RU2234314C2 - Method for treatment of nervous system disease - Google Patents

Abstract

FIELD: medicine, nervous diseases, neurology.

SUBSTANCE: invention can be used in complex treatment of patients with acute and chronic pain syndromes. Method involves epidural administration of nonsteroid anti-inflammatory agents of the oxicam group in doses for parenteral application. In treatment of root pain in discogenic radiculopathy tenoxicam in the dose 20 mg or lornoxicam in the dose 8 mg dissolved in 10-20 ml of physiological solution are administrated by epidural route every day for 5 days. In treatment of chronic pain in syndrome of unsuccessful spine surgery operations tenoxicam in the dose 40 mg or lornoxicam in the dose 16 mg dissolved in 15-30 ml of physiological solution are administrated by epidural route every day for 5-8 days. Method provides enhancing the effectiveness of treatment, to attain significant regress of pain syndrome and stable remission due to effect on different nociogenous zones and elimination of some nociogenous structures.

EFFECT: improved method for treatment.

2 tbl, 3 dwg, 3 ex

Description

The present invention relates to the field of nervous diseases and can be used in the complex treatment of patients with acute and chronic pain syndromes.

The treatment of patients with acute and chronic pain syndromes is a major medical problem. Pain complaints are most common in economically developed countries. According to various authors, more than 30% of the total population suffers from pain (9, 26, 28). Over 70% of these pains are associated with lumbar pain (“radiculitis”).

Pain has a very important socio-economic importance (1, 13). According to WHO (1986), every fifth able-bodied member of society suffers pain of various localization throughout life. Every day, 3.5 million people suffer from pain, and only in 20% of patients it is subjectively assessed as mild, in 50% it is defined as moderate and in 30% as intolerable.

However, the issues of pathogenetic therapy of pain syndromes urgently require the search for new and further improvement of known methods (2, 5-8, 16, 23, 24, 29, 36). It is important to note that, despite the achievement of significant successes in the treatment and prevention of pain, the number of patients with pain syndromes increases from year to year. The problem of eliminating and preventing pain from the moment of the origin of medicine to the present day remains extremely urgent.

The pathogenetic mechanisms of the occurrence of back pain, radicular pain syndromes have been studied for a long time. Recently, a lot of new data has appeared, which forced to subject the previous submissions to a significant revision (3, 4, 6, 9-12, 27-29).

Now it is believed that the key point in the pathogenesis of vertebrogenic pain syndromes is the development of aseptic inflammation with an interest in the dura mater, the roots of the spinal cord, structures of the ligamentous apparatus, and intervertebral joints. Thus, in the complex mechanism of radicular lumbar pain, the reactive-inflammatory and irritative processes of the shell-radicular structures of the epidural space are most pronounced (2, 6, 7, 25).

Surgical and conservative methods are used in the practice of treating lumbar vertebrogenic pain syndromes associated with a hernia of the intervertebral disc or arising as a result of undergoing operations on the spine (pain syndrome with the so-called unsuccessful surgery on the spine). One of the treatment methods is the epidural administration of drugs with the goal of a pathogenetic effect on pain. To do this, use both the technique of temporary catheterization of the epidural space (11, 13, 35) and the technique of epidural blockade using spinal needles (11, 22, 31).

There is a method of treating lumbar and radicular pain syndromes by introducing corticosteroid hormones into the epidural space, for which an injectable form of various steroid hormones is used - hydrocortisone, dexamethasone, methyl-prednisolone, etc. (14, 15, 19-21, 30, 33).

A method for treating lumbar and radicular pain syndromes by introducing local anesthetics into the epidural space is also known and widely used, for which solutions of local anesthetics of various concentrations are used (17, 18, 32, 34).

In addition, a method is used to treat lumbar and radicular pain syndromes by introducing a mixture of corticosteroid hormones and local anesthetics (11, 14, 15, 37).

