RU2301676C1 - Method for treatment of joint complications of rheumatic diseases - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to a method for treatment of locomotor system, in particular, treatment of joint complications of rheumatic diseases. Method involves intra-osseous administration of solcoseryl or actovegin solution in volume 2-5 ml by course 5-10 procedures, 2 times per a week, wherein 1 ml is administrated at the rate 0.017-0.015 ml/s, and other volume is administrated in equal parts wherein the rate administration of the first part is 0.02-0.017 ml/s and the second one - 0.061-0.1 ml/s. Method provides effective treatment based on retaining high concentration of drug by indicated administration regimen in osseous tissue for prolonged time.

EFFECT: enhanced effectiveness of treatment.

2 cl, 1 tbl, 5 ex

Description

The invention relates to medicine, namely to the treatment of diseases of the musculoskeletal system using drugs of natural origin.

Diseases of the musculoskeletal system are of great socio-economic importance due to their high prevalence, the frequent development of disability of patients, especially older age groups, as well as the associated reduction in the quality of life of patients. According to only official statistics in Russia, the overall incidence of diseases of the musculoskeletal system over the past 10 years has grown by more than 40%.

Among this group of diseases, rheumatic diseases occupy a special place. These include diseases of various origins, mainly systemic, rarely local in nature, occurring with persistent or transient articular syndrome. These are rheumatism and diffuse diseases of connective tissue, various arthritis and arthrosis, inflammatory diseases of the spine and degenerative nature and the so-called diseases of soft (extraarticular periarticular) tissues.

The most common diseases are osteoarthritis (according to foreign data, 5-10: 100 of the population), rheumatoid arthritis (PA) - (2-3: 100 of the population).

Osteoarthrosis (OA) is a joint disease in which the primary changes are mainly degenerative in nature in the articular cartilage. In osteoarthritis, in contrast to arthritis, the inflammatory component is unstable, proceeds in the form of episodes and is not very pronounced.

Osteoarthrosis affects about 80% of the population over the age of 60. The progression of the disease, accompanied by constant pain in the affected joints, is the cause of disability up to 25% of such patients.

Rheumatoid arthritis (PA) is a primary synovitis disease that can cause systemic complications, very often later in its clinical course. The pathological process is characterized by a rapid increase in synovial tissue, causing the formation of the so-called panus, which leads to the gradual destruction of articulation, invading the cartilage and the cartilage bone. According to some reports, the incidence of RA is increasing by 5% annually.

Thus, there is a significant need for the search and development of new methods and means of treatment for this group of diseases.

Conventional therapy is based on the use of anti-inflammatory agents like aspirin-like drugs (Lawrence D.R., Bennit P.N. Clinical Pharmacology: In 2 volumes - M .: Medicine, 1993; V.2: 583-84) or corticosteroids (George E, Kirwan JR. Corticosteroid therapy in rheumatoid arthritis [review]. Baillieres din Rheumatol 1990: 4: 621-47); and also the use of delayed anti-rheumatic drugs, for example, low doses of methotrexate (Beyeler C. Methotrexat-Behandlung der rheumatoiden Arthritis. Schweiz Med Wochenschr 1996; 126: 703-12). However, all of these drugs have significant side effects, and they are generally ineffective in the progression of anatomical injuries and in the prevention or limitation of functional disability.

Among drugs in practice, glucosaminoglycans such as chondroitin, hyaluronic acid have also been used (US 5,470,578, publ. 11/28/1995). However, these drugs do not have an effective effect in severe complications of rheumatic diseases.

Various physiotherapeutic methods of treatment are widely used. In particular, such techniques are described in the sources: V.D. GRIGORIEVA et al. Cryoelectrotherapy in the treatment of patients with osteoarthritis. Questions of balneology, physiotherapy and physiotherapy; 1992, No. 1, pp. 16-20. T.A. GOLUBENKO. Low-frequency ultrasound for osteoarthritis. Abstract, dissertation - M., 1991.

There are also known methods of combined exposure to cryotherapy and a high-intensity magnetic field (RU 2263491, publ. 2005.11.10), ultrasound and cryoapplication (RU 2147851, publ. 2000.04.27).

However, physiotherapeutic methods require prolonged use and have many contraindications.

Attempts have been made to combine drug treatment and physiotherapeutic effects, for example, RU 2226413, publ. 2004.04.10.

One of the promising methods of treating these pathologies is a method using the effect on the intraosseous blood flow of the vertebrae and intraosseous receptors by the administration of drugs intraosseously. In this case, the introduction of a needle into the bone is essentially a decompressive trepanation of the cortical layer, which leads to a decrease in intraosseous pressure, in addition, reparative regeneration is stimulated and local microcirculation is improved.

