RU2294204C1 - Method for treatment of stomach and duodenum ulcerous disease - Google Patents

Abstract

FIELD: medicine, gastroenterology.

SUBSTANCE: invention relates to a method for treatment of stomach and duodenum ulcerous disease. Method involves administration of combination of conventional anti-chelicobacter agents and preparation livorin forte in the dose 1 capsule, 3 times per a day, during eating for 1 month in patients with nonexpressed painful syndrome and insignificant dyspeptic disorders. Method involves administration preparations essentiale forte in combination with α-tocopherol acetate simultaneously with anti-chelicobacter agents in patients with expressed painful syndrome accompanying with nausea and vomiting wherein esentiale forte is administrated in the dose 5 ml in autoblood medium by intravenous route for the first 10 days of treatment followed by dosing by 2 capsules, 3 times per a day, during eating for 20 days. Administration of α-tocopherol acetate is carried out firstly as intramuscular injections in the dose 1.0 ml of 30% solution for 10 days followed by oral dosing by 1 capsule containing 0.2 ml of 50% preparation solution, 3 times per 24 h for 20 days. Based on eradication therapy and correction of lipids metabolism proposed method provides improving regeneration and endogenous mechanisms for protection of gastroduodenal region mucosa tissue resulting to reducing healing time of ulcers.

EFFECT: improved and enhanced effectiveness of treatment method.

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Description

The invention relates to medicine, namely to gastroenterology, and can be used to treat patients with peptic ulcer of the stomach and duodenum.

Peptic ulcer and duodenal ulcer is one of the most common diseases among residents of economically developed countries. It has now been proven that an important microbe called Helicobacter pylori plays an important role in the occurrence of this disease and the development of its complications. According to modern ideas, Helicobacter pylori is the cause of ulceration in 62% with their duodenal localization and in 44% with gastric. In the vast majority of other cases of peptic ulcer, it is important that patients take non-steroidal anti-inflammatory drugs. In addition, in a very small number of patients, the development of a peptic ulcer in the mucous membrane of the stomach or duodenum occurs as a result of the presence of diseases of other organs and systems of the body, namely: the central nervous system, digestive organs, endocrine organs, kidneys, lungs (E.K. Baranovskaya, Parit in the treatment of peptic ulcer // Clinical prospects of gastroenterology and hepatology, - 2001. - No. 5. - P.26-33). Based on this, treatment regimens for patients with gastric ulcer and duodenal ulcer have been developed.

The basis for the treatment of peptic ulcer is the eradication of Helicobacter pylori, which according to modern ideas is necessarily carried out by at least three drugs: a proton pump inhibitor (for example, the drug soars) and two antibiotics (clarithromycin and amoxicillin). This treatment regimen is called triple or first-line therapy. In cases of inefficiency of the triple regimen, a four-component regimen (quadrotherapy) is prescribed. This treatment regimen is called second-line therapy and includes proton pump inhibitors (for example, the drug soars), bismuth salts (for example, de-nol) and antibacterial agents: metronidazole and tetracycline or clarithromycin (Yu.V. Vasiliev. Eradication therapy for peptic ulcer disease . - Consilium medicum: Gastroenterology. - 2003. - No. 1. - Appendix. - S.10-13). In recent years, in connection with the emergence of resistant strains of Helicobacter pylori in the regimens of anti-Helicobacter therapy, some drugs are being replaced. In particular, bismuth preparations are used instead of amoxicillin or metronidazole.

The patent literature describes several methods for treating gastric ulcer and duodenal ulcer, including traditional anti-Helicobacter pylori drug therapy, to which an additional drug is added to improve treatment outcomes for patients. This includes "A method for the treatment of duodenal ulcer and a drug for its implementation" (patent No. 2182486, IPC A 61 K 35/78, publ. Bull. No. 14, 2002), which involves the ingestion of a drug having the properties of drugs Nosoda Helicobacter, and additionally - the homeopathic remedy Anacardium.

