RU2618928C1 - Method for treatment of degenerative-dystrophic diseases and locomotor system injuries consequences - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: for treatment of degenerative-dystrophic diseases and locomotor system injuries consequences, autoplasma enriched in platelets is preliminarily prepared, in a volume of 2.0-6.0 ml. A composition of glucosamine sulphate and chondroitin sulphate, in a volume of 3.0 and 4.0 ml, respectively, is administered intra-articularly and/or to periarticular trigger points in the pathological portion. Immediately thereafter, the prepared autoplasma is slowly introduced into the same portions. A sterile retainer is glued on the needle puncture points region. Few minutes later, an extracorporeal shock wave therapy (ESWT) session is performed excluding any expressed discomfort during the session. In the days of procedures, the patient adhers to a conservative orthopedic regime. Procedures are carried out every 10-12 days, a course of 2-6 times.

EFFECT: reduced number of relapses and increased period of remission, including by accelerating the regeneration processes, eliminated risk of post-injection side effects at minimally invasive surgery.

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Description

The present invention is a method for the treatment of degenerative-dystrophic diseases (DDD), the effects of skeletal and soft tissue injuries of the musculoskeletal system of the body, including in the postoperative period, relates to medicine, namely to orthopedics and traumatology, and can be used in complex conservative treatment of deforming osteoarthritis of the joints, osteochondrosis of the spine and intervertebral uncomplicated hernias, humeroscapular periarthrosis, insertions, tendonitis, synovitis, bursitis, etc. degenerative or post-traumatic genesis, during rehabilitation after injuries and traumatologic and orthopedic operations on joints and limbs, when relief of protracted persistent inflammatory processes and pain syndromes, fibromyalgia, to stimulate and accelerate the regeneration of damaged ligaments, muscles, tendons, sluggish pseudo-consolidated fractures.

The unsatisfactory results of conservative treatment of the musculoskeletal system (OA) and the consequences of its injuries are usually explained by the stage, degree of damage to various anatomical areas and their number, age of the patient and the presence of concomitant pathology that aggravates traditional treatment, individual characteristics of the body, its degree susceptibility to drugs and physiological effects, as well as the lack of a comprehensive and more holistic approach to the treatment of one or another pathology of ODE.

Despite a significant number of treatment methods for these pathologies, the results do not always satisfy the patient and the doctor, as the result of conservative treatment is: inadequate relief of pain and an early relapse of the disease, long-term healing of damaged ODA tissues up to the formation of false joints, cicatricial degeneration and post-traumatic osteosclerosis, as a result, the quality of life of the patient is reduced due to loss of functionality, support ability of the limbs, leading to complete Disabling features and the inability to self-service. The medical and social rehabilitation of the patient becomes extremely long and ends with his permanent disability.

The use of non-steroidal anti-inflammatory drugs and glucocorticosteroid drugs, chondroprotectors, physiotherapy, magnetotherapy, UHF therapy, physiotherapy exercises, etc., is widely known in the conservative treatment of degenerative diseases of OAA. [“Orthopedics: national leadership”. Edited by S.P. Mironova, G.P. Kotelnikova, Moscow: “GEOTAR-Media”, 2008, pp. 448-452]. However, the standard treatment regimen imposes its limits in the form of side effects of drugs and overdoses, their possible and sometimes unpredictable individual intolerance and all kinds of side effects, in particular allergic reactions and complications from various organs and systems. This, in turn, leads to the additional prescription of other drugs and excessive drug loading and, as a result, to possible drug intoxication of the body and an increase in the cost of treatment. A possible alternative in such situations is the combined simultaneous use of injectable forms of chondroprotectors - chondroitin sulfate and glucosamine sulfate, which are as close as possible in properties and structure to the matrix of native human connective tissue, PRP therapy (Platelet Rich Plasma or BTP - platelet-rich plasma, or Plazmolifting TM ”is a commercial, patented name for the PRP-therapy method) as a natural autologous biogenic stimulator that expressly activates vital processes ty body tissues, and extracorporeal shock wave therapy (ESWT).

