RU2703257C1 - Method of treating inflammatory processes of joints and prostatitis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to therapy, and can be used for treating such inflammatory processes as prostatitis and arthritis. Method according to invention includes injectable introduction of the preparation based on a complex of serum albumin recovered from a follicular fluid of cattle and a protein of the TGF family in dose of 150 to 400 mg of total protein per one injection.

EFFECT: use of the invention allows higher clinical effectiveness ensured by the strong anti-inflammatory action of the preparation, suppression of synthesis of pro-inflammatory cytokines, reduced activity of macrophages, and absence of side effects.

5 cl, 12 ex

Description

The invention relates to medicine, in particular for the conservative treatment of various inflammatory processes, such as radiculitis, arthritis, arthrosis, gout, osteochondrosis, etc.

Inflammatory processes in the human body are the most common diseases that tend to progress with age and depending on the influence of pathological factors (chronic injuries, metabolic disorders, intoxications, etc.). The etiology of the above diseases is due to a violation of cellular and tissue metabolism, the occurrence of congestion in organs and tissues, causing the development of inflammatory processes of edema, leading to biochemical changes in the tissues. The surrounding tissue, nerve fibers and neurovascular formations are involved in the process. Soreness, joint mobility limitation, reflex-tonic muscle tension, motor disorders develop. The development of diseases can lead to a degenerative change in the structure of tissues, their loss of elasticity, fibrosis and, as a consequence, to the formation of contractures in the muscles and ligaments, ossification of the cartilage, destruction of bone and atrophy of the nervous tissue, that is, to a violation of the functions of the neuromuscular and bone ligamentous apparatus.

The treatment of inflammatory processes is aimed primarily at stopping the pain syndrome and reducing inflammation, swelling, reducing reflex muscle tension, followed by exposure to the painful organ with various drugs to restore its function.

In inflammatory processes of muscles, joints, bone tissue (rheumatoid diseases), non-steroidal anti-inflammatory drugs are more often used that have anti-inflammatory, analgesic and antipyretic effects: Ketoprofen; Nimesulide; Ibuprofen; Flurbiprofen; Naproxen; Thioprofenic acid; Phenoprofen; Sinprofen. The analgesic effect, as a rule, occurs on 3-4 days, and its maximum develops only by 7-10 days. The course of treatment with non-steroid drugs should be limited to 10-14 days. This is due to the fact that with a longer intake, the risk of adverse reactions and complications increases sharply. Common complications are stomach or duodenal ulcers, liver, kidney, arterial hypertension, and allergic manifestations. In this regard, they have a limited range of uses and are used with great care in the treatment of elderly patients.

In the case when treatment with non-hormonal drugs is not enough, and the disease continues to progress, the doctor may prescribe injections of hormonal drugs. They help to quickly eliminate pain, relieve inflammation and swelling of the surrounding tissues. However, they also cause a lot of side effects, even more serious than non-hormonal ones. External use of hormones should be strictly calculated, since the active substance still enters the body.

In addition, a lot of anti-inflammatory procedures have been developed, such as physiotherapy, massage, physiotherapy exercises, which also have a stimulating effect on blood and lymph circulation, which improves tissue metabolism and reduces congestion in cells and tissues.

Inflammatory processes can have a chronic relapsing course with regularly recurring periods of exacerbations. The treatment of such diseases lasts for years. Timely treatment courses lead to an improvement in the general condition of the patient’s body and an increase in the period of remission.

A known method of treating inflammatory processes (RU 2104000, class A61K 31/155, 1998) comprising taking non-steroidal drugs or glucocorticoids with the additional prescription of the drug group of biguanides.

However, such treatment is fraught with a lot of side effects and causes only temporary relief.

It is known to use painkillers and absorbable drugs for exacerbations of lumbosacral radiculitis, sciatica, plexitis, myalgia, neuralgia, arthritis Nayaksina and Viperalgin preparations containing some fractions of snake venom, in particular neurotoxins.