Also described is a "Method for the treatment of gastric ulcer and duodenal ulcer" (RF patent No. 2192867, IPC A 61 K 33/00, publ. Bull. No. 32, 2002). It includes the prescribing to patients the usually used drug therapy in combination with the oral administration of the Trepelom mineral-containing drug of the Pervomaisky deposit of the Alatyr district of the Chuvash Republic or the Shadrinsk deposit of the Kurgan region in the form of an aqueous suspension consisting of 4-6 g of tripoli per 150-200 ml of water.

The well-known "Method for the treatment of gastric ulcer and duodenal ulcer" (RF patent No. 2240119, IPC A 61 K 31/4045, publ. Bull. No. 32, 2004). The method involves the conduct of drug therapy containing in its composition a serotoninolytic imigran in a dose of 50-80 mg.

A “Method for the treatment of Helicobacter-associated chronic duodenal ulcer” has also been developed (RF patent No. 2252777, IPC A 61 K 38/05, publ. Bulletin No. 15, 2005), for the implementation of which lycopid at a dose of 10 is additionally included in traditional eradication therapy mg orally 1 time a day on an empty stomach for 10 days.

In addition, the known "Method for the treatment of gastric ulcer and duodenal ulcer" (RF patent No. 2250767, IPC A 61 K 31/4439, publ. Bulletin No. 12, 2005), which provides for the use of the drug omeprazole included in anti-Helicobacter therapy according to 20 mg 2 times a day and at the same time with the drug Ximedon 500 mg 2 times a day for 12 days.

The main disadvantage of these methods is the lack of correction of lipid metabolism. As you know, in humans and animals, lipids are not only energy material, but also plastic. In particular, phospholipids are a structural element of all body cells and cell membranes. In peptic ulcer disease there is a deficiency of essential phospholipids of essential (essential) fatty acids - linoleic, linolenic and arachidonic (I.I. Taranov et al. Correction of essential fatty acid deficiency by parenteral nutrition in patients with peptic ulcer with gastroduodenal bleeding. - Sat .: Hygienic aspects of nutrition of a healthy and sick person. - Kiev. - 1982. - S.95-96). Due to the pain syndrome in these patients, the energy level increases and the nature of the metabolic processes changes, lipid peroxidation is disturbed. This several times increases the body’s need for essential fatty acids, which are the starting material for the endogenous synthesis of prostaglandins, prostacyclin and thrombaxane (E.K. Alimova et al. The regulatory role of dietary phospholipids in restoring the damaged lipid composition of membrane structures under various effects on the body. - In Sat: Purulent inflammation of the organs of the chest and abdomen. - Rostov-on-Don. - 1988. - P.149-150; V.N.Drozdov. New combined oral preparations in the treatment of pain // Consilium medicum: G stroenterologiya-surgery -. 2005. - №6 -. S.490-492).

According to modern views in the pathogenesis of ulcer formation and chronic ulcer, an important role is played by the violation of prostaglandin metabolism, which leads to shifts in lipid peroxidation. Adequate correction of prostaglandin metabolism improves regional blood flow and microcirculation in the wall of the stomach and duodenum, increases mucus secretion by goblet cells of the gastric mucosa, and increases its regenerative ability. This speeds up the healing process of the ulcer and improves the protection of the mucous membrane from ulcer formation (Yu.V. Vasiliev. Peptic ulcer of the duodenum and the possibility of alternative medication. // Consilium medicum: Gastroenterology. - 2003. - Issue 1. - Appendix. - C. 7-10; Yu.A. Kucheryavyy, MG Gadzhieva, Bismuth tripotassium dicitrate in the treatment regimens for erosive and ulcerative lesions of the mucous membrane of the gastroduodenal zone // Russian Journal of Gastroenterol., Hepatol., Coloproctol. - 2005. - No. 1 . - S.71-75). At the same time, practice shows that due to pain, as well as dyspeptic disorders (heartburn, nausea, vomiting), patients with peptic ulcer restrict food intake, including foods (vegetable oils, fish, eggs, fish oil) that contain irreplaceable fatty acid. It should be noted that mainly linoleic acid, as well as a small amount of linolenic acid, enter the human body with food products. The necessary amount of linolenic acid and the entire pool of arachidonic acid are then synthesized in the body from linoleic acid.

