Nise for spinal osteochondrosis

Instructions for use

Non-steroidal anti-inflammatory drugs are not always safe and effective only when used correctly. This means that the decision to use them, firstly, must be agreed upon with the attending physician, and secondly, both the doctor and the patient must become familiar with the properties and rules of use of the drug before starting a course of treatment. All features of the drugs are described in the instructions for their use. Such a manual is also included in the package with tablets, suspension and Nise gel. Familiarizing yourself with it is much more convenient than choosing treatment by trial and error.

Therapeutic effect

Like other non-steroidal anti-inflammatory medications, Nise slows down the production of the enzyme cyclooxygenase, resulting in fewer prostaglandins, mediators of pain and inflammation, produced in the body.

It copes well with fever, pain, and also with the inflammatory process. The suspension and tablets have excellent absorption into the blood (the maximum concentration of the drug occurs within 1.5 - 2.5 hours after use). The drug is able to penetrate into the tissues of the female genital organs (in these tissues, approximately half as much of the main component of Nise, nimesulide, is usually found as in plasma). If you take this medication with food, the rate of absorption will decrease.

The gel practically does not enter the bloodstream (it is not detected in the systemic circulation of persons using this version of Nise).

Nise Gel, 20 g, 1%, for external use

Pharmacological properties

1. Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) from the sulfonanilide class, has analgesic, anti-inflammatory and antipyretic effects. The effect is due to selective blockade of cyclooxygenase-2, as well as a number of other mechanisms, such as: suppression of the synthesis of platelet activating factor, reduction in the production of superoxide anion by stimulated polymorphonuclear leukocytes through suppression of protein kinase C and type IV phosphodiesterase. Prevention of bradykinin and cytokine-induced hyperalgesia by inhibiting the release of tumor necrosis factor a. , Neutralization of hypochloric acid, Prevention of inactivation of a-proteinase inhibitors, Inhibition of proteases (including elastase, collagenase), Inhibition of histamine release from basophils and mast cells, Slowing down the degradation of the cartilage matrix by inhibiting the synthesis of metalloproteases. 2. Menthol has a local irritant, analgesic, distracting, antipruritic, antiseptic, and sedative effect. The effect is mainly due to reflex reactions associated with irritation of sensitive nerve endings: irritation of skin or mucous membrane receptors stimulates the formation and release of endogenous biologically active substances (enkephalins, endorphins, peptides, kinins) involved in the regulation of pain, vascular permeability and other processes , providing analgesic, distracting and antipruritic effects. Antiseptic activity is manifested by indiscriminate damage to microbial cells. The irritating (distracting) effect helps reduce pain. The local effect is accompanied by vasoconstriction, a feeling of cold, turning into a feeling of slight burning and tingling. Skin-visceral reflexes (the reflex arc does not affect the brain) improve tissue trophism (according to the innervation zones). Reflexively changes the tone of blood vessels, both superficial and deep in tissues and internal organs. 3. Capsaicin has an effect by reducing the content of substance P, which is a neurotransmitter that carries out pain and itching reactions from the receptors of the peripheral nervous system to the central one. Capsaicin blocks the synthesis and transmission of substance P along the neuron, which leads to a decrease in the intensity of the pain impulse. 4. Methyl salicylate is a derivative of salicylic acid. When applied locally, it quickly penetrates into the deep layers of the skin, is absorbed, hydrolyzed and converted into salicylic acid anion. Non-selectively inhibits cyclooxygenase, reduces the synthesis of prostaglandins responsible for inflammation, pain, and fever. Normalizes increased capillary permeability, improves microcirculation processes, reduces swelling and infiltration of inflamed tissues, causes a decrease in pain in pathologies of joints, muscles and soft tissues. It has a local irritant effect on the skin, which helps reduce pain.

Composition and release forms

The active component of the product, as mentioned earlier, is nimesulide.

