Method for endoscopic bioplasty of gastroduodenal ulcers with complex bioplastic material

FIELD: medicine.

SUBSTANCE: what is performed is an endoscopic approach; further, biopsy forceps with a rolled complex bioplastic material cut in size of an ulcerous defect are introduced into a working path of a fibrogastroduodenoscope, laid on the ulcerous defect with the use of the biopsy forceps, and controlled with the use of an endoscopic examination 5-7 days later. The bioplastic material contains hyaluronic acid, a phosphate buffer system, omeprazole and clarithromycin taken in a certain equivalence ratio.

EFFECT: non-invasive treatment of ulcer and reduced length of mucosal tissue regeneration.

1 tbl, 2 ex

 

The invention relates to medicine, namely to abdominal surgery, gastroenterology, and may find application in the treatment of gastroduodenal ulcers.

Currently, modern trends in the treatment of gastric ulcer is aimed at developing methods, replacement surgical treatment is the creation of new drugs and new technologies for minimally invasive endoscopic techniques. Medical treatment of peptic ulcer includes two major pharmaceutical group - blockers, antacids and gastric secretion.

Antacids neutralize the hydrochloric acid that is part of the gastric juice. These drugs contain magnesium, aluminum, calcium, and combinations thereof. Secretomotor depressing effect on the mechanisms of secretion of hydrochloric acid. Among antiulcer drugs are blockers of N2-histamine receptors, prostaglandins, proton pump inhibitors.

Recently against peptic ulcer began to use antibiotics to get rid of its main causes - the bacteria Helicobacter pylori. Second, the Maastricht Treaty puts on the first place among the indications for antihelicobacter therapy of gastric ulcer and peptic ulcer disease duodenal ulcer, regardless of the phase of the disease (about ostrinia or remission), including their complicated forms (Malfertheiner p, Megraud F., S.' Morain et al. Current concepts in the management of Helicobacter pylori infection-the Maastricht 22000 Consensus Report. // Aliment oil displayed pure. Pharmacol. Ther. 2002. V.16. R). Stressed that eradication therapy for peptic ulcer disease is a medical event, and the validity of its use in this disease is based on the obvious scientific facts.

Drug treatment of peptic ulcer disease has a limitation related to the systemic effects of drugs on the body that is accompanied by the appearance of side effects, so the priority is the application of methods and means acting locally on the ulcerative process of the gastric mucosa. In this direction the most appropriate and promising is the use of endoscopic techniques in combination with the local drug action, i.e. delivery of drugs in the seat of the disease in the stomach (duodenum).

There is a method of endoscopic injections of the gastric mucosa drug (Patent RF №2179858, A61K 38/02, A61P 1/04). Spend transendoscopic around the ulcer drug splendid. Drug dose 115-230 mg diluted in 10 ml of 0.25%solution of novocaine or saline and inject 2-3 ml into three points on the edges of the ulcer into the submucosal layer. Treatment including the background of traditional protivoyazvennami, including H2blockers of histamine and H. pylori funds. Procedures injections conducted at intervals of 2-3 days, the number of treatments 4-6. The method provides a reduction of possible scarring ulcers.

The disadvantage of this method is the inability of long-term preservation of the drug at the disease site that requires frequent (4-6 per treatment). Manipulation invasive, possible complications, such as bleeding from the injection site. It should be noted that it is unpleasant and painful procedure.

The technical result of the proposed method endoscopic bioplastics gastroduodenal ulcers complex bioplastic material is minimally invasive (non-surgical) treatment of ulcers and reduction of tissue regeneration of the mucous membrane of the body.

The task is solved in that in the method of endoscopic bioplastics gastroduodenal ulcers complex bioplastic material, including endoscopic access to the working channel fibrogastroduodenoscopy enter biopsy forceps with rolled-integrated bioplastic material, cut to the size of the ulcer, stack on ulcerative defect using biopsy forceps, and control is carried out by endoscopic examination after 5-7 days, with bioplastic material contains hialuronowy acid, phosphate buffer system, omeprazole and clarithromycin in the following ratio, wt.%:

hyaluronic acid90
phosphate buffer system5
omeprazol2
clarithromycin3

Phosphate buffer system provides the neutralization of the excess of hydrochloric acid and protects the underlying mucosa of the stomach from the corrosive effect of gastric juice.

