RU2187318C2 - Method of healing chronic gastritis and duodenum ulcer disease - Google Patents

Abstract

FIELD: medicine, gastroenterology. SUBSTANCE: method involves oral administration to patient a bactisporin solution by 3 doses, 3 times per a day before eating for the first 3 days, then by 2 doses, 2 times for 7 days. Method ensures to effect on microorganisms Helicobacter pylori and stimulate the regeneration of stomach and duodenum mucosa and prevent the development of dysbacteriosis. Invention can be used for healing chronic gastritis and duodenum ulcer disease. EFFECT: enhanced effectiveness of healing. 1 tbl, 2 ex

Description

 The invention relates to medicine, namely to gastroenterology, and can be used in the treatment of superficial and erosive gastritis, duodenal ulcer.

 At present, gastroenterologists have a large selection of antibacterial drugs, enzymes for the treatment of gastritis, and duodenal ulcer. Often use rulide, tetracycline, clarithromycin.

 However, the presented drugs have several disadvantages. Firstly, there is information about the toxic and allergic effects of drugs on the stomach and liver, causing dysbiosis in the intestine. Secondly, cases of resistance to these drugs with a strain of bacteria that are the causative agents of diseases of the gastrointestinal tract have become more frequent (Mashkovsky MD, 1993. - T. 2. - P.276-277). Thirdly, all the enzymes offered in the pharmacy network are expensive and their arsenal is not large.

 The prototype of the invention is a method of treating chronic gastritis and peptic ulcer of the duodenum with amoxicillin 500 mg 4 times a day orally (Reference "Vidal". - 2000. - Section "E" .- C. 22). Amoxicillin is a broad-spectrum antibiotic, belongs to the group of semisynthetic penicillins, acts bactericidal. In combination with metronidazole, it is active against Helicobacter pylori. Amoxicillin is believed to inhibit the development of resistance of Helicobacter pylori to metronidazole. Indications for the use of amoxicillin are chronic gastritis, exacerbation of duodenal ulcer associated with Helicobacter pylori. However, side effects of the drug in the form of allergic reactions (urticaria, erythema, Quincke's edema, rhinitis, conjunctivitis, hepatitis, interstitial nephritis have been identified. It is not recommended to use the drug for prolonged diarrhea and vomiting, and liver diseases (Reference "Vidal 2000". - M., section "E" .- C.22).

 The relevance of this problem prompted us to search for new antimicrobial agents with antibacterial activity and enzymatic properties, widely available, not causing side effects, convenient to use, cheap.

 The technical result of the invention is to stimulate the regeneration of the epithelium of the gastric mucosa and duodenum and the exclusion of allergic reactions and toxic effects on the liver.

 The technical result is achieved by the use of dry bactisporin for the first time as a treatment for chronic gastritis and duodenal ulcer. The bactisporin solution is administered orally to the patient in the first three days, 3 doses 3 times 30 minutes before meals, then in the next 7 days, 2 doses 2 times.

The known drug bactisporin dry, developed and manufactured by the State Unitary Enterprise "Immunopreparat" named after Mechnikov (Ufa). Bactisporin dry is a lyophilized living bacteria Vasills subtilis strain N 3H. Bactisporin has the form of a powder, the color of which can vary from white to beige. One ampoule of the drug contains one dose (1-5x10 ⁹ CFU). The bacteria Bacilis subtilis strain N 3H secrete a broad spectrum antibacterial substance that inhibits the development of pathogenic and conditionally pathogenic microorganisms.

 Bactisporin is used to treat acute intestinal infections (including acute dysentery, salmonella, etc.) caused by pathogenic and conditionally pathogenic microorganisms, for the treatment of intestinal dysbiosis of various origins, including those complicated by allergic dermatosis and food allergy, for the treatment of bacterial vaginosis, prevention of purulent-septic complications in the postoperative period.