In domestic medicine, the founder of BoTP therapy can rightly be considered the famous surgeon V.F. War-Yasenetsky [War-Yasenetsky V.F. "Essays on Purulent Surgery", Moscow, 2000, pp. 128-132], which successfully applied in 1904-1905. during the Russo-Japanese War, autohemotherapy in the form of infiltration of whole autologous blood into the focus of the inflammatory process of soft tissues. As the methodology developed, at the end of the 20th century, blood components were used, namely autoplasma enriched with platelets, which contain the whole complex of biologically active growth factors, stimulation and healing of damaged tissues [found on the Internet in the scientific article published on 05/27/2015 http: / /prp-rost.ru/news/inektsii-plazmy-obogashchennoy-trombotsitami-v-lechenii-travm-oporno-dvigatelnogo-apparata-obzor-tem/, original article Curr Rev Musculoskelet Med DOI 10.1007 / s12178-008-9032-5 , “Platelet rich plasma injection grafts for musculoskeletal injuries: a review”, Steven Sampson, Michael Gerhardt, Bert Mandelbaum, Humana Press, 2008]. Extracorporeal shock wave therapy (ESWT) was first successfully used by domestic doctors in 1988 [Valchanov V. et al., 1991]. The end of XX - beginning of XXI centuries. were the experimental beginning of the use of ESWT and the identification of its useful properties and effects, namely, analgesic effect, activation of microcirculation and neoangiogenesis, stimulation of metabolic processes, reduction in the severity of fibrosclerotic changes, anti-inflammatory and antibacterial effects [Garilevich BA, 1992; Valchanov V. et al., 1991; Garilevich B.A., 1992; Mironov SP. et al., 1999; Nikolaev A.P. et al., 1999; Egorova E.A., 1999; Garilevich B.A., Olefir Yu.V., 2004; Siebert W., Bush M., 1997; von Eiff C. et al., 2000; Haake M. et al., 2002; Wess O., 2003; Thiele R., Schaden W., 2003; Yeung-Jen Chen et al., 2004; Gerdesmeyer L. et al., 2004; Gollwitzer H. et al., 2004; Takahiro Nishida et al., 2004; Gerdesmeyer L. et al., 2005 Haupt G., 1997; Valchanov V. et al., 1991; Loshe-Busch H. et al., 1997; Siebert W., Bush M., 1997].

The closest analogue of the proposed method is the use of extracorporeal shock wave therapy in the treatment of degenerative diseases of the musculoskeletal system ["Bulletin of Traumatology and Orthopedics", 1999, 1; 26-9; Sharabchiev Yu.T., Dudina T.V., Polyanskaya O.Yu.]. It involves the impact of a shock acoustic wave in a given mode of instrumental impact. Depending on the equipment and the principle of generation of the shock wave (pneumatic, piezoelectric, electromagnetic), indications and contraindications to ESWT vary and vary widely. During treatment, they are guided by the following parameters: exposure pressure (Bar), wave energy density (J / mm ² ), wave generation frequency (Hz), total number of strokes. As a rule, sessions are carried out as standard: once every 7 days, the total number of sessions is from 3-5 to 10 maximum, the total number of strokes per area per session is 2000.

Disadvantages: painful discomfort during an ESWT session and frequent intensification of the pain syndrome - exacerbation of chronic inflammation after the session, stereotyped and stereotyped ESWT sessions, limited exposure to trigger points without taking into account the particular course of the disease, the stage of the ongoing processes, the presence of concomitant pathology, insufficient relief pain, prolonged stages of relapse, a significant period of the rehabilitation period and the period of disability.

Tasks: to eliminate the need for systemically prescribed pharmacological agents, to ensure the highest bioavailability of drugs to the pathological focus, reduce the risks of side effects and undesirable effects at injection sites, allergic reactions and individual intolerance to the components of drugs, directly affect the main lesion - the organ target, reduce disability, reduce financial costs and time spent on complex therapy, by to increase the level of rehabilitation with the final positive most persistent effect.