The introduction of drugs directly into the bone tissue allows to achieve their maximum concentration in the bone and the most effective effect on osteoreceptors. If the introduction is carried out in the vertebrae due to the peculiarities of the outflow of blood from them, the injected drugs affect all surrounding tissue vertebrae.

Complications from intraosseous injections, according to the literature, are quite rare, less than 0.5%.

In particular, the “Method for the treatment of articular complications of rheumatic diseases” is known (Pat. No. 2205609, A61B 17/56). This method is the closest analogue and can be indicated as a prototype.

As experience has shown, intraarticular, intramuscular and intravenous drip of solcoseryl (Actovegin) did not give an independent positive effect. Therefore, in the known solution, an attempt was made to develop a method based on the introduction of a solution of solcoseryl or actovegin into the joint cavity and into the affected bone in the direction of the aseptic necrosis zone, while the solution of solcoseryl or actovegin is injected into the affected bone immediately after their introduction into the joint cavity and used injection solution of solcoseryl or actovegin in a volume of 2 ml at each injection site. The specified method does not take into account a number of features of changes in the affected tissues, and although it provides a certain range of motion in the joints, pain reduction, the effectiveness of the method is not sufficient.

The objective of the invention is to increase the effectiveness of treatment and reduce treatment time.

This problem is solved by a new developed method for the treatment of complications of rheumatic diseases.

The essence of the invention lies in the fact that injecting a solution of solcoseryl or actovegin 2-5 ml at each injection site with a course of 5 to 10 procedures 2 times a week, and the injection is carried out as follows: 1 ml at a rate of 0.015-0.017 ml / s, and the rest of the volume is administered in equal parts, the injection rate of the first of which is 0.02-0.017 ml / s, and the second is 0.061-0.1 ml / s.

As active chemotherapeutic agents, as well as in the closest analogue, biogenic stimulants that improve trophism such as solcoseryl or actovegin can be used.

Solcoseryl is a deproteinized hemodialysate containing a wide range of low molecular weight components of the cell mass and blood serum of dairy calves with a molecular weight of 5,000 Daltons (glycolipids, nucleosides and nucleotides, amino acids, oligopeptides, trace elements, electrolytes, carbohydrate and fat metabolism intermediates). Typically, an injection solution of 8.5-42.5 mg / ml is used. Actovegin is also a product of animal origin - deproteinized hemoderivative of blood of calves. As a rule, a solution of 40-100 mg / ml is used.

Intraosseous administration of solcoseryl / actovegin / patients with rheumatic diseases of the joints and osteochondrosis of the spine with pain normalizes metabolic processes in bone tissue and joint tissues, improves blood supply to bone tissue, ligaments of the joints, reduces inflammation in the joints, swelling, facilitates pain, improves mobility joints.

The difference in the structure of bone sites causes the unevenness of metabolic processes in it and the speed of blood perfusion. With various kinds of disorders caused by injuries, diseases of bones or joints, this unevenness increases. Typically, drugs are intraosseously administered at a relatively constant rate of administration. The authors of the present invention found that with a certain mode and rate of infusion, redistribution of hydrostatic pressure and more active penetration of the active substance occur and, accordingly, it is possible to increase the concentration of the active substance and prolong its action.

Moreover, the preparations selected for the implementation of the method can be administered, if necessary, in a higher dose than in the known method with practically no side effects.

The choice of course depends on the age, prevalence of the lesion, pain, weight of the patient.

When carrying out the method carry out a constant tight fixation of the syringe with a needle by the hand of the operator. Solcoseryl (actovegin) is injected into the vertebral body along the posterior-lateral surface of the spine with a depth of 0.5 cm at a certain above speed (after preliminary anesthesia). The course of treatment is repeated, usually after 4-6 months, and if necessary, the course is repeated after 12-18 months.

Since two intraosseous injections may not necessarily cause a temporary increase in pain, it is possible to additionally prescribe non-steroidal anti-inflammatory drugs (NSAIDs), usually used by patients (diclofenac, nise, movalis) to stop it in doses known from the prior art for their doses effective for these purposes. In particular, diclofenac can be administered in a dose of 50-100 mg, Movalis - 7.5-15 mg.

The new method provides the penetration of the drug into the deep structures of the bones and the effective prolonged action of the drug on the affected tissue.

The technical result achieved through the use of the proposed method is a higher treatment efficiency, reduction of treatment time to 4-6 months, reduction of pain after the 3rd injection, as regards both the administration of the drug and the pain syndrome itself. In this case, a repeat of the course of treatment requires 60-70% of patients, in the remaining 30-40%, seizures stop within 1 course of treatment.

