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INVENTION
Patent of the Russian Federation RU2236228

METHOD OF PROPHYLAXIS OF BLEEDINATION RECOVERY FROM ULCER AND EROSION
With gastric ulcer and duodenal ulcer,
ASSOCIATED WITH HELICOBACTER PYLORI

The name of the inventor: Grigoriev P.Ya. (RU); Schegolev AA (RU); Yakovenko A.V.
The name of the patent holder: Russian State Medical University
Address for correspondence: 117997 , Moscow, ul. Ostrovityanova, 1, Russian State Medical University, Patent Department, S.V. Pyzhov
The effective date of the patent: 2002.11.14

The invention relates to medicine, in particular to gastroenterology, and relates to the prevention of the recurrence of erosive and ulcerative bleeding in peptic ulcer of the stomach and duodenum associated with Helicobacter pylori. For this, patients with an endoscopic ulcer or erosion complicated by bleeding are intravenously administered omeprazole 40 mg every 8 hours for 2-4 days. With a 3-4-day prescribed 7-day course of eradication therapy, including ingestion of omeprazole, clarithromycin, tinidazole and colloidal bismuth subcitrate followed by omeprazole for 8-12 weeks. The method provides regression of destructive and inflammatory changes in the mucous membrane of the stomach and duodenum, which prevents the development of recurrence of bleeding.

DESCRIPTION OF THE INVENTION

The invention relates to clinical pharmacology and can be used in gastroenterology, in particular for the prevention of recurrences of bleeding from ulcers and erosions in peptic ulcer of the stomach and duodenum associated with Helicobacter pylori.

It is already known the use of endoscopic methods for the prevention of bleeding in peptic ulcer of the stomach and duodenum with the help of diathermocoagulation, laser photocoagulation, argon-plasma coagulation, injection method with the use of vasoconstrictors and ethanol, mechanical methods: ligation, clipping (Pantsirev Yu.M., Fedorov E .D, Mikhalev AI, etc.). Diagnosis and treatment of bleeding from the upper parts of the digestive tract with the use of endoscopic interventions. (Methodical recommendations №2001 / 114. Moscow: ZAO "Business School" Intel-Synthesis ", 2001. - 48 pp.).

It is also known that the use of inhibitors of proton pump (omeprazole) or H ₂ -receptor blockers (ranitidine, famotidine) administered intravenously for 3-5 days significantly reduced the frequency of early (within 3 days) bleeding recurrences and surgical interventions, but Had no significant effect on the mortality from this complication (Selby NM, Kubba AK, Hawkey CJ Acid suppression in peptic ulcer hemorrhage: a "meta-analysis." Aliment., Pharmacol., 2000. Vol. 14, p.1119-1126) .

It is also known to use eradication therapy to prevent repeated bleeding in patients with peptic ulcer associated with Helicobacter pylori, which included two regimens: double therapy (omeprazole 40 mg once a day for 4 weeks and amoxicillin 1000 mg 3 times a day for 2 weeks) or triple therapy (omeprazole 40 mg once a day for 4 weeks, amoxicillin 1000 mg 3 times a day and metronidazole 250 mg 3 times a day, both for 2 weeks). As a result, there was a decrease in the frequency of recurrences of peptic ulcer complicated by bleeding after eradication of Helicobacter pylori (Capurso G., Annibale B., Osbom J et al., Occurrence and relapse of bleeding from duodenal ulcer: respective roles of acid secretion and Helicobacter pylori infection. Ther. 2000. Vol 15, p. 821-829).

The object of the invention is to prevent the recurrence of bleeding from ulcers and erosions in peptic ulcer of the stomach and duodenum associated with Helicobacter pylori and to provide regression of destructive inflammatory changes in the gastroduodenal mucosa.