The essence of the method for the treatment of DDD and the effects of trauma to OA is that pre-prepared autoplasma enriched with platelets in a volume of 2.0-6.0 ml; a composition of glucosamine sulfate and chondroitin sulfate in a volume of 3.0 and 4.0 ml, respectively, is injected into the pathological site, intraarticular and / or periarticular trigger points every 10-12 days with a course of 2-6 times, immediately after that, slowly injected into those the autoplasma prepared and the area of the injection points of the needle are glued with a sterile fixator, after which, after a few minutes, the patient will experience ESWT in the patient’s regime of exclusion of sensations of strong b Olya and discomfort during the session, and in the days of the procedures the patient performs a protective orthopedic regimen. The applicant asks to leave the technique of administering the drug composition and autologous plasma as a know-how.

The technical result of the proposal is minimal invasiveness and reduced time for complex therapy, providing reliable access to the "building material" for the connective tissue matrix, many times 3-4 times the number of biologically active components - platelet growth factors directly entering the target organ, and uniform distribution them in the area of the pathological focus, minimizing side effects and allergic complications, providing a better local regeneration proliferative stimulus and the response of damaged tissues and the elimination of the risk of post-injection effects, improvement of medical and social rehabilitation and quality of life of the patient, reducing the frequency of relapses with increasing disease remission until the formation of a stable remission.

The method was tested for 3.5 years from 2012-2016 in more than 60 patients. At the same time, the above technical result is confirmed.

In the control group, 66 patients with the most pronounced clinical manifestations and stages of the manifestation of the disease from I to III stages were selected. and post-traumatic consequences. Of these, with gonarthrosis - 16 patients (24%), spinal osteochondrosis - 14 patients (21%), with post-traumatic tendonitis of the muscles of the “rotator cuff” of the shoulder - 16 patients (24%), with post-traumatic achillodynia - 14 patients (21%), with epicondylitis - 6 patients (10%). The average age of patients is 40.8 years. 58 patients (88%) were of working age. Of these, 29 people are men (50%), 29 - women (50%). The clinical results of the comprehensive and basic therapy are shown in tables 1, 2, 3.

The proposed method of treatment is carried out as follows: first, following the rules of asepsis and antiseptics, in the conditions of the treatment room, depending on the set volume of PRP necessary for the treatment of the pathological condition, venous blood is collected with a total volume of 10 to 20 ml in specially prepared sterile tubes, for example "Plasmolifting TM", or "Arthrex". Then the test tube with blood is placed in a centrifuge and centrifuged for 5 min at 3000-3200 rpm. The separated platelet-rich plasma is removed from the tube with one or more sterile syringes. Next, 3.0 ml of glucosamine sulfate (for example, Dona or Elbona) and 4.0 ml of chondroitin sulfate (for example, Chondrogard or Mucosat) are collected in a single sterile 10.0 ml syringe. or “Chondrolone”) with a total volume of 7.0 ml and inject the drug mixture directly into the pathological focus, intraarticular and / or periarticular trigger points, depending on the specific clinical situation, namely: large joints (eg knee, shoulder, ankle joints ) administered intraarticularly and in the periarticular joint s trigger points in the small joints (e.g. metacarpophalngeal, metatarsophalangeal joints) administered in periarticular trigger points, in cases of trauma and operations administered directly to pathological nidus. Immediately after the composition is introduced into the same focus, or target organ, while also observing the rules of asepsis and antiseptics, the prepared autoplasma is administered in the required volume. The volume of such plasma (2.0-6.0 ml) corresponds to the stage of the disease and the severity of pain, inflammation, physical and anatomical features of joints and periarticular tissues. Gently perform this manipulation slowly. A needle with a syringe is removed, the injection site is treated with an antiseptic solution, and a small sterile fixator of the Fixopor or Cosmopor type is glued tightly to stop capillary bleeding. Then, within the first few minutes, they start a shockwave therapy session directly on the focus of the disease and the segments adjacent to it, in the regime of eliminating the patient’s sensations of severe pain and discomfort during the session, and on the days of the procedures the patient performs a protective orthopedic regimen. They use, for example, the apparatus "MASTERPULS MP200", STORZ MEDICAL FG (Serial number: BS.1324; Model: 2009 IPX1). The exposure parameters depend on the individual pain sensitivity of the patient in each clinical situation and vary in the following minimum and maximum ranges provided for by the instructions for use of the device: pressure - from 1.0 to 4.0 Bar, frequency - from 4 to 8 Hz, total number of strokes per one area (focus and segments) - from 4000 to 8000 strokes. On the day of injections and a UVT session, the patient must observe a protective orthopedic regimen. Next, the injection and the ESWT session are repeated 1 time in 10-12 days. The total number of procedures ranges from 2 to 6, depending on the indications of the appointment of the attending physician, for example: 2 injections and sessions are a short course of therapy, 3-4 injections and sessions are an average course of therapy, 5-6 injections and sessions are a full course of therapy. The volume of autoplasma administered varies individually in each particular clinical case, as indicated above. In accordance with the essence of the invention, the drug composition and autologous platelet-rich plasma are injected into the pathological focus and immediately after that they carry out an ESWT session with the proper individual parameters and in the regime of eliminating the patient's sensations of severe pain and discomfort during the session, and on the days of the procedures the patient performs protective orthopedic mode.