 Bactisporin is administered by mouth and intravaginally. The contents of the ampoule are dissolved (shaken up to 10 times) with boiled cooled water at the rate of 10 ml (2 teaspoons) per dose of the drug. The drug should dissolve within two minutes with the formation of an opaque homogeneous suspension. The contents of the ampoule are then transferred to a glass with the required amount of water and mixed. The resulting suspension is used orally or used for vaginal irrigation and for soaking tampons for intravaginal administration. The diluted drug is drunk 30-40 minutes before a meal. Diluted preparation is not subject to storage. Bactisporin is prescribed for the treatment of patients starting from 1 month of age.

 The therapeutic dose of the drug is 1-2 doses for adults, 0.5 doses for children. The drug is used 2 times a day for 5-20 days. If necessary, the course of treatment can be repeated.

 Release form - glass ampoules containing one dose.

 A method for the treatment of chronic gastritis and peptic ulcer of the duodenum is as follows.

 Bactisporin solution is administered to the patient by the oral method in 3 doses 3 times a day 30 minutes before meals in the first 3 days, then 2 doses 2 times 7 days. This principle of treatment allows you to influence the pathogenic microflora in the first days as much as possible, then moving on to a maintenance dose.

 The use of the drug was studied in patients with gastritis (superficial and erosive) and peptic ulcer of the duodenum. Clinical observations covered 21 patients with the following diseases: superficial gastritis - 5, erosive antrum gastritis - 14, duodenal ulcer - 2. Diagnosis of diseases was based on anamnesis, clinical presentation, fibrogastroduodenoscopy (FGDS), histological examination of biopsy samples of the gastric mucosa.

 When FGDS took into account the degree of inflammation of the gastric mucosa (1-3 tbsp), the thickness of the folds, the presence of mucus on the walls of the stomach, vascular pattern, peristalsis, the presence and localization of erosion and ulcers, their size and quantity.

 During a histological examination, biopsy samples of the gastric mucosa of the body and antrum were stained according to the Giemsa method with Helicobacter pylori. The latter was found in 100% of patients with varying degrees of infection.

 EGD was performed before treatment and on day 10 during treatment with bactisporin.

 The control group consisted of 7 patients who did not receive bactisporin: 5 - had superficial gastritis, 2 - erosive antral gastritis. Helicobacter pylori infection was 100%.

 As a result of treatment of the main group, the pain syndrome, feeling of heaviness after eating, bloating, and appetite decreased in patients. During the FGDS control, puffiness, hyperemia of the gastric mucosa decreased on the 7-10th day, mucus on the walls disappeared, folds became normal, peristalsis normalized, erosion sizes decreased and regeneration processes accelerated compared with the control group. During histological examination of biopsy specimens, the contamination of Helicobacter pylori decreased sharply and disappeared.

 The effect of bactisporin on the regeneration of the gastric mucosa in erosive and ulcerative lesions was studied. Clinical observations covered 14 patients with erosive antral gastritis.

где S - площадь дефекта в мм²;
π - постоянная величина = 3,14;
R₁ - наибольший радиус дефекта;
R₂ - наименьший радиус дефекта.With fibrogastroduodenoscopy, the area of the mucosal defect was calculated by the formula

where S is the area of the defect in mm ² ;
π is a constant value = 3.14;
R ₁ is the largest radius of the defect;
R ₂ is the smallest radius of the defect.

 When FGDS took into account the degree of inflammation of the gastric mucosa (1-3 tbsp), the thickness of the folds, the presence of mucus on the walls of the stomach, vascular pattern, peristalsis, the presence and localization of erosion and ulcers, their size and quantity.

 In patients receiving bactisporin, appetite improved for 3-4 days, the feeling of heaviness after eating disappeared, and pain in the epigastric region decreased. By 5-6 days, the sensations of bloating, pain in the gastroduodenal zone during palpation decreased. On the 7-10th day with the FGDS control of erosive antral gastritis, the area of erosion lesions was significantly smaller in patients receiving bactisporin compared with the control. In the study group, against the background of treatment, puffiness, hyperemia of the gastric mucosa decreased, mucus on the walls of the stomach disappeared, peristalsis normalized, folds became normal in size.