Nise is sold in several forms:

Gel. It is transparent, with a yellow tint; Packaged in tubes of 20 g or 50 g. Recommended for external use only. 1 gram of gel contains 10 mg of nimesulide; in addition, other components are added to it (amount per 1 g): 250 mg of N-methyl-2-pyrrolidone, 100 mg of isopropanol, 100 mg of propylene glycol, 315.5 mg of macrogol, 20 mg of carbomer-940, 200 mg of purified water, 0.2 mg butylated hydroxyanisole, 0.2 mg potassium dihydrogen phosphate, 0.1 mg thiomersal, 4 mg flavoring called Narcissus-938.
Suspension. It is sold in dark glass bottles of 5 ml with dosage caps. Contains 50 mg of the main substance, as well as some auxiliary components: purified water, sorbitol, xanthan gum, propylparaben, citric acid, methylparaben, pineapple flavor, glycerol, polysorbate 80.
Granules. A solution is prepared from them. They are packaged in special sachets.
Pills. Each of them contains 100 mg of active substance. Tablets are placed in blisters of 10 pieces. There are packs of 1, 2 and 10 blisters of Nise. In addition to the main component, they also contain other substances: calcium phosphate, talc, corn starch, colloidal silicon dioxide, microcrystalline cellulose, pineapple flavor, sodium carboxymethyl starch, and magnesium stearate.

Indications

Like other non-steroidal anti-inflammatory drugs, Nise is recommended for conditions associated with inflammation, pain and high body temperature:

osteochondrotic processes, as well as their consequences (lumbago, radiculitis, sciatica, radicular syndrome, migraines, etc.);
psoriatic arthritis and other types of arthritis, as well as spondylitis and spondyloarthritis of various types;
pain in joints and muscles (of various etiologies);
pain after operations and injuries (bruises, sprains, torn ligaments, etc.);
pain during menstruation in women;
bursitis;
headaches of various nature;
neuralgia;
pain in the teeth and jaws;
synovitis;
tendinitis and tendovaginitis;
fever, especially in infectious diseases accompanied by inflammation of certain organs.

Contraindications

Nise is an effective remedy, but it cannot be prescribed to all patients. So, the list of contraindications to its use includes:

severe form of renal failure (with creatinine clearance less than 30 ml per second);
diseases of the digestive tube - ulcerative and erosive processes, bleeding, etc.;
liver diseases, various organ dysfunctions;
damage to the skin - wounds, abrasions, cuts, scratches, infectious processes and dermatoses - in this situation you cannot use the gel;
age under 24 months (two years);
pregnancy and breastfeeding in women;
allergy to the components of the drug, as well as to aspirin and other drugs containing acetylsalicylic acid.

Back pain is a fairly common symptom in the population; Over the course of a lifetime, approximately 80% of the population suffers from back pain [1]. In rheumatological practice, pain is most often associated with degenerative changes in the facet joints and intervertebral disc. In Russia, this pathology is usually called spinal osteochondrosis. In foreign literature, a similar symptom complex is defined as pain in the lower back (between the 12th pair of ribs and the lower gluteal folds), which can be local or radiating, acute or chronic. Other causes of back pain may include inflammatory diseases, such as seronegative spondyloarthritis (ankylosing spondylitis, psoriatic arthritis, etc.). Provoking factors can be: prolonged stay in a non-physiological position, insufficient motor activity, congenital or acquired structural defects of the spine, excess body weight, decreased bone mass [2].

When a patient consults about pain in the spine, the doctor must first of all remember the concept of “red flags”, which makes it possible to identify such serious diseases as spinal tuberculosis, infections, malignant neoplasms, metastasis, etc., requiring special examination.

This concept [3] includes signs that may be caused by serious organ pathology, such as:

persistent back pain in people under 15 and over 50 years of age;
non-mechanical nature of pain (pain that does not decrease with rest, lying down, or in a certain position);
progressive increase in pain;
a history of cancer;
febrile syndrome, weight loss;
prolonged stiffness in the morning;
symptoms of spinal cord damage (pelvic disorders);
changes in blood and urine tests.

