RU83180U1 - ALLERGY DIAGNOSTIC KIT - Google Patents

Abstract

Usage: in the field of medicine, namely, in immunology when establishing an etiological factor for the subsequent prevention of allergic reactions and, above all, to medicines. The essence of the utility model: A set of tools for diagnosing allergies, contains ampoules with an allergen medicine placed in a box, a set of graduated cups for washing the oral cavity, a Fuchs-Rosenthal camera, a bottle with Zadorozhny-Dozmorov dye, and a microscope. A set of tools for diagnosing allergies in accordance with the utility model allows a simple and affordable way to conduct examinations of different categories of patients (children, elderly patients, smokers, etc.) to identify drug allergies with a high degree of reliability of the results. 2 independent

Description

The invention relates to medicine, namely to immunology, and can be used to establish the etiological factor for the subsequent prevention of allergic reactions, especially to medicines.

Drug allergy is one of the five most common allergic diseases and accounts for 5-8% in the structure of the entire allergopathology.

Allergic reactions to drugs, unlike other undesirable side reactions, are unpredictable, often develop rapidly and are characterized by a significant severity of the clinical course.

The urgency of the problem of drug allergies is increasing every year due to the increase in drug consumption, the widespread use of self-medication due to the availability of drugs and the fact that the pharmaceutical industry annually produces new highly effective pharmacological agents that also have sensitizing activity.

The study of the etiology and pathogenetic mechanisms of the development of an allergic reaction in the human body to a particular factor largely determines the choice of methods for subsequent treatment of the patient. At the same time, reducing the possibility or elimination of undesirable consequences of the use of medicines and, above all,

preventing the development of drug allergies is one of the most important tasks of an allergist.

All of the above indicates that currently in medical practice one of the most urgent tasks is the creation of simple, reliable, convenient methods for specific diagnosis of drug allergy. This problem is especially serious in relation to the most commonly used medicines: antibiotics and other antibacterial drugs, local anesthetics, analgesics, non-steroidal anti-inflammatory drugs.

Known methods for specific laboratory diagnosis of drug allergy, based on the detection of specific IgE antibodies to drugs or their metabolites, as well as sensitized lymphocytes or mediators of allergy (Samoylova L.N., Tabakova T.V. "On the diagnosis of drug allergies", Ter archive, 1992, 64, No. 10, pp. 17-24) are not absolutely reliable, their results are often contradictory. In addition, most of these tests are designed and used to diagnose an allergic reaction of only a certain type and to specific drugs.

The most commonly used laboratory methods for the diagnosis of drug allergies are RAST, ELISA, specific histamine release from basophils, Shelley basophilic test for the diagnosis of IgE-mediated reactions; reactions of blast transformation of lymphocytes and reactions of inhibition of migration of leukocytes - for the diagnosis of slow reactions (ibid.). However, these in vitro diagnostic methods are more suitable for studying the mechanisms of allergic reactions than for everyday practice. They are laborious, expensive, their implementation requires specially trained employees, expensive equipment and laboratory animals, and therefore these methods are not widely used for operational specific diagnosis of drug allergies in medical practice.

Diagnostic tests “in vivo” (skin tests, sublingual test, graduated provocation) have an undeniable advantage over laboratory methods, as they allow you to simulate the immune mechanisms of the action of a pharmacological substance on the patient's body. However, for the most part, these tests are potentially dangerous, because are provocative (Kowalski M.L., Makowska J.S. Aspirin-dependent respiratory diseases. Modern approaches to diagnosis and treatment. Allergy Clin Immunol Int - J World Allergy Org Russ Ed, 2/1, 2007), p.13-23).

At the same time, these diagnostic methods are not sufficiently informative, since the medicine may have a local irritant effect and give false positive reactions.

The closest known means for the rapid diagnosis of allergies is the sublingual test (Encyclopedic Dictionary of Medical Terms, M., Soviet Encyclopedia, 1983, p. 346), in which the patient is injected with an allergen under the tongue and after 5-25 minutes the intensity of the local allergic reactions (swelling of the lips, tongue, itchy skin, burning, hypersalivation and other allergy symptoms). This test is mainly used for the diagnosis of drug allergies.