Bioplastic material contains in its structure omeprazole, which inhibits the enzyme H+- +-ATPase ("proton pump") in the parietal cells of the stomach and blocks thereby the final stage of the synthesis of hydrochloric acid. This leads to reduced levels of basal and stimulated secretion, irrespective of the nature of the stimulus.

In addition, the composition of bioplastic material included clarithromycin, which has bactericidal activity against Helicobacter pylori, recognized by many researchers as a cause of the development of peptic ulcer. Clarithromycin, unlike most antibiotics, macrolides, is not subject to hydrolysis and is of Stoychev to the action of hydrochloric acid [Lapina TL, Ivashkin V.T. Modern approaches to the treatment of gastric ulcer and duodenal ulcer // Russian medical journal. - V.3, №1, 2001. - 10-15; Lapin TL Modern approaches to the treatment of acid-N. pylori-associated diseases // prospects of Clinical gastroenterology, Hepatology. 1, 2001. - 21-27].

Thus, for a new method of endoscopic bioplastics gastroduodenal ulcers is complex bioplastic material having the composition shown in the table.

ComponentQuantitative measure%The function of the component
Hyaluronic acid90Matrix-carrier for Pharm. drugs effective regenerant. Provides adhesion (sticking) to the gastric mucosa and prolonged biodegradation (14 day)
Phosphate buffer system5Neutralization and protection from irritation of excess hydrochloric acid in the area of the ulcer
Omeprazole2Neutralization and protection from irritating dei is the conduct of excess hydrochloric acid in the area of the ulcer
Clarithromycin3Bactericidal activity against Helicobacter pylori

Thanks to an extensive network of macromolecules of hyaluronic acid polymer capable of retaining the structure of the above components in an inert chemical status. Methods of analytical chemistry has been proven that in the polymeric matrix of hyaluronic acid does not occur chemical reactions, and omeprazole and clarithromycin remain chemically stable.

To date in the medical literature do not describe the methods endoscopic application of bioplastic materials in gastroduodenal ulcers, because not developed a comprehensive biomaterials with acid resistance, adhesion to the mucous membrane of the stomach and the long-term ability to remain in the area of the ulcer until full healing effect depo drug for omeprazole and clarithromycin.

Principal scientific innovation in the proposed method, the endoscopic bioplastics is integrated bioplastic material in endoscopic techniques in the treatment of gastroduodenal ulcers. Properties acid resistance and adhesion to the biomaterial to the mucosa allows the biomaterial long to be in the blast ulcer effect of its rapid regeneration.

In fact, there is an innovative solution to use complex bioplastic materials that provide a local therapeutic effect due to the presence in the composition of omeprazole and clarithromycin. It provides a prolonged effect of drugs and faster healing gastroduodenal ulcers, which ultimately prevents surgical treatment and significantly (60%) reduces the time of the patient's stay in hospital.

The method is as follows.

First, for a method of endoscopic bioplastics gastroduodenal ulcers is preparing a comprehensive bioplastic material as follows.

1. Prescription number of crystalline powder hyaluronic acid is diluted in 100 ml of distilled water, get viscous hydrocolloid, which is within 3 hours subjected to standard drying with an elastic film 100 sq., see (10×10 cm).

2. In 10 ml of phosphate buffer system is added to the prescription amount of omeprazole and clarithromycin, mix thoroughly.

3. The resulting mixture was poured into a flat glass dish, there is placed an elastic film of the polymer of hyaluronic acid, allowed to stand for 1 hour.

4. After one hour, the film completely absorbs 10 ml of a mixture of omeprazole, clarithromycin, and phosphate buffer systems. Comprehensive bioplastic material article which becomes ready for use.

