hemorrhage at the injection site.
special instructions
In case of allergic reactions or hemorrhages, treatment should be discontinued.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated. Use during pregnancy and breastfeeding is contraindicated.
Use in elderly patients
Restrictions for elderly patients - With caution. There are no special instructions for use in elderly patients.
Use in children
Restrictions for children - Contraindicated. Use in children and adolescents under 18 years of age is contraindicated.
Research results
Based on the results of observation of groups of patients, we identified the dynamics of clinical indicators (Tables 6, 7).
Table 6 Dynamics of pain syndrome in observation groups
1st group | 2nd group | 3rd group | 4th group | |||||
Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment | |
Pain in bed at night | 41,5±3,82 | 40,9±4,11 | 41,2±2,63 | 35,1±2,41* | 40,6±3,15 | 32,4±2,77* | 41,2±3,87 | 15,3±1,96** |
Pain while sitting and lying down | 43,2±4,03 | 42,9±4,14 | 44,3±3,84 | 41,6±3,50* | 42,3±2,90 | 38,2±3,33* | 43,8±3,97 | 16,5±1,85** |
Pain in an upright position | 45,4±4,12 | 42,3±3,96 | 46,2±3,76 | 38,3±2,97* | 45,7±3,42 | 41,5±3,64* | 45,8±3,52 | 17,1±1,93** |
Pain with active movements of the upper limbs | 46,3±4,67 | 44,7±4,43 | 47,1±4,85 | 42,6±3,92* | 46,4±4,71 | 42,1±4,25* | 46,7±4,72 | 18,9±2,03** |
Pain with passive movements of the upper limbs | 49,7±5,11 | 46,2±4,93 | 50,2±4,98 | 43,9±2,86* | 49,8±5,09 | 41,6±4,11* | 50,1±5,13 | 20,1±4,35** |
Pain on palpation | 53,9±4,96 | 49,4±3,85 | 54,6±4,87 | 45,2±3,76* | 54,2±4,93 | 46,1±3,86* | 54,4±4,63 | 22,6±3,72** |
Note: * p<0.05; ** — p<0.01 – significance of intergroup differences after treatment.
Table 7 Dynamics of the severity of parameters of the WOMAC questionnaire in observation groups
1st group | 2nd group | 3rd group | 4th group | |||||
Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment | |
Section A. Pain | 42,6±3,57 | 39,5±3,26 | 43,5±4,01 | 19,6±2,82** | 44,8±4,16 | 21,4±3,18** | 44,5±3,94 | 11,2±1,37** |
Section B. Stiffness | 25,4±3,25 | 22,1±2,97 | 26,7±3,84 | 19,1±1,74* | 28,3±4,06 | 18,2±2,45* | 27,9±4,11 | 13,5±2,06** |
Section B. Difficulties in daily activities | 52,5±4,62 | 45,3±4,39 | 54,1±4,48 | 23,5±3,26** | 55,3±4,69 | 24,4±2,83** | 53,6±4,37 | 18,7±2,12** |
Note: * p<0.05;
** — p<0.01 – significance of intergroup differences after treatment. As a result of the therapy, both in the second and third groups, and during combination therapy, there was a positive dynamics of pain, stiffness and difficulties in daily activities, which proves the high effectiveness of monotherapy with the drugs “Artradol” and “Artracam”, with the synergistic effect of their joint administration .
Table 8 Dynamics of quantitative assessment of the coordination test “Get up and go”
1st group | 2nd group | 3rd group | 4th group | |||||
Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment | Before treatment | After treatment | |
Inability to get up from a chair without support (sec) | 9,1±3,75 | 8,6±2,65 | 8,9±4,26 | 4,5±2,54* | 8,1±3,51 | 3,6±2,57* | 9,0±4,05 | 0,6±0,41** |
Inability to get up from a chair without support (CHS points) | 9,2±3,84 | 8,5±2,74 | 8,5±3,97 | 4,4±2,15* | 8,0±3,38 | 3,5±2,62* | 8,8±3,63 | 0,5±0,34** |
Note: * p<0.05;
** — p<0.01 – significance of intergroup differences after treatment. Significant dynamics of the coordination test “Get up and go” characterizes the expansion of daily activities and improvement of self-care of the observed patients.
The study assessed the effectiveness of therapy by the doctor and the patient, which was calculated against the background of continuous use of NSAIDs.
