Method of prevention of stomach ulcer lesion caused by nonsteroid antiinflammatory agents

FIELD: medicine; pharmacology.

SUBSTANCE: invention can be used for prevention of erosive and ulcer lesions of stomach caused by nonsteroid anti-inflammatory agents. Invention represents calcium pectate introduced orally in daily dose 0.025-0.5 g/kg of body weight within not less than 8 days prior to nonsteroid anti-inflammatory agents.

EFFECT: improved efficiency of ulcer prevention.

3 ex, 3 tbl

 

The invention relates to clinical and experimental medicine, in particular to the pharmacology of natural origin, which prevents the formation of erosive and ulcerative lesions of the stomach, caused by the use of nonsteroidal anti-inflammatory drugs, and can be used to prevent stomach ulcers in persons, long-term use of anti-inflammatory drugs.

It is known that non-steroidal anti-inflammatory drugs remain the drugs of choice in the treatment of many rheumatic and other inflammatory diseases due to their analgesic and anti-inflammatory properties. However, the use of non-steroidal anti-inflammatory drugs is also associated with increased incidence of peptic ulcers and ulcer complications such as gastrointestinal bleeding and perforation of the stomach wall (Garcia Rodnges L.A., Hemandez-Diaz, S., De Abajo F.L. Association between aspirin and upper gastrointestinal complications: systematic review of epidemiologic studies // Br. J. Clin. Pharmacol. - 2001. - Vol.52. - P.563-571). According to American authors, in the late 90-ies in the United States of complications caused by the use of nonsteroidal anti-inflammatory drugs were the cause of at least 16,500 deaths and 107000 hospitalizations annually (Wolfe M.M., D.R. Lichtenstein, Singh G. Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs // N. Eng. J. Med. - 1999. - Vol.340. - P.1888-1899). Epidemiological what surveys show what is the frequency of gastropathy and mortality in 3-10 times higher in patients who regularly take non-steroidal anti-inflammatory drugs, compared to patients not taking these drugs (Langman MJ.S., Weil j, Wainwright P. Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs // Lancet. - 1994. - Vol.343. - P.1075-1078; Henry D., Lim, L.L.-Y., Garcia Rodrfges L.A. Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: results of a collaborative meta-analysis // B.M.J. - 1996. - Vol.312. - P. 1563-1566). Endoscopic studies show that peptic ulcer in patients taking nonsteroidal anti-inflammatory drugs, are found in 20-30% of cases (Del Valle J., Chey W.D., Scheiman J.M. Acid peptic disorders. In: Textbook of Gastroenterology, 4th (Ed.), Eds. T. Yamada, D.H. Alpers and N.Kaplowitz. Philadelphia: Lippincott Williams and Wikins, P. 1321-1376). The problem is exacerbated and even because of gastroduodenal injury from the use of nonsteroidal anti-inflammatory drugs often occur without any previous signs of peptic ulcer disease (F.K. Chan, Leung W.K. Peptic ulcer disease // Lamcet. - 2002. - Vol.360. - P.933-941). Moreover, recent epidemiological observations in combination with endoscopic data suggest that non-steroidal anti-inflammatory drugs can not only aggravate pre-existing peptic ulcers, but also to cause the formation of clinically significant peptic ulcers de novo (Garcia Rodrfges L.A., Hemandez-Diaz S. Risk of uncomplicated peptic lcer among users of aspirin and nonaspirin nonsteroidal anti-inflammatory drugs // Am. J. Epidemiol. - 2004. - Vol.159. - P.23-31).

Until now, the main approach in the prevention of unwanted effects from the use of nonsteroidal anti-inflammatory drugs is the appointment of antagonists of N2-histamine receptors, such as ranitidine and famotidine, or proton pump inhibitors such as omeprazole and lanzoprazol reducing secretion of hydrochloric acid, the use of synthetic analogues of prostaglandin E, such as misoprostol, regenerating suppressed the activity of prostaglandins, as well as in the appointment of locally acting drugs and antacids funds (Chan, F.K., Graham D.Y. Review article: Prevention of nonsteroidal anti-inflammatory drug gastrointestinal complications - review and recommendations based on risk assessment // aliment oil displayed pure. Pharmacol. Ther. - 2004. - Vol.P. 1051-1061).

