RU2573631C2 - Method of treating patients with rheumatoid arthritis - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: as medications administered are: methotrexate 15 mg per week intake, folic acid 5 mg per week intake, movalis 15 mg per day intake. Laser therapy is administered in differential way depending on degree of disease activity and leptin level. In case of second stage of rheumatoid arthritis - index DAS28 3.2-5.1, leptin level, equal or lower than 6.4±0.42 pg/ml, 7 daily procedures of intravenous laser irradiation are carried out. Radiating head KL-VLOK with wavelength 635 nm, power at the end of disposable light guide 1.5 mW, exposure time 15 minutes and laser head KL-VLOK-365 with wavelength 365 nm, power at the end of light guide 1.0 mW, exposure time 5 minutes, are alternated. In case of third degree of activity index DAS28 is higher than 5.1, leptin level is equal or is higher than 8.8±0.72 pg/ml, 10 procedures are carried out. Radiating head KL-VLOK with wavelength 635 nm, power at outlet of disposable light guide 1.5-2.0 mW, exposure time 15 minutes and laser head KL-VLOK-365 with wavelength 365 nm, power at outlet of disposable light guide 1.0 mW, time of exposure 5 minutes.

EFFECT: method makes it possible to reduce frequency of exacerbations, reduce expression of clinical manifestations, reduce drug load on patient, provides earlier arrest of disease symptoms due to differentiated approach in case of administration of intravenous laser irradiation of blood and its normalising action on dynamics of leptin level and reduction of disease activity degree.

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Description

The invention relates to medicine, namely to rheumatology, and for the treatment of patients with rheumatoid arthritis. Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease of the connective tissue, accompanied by a primary lesion of the peripheral joints and the development of erosive-destructive changes in them.

According to the WHO, the frequency of occurrence in the population is from 0.6 to 1.3%, and women suffer from this disease three times more often than men. Rheumatoid arthritis affects people of any age, including the most able-bodied, has a tendency to steady progression and very often leads to disability. The life expectancy of patients with RA is 10-15 years below the population. All this makes this disease extremely socially significant. RA is one of the most expensive diseases. Currently available drugs, although they have an undoubted positive effect on the quality of life of patients with rheumatoid arthritis, are not able to provide sufficient inhibition of the inflammatory process, destructive lesions of the joints and an increase in functional manifestations. The use of a relatively new and promising method of treating rheumatoid arthritis, such as therapy with genetically engineered biological drugs, as well as combination therapy with basic anti-inflammatory drugs (BPV), given the etiopathogenetic effect, of course leads to a significant therapeutic effect. But it is necessary to reckon with the fact that this is a very expensive method of treatment, which has many contraindications and limitations, which may not be used in all patients.

All this leads to the search for new ways and methods of treating patients with rheumatoid arthritis that would satisfy all the requirements. The literature contains information about many of the positive properties of intravenous laser irradiation of blood, in particular anti-inflammatory, antioxidant, stimulation of factors of specific and non-specific immunity. But still, aspects of the effect of intravenous laser irradiation of blood on some links in the pathogenesis of rheumatoid arthritis remain unexplored. A known method of treating rheumatoid arthritis using low-intensity laser radiation.

The closest set of essential features to the claimed invention is a method of treating patients with rheumatoid arthritis using contact laser therapy, which we took as a prototype (Evstratova EF "Clinical and pathogenetic mechanisms of the effectiveness of low-intensity laser radiation and antibodies to tumor necrosis factor alpha in patients with rheumatoid arthritis and osteoarthrosis with diseases of the internal organs. "), including the use of a sublingual preparation of arthrofoone in combination, 2 tablets 4 r / ut and / or 1st tablet 4 times a day from 3 to 6 months and epicutaneous laser radiation using a semiconductor laser device "Mustang 2000" with the radiating head LGS-2000. We used infrared pulsed laser radiation with a wavelength of 0.89 μm, the pulse frequency was 80 - 1500 Hz, for the course of treatment 10-15 procedures. Daily affected the following joints:

1. Temporomandibular joint.

2. The sternoclavicular joint.

3. Acromioclavicular joint.

4. The shoulder joint.

5. The elbow joint.

6. Metacarpophalangeal joints of the hand.

7. Proximal interphalangeal joints of the hand.

8. The hip joint.

9. The knee joint.

10. Ankle joint.

11. The calcaneal joint

12. The joint of Shopar.

13. The joint of Lisfranca.

14. Metatarsophalangeal joints of the foot.

15. Interphalangeal joints of the foot.

16. The cervical spine.

The duration of exposure on the field ranged from 1 to 4 minutes and was selected depending on the number of fields and pain sensitivity according to the Richie index. In one session, the total radiation time did not exceed 10-15 minutes when irradiating no more than 2 joints.

