RU2318505C2 - METHOD FOR TREATMENT OF CHILDREN WITH DISEASES OF UPPER DIGESTIVE TRACT SEGMENT ASSOCIATED WITH Helicobacter pylori - Google Patents

Abstract

FIELD: medicine, gastroenterology, pediatrics.

SUBSTANCE: method involves using drugs directed on eradication of microorganism Helicobacter pylori that comprises the preparation "Vetoron" additionally. The preparation "Vetoron" is prescribed in the dose 6-8 drops to children of age 7-12 years and in the dose 8-10 drops to children of age 13-17 years for 7-10 days. Invention provides decreasing the mutagenic effect in carrying out the anti-helicobacter therapy in children. Invention can be used in treatment of children suffering from diseases of upper regions of digestive tract associated with infection with Helicobacter pylori.

EFFECT: improved method of treatment.

3 tbl, 2 ex

Description

The invention relates to medicine, in particular to pediatric gastroenterologists, in particular to the treatment of diseases of the upper digestive tract associated with Helicobacter pylori (HP.)

Interest in the problem of upper digestive tract diseases associated with Helicobacter pylori is not diminishing. Currently, environmental pollution is caused by various mutagenic factors of a physical, chemical and biological nature, which are capable of affecting the human genetic apparatus. To assess mutagenesis, it is customary to use the frequency of spontaneous mutagenesis. It is likely that different medicinal substances can cause the same mutation, and one medicinal substance can cause different mutations. A large number of new mutagens raised the problem of protecting the genotypes of living creatures from the destructive effect of mutagens.

There is no data in the literature on the effect of eradication therapy regimens on the karyotype of children with helicobacter damage to the digestive system. In this regard, the main objective of the study was to study the effect of H. pylori infection, the eradication therapy regimen (quadratherapy) on the karyotype of children, and possible methods of treatment if a mutagenic effect is detected.

A known scheme using a proton pump blocker in combination with clarithromycin (500 mg twice a day) and amoxicillin (1000 mg twice a day) for at least 7 days (Vasiliev Yu.V. Peptic ulcer: pathogenesis, modern diagnostic and treatment strategy . // J. “Practical medicine.” - Kazan, 2003. - No. 4. - P.56-60).

A known scheme using bismuth colloidal subcitrate - 240 mg twice a day along with clarithromycin - 250 mg twice a day and furazolidone - 100 mg twice a day for 7 days (Isakov V.A., Shcherbakov P.L., Suggestions for using the recommendations of the second Maastricht agreement on the eradication of Helicobacter pylori. // J. "Clinical prospects of gastroenterology, hepatology." - M., 2002. - No. 4. - P.31-34).

Known scheme: proton pump blocker in a standard dose twice a day + bismuth subsalicylate / subcitrate 120 mg four times a day + metronidazole 250 mg four times a day + tetracycline 500 mg four times a day (Abdulkhakov R.A. Modern principles of ulcer treatment diseases. // "Kaz. Med. Zh." - 2002. - T.83, 3 No. - S.233-236).

Known treatment regimens are diverse and based on an empirical approach to developing optimal treatment regimens for the disease. The use of the quadrocircuit is described: amoxicillin - bismuth colloidal subcitrate - metronidazolemeprazole (Material from the international symposium "Diagnosis and treatment of diseases associated with Helicobacter pylori" Possibilities of anti-helicobacter therapy in the treatment of inflammatory and erosive-ulcer diseases of the gastroduodenal zone, as well as in the prevention of changes in the stomach. A. Scherbakov PL Proposals for using the recommendations of the second Maastricht agreement on the eradication of Helicobacter pylori. // J. “Clinical Perspectives” tiva gastroenterology, hepatology. - M., 2002. - No. 4. - P.31-34). In this scheme, taken as a prototype, we use a combination of colloidal bismuth subcitrate - 240 mg twice a day along with clarithromycin - 250 mg twice a day and with furazolidone - 100 mg twice a day for 7 days.In spite of a rather effective eradication, this treatment regimen has certain disadvantages: it causes side effects, such as intestinal microflora disturbances, allergic reactions, and disorders of the autonomic nervous system (headache, head whirling, sweating).