However, since the sublingual test is carried out with therapeutic doses of the drug and is a provocative study, its consequence may be a systemic reaction of both allergic and non-allergic genesis. For example, it is known that the fulminant phase of anaphylactic shock can develop within 2-5 minutes in the absence of visual changes from the mucous membranes. In addition, a local reaction, for example in the form of hypersalivation, can occur on the organoleptic properties of the drug (bitter, sour taste, etc.) and may not be an allergic reaction. The results of the sublingual test are evaluated by the doctor on the basis of only the appearance of the mucous membrane, which is a subjective and inaccurate assessment.

At the same time, positive sublingual tests do not always confirm the presence of sensitization to the allergen, and for final conclusions, a correlation of their results with anamnesis, clinical data and laboratory studies is necessary.

In addition, sublingual tests can be false negative (i.e., the absence of a reaction in the presence of an allergy), for example, in cases of inhibition of the mucosal reaction while taking antihistamines, corticosteroids, beta-adrenergic agonists; due to age-related characteristics of the reactivity of the oral mucosa (in children, sometimes in the elderly, in smokers) or, if the allergen is not the starting substance, but the products of its metabolism in the body, which is often found with drug allergies.

Thus, the technical result obtained by the implementation of the described invention consists in increasing the efficiency and reliability of the diagnosis of allergic diseases, by eliminating the subjective visual factor, the perception of the reaction of the oral mucosa, and the possibility of obtaining a reliable result in different categories of patients (children, elderly patients, smokers, etc.). In addition, the technical result consists in expanding the functionality of the technique due to the possibility of not only qualitative, but also quantitative assessment and improving safety, since the concentrations of drugs used in the proposed method cannot cause life-threatening reactions in patients.

The specified technical result is achieved in that the kit for the diagnosis of drug allergy, including at least one ampoule with a solution of an allergen drug and a set of graduated glasses for washing the oral cavity, placed in a box, contains a Fuchs-Rosenthal chamber, a bottle with Zadorozhny-Dozmorov dye, and binocular microscope.

Using the Fuchs-Rosenthal camera allows counting polymorphonuclear leukocytes in liquids obtained after washing the oral cavity even with a slight emigration of leukocytes, which greatly simplifies the procedure for diagnosing allergies and increases its reliability, since it allows studies with patients with a small number or absence of teeth, smokers, children and elderly people, patients with dentures, patients who have undergone inflammatory and degenerative diseases of the oral cavity (injuries, La syndrome yella, etc.) due to their hypotrophy or degenerative changes in the oral mucosa and the small number of leukocytes that emigrate to the oral cavity, while not requiring additional time for examination and expensive equipment.

The use of the Zadorozhny-Dozmorov stain makes it possible to determine viable polymorphonuclear leukocytes and easily differentiate them from other visually similar cellular elements and food impurities in the wash liquid, which significantly reduces the likelihood of errors in cell counting and improves the accuracy of diagnosis.

The described set of tools for diagnosing allergies allows you to identify true allergic reactions to drugs with sensitizing properties, it is applicable both for antibody-dependent (humoral) and antibody-independent (cellular) ways of developing allergic reactions.

The described utility model contains a vial with Zadorozhny-Dozmorov dye and at least one vial with a water-soluble allergen medicine. An allergy diagnosis kit may include a set of ampoules with aqueous solutions of such medicines as antibiotics penicillin, cephalosporin, aminoglycoside, macrolide, tetracycline, chloramphenicol and other groups, sulfonamides, local anesthetics, non-steroidal anti-inflammatory drugs.

For the diagnosis of drug allergies, water-soluble forms of medicines in the following concentrations are used as antigen:

- penicillins - 1 μg / ml,

- cephalosporins (zeporin, kefzol, cefamisin, etc.) - 1 μg / ml,

- aminoglycosides (kanamycin, gentamicin, etc.) - 10 μg / ml,

- macrolides (erythromycin, etc.) - 10 μg / ml,

- chloramphenicol (chloramphenicol) - 10 μg / ml,

- tetracyclines - 10 μg / ml,

- sulfa drugs - 100 μg / ml,

- derivatives of pyrazolone and acetylsalicylic acid - 100 μg / ml,

- local anesthetics (novocaine, lidocaine, etc.) - 100 μg / ml,

- antibiotics of other chemical groups - 10 μg / ml.