The selected prototype and the claimed invention has the following essential features: the simultaneous use of drugs and laser therapy.

In our opinion, the disadvantage of the prototype is that patients are prescribed transcutaneous laser blood irradiation, while the claimed invention has chosen the method of intravenous laser irradiation of blood, due to which a set of changes in the blood occurs, which are considered as a response of the homeostasis regulation system to pathological processes in individual organs and tissues. In addition, the onset of the clinical effect in the form of a reduction in pain, a decrease in the length of time of morning stiffness, a decrease in the configuration of the affected joints of varying severity was noted already in the 3rd - 4th procedure for the use of combination therapy using intravenous laser irradiation of blood, and at the end of the course of laser therapy in most patients, these manifestations were not observed. The clinical effect in patients who received treatment according to the prototype we compared came much later (12-14 days of the study) and the manifestations of clinical improvement were much less pronounced. The invention is aimed at solving the problem of creating a method for a differentiated approach to the treatment of patients with rheumatoid arthritis using intravenous laser irradiation of blood.

The solution to this problem will reduce the frequency of exacerbations, reduce the period of disability, reduce the severity of clinical manifestations, provide a positive impact on the pathological processes that develop with rheumatoid arthritis, reduce the drug load and provide justification for the effectiveness and need for intravenous laser irradiation in the complex treatment of patients with rheumatoid arthritis, taking into account the most important pathogenetic links of this disease.

To achieve this technical result, the claimed invention of a method for treating patients with rheumatoid arthritis includes the following essential features - the integrated use of drugs (Methotrexate, Folic acid, Movalis) and intravenous laser blood irradiation, which is prescribed differentially depending on the degree of disease activity, the level of leptin concentration in blood serum, with a second degree of rheumatoid arthritis activity - DAS28 index 3.2-5.1, leptin level equal to and less than 6.4 ± 0.42 pg / ml, - 7 daily intravenous laser irradiation procedures are performed, alternating every other day with a KL-VLOK emitting head with a wavelength of 635 nm, a power of 1.5 mW at the end of a single-use fiber, an exposure time of 15 minutes and a KL-VLOK-365 laser head with a wavelength of 365 nm, power at the end of the fiber 1.0 mW, exposure time 5 minutes; with the third degree of activity - the DAS28 index is more than 5.1, the level of leptin equal to and more than 8.8 ± 0.72 pg / ml - 10 procedures are performed with alternating every other day the KL-VLOK emitting heads with a wavelength of 635 nm, power at the output of a single-use fiber 1.5-2.0 mW, an exposure time of 15 minutes and a laser head KL-VLOK-365 with a wavelength of 365 nm, a power at the output of a single-use fiber 1.0 mW, an exposure time of 5 minutes.

In relation to the prototype, the claimed invention has the following distinctive features - Methotrexate at a dose of 15 mg per week inside is used as a basic anti-inflammatory drug, Folic acid 5 mg per week inside is additionally used and Movalis 15 mg is used as a non-steroidal anti-inflammatory drug, and an intravenous laser is prescribed in parallel blood irradiation differentially depending on the degree of activity of the disease, the level of concentration of leptin in the blood serum, with a second degree of In particular, rheumatoid arthritis - DAS28 index 3.2-5.1, leptin level equal to and less than 6.4 ± 0.42 pg / ml - 7 daily intravenous laser irradiation procedures are performed with alternating every other day the KL-VLOK radiating head with a length of waves of 635 nm, power at the end of a single-use fiber 1.5 mW, exposure time 15 minutes and a laser head KL-VLOK-365 with a wavelength of 365 nm, power at the end of the fiber 1.0 mW, exposure time 5 minutes, with the third degree of activity - the DAS28 index is more than 5.1, the level of leptin is equal to and more than 8.8 ± 0.72 pg / ml, - 10 procedures are carried out p alternating every other day with KL-VLOK emitting heads, with a wavelength of 635 nm, output power of a disposable fiber 1.5-2.0 mW, exposure time of 15 minutes and a KL-VLOK-365 laser head with a wavelength of 365 nm, power at the output of a 1.0 mW single-use fiber, the exposure time is 5 minutes.