The prototype and the claimed invention has the following essential features: children with digestive tract diseases associated with Helicobacter pylori are prescribed medicines (bismuth colloidal subcitrate - 240 mg twice a day with clarithromycin - 250 mg twice a day and furazolidone - 100 mg twice a day for 7 days) in order to eradicate Helicobacter pylori.

The disadvantage of the prototype is that the method of treating children with diseases of the upper digestive tract associated with Helicobacter pylori, described in the prototype, does not eliminate the mutagenic effect of drugs included in the eradication therapy of diseases of the upper digestive tract associated with Helicobacter pylori.

The invention is aimed at solving the problem, which consists in the development of a method for the treatment of helicobacter infection in children with the additional use of the drug VETORON.

The solution to this problem provides the elimination of the mutagenic effect of drugs included in the eradication therapy of diseases of the upper digestive tract associated with Helicobacter pylori.

To achieve this technical result, the claimed invention a method of treating diseases of the upper digestive tract associated with Helicobacter pylori, conduct a course of treatment with drugs with the additional use of the drug VETORON in a dose: from 7 to 12 years - 6-8 drops, from 13 to 17 years - 8-10 drops 1 time per day for 7-10 days.

In relation to the prototype, the claimed invention has the following distinctive features: conduct a course of treatment with the additional use of the VETORON drug in a dose: from 7 to 12 years - 6-8 drops, from 13 to 17 years - 8-10 drops 1 time per day 7-10 days.

The following causal relationship exists between the distinguishing features and the result: the drugs used to eradicate Helicobacter pylori have a pronounced mutagenic effect, the level of chromosomal aberrations after treatment is 5.2 ± 2.4% -5.6 ± 2.8% ( the norm is 0-3%). The additional use of the VETORON preparation in a dose: from 7 to 12 years - 6-8 drops, from 13 to 17 years - 8-10 drops 1 time per day for 7-10 days, led to a decrease in the level of chromosomal aberrations by 3 times (chromosomal spectrum aberrations was from 0 to 3% in 100% of children, that is, within normal limits.

VETORON - an aqueous solution of beta-carotene, consisting of beta-carotene (provitamin A - interacts with peroxyl radicals, trap O ₂ ) and vitamin E (converts O ₂ and OH and lipid radicals to inactive forms, interrupts lipid peroxidation (POL) which is the main negative effect of “oxidative stress.” The latter is expressed in a steady violation of the balance of pro- and antioxidant processes in the direction of the prevalence of the former and causes a variety of cytotoxic damage). VETORON normalizes lipid metabolism, has a radioprotective and antioxidant, immunostimulating, anti-inflammatory, adaptogenic effect. By action, it reduces the content of free radicals, protects cellular structures from destruction, inhibits lipid peroxidation, reduces blood cholesterol, normalizes the ratio of high and low density lipids. It activates cellular immunity, Ig G - antibody formation, phagocytosis. Increases adaptive capabilities and resistance to stress during intense physical exertion and exposure to noise, vibration and other environmental factors.

According to the information available to the authors, the set of essential features characterizing the essence of the claimed invention is not known, which allows us to conclude that the invention meets the criterion of "novelty."

According to the authors, the essence of the claimed invention for a specialist does not follow explicitly from a known level of medicine, since the above method of treating children with inflammatory diseases of the upper digestive tract associated with Helicobacter pylori with an additional use of the VETORON drug in a dose of 7 is not revealed up to 12 years - 6-8 drops, from 13 to 17 years - 8-10 drops 1 time per day for 7-10 days, as an antimutagen, which allows us to conclude that the criterion of "inventive step" is met.

