RU2082403C1 - Remedy of antiallergic action - Google Patents

Abstract

FIELD: medicine, allergology, therapy. SUBSTANCE: method deals with application of zeolite-containing tuff (clinoptilolite) as antiallergic remedy. Low curative dose injected by noninvasive way at high curative effect, nontoxicity and the absence of side effects, simplified and cheap technology makes industrial production and medicinal application of natural zeolite-containing tuff to be very useful. EFFECT: higher efficiency of therapy. 3 cl, 1 tbl

Description

 The invention relates to medicine, in particular to allergology, and can be used for the treatment and prevention of clinical manifestations of various allergic diseases, including hay fever, neurodermatitis, urticaria.

 There is a large group of drugs intended for use in the traditional complex pathogenetic and symptomatic therapy of allergic diseases (Mashkovsky MD Medicines. M. 1988, v. 2, p. 491).

 Among etiopathogenetic drugs, enterosorbents are known that adsorb both the allergens themselves and the reagins that occur in the body in response to allergens. The most effective drug of this kind of action is polyphepan [2], a preparation obtained by processing lignin, a product of the hydrolysis of carbohydrate components of wood; its pharmaceutical form is a fine powder, odorless and tasteless, practically insoluble in water.

 The use of enterosorption by polyphepan in the complex treatment of patients with allergic toxidermia and urticaria is known (Raznatovsky I.M. Mikheev G.N. Monakhov K.N. Medical sorbents and mechanisms of their therapeutic effect. Donetsk, 1988, p. 176 177). The duration of the treatment course is 7-14 days at a daily dosage of 0.5 to 1.0 g / kg. The therapeutic efficacy of enterosorption with polyphepan against the background of pathogenetic therapy was clinically manifested in the disappearance of itching, urticaria, edema, and in removing nutritional restrictions.

However, the commonly used high daily dosage of polyphepan causes patients discomfort, heaviness in the abdomen and fatigue towards the end of the day, as well as stool retention [2]
The objective of the invention is the search for etiopathogenetic anti-allergic enterosorbents effective at low therapeutic dosages and eliminating side effects.

 Natural zeolite-containing tuffs of various zoning are known, among which clinoptilolite rocks are of primary importance. Domestic zeolite-containing tuffs usually contain from 30 to 90% clinoptilolite (Chelishchev N.F. et al. Zeolites are a new type of mineral raw material. M. Nedra, 1987), which determines the similarity of the geochemical, adsorption, and ion-exchange properties of various varieties of zeolite-containing tuff (Feeding animals and zeolites. Guidelines for the study of natural zeolites in the feeding of farm animals. Kemerovo, 1990, S. 5-6).

 A unique combination of sorption, catalytic, ion exchange, sieve and other properties in zeolite raw materials provides a wide range of its industrial and agricultural applications. However, with the current level of technology, no data were found on the antiallergic effect of zeolite-containing tufa (clinoptilolite).

 The essence of the claimed invention lies in the use of natural zeolite-containing tuff (clinoptilolite) as a means with antiallergic effect.

 The table shows the mineralogical, physico-chemical characteristics of some domestic zeolite-containing tuffs.

 To confirm the claimed use of zeolite-containing tuff (clinoptilolite), a group of volunteers (9 men and 19 women) suffering from allergic diseases (hay fever, neurodermatitis, urticaria) in the pathophysiological stage, or stage of clinical manifestations was formed. The duration of the disease ranged from 1 year to 26 years. Enterosorption by zeolite-containing tuff has been used both as monotherapy and in the complex treatment of diseases. Dosage form of enterosorbent powder, fraction 0.1 mm. The daily dose of enterosorbent was 7.5 g and was divided into three doses (30-60 minutes before meals). The course of treatment lasted 10-15 days. According to clinical indications, 2 3 courses were performed in several cases.

 To assess the antiallergic effectiveness of enterosorption, the dynamics of the clinical picture (severity of disease symptoms) and the change in the volume of etiotropic and pathogenetic therapy, as well as immunological parameters for cellular and humoral immunity units (the number of T-lymphocytes and their subpopulations, B-lymphocytes, G immunoglobulins, were used as criteria). , A, M, E, circulating immune complexes).

 Example 1. The use of zeolite-containing tuff of the Shivyrtuy field (Shivyrtuin) as an anti-allergic drug: monotherapy of recurrent urticaria and Quincke's edema. Patient B.S.I. 46 years old. Sick since January 1992 when itching and hyperemia of the skin of the face, swelling of the eyelids first appeared. The signs of the disease gradually increased and in March 1992 was hospitalized in the allergy department with a diagnosis of recurrent urticaria, Quincke's edema. Conducted complex therapy with prolonged use of antihistamines. As a result of treatment, a marked improvement came.

 In early April 1993, when there were signs of an exacerbation of the disease, which gradually increased, the patient began taking diazolin. On examination of 04/14/93, there was hyperemia of the facial skin, severe itching, swelling of the eyelids (more on the right). Monotherapy with zeolite-containing tuff of the Shivyrtuysky field was prescribed at 2.5 g per os powder 3 times a day 30-60 minutes before meals (7.5 g per day).

 On the 3rd day of taking the drug, the signs of the disease began to decrease, and on the 7th day of treatment they completely disappeared. The course of treatment lasted 15 days. The drug was well tolerated. When monitoring after a month no complaints, there are no signs of exacerbation of the disease.