This goal is achieved because patients with endoscopically and morphologically established peptic ulcer with the presence of ulcers and erosions and Helicobacter pylori are intravenously injected with blockers of H ⁺ K ⁺ ATPase (omeprazole) for 2-4 days, with a 3-4 day prescribed 7-day course Eradication therapy (omeprazole, clarithromycin, tinidazole and colloidal bismuth subcitrate) followed by omeprazole for 8-12 weeks, with an endoscopic control study in a month, quarter and year.

The essence of the claimed invention is illustrated by the following examples:

Example 1

Patient B., 37 years old, with a duration of duodenal ulcer disease of about 15 years, with annual exacerbations, entered the hospital due to the appearance of epigastric pain, weakness and melena. In esophagogastroduodenoscopy an erosive and ulcerative process was found in the anthropyloric department of the stomach and in the bulb of the duodenum. On the back wall of the bulb, an ulcer with a red blood clot rising above its edges (Forrest IIb), that is, with stopped bleeding, but at high risk of its recurrence, was revealed. Helicobacter pylori (3rd, pronounced degree of dissemination) was found in the biopsy specimen taken from the mucous membrane of the antral part of the stomach in the area of ​​pronounced hyperemia and edema in histological study. The urease test was positive. Histological examination of biopsy specimens taken from the mucous membrane of the antral part of the stomach and duodenum, along with the detection of Helicobacter pylori, revealed active gastroduodenitis.

The patient intravenously injected 40 mg of omeprazole (losek), dissolved in 100 ml of physiological solution. Repeated administration of this drug was carried out every 8 hours for 3 days. On the 4th day, a 7-day course of eradication medication was prescribed (omeprazole 20 mg 2 times a day + clarithromycin 500 mg 2 times a day + tinidazole 500 mg 2 times a day + colloidal bismuth subcitrate 240 mg 2 times a day). After the end of the course of eradication therapy, the patient continued taking omeprazole 20 mg once a day (at 15 hours) for 8 weeks. On the 2nd day of treatment, the reaction of feces to occult blood became negative, the patient was in the stage of clinical remission (there were no complaints and physical manifestations of the disease).

With the help of daily monitoring of intragastric pH against intravenous administration of omeprazole and subsequent eradication therapy, a blockade of gastric acid production with an increase in intragastric pH above 4.0 was observed during 86% of the time of day.

On the 28th day of treatment endoscopically, cicatrization of the ulcer (white scar), disappearance of erosions and signs of active inflammation of the gastroduodenal mucosa. In biopsies taken from the same sections of the mucous membrane of the stomach and duodenum 4 and 6 months after the end of treatment, signs of activity of inflammation and Helicobacter pylori were not detected. Thus, eradication anti-Helicobacter therapy with subsequent administration of antisecretory drugs contributed to preventing the recurrence of erosive-ulcer bleeding and exacerbations of peptic ulcer of the stomach and duodenum associated with Helicobacter pylori.

Example 2

Patient V., 35 years old, with the duration of duodenal ulcer disease for about 15 years, with annual exacerbations was hospitalized due to vomiting of blood, the appearance of abundant unformed black stool and the presence of iron deficiency anemia. In an emergency endoscopic study under the conditions of the surgical department, continued jet bleeding (Forrest Ia) from duodenal ulcer ulcers was detected, which was stopped by diathermocoagulation. When repeated esophagogastroduodenoscopy was performed on the 2nd day with the help of histological examination and urease test, the relationship of chronic active gastroduodenitis with Helicobacter pylori was established.

Within 2 days, an inhibitor of proton pump (lobe) 40 mg in 100 ml of physiological solution was injected intravenously every 8 hours. From the 3rd day, eradication therapy started, including omeprazole 20 mg twice a day + clarithromycin 500 mg 2 times a day + tinidazole 500 mg 2 times a day + colloidal bismuth subcitrate 240 mg 2 times a day for 7 days. After the end of the course of eradication therapy, the patient continued taking omeprazole 20 mg once a day (at 15 hours) for 12 weeks. After a month, quarter and year, after the abolition of omeprazole, esophagogastroduodenoscopy was monitored with biopsy, histological examination of the drugs and urease test. At all stages of the study, clinico-histological remission of peptic ulcer, absence of infection of the gastroduodenal mucosa of Helicobacter pylori was noted.