The set of features characterizing the essence of the invention, in principle, can be used repeatedly in medicine with obtaining a technical result, which consists in a method of treating children with inflammatory diseases of the upper digestive tract associated with Helicobacter pylori, with the additional use of the drug VETORON in a dose: from 7 to 12 years - 6-8 drops, from 13 to 17 years - 8-10 drops 1 time per day for 7-10 days, as an antimutagen, VETORON normalizes lipid metabolism, has radioprotective and antioxidant antenna, immunostimulating, anti-inflammatory, adaptogenic effect. By action, it reduces the content of free radicals, protects cellular structures from destruction, inhibits lipid peroxidation, reduces blood cholesterol, normalizes the ratio of high and low density lipids. It activates cellular immunity, Ig G - antibody formation, phagocytosis. Increases adaptive capabilities and resistance to stress during intense physical exertion and exposure to noise, vibration and other environmental factors, which allows us to conclude that the invention meets the criterion of "industrial applicability".

This method is as follows.

The studied population of patients with gastroduodenal pathology associated with Helicobacter pylori (H.p.) - 60 children are divided into 3 groups:

Group I consisted of 16 children (21.3%) who were prescribed quadratherapy (omez, de - nol, amoxicillin, metronidazole),

Group II consisted of 14 children (18.6%) who took quadratherapy and VETORON,

III - control group consisted of 30 healthy children.

A cytogenetic study of peripheral blood lymphocytes was performed twice: upon admission and after treatment. In children with diseases of the gastroduodenal region associated with Hp, the level of chromosomal aberrations averaged 3.0 ± 0.2%, which is 1.3 times higher than the control (2.43 ± 2.25%), but is within the upper boundaries of the norm, which possibly indicates infectious mutagenesis.

Table 1
HA frequency in the control group and the main group Control group Main group Std R Chromosomal aberration 2.43 ± 2.25% 3.0 ± 0.2% 0.25 0

When studying the effect of quadratherapy in the second group (N = 16) on the karyotype of children with helicobacter damage to the digestive organs associated with H.p., the level of CA was on average 5.2 ± 2.4% (p <0.001). After quadratherapy, there is no percentage of children with a normal level of chromosomal aberration. This fact indicates the phenomenon of commutagenicity when using quadratherapy.

In the group of patients who received quadratherapy (N = 30), the CA spectrum before treatment: in 53.3%, it was from 0 to 3%, in 53.3% from 3 to 5%, and in 6.6% from 5% -7 % HA. After quadratherapy, the level of CA in 50% of children is presented from 3-5%, in 37.5% - 5-7% of CA, in 6.3% of children the level of CA exceeded 7-9% and in 6.3% exceeded 9%.

Thus, the drugs we studied included in eradication therapy (quadratherapy) have a pronounced mutagenic effect.

table 2
Changes in the level of chromosomal aberrations after quadratherapy Before treatment After treatment Std R The control 2.43% ± 2.25 Group I (21.3%) 3.0% ± 0.2 5.2% ± 0.43 4.64 <0.001

To reduce the mutagenic effect on the karyotype of children, the following modification of eradication therapy was carried out: VETORON was also used with drugs for quadrotherapy.

In children who received quadratherapy with vetoron (N = 14), the level of chromosomal aberrations averaged 1 ± 0.9% (p <0.001). When studying the structure of CA in children who received quadratherapy with veterone, the spectrum of chromosomal aberrations was 0-3% in 100% of children, that is, within the normal range, a 3-fold decrease in the level of chromosomal aberrations was noted (Table 3).

Table 3
Comparative analysis of chromosomal aberrations in children of groups I, II, III before and after treatment Before treatment After treatment the control 2.43 ± 2.25% Group I (21.3%) 3.0% ± 0.2 5.2% ± 0.43 II group (18.6%) 3.0% ± 0.2 1.2% ± 0.2

Thus, our studies allow us to recommend the additional use of the VETORON preparation in a dose: from 7 to 12 years old - 6-8 drops, from 13 to 17 years old - 8-10 drops 1 time per day for 7-10 days with medicines used for the treatment of children with inflammatory diseases of the upper digestive tract associated with Helicobacter pylori.