There is the following causal relationship between the distinguishing features and the technical result: as a result of the use of the CL-VLOK intravenous laser blood irradiation technique, a normalizing effect on the dynamics of the leptin level is noted, the degree of disease activity decreases (DAS28 index), the effectiveness of the drug therapy is increased, an earlier occurrence relief of the symptoms of the disease, the drug load on the patient is reduced.

According to the information available to the authors, the set of essential features characterizing the essence of the claimed invention is not known, which allows us to conclude that the invention meets the criterion of "novelty."

According to the authors, the essence of the claimed invention does not follow explicitly from the known level of medicine, since it does not reveal the above method of treatment of CL-VLOK, which allows us to conclude that its criterion is “inventive step”.

The set of essential features characterizing the essence of the invention, in principle, can be used repeatedly in medicine with obtaining a technical result, which consists in increasing the effectiveness of laser therapy for patients with rheumatoid arthritis, which allows us to conclude that the invention meets the criterion of "industrial applicability".

This method is as follows.

All patients with rheumatoid arthritis undergo complex drug therapy (basic anti-inflammatory drugs, non-steroidal anti-inflammatory drugs) using a course of intravenous laser therapy.

The proposed method for the treatment of patients with rheumatoid arthritis was used in 132 patients, of which 118 people were women, 14 people were men, the average age was 54.5 ± 13.3. All patients with rheumatoid arthritis were randomly divided into two groups: control (30 people) and main (102 people). In the I (control) group, only traditional drug therapy was used, patients of the II group (main), in addition to drug therapy, received a course of intravenous laser blood irradiation.

The diagnosis of rheumatoid arthritis was established on the basis of clinical, laboratory and instrumental research methods. The course of intravenous laser therapy was carried out using the Matrix-VLOK apparatus (Matrix, Russia). The course of treatment consisted of 10 and 7 sessions for one patient, depending on the detected degree of disease activity, alternating every other day with a KL-VLOK emitting head with a wavelength of 635 nm, output power of a single-use fiber 1.5-2.0 mW, exposure time 15 minutes and a laser head KL-VLOK-365 with a wavelength of 365 nm, a output power of a disposable fiber of 1.0 mW, exposure time of 5 minutes. Procedures were performed daily, seven days a week.

We studied the serum leptin content in patients of the main and control groups before and after treatment. It is believed that leptin acts not only as a hormone of adipose tissue, but also as a pro-inflammatory cytokine. It activates the phagocytic function, initiates the synthesis of pro-inflammatory cytokines by monocytes and macrophages, and increases the production of interferon by peripheral T cells. In addition, leptin stimulates the production of metalloproteinases in cartilage and, accordingly, stimulates apoptosis of chondrocytes.

In the group of patients who received, in addition to traditional drug therapy, an intravenous laser blood irradiation course, a significant decrease in leptin content from 8.825 ± 0.720 pg / ml to normal values of 6.900 ± 0.601 pg / ml (p <0.05) was noted after treatment. In the control group after treatment, a decrease was also noted from 10.36 ± 1.237 pg / ml to 8.635 ± 1.062 pg / ml, but it does not reach normal values and is statistically insignificant.

The effect of intravenous laser blood irradiation on the activity of rheumatoid arthritis was studied. So in the main group, the DAS28 indicator from 5.792 ± 0.079 decreases to 2.763 ± 0.067 (p <0.001). In the control group, the DAS28 after treatment remains significantly higher compared to the main group and is 3.232 ± 0.133 (p <0.001). Thus, from the foregoing, it follows that the anti-inflammatory effect of combination therapy with a course of intravenous laser therapy is superior to traditional drug therapy. To illustrate the method of treating patients, including the use of drugs and laser therapy (KL-VLOK-635 and KL-VLOK-365), as well as normalizing the effect on the level of leptin, reducing the activity of the disease, we give brief examples.