In addition to the articular complications of rheumatic diseases, solutions of solcoseryl (actovegin) were also introduced for prolonged pain syndromes in joints (large) according to the method described above. As a result, persistent relief of pain with the cessation of taking painkillers and anti-inflammatory drugs and restoration of joint function. A positive result of treatment is achieved during the course of treatment and lasts from 4 months to a year and a half. This reduces the dose of NSAIDs or the complete cessation of their intake. With positive clinical dynamics, positive x-ray dynamics, a change in the bone and cartilage structures, and an increase in the joint space are also noted.

The possibility of carrying out the invention can be illustrated by the following examples.

Example 1

Lyubovtseva Natalya Petrovna, 1950 D.O.

Diagnosis: OA. Coxarthrosis on the right. Aseptic necrosis of the head of the right femur. Was treated at the Institute of Rheumatology 2001-2002

Pain in the right hip joint worries about 1.5-2 years, had a growing character, subsequently joined restrictions on movement, lameness. 6 months before admission, the pain took on a pronounced character. An X-ray examination revealed a picture of aseptic necrosis, the right hip joint. Conservative treatment, NSAIDs, painkillers, physiotherapy with virtually no effect. The first course of intraosseous administration of "solcoseryl" was carried out in 2001, two procedures per five milliliters. Pain syndrome decreased by the end of treatment by 70-80% with a significant reduction in the dose of pain medication. The volume of movement increased, lameness decreased. After 8 months, due to newly growing pains, re-hospitalization was made.

A second course of intraosseous administration of Solcoseryl was carried out with a dose of 5 milliliters of 10 procedures. The introduction was carried out with a speed of: 1 ml 0.015-0.017 ml / s for 50-70 s, the next 2 ml with a speed of 0.017-0.02 ml / s for 100-120 s, the last 2 ml with a speed of 0.061-0 , 1 ml / s for 20-35 s.

That made it possible to completely stop the pain of the right hip joint. After 4 months, X-ray control of the joint was carried out, changes were noted in the femoral head in the form of a significant decrease in racemose in the femoral head, clear cartilaginous contours of the femoral head and acetabulum, an increase in the joint space. Currently, there are no complaints of joint pain, moderate limitation of movements and slight lameness are noted, does not use additional support when walking.

Example 2

Taran Sergey Ivanovich, b. 1955

Diagnosis: Rheumatoid arthritis, aseptic necrosis of the femoral head. Has been observed at the clinic of the Institute of Rheumatology since 1988 with a diagnosis of PA. Aseptic necrosis of the left femoral head was diagnosed in an X-ray in 2002, before the course of intraosseous administration of solcoseryl, the patient had severe pain in the joint, severe lameness due to a shortening of the left lower limb by 4 centimeters due to subluxation of the femoral head up and out. Conducted conservative treatment: NSAIDs, vascular preparations, pulse therapy, physiotherapeutic procedures, with practically no effect. In November 2002, a course of intraosseous administration of solcoseryl in five ml of 10 procedures was carried out: 1 ml at a rate of 0.015-0.017 ml / s for 50-70 s, the next 2 ml at a rate of 0.017-0.02 ml / s for 100 -120 s, the last 2 ml at a rate of 0.061-0.1 ml / s for 20-35 s).

As a result of treatment, the pain is completely stopped, painkillers are stopped. After a year and a half, the control x-ray showed significant positive dynamics in the form of compaction of bone and cartilage, articular gap, clear, smooth articular surfaces of the femoral head and acetabulum began to be traced. Currently, complaints of lameness due to shortening of the limbs by 2.5 cm, which is offset by an additional heel, there are no pains. Movement in the left hip joint in a moderately limited volume.

Example 3

Conchinskaya Irina Aleksandrovna, b. 1957

Diagnosis: Psoriatic arthritis. Aseptic necrosis of the head of the left humerus. The diagnosis of psoriatic arthritis for many years. Severe pain, restrictions in the left shoulder joint. Movements of almost rocking nature since 2001. An X-ray examination revealed a significant destruction of the head of the left humerus by about 1/5. Conducted conservative treatment of NSAIDs, painkillers, vascular drugs, physiotherapeutic procedures, massage, physiotherapy exercises with almost no effect. In November 2002, a course of intraosseous administration of solcoseryl in 3 ml of 10 procedures was carried out:

1 ml - with a speed of 0.015-0.017 ml / s for 50-70 s, the next 2 ml - with a speed of 0.017-0.02 ml / s for 100-120 s, the last 3 ml - with a speed) . 061-0.1 ml / s for 20-35 s.