The most common cause of spinal pain, as mentioned above, is degenerative changes in the intervertebral disc and facet joints, similar to those in osteoarthritis of large joints and caused by loss of cartilage tissue. In osteoarthritis, the loss of glycosaminoglycans leads to disintegration and splitting of the cartilage matrix, followed by its dehydration, changes in the diffusion of macro- and micromolecules, disorganization and rupture of collagen fibers, and disruption of the basic shock-absorbing function of cartilage.

In the intervertebral disc, consisting of the outer fibrous ring and the central part - the nucleus pulposus, similar changes occur: a decrease in water content, the appearance of cracks in the fibrous ring, ossification, a decrease in the height of the disc, which reduces its resistance to load. Intact intervertebral discs do not move when the body rotates, but this can happen if their structure is damaged. At later stages, the degeneration process affects the ligamentous apparatus, the elasticity of the ligaments and joint capsule decreases, which contributes to the occurrence of disc herniation [4].

Degenerative spondylolisthesis is most typical for the lumbar vertebrae L4–L5, which is due to a weaker ligamentous apparatus, greater disc height, and sagittal orientation of the articular surfaces of the facet joints. The formation of spondylolisthesis is facilitated by a decrease in the mechanical strength of the subchondral bone in osteoporosis and a decrease in the resistance of intervertebral discs to loads. As a result, the load on the facet joints increases to prevent anterior displacement of the vertebrae.

Acute pain in the spine is characteristic of a herniated disc. When the outer third of the annulus fibrosus is ruptured or the posterior longitudinal ligament is displaced, local pain develops, mediated by nociceptors in this area. Pain can also be caused by compression of the spinal roots, which causes muscle tension, which disrupts tissue metabolism and creates areas of painful compaction or trigger zones. Prolonged muscle tension in this area disrupts the function of blood vessels and nerve endings, which is, in particular, characteristic of piriformis syndrome, in which painful compactions are palpated deep in the gluteal muscle, and when rotating the hip, muscle spasm intensifies, leading to compression of the sciatic nerve and increased pain with irradiation along the back of the thigh.

The processes that cause pain in the spine are not limited to mechanical damage. The pathological components of the altered cartilage have antigenic properties and lead to the development of inflammation, which produces catabolic enzymes that destroy the collagen structures of the cartilage. Catabolic processes are associated with overproduction of proinflammatory cytokines: interleukin-1, tumor necrosis factor α (TNF-α), which induce angiogenesis, cell migration into the synovium, and proliferation of the synovial membrane. This produces algogenic substances (prostaglandins, free oxygen radicals, substance P), irritating nociceptors, which are rich in articular structures, as well as stimulating inactive nociceptors. A study of intervertebral disc fragments also revealed an increased content of pro-inflammatory substances in them [5].

The participation of pro-inflammatory cytokines has also been proven in the pathogenesis of seronegative spondyloarthritis, which clinically occurs with damage to the iliosacral joints and joints of the spine. With ankylosing spondylitis, the entheses and bone at their attachment points are primarily affected, later the synovial membrane is involved, syndesmophytes are formed, and the spinal ligaments are calcified, which limits the mobility of the spine. Psoriatic arthritis is characterized by the same localization of joint damage, but with asymmetrical involvement.

Regardless of the causes of back pain, it requires the use of medications to relieve it. In rheumatology, non-steroidal anti-inflammatory drugs (NSAIDs) are used for this purpose, which are the drugs of choice (category A).

Taking into account the combination of degenerative and inflammatory processes in spinal pain, the optimal choice is to choose a drug that, in addition to COX (cyclooxygenase)-mediated, also has a COX-independent effect. These include nimesulide, the first COX2 inhibitor introduced into clinical practice [6]. Nimesulide (4-nitrophenoxymethanosulfonanilide) has an original chemical structure, which determines its relatively high acidity index pKa (6.5) and moderate lipophilicity, which causes a fairly low ulcerogenic effect in relation to the gastrointestinal tract. Nimesulide is a NSAID with a short half-life (1.22–3.17 hours). The main therapeutic effect of the drug is especially pronounced in the area of inflammation and is due to the suppression of the production of pro-inflammatory prostaglandins.