 In terms of treatment, the appointment of zeolite with the appearance of the first signs of exacerbation of the disease.

 Example 2. The use of zeolite-containing tuff of the Shivyrtuy field (Shivyrtuin) as a means with antiallergic action: complex therapy of diffuse neurodermatitis. Patient G.E.D. 28 years. From 2 years of age, he suffers from diffuse neurodermatitis. In the last 7 years, the disease proceeds without persistent remission. Hemosorption was performed twice with a good, but short-lived effect. Constantly uses ointments with corticosteroids (up to 5 tubes per week).

 On examination 04/30/93 on the skin of the face, trunk and limbs there is a small papular rash, vesicles, pustules, combs, peeling. The skin is thinned, dry. There are concomitant diseases of chronic pancreatitis, biliary dyskinesia in the phase of unstable remission.

 05/06/93 began treatment with zeolite-containing tuff of the Shivyrtuyskoye field at 2.5 g 3 times a day (daily dose of 7.5 g). The drug was taken for 10 days, tolerated it well. As a result of treatment, there was an improvement in the absence of new skin elements, itching decreased, the frequency of hormonal ointments was reduced from 3 to 1 tube per week. At the same time, heartburn and heaviness in the epigastric region disappeared. In terms of treatment, the use of zeolite-containing tuff every 10 days of the month. The final assessment of the effect during the period of seasonal exacerbation of the disease (winter spring 1993-1994).

 Example 3. The use of zeolite-containing tuff of the Radden field as a means with antiallergic effect: complex therapy of neurodermatitis. Patient P.O.N. 45 years old. Suffers from neurodermatitis during the year. In the summer of 1992, there was a lesion of the whole body. He received complex treatment with antihistamines, herbal medicine, acupuncture.

 On examination, March 22, 93, there is a lesion of the skin of the face and hands of hyperemia, itching, areas of infiltration up to 3-5 cm in diameter, crusts, peeling. The zeolite of the Radden deposit was assigned 2.5 g 3 times a day 30-60 minutes before meals for 12 days (7.5 g / day). On the 10-11th day of treatment, mild signs of exacerbation of the disease appeared. It was decided to conduct repeated courses of therapy on the background of herbal medicine (celandine, horse sorrel). Another 2 courses of treatment were carried out: from 19.04 to 04.30.93 and from 21.05 to 02.06.93. After the second course of therapy, there was an improvement in the disappearance of itching, decreased hyperemia and infiltration. After the 3rd course of treatment, there was a pronounced reverse development of the disease, the skin was clean, there were small areas of peeling on the hands. The patient tolerated the drug well.

 According to this scheme (2.5 g of sorbent per os 3 times a day for 10 15 days), 28 sick volunteers with various allergic diseases were treated: pollinosis, neurodermatitis, urticaria.

 The clinical effectiveness of the drug was observed both with monotherapy and with complex therapy in combination with other methods of treatment (drug pathogenetic, photo, acupuncture, etc.).

 There were no complications of therapy. All patients had a good therapeutic effect: accelerating the reverse development of signs of the disease and reducing the severity of the manifestations of allergic diseases.

 The positive effect did not depend on the duration of the disease and was observed both in recently ill and in people suffering from allergic diseases for many years.

 Thus, the use of zeolite-containing tuff (clinoptilolite) as an antiallergic agent by volunteers suffering from allergic diseases, with a daily dosage of enterosorbent significantly less than in the prototype, gave a distinct therapeutic effect. Side effects and intolerance to the drug were not observed. All of the above confirms the compliance of the claimed invention with the criterion of "industrial applicability".

 1. The high therapeutic effect at a therapeutic dose of less than 10.0 g per day, significantly lower than for other enterosorbents: for example, for polyphepan daily dosage is at least 35 70 g [2] This allows you to use the inventive enterosorbent for long courses, as well as apply it in pediatrics.

 2. Refusal from massive pharmacotherapy to reduce or prevent hormonal dependence on corticosteroids used to treat allergies, which, when combined with zeolite-containing tuff, can be prescribed in smaller doses or completely abandoned.

 3. Zeolite-containing tuffs (clinoptilolites) are a simple dosage form administered non-invasively, the absence of toxic effects and contraindications when taken reduces the risk of overdose and eliminates the need for constant medical monitoring.

 4. The non-toxicity of zeolite-containing tuff, the absence of side effects, and non-injuries to the gastrointestinal tract were proved during preclinical trials on the drug safety program (Report of the Scientific Research Institute of the Institute of Biochemistry of the Siberian Branch of the Russian Academy of Medical Sciences "Assessment of the harmlessness of the use of zeolites of the Shivirtuysky deposit" submitted to the Commission for the Assessment of the Safety of Medicinal Products Pharmacological State Committee of the Russian Federation). These properties meet the requirements for enterosorbents for medical purposes.

 5. Natural raw materials are available and relatively cheap (100 rubles / kg in March 1993 prices). Unlike other enterosorbents, the production of a preparation based on zeolite-containing tuff is technologically simple.

Claims (3)

 1. The use of clinoptilolite varieties of natural zeolite-containing tuff as a means with anti-allergic effect.  2. The use according to claim 1, characterized in that clinoptilolite varieties of natural zeolite-containing tuff of the Shivyrtuiskoye field are used.  3. The use according to claim 1, characterized in that clinoptilolite varieties of natural zeolite-containing tuff of the Radden field are used.

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