As a result of treatment, complete relief of pain in the joint, after one month the function of the joint is almost completely restored, pain medication is stopped. Two years later, on a control x-ray, the complete reconstruction of the bone and cartilage structure of the head of the humerus, its restoration and increase of the joint space to normal. Currently, there are no complaints, joint function is satisfactory.

Example 4

Odinets Victoria Alexandrovna, born in 1979

Diagnosis: Systemic lupus erythematosus. Aseptic necrosis of the condyles of both tibia.

Sick since 1992, when arthritis of the joints appeared after ARI, initially diagnosed with rheumatoid arthritis, received NSAIDs, prednisone at a dose of 25 mg / day. Treatment with a positive effect. Against the background of a decrease in the dose of prednisolone until its cancellation, a "butterfly" appeared, increased hair loss, arthralgia. Conservative treatment was carried out with high doses of hormones, cytostatics. At the Institute of Rheumatology observed since 1998. Since January 2004, against the background of a general deterioration in well-being, an X-ray examination of the joints and MRI revealed aseptic necrosis of the knee joints with severe joint pain, swelling, limitation of movement and swelling of the lower leg. Conducted conservative treatment of the knee joints is ineffective. In March 2004, a course of intraosseous administration of solcoseryl in two milliliters of 5 procedures was performed in the area of the tibia epiphyses:

1 ml is injected at a rate of 0.015-0.017 ml / s for 50-70 s, the next 0.5 ml at a rate of 0.017-0.02 ml / s for 100-120 s, the last 0.5 l at a rate of 0.061 -0.1 ml / s for 2-35 s.

As a result, swelling and pain are almost stopped. Joint movement in full. After 4 months, the aggravation of the joint syndrome of the knee joints again, a repeated course of treatment with solcoseryl in 4 ml of 10 procedures in the epiphyses of the tibia was carried out:

1 ml is injected at a rate of 0.015-0.021 ml / s for 50-70 s, the next 1.5 at a rate of 0.017-0.02 ml / s for 100-120 s, the last 1.5 ml at a rate of 0.061- 0.1 ml / s for 2-35 s.

A more persistent effect is noted throughout the year. With x-ray control, aseptic necrosis is not determined. There are no complaints from the knee joints, movements are fully restored.

Example 5

Radchenko Yuri Nikolaevich, born in 1957

Diagnosis: Lumbar osteochondrosis. Radicular pain on the right at the level of L3-L4. The diagnosis of lumbar osteochondrosis for 8 years, was repeatedly treated on an outpatient basis by a neurologist with a temporary positive effect. In 2003, several exacerbations of diseases were noted in the form of radicular syndrome 3-4 times. Due to the low efficiency of drug treatment, physiotherapeutic procedures, massage, physiotherapy, manual therapy, the patient decided to take a course of intraosseous injection of solcoseryl into the body of the L3-L4 vertebrae, two ml in each vertebra of 10 procedures.

1 ml is injected at a rate of 0.015-0.017 ml / s for 50-70 s, the next 0.5 ml at a rate of 0.017-0.02 ml / s for 100-120 s, the last 0.5 ml at a rate of 0.061 -0.1 ml / s for 2-35 s.

As a result of treatment, a lasting positive effect was obtained during the year without taking additional medications. At the moment, after a year, there are no complaints, the movement in the lumbar in full. Neurological disorders are not observed.

A total of more than 500 patients were treated. In rheumatic diseases with aseptic necrosis of the joints, repeated courses of treatment were carried out. Duration of observation from 1 year to 10 years. The age of patients is from 15 to 90 years. Other diseases in which pain is effectively stopped after a course of intraosseous administration of a solution of solcoseryl (Actovegin) include post-traumatic joint pain, the so-called shoulder-scapular periarthritis (PLP), postoperative joint pain syndromes, systemic lupus erythematosus (SLE).

Table Intraosseous administration of solcoseryl / Actovegin / patients with rheumatic diseases of the joints and osteochondrosis of the spine with pain Name of joints DISEASE RA DOA Hard currency Hip joint 102 71 9 Knee-joint 64 34 four Shoulder joint 2 22 7 Spine 3 fourteen - Total: 198 141 twenty Other diseases 100 cases.

Thus, a new effective treatment method has been proposed that can be widely used in clinical practice.

Claims (2)

1. A method of treating articular complications of rheumatic diseases by intraosseous administration of a solution of solcoseryl or actovegin, characterized in that the solution is injected into the affected area in a volume of 2-5 ml with a course of 5-10 procedures 2 times a week, while 1 ml is administered at a rate of 0.017 -0.015 ml / s, and the rest of the volume is injected in equal parts, and the rate of introduction of the first of them is 0.02-0.017 ml / s, and the second is 0.061-0.1 ml / s. 2. The method according to claim 1, characterized in that the course is repeated after 4-6 months.