Unlike many NSAIDs that block the enzymatic activity of COX, nimesulide inhibited the expression and synthesis of COX-2 in cultured synovial fibroblasts, which prevents damage to cartilage and subchondral bone. Among the COX-independent effects, the ability of nimesulide to influence chondrocyte apoptosis is of great importance. This effect is believed to be mediated by the antioxidant properties of the drug. Suppression of the synthesis of superoxide radicals helps to reduce the activity of caspase-3, which is involved in the processes of apoptosis not only of chondrocytes, but also of other cells, as well as proteinases involved in the catabolism of cartilage and bone tissue [7].

The anti-inflammatory effect of nimesulide is due to its ability to suppress the expression of the proinflammatory cytokine TNF-α, which affects the function of various organs and the expression of other cytokines. Its influence on glucocorticoid receptors due to the expression of the corresponding gene has been proven [8]. The advantage of nimesulide is its ability to reduce the synthesis of metalloproteinases (stromelysin, collagenase). In cultured synovial fibroblasts, the drug reduced the synthesis of IL-6 and urokinase, which had a positive effect on the preservation of the structure of cartilage tissue [9].

An important feature of nimesulide is its good tolerability [10–12]. Nimesulide is metabolized in the liver with the participation of cytochromes (CYP 2C9, CYP 2 C 19, CYP 1 A 2), the genetic polymorphism of which may determine its effect on liver function [13]. Post-marketing studies of the effectiveness and safety of nimesulide, as well as an analysis of reports of tolerability of the drug, formed the basis for the decision of the European Union Medical Agency regarding the good tolerability of nimesulide [14]. The drug is devoid of cardiotoxic effects, in contrast to other selective COX-2 inhibitors (rofecoxib, valdecoxib); it does not cause an increase in blood pressure even in patients who initially had arterial hypertension [15].

The analgesic and anti-inflammatory effects of nimesulide have been confirmed in numerous studies, including in osteoarthritis. When comparing the therapeutic effectiveness of nimesulide (300 mg/day) and rofecoxib (25 mg/day) in patients with gonarthrosis who received therapy for 30 days, the analgesic effect occurred earlier and was more pronounced when taking nimesulide [16].

A prospective, randomized, double-blind study of the effectiveness of nimesulide therapy (200 mg/day) in 104 patients with acute nonspecific low back pain compared with ibuprofen (1800 mg/day) showed a significant effect by the 10th day of treatment. However, nimesulide provided more complete relief of pain with an increase in range of motion and restoration of posture with fewer side effects (13 versus 21%) [17].

In a double-blind prospective study in patients with osteoarthritis and low back pain who received nimesulide for 3 weeks, the authors noted a decrease in pain on a visual analogue scale (VAS), an increase in the range of active movements, a decrease in muscle tension and radicular symptoms [18] .

In the work of Shostak N.A. et al. it was shown that the use of nimesulide in 50 young (18–35 years old) patients with acute and chronic back pain significantly reduced the severity of pain (according to VAS) and improved the functional state of the spine (Schober, Thomaier test) [19].

It should be noted that for back pain, local forms of nimesulide (Nise gel) can be used as an additive therapy in a sufficient dose and frequency of application, which often makes it possible to reduce the dose of the oral drug.

The data presented indicate the high analgesic and anti-inflammatory effectiveness of nimesulide for back pain of a degenerative and inflammatory nature, its positive effect on the structure of cartilage and bone tissue, as well as its safety in relation to cardiovascular pathology.

Information about the author: Balabanova Rimma Mikhailovna – Doctor of Medical Sciences, Professor of the Institute of the Russian Academy of Medical Sciences, Research Institute of Rheumatology of the Russian Academy of Medical Sciences, Head of the Department of Correction of Autoimmunity in Rheumatic Diseases. Tel., e-mail

Mode of application

The suspension and tablets are taken orally, and it is best to do this after a meal, especially for people with diseases of the digestive tract. As a rule, adolescents over 12 years of age and adults are recommended to take 1 tablet twice a day. This is the maximum dose. For patients with chronic renal failure, the dosage is halved.