Table 9 Efficacy of initial therapy in patients included in the study, assessed by physicians and patients
Grade | Number of patients | ||
n | % | ||
sick | Very good | 0 | 0 |
Fine | 19 | 1583 | |
Satisfactorily | 61 | 5084 | |
Badly | 38 | 3166 | |
Very bad | 2 | 167 | |
Doctor | Very good | 0 | 0 |
Fine | 26 | 2167 | |
Satisfactorily | 90 | 75 | |
Badly | 4 | 333 | |
Very bad | 0 | 0 |
Table 10 Adverse side effects identified during observation in the study groups
Undesirable side reactions | Group 1 (n=30) | Group 2 (n=30) | Group 3 (n=30) | Group 4 (n=30) | ||||
Gastralgia | 1 | 333% | 2 | 667% | 1 | 333% | 2 | 667% |
Diarrhea | 1 | 333% | 1 | 333% | 1 | 333% | 1 | 333% |
Flatulence | 1 | 333% | 0 | 0% | 0 | 0% | 0 | 0% |
Facial redness | 1 | 333% | 0 | 0% | 0 | 0% | 0 | 0% |
Synovitis | 0 | 0% | 0 | 0% | 1 | 333% | 1 | 333% |
According to the data presented in Table 10, the drugs “Artradol” and “Artracam” are well tolerated, both in monotherapy and in combination therapy. The occurrence of undesirable side reactions was observed during monotherapy with Artradol in 10%, and with Artracam in 9.99%. During a course of combination therapy, an increase in undesirable side reactions was revealed to 3.32%. No serious adverse events were identified.
The association of adverse events with drug intake was possible or probable. To correct undesirable side effects, dietary measures were carried out; if gastralgia developed, NSAIDs were discontinued and antispasmodics were prescribed (once in all groups). When nausea occurred, the duration of which did not exceed 10 hours, metoclopramide was prescribed. The appearance of flatulence and facial redness did not require medication. Synovitis was controlled by prescribing NSAIDs in adequate doses. There was no need to discontinue therapy in the observation groups.
The need for NSAIDs in the observation groups decreased: after two weeks in 24 (80%) patients in group 2, in 23 (76.7%) in group 3, in 27 (90%) in group 4. After 1 month, the need for regular NSAID use continued to decrease. 27 (90%) in group 2 refused to take non-steroidal drugs, 28 (93.3%) in group 3, and 29 (96.7%) in group 4.
While monitoring patients with comorbid pathology, we did not identify any negative drug interaction reactions, which did not require changing the recommendations of specialists in the relevant field.
Artradol in complex therapy of patients with cervicobrachialgia
Cervicobrachialgia (pain in the neck and shoulder) is most common in young and middle-aged patients, being one of the main causes of disability, decreased work efficiency and quality of life [3]. The mechanism of the pain syndrome in this case is due to tissue deformation that occurs under the influence of static-dynamic loads on the cervical spine, and, as a consequence, constant irritation of pain receptors. Hereditary predisposition, microtrauma, and incorrect motor stereotypes lead to degeneration of the vertebral motion segment (SMS) [1]. Dysfunction of the spinal segment manifests itself in the form of segmental instability or segmental blockade. In the first case, an excessive range of motion is possible between the vertebrae, which can contribute to the appearance of mechanical pain or even dynamic compression of the nerve structures. In the case of a segmental block, there is no movement between the two vertebrae. In this case, movements of the spinal column are ensured due to excessive movements in adjacent segments (hypermobility), which can also contribute to the development of pain. Another source of pain is considered to be damage to the facet (facet) joints, the synovial capsule of which is innervated by articular nerves, which are parts of the posterior branches of the spinal nerves and small accessory branches from the muscular branches [3]. The facet joints provide the primary resistance to anterior translation and rotation. When bending, the facet joints account for 15 to 25% of the compression forces that increase with disc degeneration and narrowing of the spinal canal [5]. The resulting instability of the joint joint leads to “tearing off the facets” and, as a result, accelerates the pathological process in the joints themselves (arthrosis). This pathology occurs in 15–45% of patients with back pain [12, 17]. There are no specific symptoms of this pathology [8]. Unfortunately, there is still a simplified understanding of the problem of “osteochondrosis,” which makes it difficult to develop differentiated approaches to treatment. In patients with this type of pain syndrome, without identifying the pathophysiological mechanisms, it is impossible to choose the optimal treatment strategy [22]. Currently, an adequate strategy for the treatment of back pain is based on the following principles: individuality (it is necessary to take into account the localization, nature and severity of clinical manifestations of pain) and complexity (the use of drugs and non-drug therapy methods). Therapy for pain syndromes in such patients involves identifying and eliminating the source or cause that causes pain, determining the degree of involvement of various parts of the nervous system