The prototype of the proposed method for the treatment of peptic ulcer is a "Method for the treatment of diseases of the stomach and duodenum caused by Helicobacter pylori" (patent No. 2265437, IPC A 61 K 31/43, published in bull. No. 34, 2005). The essence of the method, taken as a prototype, is that patients are prescribed oral administration of a suspended mixture of 1-2 antibacterial drugs with an antacid, which is applied to the mucous membrane of the affected organ with the possibility of localizing drugs. At the same time, clarithromycin in a single dose of 50 mg, amoxicillin 100 mg are used as antibacterial agents, with course doses of 1600 and 3200 mg, respectively, and almagel is used as an antacid.

The disadvantages of this method are: 1 - in the process of treating patients with this method, lipid metabolism is not corrected, in particular, the content of phospholipids and essential fatty acids; 2 - there is a complication of the treatment process, since it becomes necessary to prepare a suspended mixture of antibacterial drugs and an antacid, observing the ratio of components in this mixture and maintaining them in suspension. These shortcomings are eliminated in the proposed technical solution.

The aim of the present invention is to accelerate the healing process of stomach ulcers and duodenal ulcers by correcting lipid metabolism, as well as simplifying the method of treating patients. This goal is achieved by the fact that patients, along with traditional drug therapy, receive drugs that correct the exchange of lipids (phospholipids and essential fatty acids) in a standard form of pharmaceutical production. For this purpose, patients with mild pain and minor dyspeptic disorders (heartburn, constipation) are prescribed livolin forte 1 capsule 3 times a day with meals for 1 month, and patients with severe pain, accompanied by nausea and vomiting, are prescribed Essential Forte along with α-tocopherol acetate (vitamin E) also for 1 month. Moreover, in the first 10 days of treatment, Essential Forte is administered intravenously to patients with autologous blood, and α-tocopherol acetate is administered intramuscularly. After this period, patients receive these drugs in capsule form.

A detailed description of the method and examples of its practical implementation

The method is as follows. After endoscopic examination and examination of the stomach for stomach ulcer or duodenal ulcer patients, Helicobacter pylori is prescribed per os the usual drug therapy in these cases, for example, preparations: soars 20 mg 2 times a day, clarithromycin 500 mg 2 times a day and amoxicillin 1000 mg 2 times a day. At the same time, patients with mild pain and minor dyspeptic disorders (heartburn, constipation) are prescribed the drug livolin forte 1 capsule 3 times a day with meals for 1 month. Patients with severe pain, accompanied by nausea and vomiting, use the drug Essential Forte. It begins to be administered intravenously in a dose of 5 ml daily for the first 10 days of treatment. The introduction of the drug is carried out on the patient's blood. To do this, in a syringe with a capacity of 10 or 20 ml, observing the rules of asepsis and antiseptics, 5 ml of the drug Essential Forte are taken from the ampoule. Then, after applying the tourniquet to the lower third of the shoulder and the corresponding treatment of the skin of the elbow bend, the cubital vein is punctured, 5 ml of the patient’s blood is collected in the syringe to the 5 ml of Essential Forte by the reverse stroke of the piston. After this, the drug mixed with the patient’s blood is slowly (within 3 minutes) injected into the vein. After 10 days of intravenous administration of Essential Forte, it is prescribed to take 2 capsules inside, containing 0.2 ml of a 50% solution of the drug each, 3 times a day with meals for 20 days. Simultaneously with the intravenous administration of essential forte, patients are given intramuscular injections of α-tocofol acetate 30% 1.0 ml once a day for 10 days. Then it is prescribed 1 capsule containing 0.2 ml of the drug, 3 times a day for 20 days. Throughout the course of treatment, the patient's condition is clinically monitored: the cessation of heartburn, pain, as well as pain in the epigastrium during abdominal palpation, improvement in general condition, normalization of stool (cessation of constipation). An endoscopic examination of the stomach and duodenum is performed once every 3 weeks, and more often if necessary.