The suspension is suitable for children from 2 to 12 years old. It should be drunk twice or thrice a day. Most often, it is recommended to calculate its dose as follows: 1.5 mg of the drug per 1 kilogram of the child’s body weight, and the maximum allowable amount of the drug per day is 5 mg per 1 kg of body weight, otherwise an overdose occurs.

As for the granules, the bags are opened and their contents are dissolved in ordinary boiled water (0.5 cup per 1 bag is enough). Drink the resulting mixture twice a day. Under no circumstances should the prepared solution be stored for several days - it must be used immediately.

Therapy with varieties of Nise, which are taken orally, is usually recommended to continue for about one and a half weeks, however, in each case, the duration of treatment is determined individually

The gel is applied to thoroughly washed and dried skin. To treat a sore spot, it is enough to squeeze out 3–4 cm of gel. You don’t need to rub it in, just lubricate the affected areas, and you can repeat the procedure three or four times a day.

Overdose

If a person accidentally takes more of the drug than is acceptable for their body weight, they will develop characteristic side effects (described below). Treatment is usually symptomatic, since an antidote has not yet been invented.

Side effects

Some patients experience discomfort during treatment with Nise:

skin rashes; urticaria, itching; sometimes the skin begins to peel off; its color changes;
pain in the stomach, as well as nausea, vomiting and heartburn, diarrhea; ulceration of the mucous membranes of the digestive tract may also be possible;
Fluid is retained in the body, therefore swelling is possible;
the appearance of blood in the urine;
dizziness and headache;
disorders of the blood composition, especially anemia, although the number of leukocytes and platelets may increase, in addition, blood clotting worsens;
agranulocytosis is possible;
liver transaminases become more active.

If these signs appear, you should definitely inform your doctor. The use of Nise is usually stopped in such a situation.

special instructions

Nise is incompatible with driving or other activities that require increased concentration.

Medicines with a myelotoxic effect, as a rule, in combination with Nise, enhance the negative effect of the latter on the composition of the blood.

Combining Nise with diuretics, drugs with lithium, drugs for hypertension and diabetes, as well as methotrexate and cyclosporine drugs requires a very careful approach.

Storage: terms and conditions

The gel is suitable for use within 24 months from the date of manufacture. The optimal temperature for storing it is room temperature, and the place where it is located should be protected from light and moisture.

Tablets and granules should also be stored for no longer than 3 years. After this period, their use is dangerous to health, so it is better to throw them away and buy a new package if there is a need for Nise treatment.

Release from pharmacies

The conditions for dispensing Nise from pharmacy kiosks depend on the dosage form. Tablets and suspensions are sold to patients only with a doctor's prescription, while the ointment can also be purchased over-the-counter.

Price

The price of Nise is determined by the pharmacy chain, the form of release and, of course, the quantity of the medicine. The average cost is:

20 Nise tablets – 198 rubles per pack;
50-gram tube of gel – 319 rubles;
20-gram tube with gel – 196 rubles.

Analogs

The main analogue of Nise is a drug of the same name as its active component - Nimesulide. It is sold in the form of tablets, gel, ointment, granules. Other products based on the same substance:

Nimika;
Nimesil;
Nimesan;
Nimulid;
Nemulex.

All of them act in approximately the same way as the described remedy, but their composition may differ slightly from Nise, so the possibility of using Nise substitutes should be discussed with a therapist.

Reasonable choice of NSAIDs for combined pathologies: joint diseases and hypertension

Nonsteroidal anti-inflammatory drugs (NSAIDs) are one of the main groups of drugs used in the treatment of rheumatoid arthritis (RA). The anti-inflammatory and analgesic effect of this group of drugs is associated with the suppression of the activity of cyclooxygenase-2 (COX-2) at the site of inflammation - the key enzyme in the synthesis of prostaglandins of pro-inflammatory activity, and the suppression of the COX-1 isoform leads to disruption of physiological reactions: in particular, to disruption of the synthesis of prostaglandins of the class E in the gastric mucosa and the development of NSAID gastropathy.