A known method of treating diseases of the musculoskeletal system and peripheral nervous system by injection of vipraxin. (Mashkovsky M. D. Medicines. - M.: Medicine, 1988, v. 2, p. 165-166). Vipraksin (Viproxinum pro injectionibus, VFS 42-1481-84, "Vipraksin for injection") - an aqueous solution of dry native unfractionated venom of the common viper (Vipera berus berus). Vipraxin is used as a painkiller and anti-inflammatory agent for neuralgia, arthralgia, myalgia, polyarthritis, myasitis.

The treatment is symptomatic, it is carried out during an exacerbation of the disease in case of pain and / or inflammation, that is, when there is swelling, soreness, redness of the sore spot.

Vipraxin is administered intramuscularly, subcutaneously or intradermally directly to the site of greatest pain. The initial dose is 0.2 ml. After the disappearance of the local and general reaction, but not earlier than 3 days later, the injection is repeated. Further treatment depends on the individual characteristics of the body. Typically, the amount of vipraxin administered is increased by 0.1 ml. The maximum single dose is 1 ml, the course of treatment is 10 injections, after which it is discontinued regardless of the effect achieved due to the danger of an overdose of poison and intoxication of the body.

However, when introduced into the body, vipraxin can cause vascular spasms, a disturbance in the rhythm of heart contractions, and lowers blood pressure; therefore, its use is contraindicated in the presence of cardiovascular diseases, insufficiency of cerebral and venous circulation, diseases of the liver and kidneys, angiospasm, and also with active tuberculosis and neoplasms. In addition, the use of this drug does not provide a long and deep therapeutic effect. The presence of a large number of contraindications prevents its widespread use in medical practice.

A known method of therapeutic use of a reparative-regenerative preparation containing a biologically active component based on poison of animal origin (RU 2146146, Cl. A61K 35/58, A61K 31/13, A61K 9/08, 2000), including the introduction of the drug into the area of the diseased organ or in projecting it onto the patient’s body together with concomitant drugs with dosing of its administration in quantitative and temporal terms until a stable therapeutic effect is achieved, taking into account the patient's tolerance and reaction to the administration of this drug. As a concomitant drug, a conductor anesthetic is chosen that prevents the occurrence of negative side effects on the administration of the reparative-regenerative drug, given that these drugs are administered cyclically in n ₂ stages within 1≤n ₂ ≤25 with a total number of n ₃ injections, which are chosen in within 1≤n ₃ ≤154 so that at each stage n ₄ injections are made, which is chosen within 1≤ (n ₃ + n ₄ ) / n ₄ . Injections are carried out to a depth of L ₁ , which is selected with respect to the maximum permissible depth L ₂ within 1≤ (yL ₁ + L ₂ ) / L ₂ ≤2, where y is the experimental coefficient, which is chosen depending on the necessary reduction and regulatory and / or organ exposure to the drug within 0.65≤y≤1.4. The injection injection area S ₂ is selected with respect to the area S _{3 of the} projection of the diseased organ onto the surface of the patient’s body within 1≤ (δS ₁ + S ₃ ) / S ₃ ≤7, where δ is the experimental coefficient chosen depending on the patient’s local response to the drug and / or the degree of localization of the disease process within 0.56≤δ≤1.8, using the total dose m _{1 of the} drug as a whole, which is chosen in relation to the mass m _{2 of the} sick patient within 3.3 • 10 ^-6 ≤m ₁ / m ₂ ≤1.5 • 1.5 • 10 ^-4 , while the dose of m ₃ conductive anesthetic is chosen with respect to m ₁ within 0.28≤εm ₃ / m ₁ ≤3.4, where ε is the experimental coefficient selected depending on the pharmacological and / or pharmacokinetic effectiveness of the anesthetic in the range 0.35≤ε≤1.4.

The indicated method of treatment is quite complicated when used, because requires accurate dosage and the exact injection site, which requires highly qualified medical personnel. In addition, when using this method of treatment, it is necessary to use concomitant drugs - conductive anesthetics to prevent adverse side effects on the administration of the drug. Treatment with a drug based on animal poison has contraindications in the form of intolerance by some patients of poisons. In this case, the treatment does not have a lasting effect.

The problem of the invention is the development of a simple, safe and effective method of treating inflammatory processes in which there are no disadvantages of the known methods.

The technical result of the invention is to increase the therapeutic effect in the practice of treating inflammatory processes of the joints and prostatip due to inflammatory processes without side effects, as well as expanding the arsenal of medications for conservative treatment.