However, it is shown that an inhibitor of H2-histamine receptors ranitidine and locally acting drug sucralfate insufficiently effective in the treatment and prevention of gastric ulcers in patients receiving long-term nonsteroidal anti-inflammatory drugs (Yeomans N.D., Tulassay z, Juhasz L. A comparison ofomeprazole with ranitidine for ulcers associated with nonsteroidal anti-inflammatory drugs // N. Eng. J. Med. - 1998. - Vol.338. - P.719-725; Micklewright R., Lane, S., Linley W. Review article: NSAIDs, gastroprotection and cyclooxygenase-II selective inhibitors // aliment oil displayed pure. Pharmacol. Ther. 2003. - Vol.17. - P.321-332).

Other antagonists of N2-histamine receptors and proton pump inhibitors are not effective what s for the treatment and prevention of gastric ulcers caused by the use of nonsteroidal anti-inflammatory drugs, in cases of long-term therapy of these funds. The use of analogues of prostaglandins limited by their side effects, such as diarrhea and abdominal cramps (Silverstein F.E., Graham D.Y., Senior J.R. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drug: A randomized, double-blind, placebo-controlled trial // Ann. Intl. Med. - 1995. - Vol.123. - P.241-249).

Thus, the available funds are recommended for the treatment of ulcerative lesions of the stomach, is not suitable for preventing the formation of ulcers caused by the use of nonsteroidal anti-inflammatory drugs, due to the low efficiency and the presence of side effects.

The goal of the invention is to increase the efficiency of measures aimed at the prevention of the formation of ulcers, due to the expansion of the means of assisting in the prevention of azoobdoogari induced by nonsteroidal anti-inflammatory drugs.

The problem is solved by the fact that as a means of reducing the frequency of azoobdoogari, i.e. prevention of ulcerative lesions of the stomach, caused by the use of nonsteroidal anti-inflammatory drugs, it is proposed remedy, containing as active principle to apply calcium pectate (kallivayalil pectin).

The applicant discovered that calcium pectin has the ability to prevent the formation of mucosal damage in the stomach caused by the intragastric administration of indomethacin (international name of active substance recommended by the world Health Organization). Indometacin indoluksusnoy derivative of the acid and is one of the nonsteroidal anti-inflammatory drugs.

Know the use of calcium pectate as a binder material in the pharmaceutical and cellular technology (M. Hiorth, Versland T., Heikkila J. et al. Immersion coating of pellets with calcium pectinate and chitosan // Int J Pharm. 2006. - Vol.308. - P. 25-32; Kurillova L., Gemeiner P.. Vikartovska A. et al. Calcium pectate gel beads for cell entrapment. 6. Morphology of stabilized and hardened calcium pectate gel beads with cells for biotechnology immobilized // J Microencapsul. - 2000. - Vol.17. R. 279-296) and sorbent with high metallovedeniye activity (Harel P., L. Mignot, Junter GA Sugar beet Ca-pectate gel as a cost-effective immobilized-cell matrix for metal biosorption // Scrubbed Rijksuniv Gent Fak Landbouwkd Toegep Biol Wet. - 2001. - Vol.66. - P.291-294).

Information about the effects of calcium pectate on the formation of ulcers and erosions of the gastric mucosa in humans and animals caused by the use of nonsteroidal anti-inflammatory drugs in the literature by the applicant could not be found.

The task is also solved by a method of application of the above pharmacological tools.

Method of prevention of ulcerative lesions of the stomach, caused by taking non-steroidal anti-inflammatory drugs, by enteral preventative products containing calcium pectate as the current started at a daily dose of 0.025-0.5 g/kg body weight for at least 8 days prior to receiving non-steroidal anti-inflammatory drugs.

Enteral prophylactic agent containing as an active start calcium pectate, in a daily dose of less than 0.025 g/kg of body weight does not reduce the number of defects of the gastric mucosa, resulting from the use of nonsteroidal anti-inflammatory drugs.

Enteral prophylactic agent containing as an active start calcium pectate, in a daily dose of more than 0.5 g/kg of body weight leads to undesired effects, such as flatulence and intestinal dyskinesia.