The set of tools for diagnosing allergies in accordance with the utility model also contains a Fuchs-Rosenthal camera, a microscope and four graduated cups for washing the oral cavity.

A survey using the described set of tools for diagnosing allergies is carried out as follows.

A previously prepared patient conducts successive rinses of the front of the oral cavity (vestibule and sublingual region) for 2 minutes with 10 ml of physiological saline (pH 7.3-7.4). In this case, after each washing, liquid from the oral cavity (washing liquid) is collected in cups, which are numbered in accordance with the rinse order.

In a cup No. 1, liquid is collected from the oral cavity (washing liquid) after the first washing, as the initial portion (control).

15 minutes after the first washing, a liquid is collected in a cup No. 2 after the second washing with physiological saline with the test medication diluted in it (the alleged allergen drug).

In the cup No. 3, the washing liquid is collected after the third washing, carried out 15 minutes after the second washing.

In the cup No. 4, the washing liquid is collected after the fourth washing, carried out 15 minutes after the third washing.

Next, staining and counting of leukocytes in the material collected for the study is performed. For this, the washing liquid from the glasses No. 1, 3, 4 after thorough mixing is successively placed using a micropipette on the watch (or object) glass, 0.02 ml from each glass.

In these portions of washing liquid, 0.04 ml of Zadorozhny-Dozmorov dye is added, then after 5 minutes of staining the test mixture is placed under the ground glass of the Fuchs-Rosenthal chamber. Next, under a microscope (enlarged × 200), white blood cells are counted in the entire volume of the Fuchs-Rosenthal chamber.

Thus, the number of leukocytes in the control and experimental portions of the washing liquid is calculated at different stages of the examination.

The leukocyte emigration index in the oral cavity is calculated by the formula:

Нк - the number of leukocytes (neutrophils) in the initial (control) portion (cup No. 1); But - the number of leukocytes (neutrophils) in the experimental portions 3 and 4.

The smallest number of leukocytes from the experimental portions, i.e. the highest percentage of braking.

The test is assessed as positive with a decrease in the number of cells by the Emigration Index by more than 30%. A positive in vivo test is also considered when

the leukocyte emigration index (IE) will be reduced by more than 30% even in one (any) experimental portion.

Inhibition of leukocyte emigration by more than 30% after exposure to a weak solution of a specific allergen on the oral mucosa was detected in patients with allergic diseases and proved sensitization to pollen allergens, house dust allergens, penicillin, etc. The phenomenon of inhibition of leukocyte emigration was detected as in allergic reactions immediate type, and with a delayed-type allergy (cell-mediated reactions).

The described set of tools for diagnosing allergies using Zadorozhny-Dozmorov dye and using the Fuchs-Rosenthal camera showed a complete correlation of the results obtained in patients with normal white blood cell counts in the oral cavity when tested by other known methods. The use of the Fuchs-Rosenthal camera in testing 29 patients even with a small number of cells in the oral cavity made it possible to study a large volume of the wash liquid sample and record a sufficient number of cells in the washouts for reliable calculation of the emigration index.

Thus, a set of tools for diagnosing allergies in accordance with the utility model allows a simple and affordable way to conduct examinations of different categories of patients (children, elderly patients, smokers, etc.) to identify drug allergies with a high degree of reliability of the results.

The test does not require a specially equipped laboratory, expensive equipment and reagents, the use of laboratory animals; the test can be performed by an allergist directly during the patient’s appointment, and the test result is known on the day of testing.

Claims (1)

A set of tools for diagnosing allergies, including at least one ampoule with an allergen medicine placed in a box and a set of graduated glasses for washing the oral cavity, characterized in that it contains a Fuchs-Rosenthal camera, a bottle with Zadorozhny-Dozmorov dye, and a microscope.