The posed problem and the indicated technical result is achieved by the fact that the method of treating inflammatory processes of the joints and prostatitis is carried out by intramuscular injection of the drug based on a biologically active component. According to the invention, the injection is carried out on the basis of a complex of serum albumin isolated from cattle follicular fluid and a protein of the TGF family in a dose of 150 to 400 mg of total protein per injection.

The course of treatment includes from 5 to 10 injections, 1 injection daily.

Treatment, depending on the severity of the disease, is carried out in courses from 1 to 5 with breaks between courses of one month.

Before injection, the drug is preheated in water from 90 to 100 ° C.

As a preparation based on a biologically active component, including a complex of serum albumin isolated from cattle follicular fluid and a protein of the TGF family, Endoferin is used, which is used to treat endometriosis. The study revealed that this drug has a lasting therapeutic effect in the treatment of inflammatory processes in the joints (arthritis, arthrosis, gout, osteochondrosis), as well as non-infectious forms of prostatitis).

The complex of biologically active components of serum albumin isolated from cattle follicular fluid and a protein of the TGF family are proteins from the TGF-β superfamily, which was confirmed both in in vitro experiments using specific antibodies and in vivo biological activity. As a result of the experiments, it was found that the drug “Endoferin” has a strong anti-inflammatory effect, inhibits the synthesis of pro-inflammatory cytokines (IFNα and β, IFNγ, IL1β, IL6) by 50% - 100%, reduces the activity of macrophages. These proteins have the ability not only to suppress inflammation, but also contribute to the growth (restoration) and differentiation of bones.

The selected dose of 150 to 400 mg of total protein per injection is calculated according to existing methods and depends on the disease and its severity, on the person’s body weight. Moreover, when a single dose of less than 150 mg is administered to the patient, there will not be a persistent anti-inflammatory effect, and exceeding a single dose of more than 400 mg does not lead to an increase in action compared to lower doses.

Treatment with a course of 5 to 10 injections also depends on the disease and its severity, as well as on the gender and age of the patient. The number of injections less than 5 is not effective, only temporary relief of symptoms occurs with mild forms of the disease, and exceeding doses of the drug more than 10 times is inappropriate. Moreover, for a more lasting effect in especially severe cases of diseases, it is possible to repeat treatment courses up to 5 times with interruptions of 1 month. Exceeding the five-time course is impractical.

Preliminary preparation of the drug by heating and then cooling is necessary to exclude anaphylactic reactions.

A method of treating inflammatory processes is illustrated by the following examples.

Example 1

The man is 63 years old. Diagnosis after hospitalization (10/05/2017 02/11/2017): purulent arthritis of the left knee joint, condition after surgical treatment (05/05/2017), exacerbation, contracture of the knee joint of the Federal Tax Service 2. Treatment: antibiotics (teicoplanin, imitsinem , vancomycin), fluconazole, l / lysine escinate, B vitamins, antiplatelet agents.

Radioisotope study of the knee joint zone from 11/09/2017. Scintigraphically pronounced hyperfixation of the osteotropic radiopharmaceutical in the left knee joint, mainly in the subchondral region of the condyles of the femur and tibia. The accumulation rate is about 250-450% with respect to the right knee joint.

A course of treatment with Endoferin was performed in the amount of 10 injections intramuscularly daily. Before injection, Endoferin was dissolved in water, and then heated in boiling water for 3 minutes, and then cooled to room temperature over 30–40 minutes. The course of treatment included 10 injections per month, repeated for three consecutive months from February 2018 to April 2018. The dose of Endoferin was 300 mcg per 1 injection.

MRI - study of the knee joint zone after treatment from 05/21/2018 - organic changes in the structures of the left knee joint. Moderate synovitis of the left knee joint. Left-sided gonarthrosis. Radioisotope study of the knee joint zone from 05/21/2018. Diffuse focal hyperfixation of an osteotropic radiopharmaceutical in the left knee joint with an intensity of up to 210% is visualized. With spectral tomography of the knee joints, an increase in the accumulation of the drug is noted in the projection of the condyles of the left tibia.