 Regeneration of the gastric mucosa in patients receiving bactisporin was completed on 9.3 ± 1.02 days, and in the control group, by 14.3 ± 1.21 (P <0.05). The research results allow us to conclude that, against the background of treatment with bactisporin, acceleration of the processes of regeneration of the gastric mucosa and a reduction in the duration of treatment are observed.

 In no case did bactisporin cause irritation of the gastric mucosa and duodenum.

 The results of comparative studies of the therapeutic efficacy of bactisporin are presented in the table.

 As can be seen from the data presented, the best results were obtained in the treatment of patients with bactrosporin erosive gastritis. For example, reliably (P <0.01) at an earlier date, the disappearance of mucus on the walls of the stomach occurred, epithelialization of erosion of the gastric mucosa was completed, and the time for stopping the inflammatory process and treatment was reduced.

 The clinical results of the treatment of patients with erosive gastritis are confirmed by histological studies. When studying bioptites of the gastric mucosa, the dissemination of Helicobacter pylori significantly (P <0.01) decreased or the pathogen was not detected.

 An acceleration of the process of epithelialization of the gastric mucosa during treatment with bactisporin was revealed. The use of bactisporin prevented the development of erosive hemorrhagic gastritis. Bactisporin reduces the dissemination of Helicobacter pylori, does not irritate the gastric mucosa.

 Example 1. Patient I. was admitted to the Ufa Research Institute of Occupational Medicine and Human Ecology with complaints of abdominal pain, heaviness after eating, loss of appetite. The patient was examined: a general blood test, a general urine test, electrocardiography, an ultrasound examination of the gastrointestinal tract, FGDS with taking biopsy samples for histological examination. The clinical diagnosis is established - Chronic gastritis type "B" of moderate severity; endoscopically - superficial antral gastritis of the II Art. the intensity of inflammation, histologically - the dissemination of Helicobacter pylori (+++). The course of treatment was started from the 2nd day of stay: the bactisporin solution was administered orally in the first 3 days, 3 doses 3 times a day for 30 minutes and in the next 7 days, 2 doses 2 times. On day 4-5, clinical improvement was noted - increased appetite, the absence of pain and heaviness in the abdomen. During the control EGF on the 10th day of treatment, a positive dynamics was revealed: a decrease in the degree of inflammation, a decrease in the dissemination of Helicobacter pylori to (+). A second course of treatment with bactisporin after 2 months is recommended.

 Example 2. Patient S., born in 1969, was admitted with complaints of aching pain in the epigastric region at night. The examination was performed: a general blood test, a general urinalysis, electrocardiography, FGDS with taking a biopsy from the gastric mucosa and duodenum for histological examination. Diagnosed with peptic ulcer of the duodenum in the acute stage. Endoscopically: ulcer of the duodenal bulb (4x5 mm). Histologically identified Helicobacter pylori (+++). The patient was prescribed bactisporin: a solution of bactisporin orally in the first 3 days, 3 doses 3 times a day for 30 minutes and in the next 7 days, 2 doses 2 times. In the course of treatment, the patient disappeared at day 4-5, night pains, improved appetite, sleep. On the control FGDS on the 10th day of treatment, a zone of granulation tissue and epithelization was observed along the edges of the ulcer, the size of the ulcer decreased to 3 mm in diameter, and the ulcer bottom cleared of fibrin plaque. Histologically, stromal edema, leukocyte tissue infiltration and the absence of Helicobacter pylori decreased. When FGDS control on day 20 there was a complete epithelization of a peptic ulcer of the duodenal mucosa. Endoscopic diagnosis: ulcer of the duodenal bulb in the stage of the red scar.

 21 patients were treated and it was found that bactisporin helps to reduce the severity of the inflammatory process and accelerate its subsidence, stimulates the regeneration of the gastric mucosa and duodenum, has anti-Helicobacter activity. The use of bactisporin prevented the development of complications such as dysbiosis, allergic reactions. Clinically, a worsening of well-being was not noted in any case.

Claims (1)

 A method of treating chronic gastritis and duodenal ulcer by administering a drug, characterized in that the patient is orally administered a solution of bactisporin 3 doses 3 times before meals in the first 3 days, then 2 doses 2 times for 7 days.

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