RU2259846C1 - Method and means for carrying out specific immunotherapy of allergic disease patients having sensitization to gnat stings - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: allergen is taken as aqueous salt solution of protein polysaccharide complex of 10000 PNU activity produced by extracting dry degreased gnat of Aedes aegypti with alkaline buffer solution at pH of 8.0-8.2 with following cleaning as means for specific immunotherapy means applicable to allergic disease patients having sensitization to gnat stings. Method involves applying allergen of 10000 PNU concentration in 10-fold dilution introduced to a patient beginning from a dose of 0.2 ml with 1-2 days long pause. Supporting doses of the allergen are administered to the patients before gnat flight season with 10-12 days long pauses.

EFFECT: high effectiveness of the allergen and treatment method.

3 cl

Description

The invention relates to the pharmaceutical industry and relates to a preparation for specific immunotherapy (SIT).

An allergen from mosquitoes of the species Aedes aegypti is known for the diagnosis of sensitivity to mosquito bites. The allergen was obtained from dry fat-free mosquitoes by extraction with an alkaline buffer solution at pH 8.0-8.2, followed by centrifugation at 6000 rpm for 30 minutes at 2-8 ° C. The allergen is a clear liquid from light yellow to brown in 1 ml of which the protein nitrogen content is 10,000 + 2,000 PNU / ml.

An object of the present invention is the use of said allergen for specific immunotherapy of patients with allergic diseases having hypersensitivity to mosquito bites.

To solve this problem, a group of inventions is proposed, united by a common inventive concept.

The use of an allergen, which is an aqueous-salt solution of a protein-polysaccharide complex with an activity of 10,000 PNU, is obtained by extracting dry fat-free mosquitoes of the species Aedes aegypti with an alkaline buffer solution at pH 8.0-8.2, followed by purification as a means for specific immunotherapy of patients allergic diseases having hypersensitivity to mosquito bites. A method of allergen-specific immunotherapy of patients with allergic diseases having sensitization to mosquito bites with an allergen concentration of 10,000 PNU / ml in tenfold dilutions is also proposed by introducing increasing doses of a specific allergen from mosquito bodies to the patient, starting from a dose of 0.2 ml with an interval of mainly 1-2 days. The main goal of SIT is to reduce the patient's hypersensitivity to mosquito allergens in order to prevent allergic reactions to mosquito bites during periods of insect departure. Patients before the season of mosquito departure can be administered with maintenance doses of the allergen at intervals of 10-12 days. To conduct SIT, ten-fold dilutions of the allergen are prepared (initial concentration - 10,000 PNU / ml). The minimum concentration of the drug during SIT is determined individually for each patient based on the results of cutaneous Prick titration with ten-fold dilutions of the allergen (from 10,000 PNU / ml to 0.001 PNU / ml). The initial dose of allergen during SIT corresponds to 0.2 ml of the drug in a concentration corresponding to the skin titer - the minimum concentration of allergen, the first giving a weakly positive (+) reaction when Prick-titration. The scheme can be changed for individual patients according to their individual sensitivity to the drug. The intervals between injections can be increased depending on the tolerability of the drug to patients (local reactions in the form of hyperemia, itching and swelling). Perhaps the introduction of maintenance doses of the drug with an interval of 1-12 days before the season of mosquito departure.

An allergenic treatment drug from mosquitoes of the Aedes aegypti type is considered safe for CIT if all (100%) of the examined individuals lack common (fever, headache, hyperthermia, etc.) and local hyperergic reactions (the sizes of which exceed the maximum prescribed by the established reaction accounting scheme) when conducting SIT with this allergen.

Laboratory tests of blood, urine should also confirm the absence of acute and chronic toxicity of therapeutic doses of allergens from mosquitoes of the species Aedes aegypti.

The results of SIT allergens from mosquitoes of the species Aedes aegypti were evaluated at the end of the mosquito departure season. Clinical manifestations of mosquito bites at the end of the season were evaluated on the basis of objective examinations of patients by an allergist (at least 2 times in the season of mosquito departure). The severity of clinical manifestations for bites was recorded according to the generally accepted 5-point system: excellent effect - 3 points, good - 2, satisfactory - 1. The therapeutic drug - an allergen from mosquitoes of the species Aedes aegypti was effective, there was a decrease in the clinical manifestations of an allergy to mosquito bites or complete absence these symptoms (1 to 3 points). The therapeutic effect occurred in at least 60% of patients. The effectiveness of the drug was also evaluated by the level of synthesis of specific IgG antibodies by ELISA. An increase in the titer of specific IgG block antibodies in blood serum samples of patients with sensitization to mosquito bites after a course of SIT indicates the effectiveness of the allergen.

To study the therapeutic value of the Aedes aegypti mosquito allergen in SIT, it was tested on 30 patients with allergies to mosquito bites from 18 to 50 years old. The effectiveness of SIT by an allergen from mosquitoes was evaluated according to generally accepted criteria with the assessment: excellent effect, good, satisfactory, unsatisfactory. Improvement was noted in all treated patients. Excellent results were obtained in 30% of patients, good in 40%, satisfactory in 30%. Poor (no effect) results were not found. The use of mosquito allergen for SIT of patients with allergic diseases with IgE-mediated allergy revealed the high efficiency of the allergen and the developed drug administration scheme (70%). With pharmacotherapy, it is not possible to obtain the indicated treatment effect.

Claims (3)

1. The use of an allergen, which is an aqueous-salt solution of a protein-polysaccharide complex with an activity of 10,000 PNU, obtained by extraction of dry fat-free mosquitoes of the species Aedes aegypti with an alkaline buffer solution at pH 8.0-8.2, followed by purification, as a means for specific immunotherapy of patients with allergic diseases having hypersensitivity to mosquito bites. 2. A method for specific immunotherapy of patients with allergic diseases having hypersensitivity to mosquito bites, characterized in that the agent according to claim 1 is used, wherein the allergen concentration of 10,000 PNU / ml in tenfold dilution is administered to the patient, starting from a dose of 0.2 ml with an interval mainly 1-2 days. 3. The method according to claim 2, in which up to the season of departure of mosquitoes can be introduced supporting doses of the allergen with an interval of 10-12 days.