The obtained data testify to the effectiveness of this method of treatment in the prevention of both early and late relapses of peptic ulcer and, consequently, bleeding.

Example 3

Patient G., 46, with peptic ulcer and duration of the disease for 5 years with annual exacerbations, entered the hospital due to the emergence of intense pains in the epigastric region, which spontaneously stopped in a day and with the presence of a black unformed stool. During esophagogastroduodenoscopy an erosive and ulcerative process was found in the anthropyloric department of the stomach and in the bulb of the duodenum. In the antrum, an ulcer with a diffuse leakage of blood (Forrest 1b), that is, with continued capillary bleeding, was detected. In biopsies taken from the mucous membrane of the antral part of the stomach histologically and with the urease test, Helicobacter pylori was detected. Histological examination of biopsies taken from the mucous membrane of the antrum of the stomach and duodenum, along with the detection of Helicobacter pylori, revealed an active erosive-ulcerative gastroduodenitis. The patient was intravenously administered 40 mg of omeprazole in 100 ml of physiological solution every 8 hours for 3 days. On the 4th day, a 7-day course of eradication medication was prescribed (omeprazole 20 mg 2 times a day + clarithromycin 500 mg 2 times a day + tinidazole 500 mg 2 times a day + colloidal bismuth subcitrate 240 mg 2 times a day). After finishing the course of eradication therapy, the patient continued to take omeprazole 20 mg once a day for 10 weeks. On the third day of treatment, the reaction of feces to occult blood became negative, the patient was in the stage of clinical remission. On the 28th day of treatment endoscopically, cicatrization of the ulcer, disappearance of erosions and signs of active inflammation of the gastroduodenal mucosa. In biopsies taken from the same parts of the gastric mucosa, 4 months after the end of treatment, signs of inflammatory activity and Helicobacter pylori were not detected. In the following 2 years, peptic ulcer was not exacerbated.

Despite the apparent simplicity of the claimed method of preventing relapses of bleeding from ulcers and erosions in peptic ulcer of stomach and duodenum associated with Helicobacter pylori, we present an optimal variant of the prevention regimen, both early recurrences of bleeding and exacerbations of peptic ulcer, and consequently, late bleeding . The method was developed as a result of long-term clinical and scientific studies using labor-intensive instrumental research methods: esophagogastroduodenoscopy with biopsy and histological, cytological and urease test, daily intragastric pH monitoring, tissue cytokine level and oxidative stress mediators. As a result, a simple and effective scheme for preventing early recurrences of bleeding and prevention of peptic ulcer exacerbations, ensuring the prevention of late relapse of the disease, has been worked out.

In total, the clinic now has accumulated experience in preventing recurrence of bleeding for 106 patients. The results are stable, statistically reliable. The scheme is successfully used in the basic clinics of the department.

The developed method of preventing recurrent bleeding from ulcers and erosions in peptic ulcer of the stomach and duodenum associated with Helicobacter pylori has an important socio-economic significance, since it prevents the recurrence of bleeding from ulcers and erosions in peptic ulcer of the stomach and duodenum associated with Helicobacter pylori , And as a result to avoid surgical interventions that have recently been performed in this group of patients, disabling them.

CLAIM

A method for preventing recurrent bleeding from ulcers and erosions in peptic ulcer of the stomach and duodenum associated with Helicobacter pylori, including administration of antisecretory and antibacterial drugs, characterized in that patients with endoscopically diagnosed ulcer or erosion complicated by bleeding are intravenously injected with omeprazole of 40 mg every 8 hours for 2-4 days, and from 3-4 days prescribed a 7-day course of eradication therapy, which includes ingestion of omeprazole, clarithromycin, tinidazole and colloidal bismuth subcitrate followed by omeprazole for 8-12 weeks.

print version
Date of publication 29.03.2007gg

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