The results of treatment of patients by the proposed method is illustrated by the following examples:

Example 1. Patient S., 43 years old, turned to the City Polyclinic No. 1 of the city of Rostov-on-Don with complaints of pain in the epigastric region that appear 2 hours after eating, heartburn, sour belching, constipation. On examination, the patient's condition is satisfactory, low nutrition. Ulcerative history 3 years. On palpation of the abdomen, pain in the epigastrium and right hypochondrium is noted. During fibrogastroduodenoscopy, a ulcerative defect of size 0.6 × 1.2 cm in round shape was found on the anteroposterior wall of the duodenal bulb. Its surface is covered with fibrin. In addition, there was hyperemia and friability of the mucous membrane of the duodenum. A quick urease test showed a pronounced contamination (+++) of the duodenal mucosa of Helicobacter pylori. At this time, the content of phospholipids in blood serum was 1.67 mmol / L (normal 2.03 ± 0.17 mmol / L), essential fatty acids in phospholipids: linoleic - 8.12% (normal 12.61 ± 1.24 %), linoleic - 0.28% (norm 1.12 ± 0.10%), arachidonic - 1.63% (norm 2.64 ± 0.34%), the amount of essential fatty acids in phospholipids - 10.03% (norm 16.37 ± 2.15%). The patient was prescribed drug therapy: he soars 20 mg orally 2 times a day, clarithromycin 500 mg 2 times a day, amoxicillin 1000 mg 2 times a day. At the same time, the patient took livolin forte, 1 capsule 3 times a day with meals. The patient took anti-Helicobacter pills for 7 days. After that, clarithromycin and amoxicillin were canceled. In prescriptions left the drug soars 20 mg once a day in the morning on an empty stomach and livolin forte in the same dose for up to 1 month. An endoscopic examination after 3 weeks revealed the healing of ulcers of the duodenal bulb, the disappearance of the phenomena of hyperemia and friability of its mucous membrane. The content of phospholipids in blood serum during this period amounted to 1.86 mmol / L, of essential fatty acids in phospholipids: linoleic - 10.34%, linolenic - 0.66%, arachidonic - 2.07%, the sum of essential fatty acids in phospholipids - 13.07%. With further monitoring of the patient until the end of drug treatment, a significant improvement in the general condition of the patient, increased appetite, cessation of heartburn, and restoration of working capacity were noted. The content of phospholipids in the blood serum reached the norm - 1.98 mmol / l, of essential fatty acids in phospholipids: linoleic - 12.37%, linolenic - 1.34%, arachidonic - 2.43%, the sum of essential fatty acids in phospholipids - 16 ,fourteen%. At the end of the course of treatment with livolin forte, maintenance therapy for peptic ulcer is recommended: the drug soars 10 mg in the morning on an empty stomach for 1 month, as well as a second course of treatment with livolin forte after 3 months.

Example 2. Patient Peninsula, 37 years old, turned to the City Polyclinic No 1, Rostov-on-Don, with complaints of severe epigastric pain, nausea, and vomiting 1.0-1.5 hours after eating general weakness. From the anamnesis it was found out that he suffers from gastric ulcer for 12 years, he was repeatedly treated in hospitals. The exacerbation of the disease occurs in the spring and autumn. The patient is undernourished (weight deficit 12.4 kg), the correct physique. Palpation of the abdomen is painful in the epigastrium. With fibrogastroduodenoscopy, a ulcerative defect of 0.8 × 1.7 cm in size was revealed on the lesser curvature of the stomach in the area of his body. The mucous membrane is moderately hyperemic, shiny. Peristalsis of the stomach in moderate waves. In the antrum there are 2 flat erosions of 0.2-0.3 cm in size. The gatekeeper is of the correct form, his patency is free. Conclusion: peptic ulcer of the stomach, erosive gastritis. A quick urease test performed showed pronounced contamination (+++) of the gastric mucosa Helicobacter pylori. Serum phospholipids were reduced. It amounted to 1.79 mmol / L. The content of essential fatty acids in phospholipids was also reduced: linoleic - 8.41%, linolenic - 0.26%, arachidonic - 1.72%, the sum of essential fatty acids in phospholipids - 10.39%.