Nevertheless, the applied methods of treating vertebrogenic diseases of the nervous system, the pain syndrome being dominant in the clinical picture, require the use of relatively expensive pharmaceuticals. The introduction of local anesthetics is accompanied by the appearance of unpleasant subjective sensations in patients in the form of numbness, weakness of the lower extremities; in addition, the introduction of both local anesthetics and steroid hormones causes a change in hemodynamics and, sometimes, complications requiring medical correction (18, 32, 34, 38). The high sensitizing ability of local anesthetics is known, which in some patients makes it impossible to use these methods of treatment of diseases of the nervous system.

In connection with the foregoing shortcomings of existing methods of treating vertebrogenic diseases of the nervous system, as well as on the basis of modern ideas about the pathogenesis of the radicular syndrome, it is highly justified to develop new methods of treating diseases of the nervous system based on the use of other groups of pharmaceuticals for introduction into the epidural space with the aim of influencing various nociogenic zones and the elimination of a number of nociogenic structures in the absence of these disadvantages.

The aim of the present invention is to increase the effectiveness of a method of treating diseases of the nervous system. This goal is achieved by the epidural administration of non-steroidal anti-inflammatory drugs of the oxycam group in dosages authorized for parenteral administration, in which, in accordance with the invention and according to the indications, 20 mg of tenoxicam (or 8 mg of lornoxicam) are dissolved epidurally, dissolved in 10-20 ml of physiological solution every day for 5 days with discogenic radiculopathies; or - in the treatment of chronic pain in the case of unsuccessful surgery on the spine - epidurally injected with 40 mg of tenoxicam (or 16 mg of lornoxicam), dissolved in 15-30 ml of saline, every day for 5-8 days.

The epidural administration of oxycams is most justified when the pathological focus is localized in the shell-radicular structures of the epidural space. Despite the variety of factors causing an aseptic inflammatory reaction in the epidural space, the response to damage, the patterns that occur in the tissues, are of the same type and are well known. They are represented by the unity of three main phenomena: alteration, exudation (violation of microcirculation), proliferation. All these phenomena are interconnected and occur in parallel. As the pathological process develops in the epidural space, cell membranes are damaged, which is accompanied by the release of inflammatory mediators, the important representatives of which are prostaglandins. Inflammatory mediators act mainly on the microvasculature. Most mediators cause vascular reactions. The resulting mediators also affect the moving blood cells, they stimulate their exit from the bloodstream to the focus, stimulate chemotaxis.

Nonsteroidal anti-inflammatory drugs are generally known to inhibit cyclooxygenase (prostoglandinsynthetase), an enzyme that catalyzes the conversion of arachidonic acid to cyclic endoperoxide, a precursor to prostaglandins (13). All non-steroidal anti-inflammatory drugs, to one extent or another, in addition to acting on prostaglandins, are able to inhibit neutrophil migration and lymphocyte reactivity, which also explains their favorable anti-inflammatory and analgesic effect. In oxycams, these properties are most pronounced, which is why one should expect a very effective effect on aseptic inflammation, which in a certain sense represents a detailed immunological reaction in response to the entry of antigens (which are formed during degenerative-destructive processes in the spine and surrounding structures) into the epidural space that takes place with protrusion of the intervertebral disc, adhesions in the epidural space, etc.

The high therapeutic efficacy of the epidural administration of non-steroidal anti-inflammatory drugs of the oxycam group with the relatively low cost of treatment and the relative technical simplicity of the method makes it possible to recommend this method for wider use in clinical practice for the pathogenetic treatment of lumbar pain.

The result of treatment in accordance with the well-known scheme was a reduction in the cost of treating patients with vertebrogenic diseases of the nervous system who have serious pain, improving the quality of life of such patients due to the absence of unpleasant subjective sensations in the process of applying the treatment method and achieving significant regression of pain syndrome with persistent remission.

The method is as follows. An epidural catheter is installed at the level of the lumbar vertebrae by a standard technique. Through an established epidural catheter, 20 mg of tenoxicam or 8 mg of lornoxicam dissolved in 10-20 ml of physiological saline are injected every day for 5 days. In the treatment of chronic pain in the case of unsuccessful surgical interventions on the spine, 40 mg of tenoxicam (or 16 mg of lornoxicam), dissolved in 15-30 ml of physiological saline, are epidurally administered every day for 5-8 days.