Example 1

David B., 7 years old, 08/01/1996 year of birth, was admitted to the Russian Children's Clinical Hospital on May 27, 2004, with a diagnosis of Chronic gastroduodenitis? Complaints on admission to pain in the epigastric region, 15 minutes after eating, are cramping. Concerned about nausea, belching of air. Duration of the disease is up to 1 month. Primary hospitalization. Heredity is burdened on the paternal side (grandfather suffers from peptic ulcer of the duodenum). A child of an average level of physical development. The tongue is coated with white plaque, putrid breath odor. On palpation of the abdomen, pain in the epigastric region is determined. Liver increased by 0.5 cm.

Data of paraclinical research methods: in total. blood and urine tests - no pathology was detected. On EGDS dated May 14, 2004 No. 255 (amb), erosive gastritis of the antrum, associated with Helicobacter pylori, duodenopathy, is determined. Breathing test - 7 mm (positive), urease test - 3 mm (positive). Using karyotyping before treatment, the level of chromosomal aberrations was determined - 4 ± 1.25%.

Diagnosed with Erosive gastritis associated with Helicobacter pylori. Duodenopathy.

Eradication therapy was carried out (omez 20 mg once a day, de-nol 240 mg 2 times a day, amoxicillin 1000 2 times a day, metronidazole 500 2 times a day) and Vetoron, 7 cap. Once a day for 7-10 days. On repeated endoscopy - the gastric mucosa with moderate inflammatory changes. Urease and breath tests are negative. The level of chromosomal aberrations after treatment was 1.6 ± 1.6%.

Example 2

Inal D., 13 years old, born in 1991, was admitted to the Republican Children's Clinical Hospital on 01.04.2004 with a diagnosis of Chronic gastroduodenitis? Complaints upon admission: pain in the epigastric region, in the pyloroduodenal zone, 1 hour after eating, cramping, disturbed by nausea, heartburn, belching with air, the duration of the disease for more than a year. Hospitalization is repeated. Heredity is not burdened.

Objectively: A boy of an average level of physical development. The skin is pale pink. The tongue is coated with white plaque. Odor from the mouth putrid, belching sour. Palpation of the abdomen is painful, determined in the epigastric region, in the pyloroduodenal zone, in the right hypochondrium. The liver is not enlarged, cystic symptoms are positive.

Data of paraclinical research methods: In total. blood and urine tests revealed no pathology. EGDS is determined by erosive gastropathy. Urease and breath tests are positive. Ultrasound of the internal organs determines the deformation of the gallbladder with an excess in the body.

Diagnosed with Erosive gastritis associated with Helicobacter pylori. JWP

The level of chromosomal aberrations before treatment was 4 ± 2.8%.

After quadrotherapy (denol 240 mg 2 times a day, amoxicillin 500 mg 2 times a day, metronidazole 500 mg 2 times a day, omez 20 mg 1 time per day) for 7 days plus Vetoron 10 drops. 1 time per day for 7-10 days. On repeated endoscopy of the mucosa without inflammatory changes. The urease test is negative, the respiratory test is 3 mm, the level of chromosomal aberrations after therapy was 2 ± 1.9.

Thus, the additional use of the VETORON preparation in a dose: from 7 to 12 years - 6-8 drops, from 13 to 17 years - 8-10 drops 1 time per day for 7-10 days, as an antimutagen, ensures the elimination of the mutagenic effect drugs included in the eradication therapy of diseases of the upper digestive tract associated with Helicobacter pylori. VETORON normalizes lipid metabolism, has radioprotective and antioxidant, immunostimulating, anti-inflammatory, adaptogenic effects, reduces the content of free radicals, protects cell structures from destruction, inhibits lipid peroxidation, reduces blood cholesterol, normalizes the ratio of high and low density lipids. It activates cellular immunity, Ig G - antibody formation, phagocytosis.

Claims (1)

A method of treating children with inflammatory diseases of the upper digestive tract associated with Helicobacter pylori, including the use of drugs aimed at eradicating Helicobacter pylori, characterized in that they conduct a course of treatment with the additional use of the drug VETORON in a dose: from 7 to 12 years - 6- 8 drops, from 13 to 17 years - 8-10 drops 1 time per day for 7-10 days.