Enteral prophylactic agent containing as an active start calcium pectate at a dose of 0.025-0.5 g/kg body weight, for at least 8 days prior to receiving non-steroidal anti-inflammatory drugs can significantly reduce the number of defects of the mucous membrane of the stomach, resulting from the use of nonsteroidal anti-inflammatory drugs.

Enteral introduction PR is a preventive means, containing the active start calcium pectate at a dose of 0.025-0.5 g/kg body weight, for less than 8 days prior to receiving non-steroidal anti-inflammatory drugs does not lead to a significant decrease in the number of defects of the gastric mucosa, resulting from the use of nonsteroidal anti-inflammatory drugs.

The operability of the claimed invention is confirmed by the following experiments and examples.

In examples 1, 2 and 3 used calcium pectate, for which he took as raw materials commercial vysokotarifitsirovannyh citrus pectin with a degree of esterification of 60.2% (manufacturer-Copenhagen Pectin A/S, Lille Skensved, Denmark). Viscoelastically pectin was obtained from vysokotarifitsirovannyh pectin by the method of alkaline deesterification. Before this vysokotarifitsirovannyh pectin were washed in 50% ethanol for 2 hours and was separated by filtration, then washed on the filter with 1.5 liters of 50% solution of ethanol, 1 l of 95% ethanol and dried at a temperature of 70°C. the Process of deesterification carried out as follows: 100 g of peeled vysokotarifitsirovannyh pectin suspended in 1600 ml of 50% solution of ethanol and then added 20 g of sodium hydroxide and 20 g of potassium hydroxide with constant stirring at a temperature of about 20°C. Th is achieve the desired degree of esterification (approximately 1%) the mixture was stirred for 2 hours and acidified using 1 M hydrochloric acid solution in 50% ethanol to pH 5-6. The resulting pectin was separated from water-ethanol solution using a glass filter, rinsed 1500 ml of 50% solution of ethanol, 750 ml of 95% ethanol and dried at a temperature of 70°C. For the preparation of calcium pectate took 100 g of the obtained nizkoenergeticheskogo pectin, suspended in 500 ml of 70% solution of ethanol and slowly added to 100 ml of 70% solution of ethanol containing 22,6 g of an aqueous calcium chloride. The obtained calcium pectate separated using a glass filter, washed with 800 ml of 70% ethanol and dried at 60°C.

Received a sample of calcium pectate was characterized by the following parameters: content anhydrogalactose acid - 67,3%, the content of calcium 38 mg/g of the sample, the degree of esterification is less than 1.2%, molecular weight 39300 Dalton.

The evaluation of the preventive action of calcium pectate experimental investigations were carried out on laboratory animals in a certified vivarium of the Institute of pharmacology, Tomsk scientific center SB RAMS. In our experiments we used healthy adult white rats-males weighing 220-280 g Rats were randomly divided into groups of 6-10 animals in each. Animals of the control group was fed a standard diet and an hour before feeding, at 8 o'clock in the morning, they were introduced into the stomach through the metal probe water in an amount of 1.0 ml per 100 g of t the La during the period of the experiment. Animals in the experimental groups during the same period of time, at the same time and in the same way you entered the suspension pectate calcium in various doses. At the end of the period of introduction of the test means animals not fed for 20 hours, but provided free access to water. After this, the animals of the control and experimental groups using a metal probe into the stomach was administered indomethacin (in the form of a suspension in 1.0 ml of saline with the addition of tween-80) in a dose of 60 mg/kg of body weight. After 6 hours after administration of indomethacin animals were killed by an overdose of diethyl ether, and the stomach was removed, dissected along the greater curvature and gently washed with saline. Damage of the gastric mucosa was detected by the naked eye in the form of small red-and-black dots (0.5-1 mm in diameter), large red-black spots (1-2 mm in diameter) and elongated red-black stripes (1-10 mm in length and 0.5-1 mm wide), parallel to the long axis of the stomach. On the extent of gastric mucosal injury was judged by the number of point defects, large spots and elongated strips and the total number of lesions per animal, as well as the damage index, expressed in the total length of all defects. Quantitative data were expressed as average±standard error of the mean (M±m). Statistical anal is C performed, using the software package SPSS (Statistical Package for Social Sciences) for Windows, version 11.0 in. The differences were considered significant at p<0,05.