The proposed method was used to treat 30 patients with severe intense pain in the lumbar region: 10 patients with unsuccessful surgery on the spine and 20 with discogenic radiculopathy. The average age of patients was 42 years. Men - 45%, women - 55%. The duration of the disease averaged 132 weeks (minimum - 4 weeks, maximum - 25 years). 40 mg epidural tenoxicam was administered to 6 patients with unsuccessful spinal surgery syndrome; 4 patients - lornoxicam 16 mg. Epidural administration was carried out by performing blockade with the help of special spinal needles, blockade was performed every day, on average, the course of treatment was 7 days. 14 patients with radicular pain syndrome with discogenic radiculopathies received epidural tenoxicam at 20 mg; 6 people - 8 mg of lornoxicam. Epidural administration was carried out by temporary catheterization of the epidural space with a sterile disposable epidural catheter, after which the indicated preparations were administered every day through the installed catheter, the course of treatment was 5 days. All patients of the first group subjectively evaluated their pains at 8-9 points on a visual analogue scale (VAS) with a maximum possible score of 10 points. Patients of the second group on average rated their pains at 7 points according to YOUR.

All patients underwent magnetic resonance imaging of the lumbosacral spine to verify nociogenic structures (herniated discs, adhesions). Subjective sensations and data from an objective neurological examination were taken into account. All data was formalized and processed by an artificial neural network to objectify the pain syndrome, to compare the structural-functional nocial relationships in each patient and for the subsequent objective assessment of the treatment results of the proposed method in comparison with the known ones.

The control group consisted of 30 people who underwent epidural administration of a mixture of corticosteroid hormones and local anesthetics (7 mg betamethasone + 20 ml of a 0.25% solution of bupivacaine hydrochloride) for 5 days with discogenic radiculitis and 5-8 days for unsuccessful surgery on the spine . The studied and control samples of patients are equivalent in composition, duration of the disease, intensity of the pain syndrome, i.e. representative; a significant difference was only in the administered drugs (methods of treating pain syndromes with vertebrogenic diseases of the nervous system). Tables 1 and 2 show the comparative characteristics of the control and study groups of patients according to indicators of interest to us.

Analyzing the data obtained, it is impossible not to note the high economic efficiency and justification for the use of the method of treatment of pain syndromes in vertebrogenic diseases of the nervous system.

Thus, the epidural administration of oxycams contributes to the elimination or reduction of regional pathological changes in the zone of disco-radicular conflict and leads to the restructuring of the neuroreflexive, neurohumoral and immunobiological reactions of the body.

Clinical examples.

Example 1

Patient K., 41 years old, was admitted to the hospital with complaints of intense pain in the lower back and on the posterolateral surface of the left lower leg, aggravated by prolonged walking, limiting physical activity.

From the anamnesis it is known that the patient was observed by a neurologist for about 12 years about osteochondrosis of the spine, vertebral lumbar ischialgia. Recently (4 months ago), the patient noted an increase in pain in the lower back and in the left leg after long work in the garden. During the previous 2 months it was treated conservatively on an outpatient basis and for 4 weeks - in a neurological hospital. Satisfactory positive dynamics were not achieved: the pain syndrome remained almost unchanged.

On examination, the skin and mucous membranes of normal color; somewhat increased nutrition. In the lungs - vesicular breathing. Heart - tones are clear, clean, rhythmic. ECG: horizontal position of the electrical axis. HELL = 130/80 mm Hg. The abdomen is soft, painless on palpation. Nervous system: smoothness of lumbar lordosis, moderate scoliosis, restriction of active movements in the lumbosacral spine, severe tension of the paravertebral muscles, mild atrophy of the muscles of the left leg, soreness along the left sciatic nerve, symptoms of tension on the left are positive. Tendon reflexes from the hands: d = s, from the legs: knee - d = s, Achilles - s - abs; d - N. Radiography of the lumbosacral region revealed signs of osteochondrosis at the level of L _III - L _IV - L _V - S _I ; MRI of the spine determines prolapse of the intervertebral disc L _V - S _I (see Fig. 1).