in the formation of pain, and, finally, suppressing the pain itself [9]. In recent years, the pharmacological arsenal of treatments for patients with back pain has significantly improved [1, 4]. However, the problem of pain is still far from being resolved. The need for long-term therapy and the presence of a large number of concomitant diseases in people with dorsalgia determine special requirements for the safety of the drugs used. Traditional conservative treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesics may be accompanied by side effects from the gastrointestinal tract (GIT) and cardiovascular system, which limits their widespread use, especially in older age groups. This determines the search for new treatment options. One of these areas is the use of chondroprotectors [21]. Interest in this group of drugs as potential analgesics is due to their anti-inflammatory properties and safety of use. The effectiveness of these drugs in the treatment of joint pathology has been well studied [11–15], while they are used much less frequently in the treatment of chronic back pain [4]. Special studies have shown that components of chondroprotective drugs such as glucosamine and chondroitin, in large doses, have certain anti-inflammatory effects and reduce pain [6–10]. The drugs of this series existing on the market are in tablet forms and are used for a long time in the complex treatment of joint diseases. In these cases, the therapeutic effect is usually expected within several months. Injectable drugs containing chondroprotective components look more attractive from the point of view of pain therapy [16–18, 21]. In neurological practice, preference is given to drugs for parenteral administration. Chondroitin sulfate is traditionally available in oral forms [1, 2]. When taken orally, chondroitin sulfate is quickly adsorbed from the gastrointestinal tract, and its bioavailability ranges from 10 to 20%. In this case, predominantly low-molecular-weight derivatives, which have less pharmacological activity compared to native molecules, enter the systemic circulation. The use of drugs in injection forms increases bioavailability and clinical effectiveness. When administered intramuscularly, chondroitin sulfate is well absorbed after 30 minutes. found in significant concentrations in the blood, and after 15 minutes. – in synovial fluid. The drug accumulates mainly in cartilage tissue, with maximum concentration in articular cartilage reached after 48 hours. The use of chondroitin sulfate in injectable forms could potentially be more effective in the management of patients with vertebrogenic cervicobrachialgia. One of the chondroprotective drugs is the domestic drug Artradol (chondroitin sulfate) [4]. The drug is administered intramuscularly at a dose of 0.1 g every other day. Before use, the contents of the ampoule are dissolved in 1 ml of water for injection. If well tolerated, the dose is increased to 0.2 g, starting with the 4th injection. The course of treatment is 25–35 injections. The purpose of this study was to study the clinical effectiveness of the drug Artradol in patients with vertebrogenic cervicobrachialgia. Materials and methods A comparative clinical examination of 90 patients (50 women and 40 men) aged from 35 to 70 years (average age – 45.7±3.5 years) with a verified diagnosis of “dorsopathy of the cervical spine” was carried out on the basis of the neurological departments of the MRC "Belyaevo" (Moscow). The diagnosis was verified using radiography and MRI of the spine. All patients had a chronic relapsing or persistent course of the disease with an exacerbation duration of no more than 1 month. The severity of pain varied from moderate (60%) to severe (40%). The duration of the study was 3 months: 1 month. – treatment period and 2 months. – observation period. All patients were examined on the 1st day of admission, after 1 month. after the start of treatment, and also after 2 months. after discontinuation of the drug (±10 days). A clinical neurological examination was carried out, which consisted of collecting complaints, medical history, family history, and examining the neurological status using standard methods. The functions of cranial nerves, tendon and skin reflexes, muscle strength and tone, pain sensitivity, and generally accepted coordination tests were studied. In the vertebrological status, all patients had a blockage of C0–C1, 86 (95.6%) had a blockade of C1–C2, and 84 (93.3%) had a blockage in the area of the cervicothoracic junction. Hypermobility in the mid-cervical spine was registered in 64 (56.1%) patients. Smoothing of cervical lordosis was observed in 41 (45.6%) patients, and its intensification in 57 (63.3%). 