Example 1. Patient K., 40 years old. Was admitted to the rheumatology department with complaints of pain in the small joints of the hands, wrist, elbow, knee, ankle joints, "inflammatory" rhythm, swelling of the joints, limitation of the range of motion in them due to pain, stiffness in the morning, lasting until lunchtime, general weakness. The onset of the disease about 2 years ago, when there were pains, limitation of movements, swelling of small joints of the hands, ankles. The onset of the disease does not associate with anything. Gradually, other joint groups began to get involved in the process. During the examination, the diagnosis of Rheumatoid Arthritis was verified. Accepts BPVP-Methotrexate 10 mg / week. The real deterioration in the last month, when the above complaints intensified. Objectively: the general state of moderate severity of the articular syndrome. The color of the skin is pale pink. Peripheral lymph nodes are not enlarged. Status localis - the configuration of proximal interphalangeal, metacarpophalangeal, wrist, ankle, knee joints due to exudative-proliferative changes. Palpation of the joint spaces is painful. The symptom of lateral compression of the hands is positive. Compression force into a fist 3 points. The range of motion in the joints is limited. Hypotrophy of the interosseous muscles. YOUR - 80 points.

In the lungs - vesicular breathing, no wheezing. NPV 16 in 1 min.

Cor-tones: I tone is muffled, the rhythm is correct. Heart rate - 71 beats per 1 min. HELL 110/70 mm Hg

The abdomen is soft, painless. The liver does not come out from under the edge of the costal arch. The size of the liver according to Kurlov is 9-8-7 cm.

The symptom of lumbar effusion is negative on both sides.

General blood test: Er - 4.07 × 10 ¹² / l; Hb - 112 g / l; Ht - 35.8%, Lc - 11.2 × 10 ⁹ / L; Tr - 173 × 10%, ESR - 46 mm / hour.

Urinalysis without pathological changes.

Biochemical analysis of blood: RF - 39e, CRP - +++.

Research of ATsPP: ADTSP - 125 Units / ml.

R ⁰ gr. hands: signs of deforming arthrosis of the left wrist joint, the joint gap narrowed with severe sclerotic changes in the articular surfaces.

When examining the level of leptin before treatment, it amounted to 8.720 pg / ml. The DAS28 index before treatment was 5.7, which corresponds to the third degree of disease activity.

A course of intravenous laser blood bleaching was prescribed for 10 days, alternating every other day with KL-VLOK emitting heads with a wavelength of 635 nm, a output power of 1.5 mW disposable fiber, an exposure time of 15 minutes, and a KL-VLOK-365 laser head for U FOK with a wavelength of 365 nm, a single-output fiber output power of 1.0 mW, an exposure time of 5 minutes. Procedures were performed daily, seven days a week. Laser therapy was carried out while taking medications.

By the fourth procedure, the patient began to notice a decrease in pain, a decrease in swelling of the affected joints, an increase in the range of motion in the affected joints. By the end of the course of treatment, patient K. noted a complete relief of pain, the range of motion in the joints increased significantly, the movement in the affected joints became freer. Joint defenses were practically absent; the patient was not marked by morning stiffness by the time the course of laser therapy was completed. YOUR - 30 points.

In the study of a general blood test after treatment, positive dynamics were noted: a decrease in the level of leukocytes, ESR: Er - 4.10 × 10 ¹² / l; Hb - 120 g / l, Ht - 36.0%, Tr - 164 × 10 ⁹ / l, Lc - 5.4 × 10 ⁹ / l, ESR - 7 mm / hour. In the biochemical analysis of blood, a decrease in the level of the RF and CRP was noted: RF - 15e; CRP - neg.

After the complex treatment, we noted a decrease and normalization of leptin levels to 6.954 pg / ml. The DAS28 index after treatment in this patient was 1.7.