VAS pain score was 8 points. The component of acute and tingling pain prevailed in the structure of the algic syndrome.

The diagnosis was made: discogenic radiculopathy of S _I root on the left, caused by prolapse of the intervertebral disc L _V -S _I with moderate muscular tonic and pain syndrome.

The duration of the pain syndrome, the ineffectiveness of conservative therapy (analgesics, aminophylline, B vitamins; physical therapy, massage, electrophoresis with lidase to the uterine spine, acupuncture), the presence on the MRI of marked prolapse of the intervertebral disc L _V- S _I made it possible to talk about the indications of surgical treatment. But the patient refrained from the proposed operation. Then it was decided to conduct a course of epidural administration of oxicam (tenoxicam). An epidural catheter was inserted into the patient in the interval L _V -S _I , through which 20 mg of tenoxicam was administered. A total of 5 injections per course, one injection every day. After the first epidural blockade, there was a significant improvement in the form of a regression of pain. By the end of the course, a steady improvement was noted: in addition to the regression of pain (YOUR score is 2 points), the regression of the muscular-tonic syndrome and the expansion of the dynamic regimen were noted.

Discharged on the 10th day with recommendations aimed at preventing exacerbation.

Example 2

Patient Ch., 40 years old, was admitted to the hospital with complaints of intense pain in both lower extremities, mainly along the posterolateral surface of the thigh, lower leg and thumbs, more on the left, aggravated by physical exertion (especially static - prolonged sitting, standing).

From the anamnesis it is known that back pain was disturbed for about 8 years, was treated independently and, periodically, as an outpatient. About 2 weeks ago, during a weightlift amid hypothermia, I felt a sharp shooting, intense pain in my left leg. The next day, pain in the left leg intensified, and pains in the right leg joined.

On examination, the skin and mucous membranes of normal color. In the lungs - vesicular breathing. Heart - tones are clear, clean, rhythmic. ECG: horizontal position of the electrical axis. HELL = 120/80 mm Hg. The abdomen is soft, painless on palpation. Nervous system: smoothness of lumbar lordosis slight, moderate scoliosis, block of active movements in the lumbosacral spine due to pain, severe tension of the paravertebral muscles, sharp pain in the paravertebral points at levels L _IV- L _V and L _V -S _I , more on the left; soreness at the piriformis muscle on the left, tension symptoms positive on both sides (Laseg symptom from an angle of 30 °). Tendon reflexes from the hands: d = s, from the legs: knee - d = s, Achilles - s - abs; d - reduced slightly. Radiography of the lumbosacral region revealed signs of common osteochondrosis of the lumbosacral spine, as well as signs of arthrosis of the facet joints; with MRI of the spine, protrusions of the intervertebral discs L _III -L _{IV are} determined; L _IV -L _V ; L _V -S _I (see Fig. 2).

The patient immediately upon admission, given the severity of the pain syndrome (VAS score was 9 points), it was decided to install an epidural catheter for the purpose of subsequent administration of oxycams. Epidurally, in the interval L _IV -L _V , a disposable epidural catheter was inserted, through which 20 mg of tenoxicam was administered once a day. In total, this patient received 5 infusions over the course of 5 days. After the first epidural blockade, there was a significant improvement in the form of a regression of pain (5 points according to YOUR). By the end of the course, a steady improvement was noted: pain syndrome completely regressed (0-1 point according to YOUR), the range of active movements in the lumbar spine and lower extremities significantly expanded.

Discharged on the 8th day with recommendations aimed at preventing exacerbation.

Example 3

Patient A., 42 years old, was admitted to the hospital with complaints of intense pain in the lumbar spine and in both lower extremities (YOUR score is 9 points), mainly on the posterolateral surface of the thigh and lower leg, inability to walk and sit due to pain.