The proposed method of complex treatment is used for deforming osteoarthritis of the joints, periarthropathy, for chronic pain after injuries and traumatological operations, for tendomyogenic contractures of the joints, tendinopathies, insertions, prolonged persistent inflammatory processes, fibromyalgia, to stimulate and accelerate the regeneration of damaged muscles, dry muscles, ligaments, dry joints sluggish consolidating fractures and pseudoarthrosis and other degenerative diseases of the musculoskeletal system in those cases when there is an individual intolerance to NSAIDs and GCS, with allergic reactions to drugs and concomitant pathology of organ systems, in which the introduction of NSAIDs, GCS and other drugs is contraindicated.

Example 1. Patient O., born in 1973, was on outpatient treatment from 06/17/2013 to 08/08/2013 with a diagnosis of "post-traumatic deforming osteoarthritis of the right ankle joint of 3 tbsp. Condition after metal osteosynthesis of a three-ankle fracture on the right (10.17.2012). Persistent severe arthralgia. Combined contracture of the right ankle joint, swelling of the soft tissues of the right foot and lower third of the leg »(MRI 06/11/2013: MP-signs of degenerative changes in the hyaline cartilage, capsule, ligamentous apparatus of the right ankle joint, trabecular edema of the bone marrow of the talus, distal epiphysis of the right tibia). According to the patient, she was injured on October 11, 2012, after the operation, the ankle joint hurts when walking and at rest, is constantly swollen, almost does not move. She underwent a course of therapy according to the proposed method, consisting of five injections of a medicinal composition of glucosamine sulfate and chondroitin sulfate and autoplasma enriched with platelets, and five sessions of ESWT. The method consisted of the following: previously, in the treatment room of the patient, venous blood was collected with a total volume of 18 ml in specially prepared sterile tubes “Plasmolifting TM”. Then the blood tube was placed in a centrifuge and centrifuged for 5 min at 3200 rpm. Separated platelet-rich plasma (BTP), 6 ml in volume, was removed from the tube with a sterile syringe. Then, according to the rules of asepsis and antiseptics, 3.0 ml of glucosamine sulfate (Don) and 4.0 ml of chondroitin sulfate (Mucosat) were sequentially taken into another sterile ten-milliliter syringe according to the rules of asepsis and antiseptics. A patient on a couch lying on his back with a roller under the ankle joints. After treatment with an antiseptic solution on the lateral surfaces of the right ankle joint, 7.0 ml of the drug composition was introduced into the trigger zones. After treatment of the area of the alleged injection, after the treatment of the area of the proposed ankle joint, 1.0 ml of BOTP was injected gently and slowly, the remaining 5.0 ml was injected into the periarticular trigger points. The injection sites were treated with an antiseptic solution and the needle points were tightly sealed with small sterile fixators of the Fixopor type. Then, within the first few minutes, they started the ESWT session directly on the right ankle joint, as well as the lower leg muscles and periarticular tissues. In this case, we used the MASTERPULS MP200 apparatus, STORZ MEDICAL FG (Serial number: BS.1324; Model: 2009 IPX1) and the following individual exposure parameters, which exclude the patient from severe pain and discomfort during each session: first session - pressure 2 , 0 Bar, frequency - 8 Hz, number of strokes - 8000 per session, second session - pressure 2.4 Bar, frequency - 7 Hz, number of strokes - 7000 per session, third session - pressure 2.8 Bar, frequency - 6 Hz , the number of strokes - 6000 per session, the fourth session - pressure 3.0 Bar, frequency 5 Hz, the number of strokes - 7000 per session, fifth session - pressure 3.6 Bar, frequency 5 Hz, the number of strokes per session - 8000 strokes. On the day of injection of the medicinal composition and BTP and the ESWT session, the patient observed a protective orthopedic regimen; no pronounced side effects were noted. In total, 5 injections of 7.0 ml of the drug mixture and 6.0 ml of BoTP and 5 sessions of ESWT were performed with an interval of 10 days. During treatment, the pain syndrome was stopped by 90-95%. The angle of flexion and extension were 90 and 170 degrees, respectively. Long-term results (1.5 years) are satisfactory, no complaints.