86 (95.6%) patients had asymmetry of the shoulder girdle, 61 (67.8%) had smoothed thoracic kyphosis, and 70 (77.8%) had blocking in the mid-thoracic spine, often combined with hypermobility in the same section. In 52 (57.8%) patients, blocking of the sacroiliac joint was detected, in 79 (87.8%) - blocking in the L4–L5, L5–S1 segments. In 30 (27%) patients, protrusion of the intervertebral disc without root compression was diagnosed, in 18 (20%) - radiculopathy due to disc herniation or stenosis of the intervertebral foramen. Among the muscular-tonic syndromes, inferior oblique muscle syndrome was identified in all patients, anterior scalene muscle syndrome in 89 (98.9%), as well as dystonic changes in the trapezius and other muscles of the neck and shoulder girdle. X-ray changes in the cervical spine were found in 100% of patients, among them uncovertebral arthrosis - in 61%, spondyloarthrosis - in 38%, spondylolisthesis - in 34%, subluxation according to Kovacs - in 5%. MRI of the cervical spine was performed in 60 patients of the main group: 30 of them had protrusion of intervertebral discs, 26 had disc herniations at the C4–C7 level, and 24 had polysegmental lesions. All patients were divided into 2 groups using a free sample method. In group 1 (main, n=60), patients took standard therapy for the treatment of dorsopathy, including NSAIDs, analgesics, antidepressants, muscle relaxants + Artradol 1 ml IM for 20 days. Group 2 (comparison, n=30) received standard therapy for the treatment of dorsopathy: analgesics, NSAIDs, muscle relaxants, antidepressants. Both groups were comparable by gender and age. In both groups, during the entire period of treatment and observation, physiotherapeutic methods, reflexology, massage or manual therapy were not used; intra-articular injections of glucocorticoids, hyaluronic acid preparations and any other drugs with chondroprotective properties were not allowed. To objectify indicators of neurological deficit and neuropsychological disorders, the following scales were used: self-assessment of the state of back pain; vertebral and glenohumeral syndromes; general clinical impression; cervicobrachialgia; quality of life EQ–5D; Hospital Anxiety and Depression Scale. Results and discussion The use of the drug Artradol in patients with vertebrogenic cervicobrachialgia revealed its positive effect on the dynamics of neurological manifestations: a persistent decrease in pain, an increase in spinal mobility, and an expansion of the functional capabilities of patients were noted. All patients complained of headache before treatment. Against the background of therapy in the comparison group after 1 month. the total number of patients with headaches decreased; 10 patients continued to complain of mild headaches. After 3 months the frequency of complaints changed: all patients developed a moderate headache. In the main group receiving treatment with Artradol, after 1 month. the total number of patients with headaches decreased, 5 patients continued to complain of mild headaches. During subsequent visits, these patients did not reveal any changes, which is likely due to the personal characteristics of the subjects. Pain in various parts of the spinal column and paresthesia in the extremities, noted during the initial examination, disappeared in almost all patients of the main group. After 3 months pain in the cervical spine was recorded in 10 patients. In patients with clinical signs of reflex muscle syndrome, the positive dynamics were more pronounced, while in patients with disc protrusion, the clinical effect of therapy appeared later and was somewhat lower. In patients with clinical signs of facet syndrome, the positive dynamics of both subjective manifestations and objectively assessed vertebral neurological syndrome were most pronounced (Table 1). In patients with radiculopathy, the effect of Artradol appeared later and was significantly lower than in facet syndrome. 4 patients with clinically significant spinal canal stenosis were resistant to the therapy. At the same time, in almost all patients in the comparison group, pain in various parts of the spinal column and paresthesia in the extremities, noted during the initial examination, also disappeared after therapy, but after 3 months. returned to previous characteristics. Therapy with Artradol allowed patients in the study group to quickly restore their motor abilities, which overall led to a significant improvement in the quality of life indicator according to the EQ-5D questionnaire (Table 2). There were no statistically significant changes in the HADS scale in patients of both groups before and after treatment. A general assessment of the results of treatment by a doctor showed that a moderate or significant effect (2 and 3 points) during treatment with the drug was observed in 90% of cases. At the same time, in the comparison group the same figures were 30%. However, no cases of deterioration of the condition were recorded in both groups. The effectiveness of Artradol therapy was confirmed using the Clinical Global Impression Scale. Thus, in the main group, no improvement (0 points) was recorded in 15% of patients immediately after treatment, a slight improvement (1 point) in 25%, a moderate improvement (2 points) in 40%, a significant improvement (3 points) in 20%. No deterioration of the condition was detected in any patient. At the same time, in the comparison group there was no effect of therapy (0 points) in 30% of patients, a slight improvement (1 point) in 40%, a moderate improvement (2 points) in 