The patient was prescribed standard drug therapy with pariet, clarithromycin, amoxicillin in conventional doses for 7 days. Given the patient’s pain and vomiting, he began intravenous administration of 5 ml Essential Forte for autologous blood 1 time per day for 10 days and intramuscular injection of α-tocopherol acetate 30% 1.0 ml 1 time per month to correct lipid metabolism. day for 10 days. After 3 days, the patient noted improvement, a decrease in abdominal pain and the termination of vomiting after eating. Patient treatment continued. After a seven-day course of such therapy, clarithromycin and amoxicillin were canceled. The pariet dose is reduced by 2 times: the patient began to take it at 20 mg 1 time per day in the morning on an empty stomach. At the end of 10 intravenous doses of Essential Forte, this drug is prescribed to the patient for oral administration of 2 capsules 3 times a day with meals for 20 days. Injections of α-tocopherol acetate are also canceled and this drug is prescribed for oral administration in 1 capsule containing 0.2 ml of a 50% solution of the drug, 3 times a day for 20 days. At the end of the 10-day administration of essentiale forte and α-tocopherol acetate, the content of phospholipids in the blood serum was 1.97 mmol / l, the level of essential fatty acids in phospholipids: linoleic - 11.04%, linolenic - 0.69%, arachidonic - 2 , 14%, the sum of essential fatty acids in phospholipids is 13.86%. This indicated a significant recovery of these indicators in the blood. An endoscopic examination of the stomach, performed 3 weeks after the start of treatment, did not reveal a peptic ulcer. In its place there was a delicate scar of the mucous membrane. The content of phospholipids in the patient's blood serum was normal at the end of the course of treatment (2.13 mmol / L). The levels of essential fatty acids in phospholipids also reached normal levels: linoleic - 12.83%, linolenic - 1.19%, arachidonic - 2.67%, the amount of essential acids - 16.67%. At the end of the course of treatment, the patient is recommended to take the drug soars 10 mg per day in the morning on an empty stomach for 1 month and a second course of treatment with Essential Forte along with α-tocopherol acetate after 3 months.

Treatment with the use of the drug livolin forte was performed in 18 patients with peptic ulcer of the stomach and duodenum, with the use of the drug essentiale forte and α-tocopherol acetate - in 26 patients. In 38 cases, a positive effect was achieved after 3 weeks from the start of the course of treatment. In 6 cases, a four-week course of treatment was required.

Thus, the proposed method for the treatment of gastric ulcer and duodenal ulcer has the advantages that, thanks to the additional correction of lipid metabolism (phospholipids, the level of essential fatty acids), the metabolic processes in the body of the patient are more quickly normalized and, therefore, regeneration and endogenous mechanisms are improved protection of the mucous membrane of the gastroduodenal zone. This speeds up the healing process of ulcers.

Claims (1)

A method of treating gastric ulcer and duodenal ulcer, including the administration of drugs, characterized in that patients are given anti-Helicobacter drugs as medications, while patients with unexpressed pain and minor dyspeptic disorders are supplemented with traditional anti-Helicobacter drugs combined with the administration of the drug livolin forte 1 capsule 3 times a day with meals for 1 month, and in patients with severe pain, accompanied by nausea and vomiting, at the same time as anti-Helicobacter pills, prescribe Essential Forte along with α-tocopherol acetate according to the following scheme: Essential Forte 5 ml intravenously in autologous blood during the first 10 days of treatment, and then 2 capsules 3 times a day with meals during 20 days, α-tocopherol - first in the form of intramuscular injections of a 30% solution of 1.0 ml for 10 days, followed by oral administration of 1 capsule containing 0.2 ml of a 50% solution of the drug, 3 times a day within 20 days.