Example 2. Patient T., born in 1964, was on outpatient treatment from 03/20/2014 to 04/25/2014 with a diagnosis of “closed rupture of the Achilles tendon on the left. Condition after open tenorography (02/06/2014 year). Persistent severe pain syndrome. Combined contracture of the left ankle joint. ” According to the patient, the injury was on 02/02/2014. At the time of the complaint, a sharp restriction of movement, constant swelling and pain at rest and during movements in the left ankle joint, inability to stand on the toe. The patient was treated conservatively after the operation (NSAIDs, FTL, exercise therapy), positive results were unstable for a short time. They performed therapy according to the proposed method: in the patient’s position, lying on a couch on the abdomen with a roller under the ankle joints, successively in the projection of the operated Achilles tendon, observing the rules of asepsis and antiseptics, injected was a medicinal mixture containing chondroitin sulfate (“Chondrogard”) and glucosamine sulfate ( "Don") with a volume of 7.0 ml, and pre-prepared BOTP with a volume of 4.0 ml. Immediately after injection, an ESWT session was immediately performed with the MASTERPULS MP200 apparatus, STORZ MEDICAL FG (Serial number: BS.1324; Model: 2009 IPX1). The exposure parameters were as follows and were of a nature that excluded the sensation of severe pain and discomfort during each session: the first session - pressure 1.8 Bar, frequency - 7 Hz, the number of strokes - 6000 per session, the second session - pressure 2.2 Bar, frequency - 6 Hz, the number of strokes - 7000 per session, the third session - pressure 3.0 Bar, frequency - 5 Hz, the number of strokes - 8000 per session. On the day of injections and a session of ESWT, the patient observed a protective orthopedic regimen, after the first session and with each subsequent session, a gradual improvement of the condition occurred. In total, 3 injections of 7.0 ml of the drug composition and 4.0 ml of BTP and 3 sessions of UHT were performed with an interval of 12 days. During treatment, the pain syndrome was completely stopped, the range of motion in the joint increased. The patient is additionally prescribed exercise therapy, swimming, dosed development of muscles of both lower extremities. Condition monitoring after 6 months, 1.5 years: the patient has no complaints.

Claims (1)

A method of treating degenerative-dystrophic diseases and the consequences of injuries of the musculoskeletal system, including extracorporeal shock wave therapy (ESWT), characterized in that pre-prepared autoplasma enriched with platelets in a volume of 2.0-6.0 ml; a composition of glucosamine sulfate and chondroitin sulfate in a volume of 3.0 and 4.0 ml, respectively, is injected into the pathological site, intraarticular and / or periarticular trigger points every 10-12 days with a course of 2-6 times, immediately after that, slowly injected into those on the same side, the prepared autoplasma and a needle puncture point area are glued with a sterile fixative, after which a few minutes later the ESWT session is performed in the regime of eliminating the patient’s feelings of severe discomfort during the session, and on the days of the procedures the patient performs about Orthopedic-enforcement mode.