20%, a significant improvement (3 points) in 20% of patients. at 10%. Subjective assessment of the effectiveness of therapy by patients corresponded to the obtained clinical effect: “good” (4 points) was given by 60% of patients in the main group and 30% of the comparison group, “satisfactory” (3 points) - 40% of patients in the main group and 40% of the comparison group, “unsatisfactory” “(0 points) was not registered in the main group, in the comparison group – in 30%. Conclusion One of the important peripheral pathogenesis factors that predetermine the tendency to chronic back pain is the destruction of cartilage tissue, involving both intervertebral discs and intervertebral joints. It causes persistent biomechanical disorders that contribute to the constant resumption of pain, and provokes further progression of the pathological process in the structures of the spine, closing a vicious circle in spinal osteochondrosis. In this regard, the use of chondroprotectors in the complex treatment of spinal osteochondrosis seems logical. In the treatment of vertebrogenic cervicobrachialgia, mainly with arthrosis of the facet joints, chondroprotective drugs occupy a special place because they help inhibit the degenerative process and reduce the likelihood of chronic pain [22]. A course of treatment with Artradol for 20 days (1 intramuscular injection daily) led to a significant decrease in the intensity of pain in the study group of patients with vertebrogenic cervicobrachialgia with a tendency to chronicity. A decrease in pain was noted from the 2nd week. injections, reached a maximum at the end of the course. The analgesic effect lasted for 1 month. after completion of treatment. As a result of therapy, a significant improvement in the motor functions of patients was noted, which is an important factor in the prevention of relapses and chronic pain. In patients taking Artradol, a more pronounced regression of pain syndrome and restoration of lost functions were recorded. However, it should be noted that the drug was more effective in young patients and patients with clinical signs of reflex muscle syndrome, while in patients with disc protrusion the clinical effect appeared later and was somewhat lower. In patients with clinical signs of facet syndrome, the positive dynamics of both subjective manifestations and objectively assessed vertebral neurological syndrome were most pronounced. In patients with radiculopathy, the effect of Artradol appeared later and was significantly lower than in facet syndrome. Patients with clinically significant spinal stenosis were resistant to therapy. The presence of polysegmental lesions (several parts of the spinal column) is an additional indication for the use of Artradol, because in these categories of patients, the most difficult to treat, the earliest (at the beginning of 1 week) and most pronounced clinical effect was recorded. The analgesic effect of the drug in a fairly short time is probably due to its anti-inflammatory properties. Many studies emphasize that chondroprotective drugs containing glucosamine sulfate, chondroitin, etc., have anti-inflammatory properties and can reduce pain regardless of the structure-modifying effect [4, 5, 8, 11, 12, 17–20, 23]. Artradol in injection form reduces pain intensity much faster than oral chondroprotectors [4]. One of the results of the study was a significant decrease in the degree of impairment of the patient’s functional abilities during treatment, assessed on the scales of cervicobrachialgia and vertebral, scapulohumeral syndromes. This result is extremely important because the fastest return of the patient to daily physical activity is the main factor in the prevention of relapses and prevents pain from becoming chronic [16]. It is known that in case of chronic back pain, prolonged bed rest (lying down) and refusal of any physical activity are associated with a poor prognosis in terms of recovery and reduction in pain intensity. Often, patients, most often because of pain and fear of its intensification, choose such tactics (passive coping strategy), which further shapes their pain behavior, leading to poor recovery and maladjustment. Therapy with Artradol allowed patients in the study group to quickly restore their motor abilities, which overall led to a significant improvement in the quality of life indicator according to the EQ-5D questionnaire. A study of the drug Artradol in patients with vertebrogenic cervicobrachialgia showed good tolerability of the drug, the absence of significant side effects when combined with muscle relaxants and NSAIDs. During the observation period, no side effects or complications were reported in any patient while taking the drug. During the therapy, the patients did not experience any negative effects on blood pressure and heart rate. Good tolerability of the drug and the absence of side effects are significant advantages of the drug compared to NSAIDs. Thus, the results of the study allow us to consider Artradol as an effective and safe drug in the complex treatment of vertebrogenic cervicobrachialgia.
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