Scintigraphic signs of osteochondrosis, arthroso - arthritis of the left knee joint are noted.

Thus, the reduction of the symptoms of the disease is on the face, and not just a temporary decrease in their manifestation, as with other drugs.

Endoferin treatment did not reveal side effects.

Example 2

The patient is 65 years old. An acute attack of radiculitis. Conducted 1 course of treatment with Endoferin (10 injections every day intramuscularly) similarly to example 1. After the fourth injection, the pain was removed. The patient returned to a normal lifestyle. Side effects in the treatment with Endoferin have not been identified.

Example 3

The patient is 62 years old. Exacerbation of the inflammatory process in the knee joint (bed patient, severe pain). Conducted 1 course of treatment with Endoferin (10 injections every day intramuscularly) as in example 1. At the fifth injection, the pain syndrome was removed. Walks with a cane after two courses of treatment. Endoferin treatment did not reveal side effects.

Example 4

The patient is 70 years old. Radiculitis. Severe pain (could not walk a hundred meters). Conducted 1 course of treatment with Endoferin analogously to example 1. At the fifth injection of Endoferin, the pain was completely relieved. After the second course of treatment, he moves freely. Endoferin treatment did not reveal side effects.

Example 5

The patient is 75 years old. Osteochondrosis. He lay, was not able to turn even to his side. Conducted 1 course of treatment with Endoferin (course of 10 injections of 300 μg) as in example 1. At the fifth injection, the pain syndrome was removed. It goes. Checked out. Within 9 months, the pain did not recur. Endoferin treatment did not reveal side effects

Example 6

The patient is 55 years old. An attack of gout, conducted five injections of Endoferin, a dose of 400 mg of total protein, after which gout attacks do not resume within a year.

Example 7

The patient is 59 years old. Prostatitis, one course was carried out, ten injections of Endoferin, a dose of 150 mg of total protein. Normal urination recovered, pain disappeared. Symptoms of prostatitis were not noted during the year.

Example 8

The patient is 45 years old. An attack of radiculitis. Conducted 2 courses of treatment with Endoferin (20 injections) of 300 mg of total protein. After the fourth injection of Endoferin, the pain was relieved. The patient returned to a normal lifestyle.

Example 9

The patient is 47 years old. Osteochondrosis. Moved with great difficulty. After 10 injections with Endoferin, a dose of 150 mg of total protein, the pain was relieved. It goes. Checked out. In the following months, two more courses of treatment were carried out. Within 8 months, the pain did not recur.

Example 10

The patient is 50 years old. Exacerbation of the inflammatory process in the hip joint, moved on crutches. After 4 courses, with a dose of 400 mg, the patient moves freely without crutches and sticks. During the year, the pain did not recur.

Example 11

The patient is 47 years old. The exacerbation of the inflammatory process in the knee joint was difficult to move. After one course, a dose of 300 mg of endoferin pain disappeared. Moves freely throughout the year, pain attacks did not recur, allergic phenomena were not observed.

Example 12

The patient is 52 years old. Started prostatitis, after five courses with a dose of Endoferin 150 mg, the symptoms of the disease are removed. During the year, the patient feels satisfactorily, the attacks of the disease did not recur, allergic phenomena were not observed.

Thus, the benefits of treating inflammatory processes of the joints, as well as prostatitis by Endoferin, are obvious. In addition, during clinical trials there were no cases with side effects. The treatment is effective and multifunctional.

Claims (5)

1. A method of treating inflammatory processes of joints and prostatitis by intramuscular injection of a drug based on a biologically active component, characterized in that the drug is injected based on a complex of serum albumin isolated from cattle follicular fluid and a TGF family protein in a dose of 150 to 400 mg total protein per injection. 2. The method according to p. 1, characterized in that the course of treatment includes from 5 to 10 injections, 1 injection daily. 3. The method according to p. 1, characterized in that the treatment is carried out in courses from 1 to 5 with breaks between courses of one month. 4. The method according to p. 1, characterized in that before the injection, the drug is preheated in water from 90 to 100 ° C. 5. The method according to p. 1, characterized in that endoferin is used as a preparation based on a complex of serum albumin isolated from cattle follicular fluid and a protein of the TGF family.