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INVENTION
Patent of the Russian Federation RU2245716

METHOD OF ENDOSCOPIC TREATMENT OF GASTROINTESTINAL TRACT DISEASES

The name of the inventor: Gerasimov VB (RU); Berzin S.A. (RU); Emelyanova I.V. (RU); Mosyan GI (RU); Emelyanov A.S.
The name of the patent holder: OOO "Organization of Laboratory Research of Medical Preparations" (OOO "OLYMPUS") (RU); Gerasimov Valery Borisovich
Address for correspondence: 620075, Yekaterinburg, ul. Bazhova, 79, of.315, LLC "Olympus", the gene. To the director AS Emelyanov
Date of commencement of the patent: 2002.09.16

The invention relates to medicine, namely to gastroenterology using endoscopic methods of treatment. The endoscope is introduced, the surface is cleaned and the treatment is applied to the affected surface under visual control. In this case, a therapeutic composition in the form of a gel based on the substance of Tizol (aqua complex of glycerol solvate of titanium) is applied to the affected surface through the endoscope. Tysol is used in the form of an aqueous solution with a Tysol concentration of at least 60%, the composition is applied to the affected surface for one session from 2 to 8 ml. The number of treatment sessions is from 1 to 7, and the treatment sessions are carried out in 3-5 days. The therapeutic composition in the form of a gel based on the substance Tizol is prepared by mechanically mixing the therapeutic micro-additives with the substance Tizol. In this case, the therapeutic micro-additives are administered in a total amount of up to 7.26% of the weight of the composition, selecting the components depending on the disease, and the therapeutic composition is applied with a layer of 1-2 mm. In the treatment of erosion and gastritis, as therapeutic additives in Tysol, sea buckthorn oil and / or a propolis solution are administered. In the treatment of stomach and duodenal ulcers, as therapeutic additives in Tysol, methyluracil, hydrocortisone, cycloferon, and aecol are administered. In the course of treatment, the composition of the composition is adjusted according to the sessions taking into account the results of visual control and analysis, and after applying the composition, the patient is limited to eating and drinking for at least 0.5 hours. The method allows for the introduction of therapeutic preparations into the mucous membrane and tissues without the use of needle injectors to rapidly remove pain and swelling with effective healing of inflammation and ulcers with minimal amount of injections and minimal trauma to the patient.

DESCRIPTION OF THE INVENTION

The invention relates to medicine, namely to gastroentology using endoscopic methods of treatment and can be used for the treatment of inflammatory and ulcerative diseases of the esophagus, stomach and duodenum. The method can be used both in hospital and outpatient settings.

A method for treating gastric and duodenal ulcers is known, which includes an intragastric application for an ozonitis ulcer in an amount of 3 ml every other day (see RF patent No. 2147877, A 61 K 31/19, published on 27.04.2000, Bulletin No. 12) . A certain complexity of such treatment is that the application procedures are performed every other day, which is tiring for the patient, and that the oil solution, due to its low adhesive capacity, can slide down from the gastric mucosa, reducing the effectiveness of the treatment.

An endoscopic method for treating gastroduodenal ulcers with solcoseryl and sea buckthorn oil is known (see Akhmetova, RA, et al., Endoscopic method in the complex treatment of peptic ulcer and erosive gastroduodenitis in children., Pediatrics, 1990, No. 12, p.79-80), including Irrigation through a catheter of the biopsy channel of ulcerous and ulcerous surface with sea buckthorn oil (single dose of 5 ml) with application of sorcosel (single dose 2 ml). The procedure is carried out every other day. The course of treatment includes from 5 to 11 endoscopic irrigation with salt-seryl and sea buckthorn oil.

The disadvantage of the method of treatment is the long-term preservation of the pain syndrome - up to 10 days, due to the fact that therapeutic drugs are applied superficially to the affected surface of ulcers and the gastric mucosa and as a result they do not have time to be absorbed into the tissues, and by means of gastric juice and food they are quickly removed from the site of application , Reducing the effectiveness of treatment.