Example 1. The effect of 8-day prophylactic use of calcium pectate at a dose of 25 and 50 mg/kg body weight on formation damage of the gastric mucosa caused by the intragastric administration of indomethacin, in rats.

Control animals received daily for 8 days in the stomach of the injected water. The first and second experimental groups of animals during the same period in the stomach was injected calcium pectate at a dose of 25 and 50 mg/kg body weight, respectively. On the 9th day after a 20-hour fast to all the animals in the stomach was administered indomethacin at a dose of 60 mg/kg of body weight. After 6 hours the animals were killed and examined gastric mucosa (table 1).

Table 1 shows that the pretreatment with calcium pectate at a dose of 25 mg/kg body weight reduced the number of dot damage of the gastric mucosa caused by the subsequent administration of indomethacin, on average, 4.5 times; the number of stripe-shaped damage was less on average 41.7%, the total amount of damage is less than 45.2 percent and index corruption - 39.4% less than in the control group. Pre-treatment with the calcium pectate dose of 50 mg/kg body weight reduced the number of dot damage of the gastric mucosa caused by the subsequent administration of indomethacin on average 16.7 times; the number of stripe-shaped damage decreased to an average of 47.5%, the total amount of damage - 51.7% and the damage index is 39.2%.

Example 2. The impact of the 21-day prophylactic use of calcium pectate at a dose of 100 mg/kg body weight on formation damage of the gastric mucosa caused by the intragastric administration of indomethacin, in rats.

Control animals received daily for 21 days in the stomach of the injected water. The experimental group animals at the same time in the stomach was injected calcium pectate at a dose of 100 mg/kg of body weight. On the 22nd day after the 20-hour fast to all the animals in the stomach was administered indomethacin at a dose of 60 mg/kg of body weight. After 6 hours the animals were killed and examined gastric mucosa (table 2).

From table 2 it follows that the pretreatment with calcium pectate at a dose of 100 mg/kg body weight reduced the number of dot damage of the gastric mucosa caused by the subsequent administration of indomethacin, in average, 16,75 times; the number of large spots in the experimental group were 2.9 times less than in the control group, the number of stripe-shaped damage was 56.1% less than in the control group, the total number of damage - 68,1% less, and the damage index is at 61.9% less than in the control group.

Example 3. The effect of 8-day prophylactic use of pectate calcium in e is ze 500 mg/kg body weight on formation damage of the gastric mucosa, caused by the intragastric administration of indomethacin, in rats.

Control animals received daily for 8 days in the stomach of the injected water. Experimental animals at the same time in the stomach was injected calcium pectate at a dose of 500 mg/kg of body weight. On the 9th day after a 20-hour fast to all the animals in the stomach was administered indomethacin at a dose of 60 mg/kg of body weight. After 6 hours the animals were killed and examined gastric mucosa (table 3). From table 3 it follows that the pretreatment with calcium pectate at a dose of 500 mg/kg body weight reduced the number of dot damage of the gastric mucosa caused by the subsequent administration of indomethacin, on average 6.3 times; the number of large spots in the experimental group was 3.25 times less than in the control group, the number of stripe-shaped damage was 56.5% less than in the control group, the total number of damage - at 70.3 per cent less, and the damage index - 65.2% less than in the control group.

The results presented in tables 1, 2 and 3 illustrate the fact that the use of calcium pectate according to the claimed method delays the formation of mucous membrane injuries caused by use of nonsteroidal anti-inflammatory agents.

The research conducted in the framework of the inventive method using pharmacological tools, containing the it as the beginning of the current calcium pectate in the amount of from 0.025 to 0.5 g/kg body weight, visually confirm the possibility of preventing the formation of ulcerative lesions of the stomach, caused by taking non-steroidal anti-inflammatory drugs.

Advantage of new pharmacological agents for the prevention of ulcerative lesions of the stomach, caused by taking non-steroidal anti-inflammatory drugs can be considered that the pectins are natural substances that are not alien to the human body without causing side effects that are typical for most synthetic drugs.