Then in the working channel of fibrogastroduodenoscopy enter biopsy forceps with excretion lips forceps through the distal opening of the channel. Rolled in a tube fragment complex bioplastic material, cut to the size of the ulcer (1-2 cm in diameter), fixed biopsy forceps. Performed endoscopic examination, during which a comprehensive bioplastic material stack on ulcerative defect using biopsy forceps. The procedure is carried out once with the control endoscopic examination after 5-7 days. The method provides a reduction of possible scarring ulcers and scarring of the long-term healing of ulcers, not treatable by other means.

Examples of specific performance.

Example 1.

Patient W., 39 years old, was admitted to the reception area 11.09.2012, with complaints of weakness, vomiting "coffee grounds". Ulcer history denies. Admission: state of moderate severity. Pale skin color. The heart rate of 108 beats / min, HELL 10/60 mm Hg Abdominal palpation soft, pain in the epigastrium. When the finger examination of the rectum on the glove defined black feces. Made fibrogastroduodenoscopy: on the back of the bulb of the duodenum revealed ulcerative defect to 1.5 cm in diameter to a depth of 0.5 cm with spots of hydrochloric acid gamut is on. Conclusion: chronic duodenal ulcer complicated by bleeding. Low risk of recurrence (Forrest IIC). Hospitalized in the surgical Department.

The branch was held conservative hemostatic therapy, antiulcer therapy (proton pump inhibitors in/in). Against the backdrop of ongoing conservative treatment condition improved. When control EGD after 24 hours, the bottom of the ulcer is covered by fibrin. On ulcerative defect produced endoscopic applique bioplastic material. In the future the patient received conservative antiulcer therapy at lower doses, including proton pump inhibitors oral and H. pylori drugs. Fibrogastroduodenoscopy control after 5 days after application - healing ulcers.

Example 2.

Patient D., 48 years old. Suffering from gastric ulcer for 6 years. Twice a year exacerbation of ulcer. Were outpatients and inpatient with temporary success. Last exacerbation with 15.10.2012, were outpatients received proton pump inhibitors oral and H. pylori drugs. Due to the lack of effect 30.10.2012 was admitted to the medical Department, where he received complex antiulcer drugs (blockers of the proton pump, antibiotics, antacids, vitamins). On a background of treatment pain decreased, but e is roscopically positive dynamics were absent. Fibrogastroduodenoscopy control from 10.10.2012, ulcer on the lesser curvature of the stomach 2 cm in diameter. Performed endoscopic applique bioplastic material on ulcerative defect. In the future the patient received conservative antiulcer therapy, including proton pump inhibitors oral and H. pylori drugs. Fibrogastroduodenoscopy control after 5 days after application: the defect was reduced to 1 cm, the bottom filled with granulation tissue. Fibrogastroduodenoscopy control within 10 days after application: the defect is healed.

Thus, compared with the prototype method endoscopic bioplastics gastroduodenal ulcers complex bioplastic material provides:

- improving the efficiency of endoscopic treatment of gastroduodenal ulcers;

- prevention of surgical operations;

- a significant reduction in terms of tissue regeneration of the mucous membrane of the body, and consequently the time of the patient's stay in hospital.

A method of endoscopic bioplastics gastroduodenal ulcers complex bioplastic material, including endoscopic access, characterized in that the working channel of fibrogastroduodenoscopy enter biopsy forceps with rolled-integrated bioplastic material, cut to the size of the ulcer, stack on ulcerative defect with the aid of the completion of the biopsy forceps; and control is carried out by endoscopic examination after 5-7 days, with bioplastic material contains hyaluronic acid, a phosphate buffer system, omeprazole and clarithromycin in the following ratio, wt %:

hyaluronic acid90
phosphate buffer system5
omeprazol2
clarithromycin3



 

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Connecting element // 2404821

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1 tbl, 1 dwg, 13 ex

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3 cl, 19 ex, 1 tbl

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18 cl, 20 dwg, 3 tbl, 19 ex

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