Known is the "Method for treating duodenal ulcer", (see RF patent No. 2082413, published on June 27, 1987, Bulletin No. 18), in which, after the endoscope is inserted, the ulcer is cleaned with a special brush from food debris and fibrin plaque and the ulcer edge First cut off with lysozyme in a dose of 100-150 mg, and then solcoseryl or actovegin in a dose of 4-5 ml. After splitting, the ulcer is irrigated with sea buckthorn oil (5 ml), while the injection points are changed in a subsequent procedure. The procedure is carried out every other day with a course of treatment of 3-5 procedures.

With good quality of treatment, the drawbacks of the method are the difficulty of its implementation, including the splitting of the ulcer by a special needle-injector through the endoscope, which can increase edema and the duration of the procedure, which tires the patient, since it is required to inject separately the two preparations and to conduct surface treatment of the ulcer with sea-buckthorn oil.

The object of the invention is to develop a method for endoscopic treatment of acute inflammatory-destructive processes in the mucous esophagus, stomach and duodenum, which allows the introduction of therapeutic preparations into the mucous membrane and tissues without the needles for the rapid removal of pain and edema with effective healing of inflammation and Ulcers with a minimum number of injections and minimal trauma to the patient.

The problem is solved by the fact that in the treatment after the introduction of an endoscope and cleaning of the affected surface, a therapeutic composition is applied to the treatment site in the form of a gel based on the substance Tizol (aquacomplex of glycerol solvate of titanium). In this case, Tysol is used in the form of an aqueous solution with a Tysol concentration of at least 60%. The composition is applied to the affected surface in one session from 2 to 8 ml. The number of treatment sessions is from 1 to 7, sessions are carried out in 3-5 days.

The therapeutic composition is prepared by mechanically mixing the therapeutic micro-additives with Tysol substance, while the micro additives are administered in a total amount of up to 7.26% by weight of the composition, selecting components depending on the disease, and the therapeutic composition is applied with a layer of 1-2 mm. In the treatment of erosion and gastritis, as medicinal microadditives in Tysol, it is preferable to include sea buckthorn oil, a propolis solution.

In the treatment of gastric and duodenal ulcers, as therapeutic additives in Tysol, methyluracil, hydrocortisone, cycloferon, and aecol are administered.

In the course of treatment, the composition of the composition is adjusted according to the sessions taking into account the results of visual control and analysis, and after applying the composition, the patient is limited to eating and drinking for at least 0.5 hours.

Tizol - gel substance - FS 42-3414-97 (instead of VFS 42-2188-93), developed and manufactured by the company "Society for Laboratory Research of Medical Preparations", Ekaterinburg. Has a high transcutaneous conductivity, non-toxic, easily miscible with therapeutic additives.

Tysol's form is a gel of white color. Tysol does not accumulate fluid in tissues, at the same time it protects tissues from drying and edema, and intensifies their oxygenation. Tysol is authorized for medical use in Russia by Order No. 192 of the Ministry of Health and Medical Industry of the Russian Federation of 16.08.1993 (see Pharmacia No. 2, 1994, p. 9-10) and registered for No. 93/192/1.

Tysol used in the process is used as the main (by weight) component to accelerate the absorption and expansion of the zone of administration of drugs in the tissues of the gastrointestinal tract when applying the formulation in the form of applications through the endoscope. Tysol also has additional therapeutic properties and the ability, mixing with the preparations of the main action, to form with them a homogeneous gel composition - a composition with an increased penetrating and adhesive (adherent) ability.

The drug substance Tisol is widely used in medicine, in particular, in a mixture with 0.1-3% microwave extract from medical leeches, which is used for the skin wound-healing application (Patent of the Russian Federation No. 2141326, published on November 20, 1999. Bulletin No. 32 ).