The inventive method is simple to implement and can be used for the prevention of ulcerative lesions of the stomach of any etiology. The proposed method allows you to take preventive measures for the prevention of ulcerative lesions of the stomach in the hospital and in outpatient settings in those cases when assigned to non-steroidal anti-inflammatory drugs as symptomatic and/or pathogenic drugs.

In the framework of the claimed inventions calcium pectin can be used as drugs or biologically active food supplements, which reduces the risk of ulcerogenic complications of nonsteroidal anti-inflammatory drugs and reduce the mortality rate from the use of non-steroidal anti-inflammatory drugs.

Table 1
The group of animalsThe number of animals with lesions of the gastric mucosa(%)The number of point of damage per animalA large number of spots per animalThe number of stripe-shaped lesions per animalThe total number of lesions per animalThe damage index(mm)
Control (n=9)10010,0±1,812,3±1,525,9±1,748,2±2,177,6±4,7
Calcium pectate,25 mg/kg (n=10)1002,2±0,9*9,1±1,415,1±2,0*26,4±2,9*47,0±5,9*
Calcium pectate, 50 mg/kg (n=10)**1000,6±0,3*9,1±1,213,6±2,223,3±2,6*47,2±6,4*
Note: * difference from control significant (p<0,05).
** - the number of animals

Table 2
The group of animalsThe number of animals with lesions of the gastric mucosa (%)The number of points is cnyh damage per animal A large number of spots per animalThe number of stripe-shaped lesions per animalThe total number of lesions per animalThe damage index (mm)
Control (n=6)10013,4±1,913,5±1,627,1±2,354,3±5,282,2±7,9
Calcium pectate, 100 mg/kg (n=9)1000,8±0,4*4,6±0,7*11,9±1,9*17,3±2,0*31,3±3,7*
Note: * difference from control significant (p<0,05).
** - the number of animals

Table 3
The group of animalsThe number of animals with lesions of the gastric mucosa (%)The number of point of damage per animalA large number of spots per animalThe number of stripe-shaped lesions per animalThe total number of lesions per animalThe damage index (mm)
Control (n=6)1008,2±1,310,4±1,222,3±2,669,8±5,9
Calcium pectate, 500 mg/kg (n=8)1001,3±0,6*3,2±0,9*9,7±2,1*14,3±2,5*24,3±2,9*
Note: * difference from control significant (p<0,05).
** - the number of animals

Method of prevention of ulcerative lesions of the stomach, caused by taking non-steroidal anti-inflammatory drugs, by enteral preventative means, characterized in that as a preventive measure imposed calcium pectate in a daily dose of 0.025-0.5 g/kg body weight for at least 8 days prior to receiving non-steroidal anti-inflammatory drugs.



 

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1 ex

FIELD: medicine.

SUBSTANCE: method involves applying dietotherapy of zoosterol as 0.5% of aqueous solution in the amount of 100-200 ml in the morning 30 min before taking meals at a daily dose of 0.5-1.0 g in 21 days long course.

EFFECT: enhanced effectiveness in correcting metabolism disorders.

1 tbl

FIELD: medicine, gastroenterology.

SUBSTANCE: invention relates to methods for treatment of chronic helicobacter pylori-associated gastritis. Method is carried out by monotherapy with the probiotic "Laminolakt" in the dose 3 dragees per 24 h for 1 month. Method provides elimination of Helicobacter pylori cells on the background of activation of the immune response in stomach mucosa by effect on microflora and the colon intestine immune system.

EFFECT: enhanced effectiveness of treatment.

2 tbl, 1 ex

The invention relates to medicine and applies polyuronic acids or their salts as a means of therapy for treatment of diseases associated with impaired metabolic processes, in particular conjugation reactions with glucuronic acid (coma renal, hepatic cell failure, hepatitis, jaundice, and others)

FIELD: medicine, gastroenterology.

SUBSTANCE: invention relates to methods for treatment of chronic helicobacter pylori-associated gastritis. Method is carried out by monotherapy with the probiotic "Laminolakt" in the dose 3 dragees per 24 h for 1 month. Method provides elimination of Helicobacter pylori cells on the background of activation of the immune response in stomach mucosa by effect on microflora and the colon intestine immune system.

EFFECT: enhanced effectiveness of treatment.

2 tbl, 1 ex

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