Most “standard” NSAIDs are able to suppress the activity of both COX isoforms, so their use is often limited due to the development of side effects, primarily from the gastrointestinal tract (GIT). Subjective symptoms from the gastrointestinal tract occur in approximately a third of patients, and in 5% of cases they pose a serious threat to the lives of patients. That is why in recent years the problem of the safe use of NSAIDs has attracted particular attention. It is believed that drugs that are more selective for COX-2 are less likely to cause the development of NSAID gastropathy. The study of the mechanisms of action of NSAIDs gave impetus to the creation of new drugs that have all the positive properties of standard NSAIDs, but are less toxic—specific COX-2 inhibitors [3, 4, 13].

In recent years, the problem of interaction between NSAIDs and antihypertensive drugs, as well as the connection between the use of NSAIDs and the development of hypertension, has become particularly relevant. Non-selective NSAIDs can lead to an increase in blood pressure (mainly diastolic) not only in patients with arterial hypertension (AH), but also in people with normal blood pressure due to inhibition of systemic and local, intrarenal prostaglandin synthesis. It is known that chronic use of NSAIDs causes an increase in blood pressure in patients by an average of 5.0 mmHg. Art. A characteristic property of NSAIDs is also their interaction with antihypertensive drugs, the hypotensive action of which is based primarily on prostaglandin-dependent mechanisms. Prescribing NSAIDs to patients receiving beta-blockers, ACE inhibitors and diuretics for hypertension leads to a decrease in the hypotensive effect [8, 9].

Nimesulide was developed back in 1985 and is one of the first NSAIDs, the study of which demonstrated higher selectivity for COX-2 and accumulated extensive clinical experience. Numerous in vitro and in vivo studies have shown that nimesulide is approximately 5 to 20 times more selective in inhibiting COX-2 than COX-1. Of great interest is the fact that nimesulide has a wide range of COX-independent effects, which can determine its anti-inflammatory, analgesic and chondroprotective activity [1, 2, 5, 7, 11, 12].

Nimesulide is well tolerated by patients and rarely causes serious side effects requiring discontinuation of the drug. According to the results of a number of studies, the frequency of side effects that develop while taking nimesulide is not significantly different from placebo or is lower than when taking other NSAIDs. For example, according to a meta-analysis, in patients receiving nimesulide, the overall incidence of gastrointestinal adverse reactions was significantly lower (8.7%) than when prescribing other NSAIDs (16.8%). The low incidence of gastrointestinal lesions during treatment with nimesulide is associated not only with the COX-2 selectivity of the drug, but also with the antihistamine effect, leading to a decrease in the secretion of hydrochloric acid in the stomach [6, 10, 13].

Thus, nimesulide is a selective COX-2 inhibitor, comparable in effectiveness to “classical” NSAIDs, but has a more favorable toxicity profile. Pharmacoeconomic analysis indicates the advantages of nimesulide compared to diclofenac, primarily due to the lower incidence of gastrointestinal lesions.

The purpose of our study was to study the effectiveness and tolerability of Nise (nimesulide) in patients with RA in comparison with ortofen (diclofenac).

Materials and methods

Both NSAIDs were randomly assigned to 40 patients from the time of first diagnosis of RA, according to the criteria of the American College of Rheumatology. Nise was used in the form of tablets of 100 mg twice a day, ortofen - in the form of tablets of 25 mg in a daily dose of 150 mg. At the same time, all patients received basic therapy, mainly methotrexate or sulfasalazine. The efficacy and tolerability of NSAIDs were assessed after 3 weeks. from the start of treatment, i.e. in those periods when the effect of basic drugs did not yet have clinical significance.

In group I of 20 patients receiving Nise, there were 14 women and 6 men, the average age of the patients was 55.1 years, the duration of the articular syndrome at the time of diagnosis was from 3 to 14 months, on average 7.25 months. In group II of 20 patients receiving ortofen, there were 18 women and 2 men, the average age of the patients was 42.75 years, the duration of the articular syndrome was from 2 to 14 months, on average 5.65 months. Clinical characteristics of both groups are presented in Table 1.