In dentistry, Tizol is used in the treatment of candidiasis of the oral mucosa in a mixture with nystatin - as an application (Patent of the Russian Federation No. 2142267, published on 10.12.99, Bulletin No. 34). In mixture with propolis from 5 to 20% by weight Tysol is used in formulations for fixing removable dental prostheses (Patent of the Russian Federation No. 2,177,304, published on 27.12.01, Bulletin No. 36). However, the administration of drugs in the gastrointestinal tract through the application of the gel composition with Tizol in the form of applications through the endoscope has not previously been used and data on the possibilities of Tizol to conduct therapeutic substances in the mucosa and tissues of the gastrointestinal tract was not known.

The method of treatment is as follows. An empty stomach in the position on the left side after irrigation of the pharynx with a 10% solution of lidocaine produces fibrogastroduodenas, in which gastric ulcer or inflammatory processes in the esophagus are revealed. When an ulcer is detected, it is purified by irrigation with water or a special brush through the endoscope from food residues and fibrin plaque, examine and roughly determine the affected area for application of a mixture of a therapeutic composition based on Tysol. Determined in the required amount of the drug, apply a therapeutic composition in an amount of 2 to 8 ml, determined for the diagnosis. The total amount of additives is up to 7.26% of the weight of the composition. The therapeutic composition is prepared from the calculation of a single dose from 2 to 8 ml, depending on the area to be treated.

The prepared composition through a catheter inserted into the endoscope is applied to the affected surface with a uniform layer 1-2 mm thick. In this case, the composition is also treated with a surrounding surface area of ​​4 to 20 cm ² . After applying the composition, the patient is restricted to eating and drinking for at least 0.5 hours. The treatment sessions are carried out in 3-5 days, the total number of sessions is 1-7.

Each subsequent procedure is carried out after visual inspection of the surface to be treated, adjusting the amount of the composition administered and the area to which it is applied. Treatment stops after cicatrization of the ulcer to the soft red rumen depending on its depth and the area of ​​the affected surface, in case of inflammation of gastritis - after removing the edema and healing of erosion, 1-2 more sessions are performed to fix the obtained therapeutic effect.

After carrying out experiments on animals and testing the effectiveness of the method on individual patients, clinical and laboratory tests of the proposed method of endoscopic treatment of acute inflammatory-destructive processes on the mucous esophagus, stomach and duodenum, with the use of therapeutic compositions with an aqueous solution of Tizol, conducted clinical studies at the Department of Oncology And X-ray radiology of the Ural State Medical Academy on the basis of the polyclinic №3 of the Central Clinical Hospital No.7 of the city of Yekaterinburg in 1999-2000.

Diagnosis of diseases of the esophagus, stomach and duodenum, and local endoscopic treatment according to the proposed method was carried out with the help of fibroendoscopes such as "Puchok-MT-11" (Russia) and GIF-Olipas (Japan). Prior to treatment, the patient underwent primary fibroendoscopy with biopsy and cyto-histological analysis to determine the nature of the concomitant inflammatory process. To exclude malignant changes, complex laser, endoscopic diagnostics in combination with chondrojstroscopy (IDM) and repeated biopsy with cyto-histological examination were additionally carried out.

The introduction of a mixture of drug gel preparation into the lumen of the organ and its application to the mucosa was performed under visual control and with the help of tele-photo-video control, using special catheters, which were applied. Cytological and histological examination of biopsies was performed according to standard methods.

Gel compositions based on Tysol were introduced through a catheter inserted into the endoscope, followed by irrigation or application to the stomach wall in an amount of 2-8 ml.

Variants of therapeutic compositions with Tizol are presented in Table 1.