From the anamnesis it is known that back pain has been disturbed for about 12 years, has not been treated anywhere. A patient about 1 year ago underwent surgery: laminectomy of L _IV , L _V vertebrae, decompression of roots L _V , S _I on both sides. During the operation, pronounced hypertrophy of the yellow ligaments, pronounced arthrosis-arthritis of the facet joints were noted, an anomaly of the spine was found in the form of bone “jumpers” between the vertebral arches, which necessitated wide access (laminectomy at 2 levels) for adequate revision of the cauda equina roots and their decompression. No herniation of the intervertebral disc L _IV -L _{V was} found.

At present, admission is marked by a forced position (lying on your back). On examination, the skin and mucous membranes of normal color. In the lungs - vesicular breathing. Heart - tones are clear, clean, rhythmic. ECG: horizontal position of the electrical axis. AD = 110/60 mm Hg. The abdomen is soft, painless on palpation. Nervous system: severe flattening lumbar lordosis ( "doskoobraznaya spin"), moderately expressed scoliosis, block active movements in the lumbosacral spine, because of pain expressed paravertebral musculature tension, sharp pain in the paravertebral points on L _IV levels -L _V and L _V -S _I ; soreness at the piriformis muscle on both sides, tension symptoms positive on both sides (Laseg symptom from an angle of 20 °). Hand tendon reflexes: d = s, live; from the feet: knee - d = s, torpid; Achilles on both sides - abs. Radiography of the lumbosacral region revealed signs of common osteochondrosis of the lumbosacral spine, as well as signs of arthrosis of the facet joints with a relative narrowing of the lumen of the spinal canal.

An MRI scan of the lumbosacral spinal cord was performed. The absence of any changes in the intervertebral discs of the lumbosacral region was noted, but there were signs of an adhesive process in the epidural space at this level (Fig. 3).

The final diagnosis was formulated as follows: vertebrogenic radiculopathy L _V , S _I on both sides, caused by stenosis of the spinal canal mainly at the level of L _IV -L _V -S _I , facet syndrome, anomaly of the spine (inter-osseous bone “jumpers”) with pronounced pain syndrome and muscular-tonic manifestations; the state after laminectomy of the L _IV , L _V vertebrae, decompression of the roots L _V , S _I on both sides; adhesive process of the epidural lumbar space.

A course of epidural pharmacotherapy was conducted. An epidural patient, in the interval L _IV -L _V , 20 mg of tenoxicam was administered every day, for a total of 7 injections. Improvement was noted after the second blockade in the form of a moderate regression of pain, an improvement in overall well-being and an expansion of the motor regime. By the end of the course, a significant reduction in pain was noted (pain assessment according to YOUR 3 points), a regression of the muscular-tonic syndrome was noted.

In addition, the patient was admitted to the clinic 12 months after surgical treatment - in a planned manner. There was a decrease in the severity of pain, compared with the previous hospitalization, but, nevertheless, residual pain was present. In this regard, as well as for the prevention of further adhesions, a course of epidural pharmacotherapy was carried out. As a result of treatment, the pain syndrome became practically not expressed, the patient was discharged in a satisfactory condition.

As can be seen from the obtained results, the proposed method of treatment is highly effective, economically viable, safe. Its use leads to a lasting therapeutic effect in a short time.

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Claims (1)

A method of treating diseases of the nervous system by regional exposure of the patient to drugs, including epidural administration of therapeutic agents, characterized in that, in accordance with the indications, non-steroidal anti-inflammatory drugs of the oxycam group are administered epidurally in dosages authorized for parenteral use, while treating radicular pain with discogenic radiculopathies is epidurally administered in 20 mg of tenoxicam or 8 mg of lornoxicam dissolved in 10-20 ml of physiological solution, daily for 5 days, and in the treatment of chronic pain with unsuccessful surgical interventions on the spine, 40 mg of tenoxicam or 16 mg of lornoxicam dissolved in 15-30 ml of physiological saline are epidurally administered daily for 5-8 days.

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