The treatment results were assessed by the dynamics of joint syndrome indicators (Ritchey joint index (RI), painful joint score (PJS), swollen joint score (SJS), duration of morning stiffness (min), severity of pain on a visual analogue scale (VAS)) and on based on an overall assessment of the effectiveness of treatment, in the opinion of the doctor and the patient. In addition, the dynamics of blood pressure during treatment with NSAIDs was assessed in all patients.

results

In group I, during treatment with Nise at a daily dose of 200 mg for 3 weeks. treatment, reliable dynamics of articular syndrome indicators was achieved. At the same time, the effectiveness of therapy was assessed by 17 patients (85%) as good and 3 (15%) as satisfactory. According to the doctor, in 16 cases (80%) good effectiveness of the drug was observed, in 4 cases (20%) it was satisfactory (Fig. 1). Tolerability of Nise was good in 85%, only 2 patients (10%) had heartburn and gastralgia, and 1 patient (5%) had a feeling of heaviness in the epigastric region. However, fibrogastroscopy did not reveal erosive damage to the gastric mucosa in these patients. In the group of patients taking Nise, not a single patient required discontinuation of the drug.

Drawing. Assessing the effectiveness of drugs based on the opinions of the patient and the doctor

In group II, during therapy with ortofen at a daily dose of 150 mg every 3 weeks. Significant dynamics of articular syndrome indicators were also noted. However, an assessment of the effectiveness of therapy showed that only 11 patients (55%) rated the effectiveness of the drug as good, 6 (30%) as satisfactory, and three patients (15%) considered it unsatisfactory. According to the attending physician, sufficient effectiveness of ortofen, corresponding to the “good” gradation, was noted in 12 cases (60%), satisfactory - in 3 (15%) and unsatisfactory - in 5 (25%) cases (Fig.).

Tolerability of the drug Ortofen was worse than that of Nise: 9 patients (45%) had symptomatic side effects, and 3 patients (15%) required discontinuation of the drug after 2 weeks. from the start of treatment due to erosive lesions of the mucous membrane of the antrum identified during FGDS. In general, the most common side effects were heartburn - in 7 (35%) patients, gastralgia - in 8 (40%), nausea - in 4 (20%) and diarrhea - in 2 (10%) patients.

Of particular interest is the effect of the studied NSAIDs on blood pressure levels, since out of 40 patients, 15 had concomitant hypertension, for which antihypertensive therapy was carried out. The dynamics of blood pressure levels in both groups during treatment with Nise and Ortofen are presented in Table 2. It should be noted that Nise therapy did not require an increase in ongoing antihypertensive therapy (β-blockers, ACE inhibitors, diuretics) and did not cause an increase in blood pressure in previously normotensive patients. At the same time, treatment with ortofen required dose adjustment of antihypertensive drugs in 4 (66.7%) of 6 patients with hypertension and caused an increase in blood pressure in 5 (25%) postmenopausal women with initially highly normal blood pressure. This effect of a non-selective NSAID - ortofen - should be considered predictable, especially taking into account the nature of the antihypertensive therapy being carried out. All hypertensive patients received β-blockers, ACE inhibitors and diuretics in various combinations; however, not a single patient was prescribed the dihydropyridine Ca antagonist amlodipine, which is the drug of choice for the treatment of hypertension in the setting of NSAID therapy.

Thus, the results of an open clinical trial showed that the drug Nise in patients with RA exhibits pronounced anti-inflammatory activity, superior to diclofenac. At the same time, Nise is characterized by good tolerability, a small number of symptomatic side effects and, from this point of view, is superior to the most widely used in clinical practice, ortofen. An additional advantage of the drug Nise can be considered a less pronounced effect on blood pressure levels. When prescribing Nise, no increase in the dose of antihypertensive drugs was required. Given the high prevalence of essential hypertension in the population, the interaction of NSAIDs with the most commonly used antihypertensive drugs seems to be an urgent problem. Rheumatic diseases that require constant NSAID therapy are often combined with hypertension. Moreover, in the majority of patients with hypertension, blood pressure correction can be achieved only through combination antihypertensive therapy, and monotherapy with dihydropyridine calcium antagonists is considered insufficiently effective. Consequently, in most cases, when treating inflammatory rheumatic diseases in people suffering from hypertension, it is impossible to completely neutralize the negative interaction of “standard” NSAIDs with the main cardiac drugs - beta-blockers, ACE inhibitors and diuretics. In such a situation, it seems a rational choice for anti-inflammatory therapy with specific COX-2 inhibitors, of which Nise is a representative.