Example 2. Patient W, 67 years old. Suffers from rheumatoid arthritis since 2002. Debut of the disease with pain and swelling of the knee joints. The onset of the disease does not associate with anything. In 2005, he was diagnosed with Rheumatoid Arthritis. Received inpatient, outpatient treatment. Since 2010, he began to notice the appearance of deformed small joints of the hands. FROM BPVP takes methotrexate 10 mg / week. Deterioration in recent months in the form of the appearance of "inflammatory" pain in the small joints of the hands, feet, ankle, wrist, knee, elbow, and shoulder; swelling of the affected joints; limitation of range of motion in them, stiffness for 2-3 hours, general weakness. Objectively: the state of moderate severity of the articular syndrome. The color of the skin is pale pink. Peripheral lymph nodes are not enlarged. Status localis - deformation, configuration of proximal interphalangeal, metacarpophalangeal, wrist, ulnar, metatarsophalangeal, interphalangeal feet, ankles, knee joints due to exudative-proliferative phenomena. Ulnar deviation of the metacarpophalangeal joints on the left. Hypotrophy of the interosseous muscles. Palpation of the joint spaces is painful. Symptom of lateral compression of the hands, feet positive. The range of motion in them is limited. Compression force into a fist 3 points. YOUR - 80 points.

When conducting additional research:

General blood test: Er - 5.04 × 10 ¹² / l; Hb - 133 g / l; Ht - 40.1%, Lc - 11.1 × 10 ⁹ / L; Tr - 237 × 10 ⁹ / l, ESR - 20 mm / hour.

Urinalysis without pathological changes. Biochemical blood test: RF - 20e, CRP ++.

Research ATsPs: ATsPs - 4 Units.

R ⁰ gr. hands: Arthroso-arthritis of the joints of both hands.

In the study of leptin, its concentration in the blood was 7.844 pg / ml. The DAS28 index before treatment was 4.9, which corresponds to the II degree of activity of this disease.

A course of intravenous laser blood bleaching was prescribed for 7 days, alternating every other day with KL-VLOK emitting heads with a wavelength of 635 nm, a output power of 1.5 mW disposable fiber, an exposure time of 15 minutes, and a KL-VLOK-365 laser head for U FOK with a wavelength of 365 nm, a single-output fiber output power of 1.0 mW, an exposure time of 5 minutes. Procedures were performed daily, seven days a week. Laser therapy was carried out while taking medications.

By the third procedure, the patient began to notice some improvement: the pain syndrome became less intense, the range of movements in the affected joints increased slightly. Towards the end of the course of laser therapy, the patient noted a positive trend in the form of the absence of pain, there were no configurations of the affected joints, the range of movements in the joints became larger and freer; stiffness in the morning did not note, became more active. YOUR - 30 points.

After the treatment is repeated: general blood test: Er - 4.85 × 10 ¹² / l; Hb - 131 g / l; Ht - 38.2%, Lc - 9.2 × 10 ⁹ / L; Tr - 266 × 10 ⁹ / l, ESR - 13 mm / hour. In a biochemical blood test: CRP - neg.

Repeatedly the level of leptin, which amounted to 6.020 pg / ml. After treatment, the DAS28 index was 1.3, which corresponds to remission of the disease.

Thus, we can say that laser therapy, and in particular, intravenous laser blood irradiation, helps to normalize the level of leptin in the blood serum, and also reduces the duration of the articular syndrome, significantly reduces the degree of activity of this disease.

Claims (1)

A method of treating patients with rheumatoid arthritis, including the combined use of drugs and laser therapy, characterized in that methotrexate 15 mg per week inside, folic acid 5 mg per week inside, 15 mg per day inside, movial therapy are prescribed differentially depending on the degree of disease activity, leptin level, with the second degree of rheumatoid arthritis activity - DAS28 index 3.2-5.1, leptin level equal to and less than 6.4 ± 0.42 pg / ml, 7 daily procedures for intravenous laser irradiation alternating every other day with a KL-VLOK emitting head with a wavelength of 635 nm, a power at the end of a single-use fiber of 1.5 mW, an exposure time of 15 minutes and a KL-VLOK-365 laser head with a wavelength of 365 nm, power at the end fiber 1.0 mW, exposure time 5 minutes, with the third degree of activity - DAS28 index more than 5.1, leptin level equal to and more than 8.8 ± 0.72 pg / ml, 10 procedures are carried out with alternating emitting heads every other day KL-VLOK with a wavelength of 635 nm, a power output of a single-use light and 1.5-2.0 mW, the exposure time of 15 minutes and the laser head ILIB CL-365 with a wavelength of 365 nm, output power of 1.0 mW single fiber, the exposure time was 5 minutes.