Table №1. Variants of therapeutic compositions of Tizol.
No.	Composition of the composition	Number of medications. Of additives,%	Total number of patients	Number of patients by type of pathology
1.	Water 60% of the Tysol river - 94%, Sea buckthorn - 5%. Propolis - 1%.	6.0	35	25 - erosion	5/1; 10/2; 5/5; 5/7	10/2; 5/4
				10 - gastritis	3/2; 4/5; 3/7	2/2; 4/3; 2/5; 2/8
2.	Water 60% of the Tysol river - 94.975%, Metuluracil - 5%. Hydrocortisone - 0.025%	5,025	21	5 - stomach ulcer	1/1: 2/3; 3/5	1/2; 2/5; 1/6; 1/8
				16 - ulcer 12 - the peritoneum	1/1; 5/3; 5/5; 2/2; 3/7	3/2; 6/5; 4/6; 3/8
3.	Water 60% of the Tysol river - 96.67%, Cycloferon - 0.33%; Aekol - 3.0%	3.63	20	Acute period of chronic processes: 8 - ulcers	1/2; 3/5: 4/7	1/2; 3/5; 4/8
				4 - erosion	1/1; 1/2; 1/5: 1/7	1/2; 2/5; 1/8
				8 - inflammation of the stomach	1/2; 3/5; 4/7	1/2; 3/5; 4/8
4.	Water 60% of the Tysol river - 92.74%, Cycloferon - 0.33%, Aekol - 3.3%, Metronidazole - 3.3%, Amoxicillin - 0.33%	7.26	20	Acute period of chronic processes: 8 - ulcers	1/2; 3/5: 4/7	1/2; 3/5; 4/8
				4 - erosion	1/1; 1/2; 1/5: 1/7	1/2; 2/5; 1/8
				8 - inflammation of the stomach	1/2; 3/5; 4/7	1/2; 3/5; 4/8

The efficacy of treatment was assessed by control cytohistological analysis-a decrease in the degree of activity of the inflammatory process, proliferation (P), inguinal Helicobacter pilori (Hp), degenerative-dystrophic changes (DD), intestinal metaplasia (CM), and dysplasia (D) of the epithelium, Clinical and visual data of endoscopy, chromoluminescent fibroendoscopy.

Among the 113 patients examined, there were several more men than women, most of the patients were between the ages of 40 and 60 years. Each examined patient had several pathological processes (an average of 2.4), each had chronic gastritis manifestations at the stage of exacerbation.

The control group of patients treated with injections of the solcos series and the applications of sea buckthorn and propolis consisted of 12 people with a combined inflammatory pathology of the esophagus, stomach and duodenum.

Patients with chronic gastritis and peptic ulcer and duodenal ulcer predominated among the treated patients. The main complaints in patients, regardless of the morphological changes were: the severity of epigastric after eating, pain and heartburn. The leading endoscopic symptoms were signs of inflammation on the atrophic and hyperplastic mucosa. Cytological parameters of treated patients are presented in Table 2.

Most of the treated patients had a moderate and severe degree of dysplasia (76.5%) and infection with Helicobacter pilori (65.2%). The histological parameters of the treated patients (in%) are presented in Table 3.

From Table 3 it can be seen that most of the treated patients had severe atrophic changes in the coolant, a severe inflammatory process with marked activity and the presence of Hp infection.

Patients were conducted from 1-8 sessions of endoscopic treatment at intervals of 3 to 7 days.

A positive result of the method of endoscopic treatment with Tysol and compositions based on it was noted in all patients.

On days 1-2 after 1 treatment, the pain disappeared, after 2-3 treatment sessions, dyspeptic manifestations, heartburn decreased or disappeared. The analgesic effect was especially pronounced in the presence of an ulcer in the duodenum.

When analyzing the data, it can be seen that the compositions with Tizol most effectively acted on the acute inflammatory-destructive process of the mucous esophagus, stomach, and duodenal ulcer. Inflammatory changes in the coolant disappeared practically in all the observations already in 2-3 sessions of endoscopic treatment. Cicatrization of ulcers occurred in all cases, the time of scarring was reduced by 3-6 days, there was no evidence of coarse scar formation or rough deformation of the wall. During the period of observation of the treated patients, the degree of atrophy and hyperplasia of the coolant did not change much.