Literature

Balabanova R. M. Nimesulide is an anti-inflammatory drug with selective inhibition of COX-2. - RMJ, 2001. - 9. - pp. 291-292.
Nasonov E. L. Prospects for the use of the new non-steroidal anti-inflammatory drug nimesulide. - Wedge. Pharmacol. and therapy, 1999. - 8. - P. 65–69.
Nasonov E. L. The use of non-steroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors at the beginning of the 21st century. - RMJ, 2003. - T. 11. - No. 7.
Nasonov E. L. Specific inhibitors of COX-2: solved and unresolved problems. - Wedge. Pharmacol. and therapy, 2000. - 1. - P. 57–64.
Nasonov E. L. Efficacy and tolerability of the non-steroidal anti-inflammatory drug Nimesulide: new data. - RMJ, 2001. - 9. - P. 636-639.
Bennet A., Villa G. Nimesulid: an NSAID that preferentially inhibits COX-2, and has various unique pharmacological activities. Exp. Opin. Pharmacotherapy, 2000, 1, 277-286.
Bernareggi A. Clinical pharmacokinetics of nimesulide. Clinical Pharmacokinet., 1998, 35, 247-274.
Gurwitz JH, Avorn J, Bohn RL et al. Initiation of antihypertensive treatment during nonsteroidal anti-inflammatory drug therapy. JAMA, 1994, 272, 781-786.
Jonson AG, Nguyen TV, Day RO Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta analysis. Ann. Intern. Med., 1994, 121, 289-300.
Rabasseda X. Safety profile of nimesulide: ten years of clinical experience. Drugs of Today, 1997, 33, (Suppl.1), 1-11.
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Singla AK, Chawla M., Singh A. Nimesulid: some pharmaceutical and pharmacological aspects - an update. J. Pharmac. Pharmacol., 2000, 52, 467-486.
Wolfe F, Anderson J, Burke TA, Arguelles LM, Pettitt D. Gastroprotective therapy and risk of gastrointestinal ulcers: risk reduction by COX 2 therapy. J. Rheumatol., 2002, 29, 467-473.

I. M. Marusenko , Candidate of Medical Sciences N. N. Vezikova , Candidate of Medical Sciences, Associate Professor V. K. Ignatiev , Doctor of Medical Sciences, Professor Petrozavodsk University, Department of Hospital Therapy

For osteochondrosis

Many people in the 21st century suffer from osteochondrosis. This pathology is almost always accompanied by severe pain in problem areas. Of course, in this situation, gymnastics and physiotherapeutic procedures are needed, but they are not suitable for everyone, and the effect of such treatment does not occur immediately. Therefore, you have to use painkillers:

“I’ve been taking it recently and only for pain. I have osteochondrosis. Helps. I sleep normally at night, almost never wake up; I’m afraid to take it often: it has a great effect on the liver, and I also don’t have a gallbladder.”
“I have deforming osteochondrosis of the knees. Later, my shoulders also began to hurt... Both my shoulders and my knees either hurt or don’t hurt. As if some kind of inflammation periodically develops in them. I may not be treated with anything, but then the pain can persist for weeks and months. Then suddenly he’ll let you go for a few months. But with Nise, the pain goes away in a few days.”
“For several months I had terrible back pain, so I had to visit a doctor. One of the medications that the doctor prescribed for me was Nise tablets. To my surprise, the pills had no effect on me, the pain still did not subside.”

It turns out that this medicine helps most people suffering from osteochondrosis, but not all. You should also be aware that there are patients for whom this medicine causes side effects (although this is rare). To avoid undesirable developments, the selection of a drug for pain due to osteochondrosis and other diseases should be left to doctors.