The overall effectiveness of treatment with the use of Tisol compositions on the basis of cytological histological parameters is presented in Table 4. A good effectiveness of Tysol compositions was noted in the treatment of degenerative-dystrophic changes and a decrease in the activity of the inflammatory process, a lesser effectiveness in Hp eradication and antiproliferative action.

It has been established that the Tisol composition, including methyluracil and hydrocortisone (43.5%), has a good anti-inflammatory activity. The average anti-inflammatory activity of Tysol compositions = 31.5%.

Therapeutic effect: D max at kT №3 = 83,3%, KM max for kT №6 = 63,6%, (Д + КМ) max for kT №5 = 72,2%.

The effectiveness of endoscopic treatment with Tizol compositions of inflammatory and premalignant changes in the gastric mucosa by morphological criteria is 90.0% and only 50.0% in the control group. Moderate, pronounced and absolute effectiveness of treatment was 72.0% and only 16.6% in the control group.

Determined that:

Tizol is one of the few medicines that allow to successfully carry out endoscopic treatment of most diseases of the esophagus, stomach, duodenum, which are urgently needed by endoscopists and gastroenterologists.

Local production and low price of the drug ensures its availability for medical and preventive institutions and for a wide stratum of the population.

The pronounced analgesic and anti-inflammatory effects from the use of the preparation in pure form and in the form of compositions with application allow improving the quality of life of patients.

The estimated economic efficiency of the method (for 100 patients in 2000 prices) is at least 60-80 thousand rubles. At the expense of reducing the cost of treatment course of peptic ulcer 12 duodenum by the proposed method 2-3 times and reducing the number of emergency and planned surgical interventions in 6-8% of patients for complications of peptic ulcer.

Experiments and experiments have shown that Tizol drug compositions can be effectively used for endoscopic treatment of inflammatory changes in the mucous membranes of the esophagus, stomach and duodenal ulcer and peptic ulcer according to the proposed method, without requiring additional new equipment and special personnel training.

A new, non-obvious effect of the method is the rapid removal of pain and swelling with a fairly simple treatment regimen, which allows us to recommend a method for introduction into broad practice.

The proposed method of endoscopic treatment of diseases of the gastrointestinal tract can be widely used in medical institutions in Russia, both inpatient and outpatient treatment.

CLAIM

1. A method for endoscopic treatment of acute inflammatory-destructive processes in mucous esophagus, stomach and duodenum, including the introduction of an endoscope, cleaning of the affected surface and application of a medicinal composition to the affected surface under visual control, characterized in that the affected surface is medicated through the endoscope A composition in the form of a gel based on the substance Tizol (aqua complex of glycerol solvate of titanium), while Tysol is used as an aqueous solution with a Tysol concentration of at least 60%, the composition is applied to the affected surface for one session from 2 to 8 ml, and the number of treatment sessions from 1 to 7, and treatment sessions are carried out in 3-5 days.

2. A method according to claim 1, characterized in that the therapeutic composition in the form of a gel based on the Tisol substance is prepared by mechanically mixing the therapeutic micro-additives with Tysol substance, while the therapeutic microadditives are administered in a total amount of up to 7.26% by weight of the composition, Depending on the disease, and the therapeutic composition is applied a layer of 1-2 mm.

3. The method according to claims 1 and 2, characterized in that, in the treatment of erosion and gastritis, therapeutic sea-food additives are preferably introduced into Tysol, preferably sea buckthorn oil and / or a propolis solution.

4. A method according to claims 1 and 2, characterized in that in the treatment of gastric and duodenal ulcers, as therapeutic additives in Tysol, methyluracil, hydrocortisone, cycloferon, and aecol are administered.

5. The method according to claims 1 and 2, characterized in that during the treatment, the composition of the composition is corrected by sessions, taking into account the results of visual inspection and analysis, and after applying the composition, the patient is restricted in eating and drinking for at least 0.5 h.

print version
Date of publication 29.03.2007gg

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