Method for anti-helicobacter therapy of stomach and duodenum

FIELD: medicine.

SUBSTANCE: method involves prescribing proton pump inhibitor with one antibiotic in a dual therapy and with two antibiotics with a triple therapy twice a day within the course of 7-10 days. Helicobacter is eradicated by the separate administration of drugs. The proton pump inhibitor (omeprazole or pantoprazole) is administered two hours before the antibiotic in the dual therapy and four hours before the second antibiotic in the triple therapy. The drugs are taken for the second time 12 hours after the first one. The antibiotics (clarithromycin, amoxicillin or fromilid) are taken with water 250ml.

EFFECT: invention enables providing the more effective eradication of Helicobacter by the exposure of total therapeutic bioavailability of each preparation with underlying permanent gastric alkaline environment.

2 cl, 3 ex

 

The invention relates to medicine, namely to a gastroenterologist, and can be used for the treatment of patients with chronic atrophic gastritis (CG), peptic ulcer (HX) or duodenum (YADPK) associated with infection by Helicobacter pylori (Hp).

The known method antihelicobacter therapy (AGT). An international team of gastroenterologists declared the eradication of Hp (loss) as a method of treatment of HG, HX and YADPK, explained in numerous schemes 4 the Maastricht consensus (1996, 2000, 2005 and 2010) and implemented in National guidelines in many European countries, including Russia [L. C. Bohun. Helicobacter pylori infection: issues of resistance and current approaches to eradication therapy. News of medicine and pharmacy. 2011, No. 8, S. 10-12]. The international community gastroenterologists and hoped, in fact, successful eradication of Hp with the help of 3-4 drugs.

Known developed by leading gastroenterologists in the world is the same for all countries 7-day starter triple first-line therapy, including the simultaneous reception of two times a day: omeprazole 20 mg, amoxicillin 1000 mg and clarithromycin 500 mg This method of therapy is recognized as acceptable and effective, as eradication is not less than 80%. However, 20% of patients it is impossible to achieve 100% eradication of Hp due to high bacterial is asistentes (immunity) Hp to antibiotics and INN [Etc. Lapin. The selection scheme of eradication therapy for Helicobacter pylori: if necessary re-treatment // Ukr.: Physician, 2008, No. 4, S. 64-67].

The main disadvantage of this method (analog) is low Hp eradication (from 30% to 25%), due to the simultaneous reception twice daily PPIS with two or three antibiotics due to the following circumstances:

- the main reason for low eradication is pharmacokinetic drug incompatibility interactions between PPIS and antibiotics, which leads to reduced bioavailability (blood concentration) of each drug, thereby depriving them of the total highly effective therapeutic impact on the eradication of Hp;

- kislotoneustoichiv antibiotics (clarithromycin, amoxicillin) dissolved in the acidic environment of the stomach;

- IPP capsules do not reduce acidity in the stomach, they are absorbed into the General blood flow in the alkaline environment of the small intestine, begin to lower the acidity within 1 hour after the initial appointment, reaching a maximum within 2 to 4 hours;

- PPIS and the remaining antibiotics are absorbed from the small intestine into the General bloodstream and returned to the bloodstream of the stomach within 2 to 4 hours in negligible concentrations with different goals: PPIS to reduce acidity in the stomach and protection kislotoneustoichiv antibiotics, and the antibiotics for the eradication of Hp;

drug interactions of three drugs with additional cardiometabolic lead to various serious complications and side effects;

- after the second day of medication increases the acidity in the stomach (pH<4) at night because of the 16-hour night interruption. The second medication creates favorable conditions at night for the development of Hp and coccoid forms. The last increase resistance to antibiotics and PPIS;

the so - called "nocturnal acid breakthrough - night increase the acidity (pH<4), which is observed in 70% of patients. To end the cause of this phenomenon is not clear, however, is quite understandable from our point of view. While receiving PPIS with 2-3 antibiotics 2 times a day night time period of medication shall be extended to 16 h (withto), a day is equal to 8 hours (withto).

For 16 h at night time there is a change in an alkaline environment of the stomach acidic (pH<4) in 70% of patients by reducing the maximum effect of the second receiving PPIS (). This is the "nocturnal acid breakthrough" with the return of all active processes Hp in the acidic environment of the stomach for 16 hours

In fact, the triple regimen turns into a single (due IPP) with low efficiency AGT (from 85% to 30%) and low Hp eradication in the starting circuit (up to 25%).

For microbes Hp high acidity in the stomach (pH 1) is an ideal habitat, consequently the ones which they are protected from the action of hydrochloric acid in a thick layer of mucus, immune to the antibiotics have active replication and AMF inoculum effect, form coccoid forms, show resistance to antibiotics and PPIS, are able to infiltrate the gastric cells and free to live under the protective layer of gastric mucus. In the acidic environment of the stomach are destroyed kislotoneustoichiv antibiotics (clarithromycin, amoxicillin) [L. C. Bohun. Helicobacter pylori infection: issues of resistance and current approaches to eradication therapy. News of medicine and pharmacy. 2011, No. 8, S. 10-12; A. E. Dorofeev. Erosive-ulcerative lesions of the gastroduodenal zone // in the book: Diagnosis and treatment of diseases of the digestive tract. Nord-Press, Donetsk, 2009. - S. 74-117.].

Closest to the proposed method, adopted as a prototype, is a method of treatment of HG, HX and AGNC associated with Hp infection by simultaneous reception of twice-daily PPIS with one antibiotic dual therapy within two weeks or two antibiotic in the triple therapy one week [Century, Perederiy, C. M. weaver, O. C. Peredery. Diagnosis and treatment of chronic gastritis, gastric ulcer and peptic ulcer of the duodenum... // Kyiv, 1999, S. 147-151].

The main disadvantages of the method (prototype) are the same as the similar. In addition, double starting therapy the effectiveness of eradication of Hp through the ve weeks of treatment is 50-70% with adverse reactions (diarrhea, nausea and allergic reactions), in triple therapy for the eradication of Hp more than 90% of the time during the week with adverse events (diarrhea, nausea, dysgeusia) [ibid].

To improve the quality of AGT due to high Hp eradication by the sum of therapeutic effects of higher bioavailability (PPIS and antibiotics) with positive pharmacokinetic compliance should:

- to increase the bioavailability of each drug due to separate them taking twice a day every 12 hours, and PPIS should be taken 2 hours before first antibiotic (with the aim of improving therapeutic qualities of the IPP as the "gold standard" with preservation activity kislotoneustoichiv antibiotics from destruction in the sour environment) and 4 hours before the second antibiotic at the height of the maximum action of PPIS;

to additional increase the bioavailability of the antibiotic. Simultaneous administration of an antibiotic (amoxicillin 500 mg) with a large volume of water (250 ml) after 3 hours, additional increases bioavailability in the blood of 2.2 times compared with 25 ml of water [L. E. Kholodov, V. P. Yakovlev. Clinical pharmacokinetics. The leadership. M, "Medicine", 1985, S. 83-93];

to additional increase the bioavailability of omeprazole at 2 times background for maximum bioavailability of antibiotics (clarithromycin, ketoconazole) [N. Blume, F. Donath, A. Warnke et al. Pharmacokinet the ical features of drug interactions proton pump inhibitors // Therapia, 2008, No. 2, S. 39-44];

to lower the acidity due to the use of 500-1000 ml of water per day with antibiotics to reduce the activity of Hp and increase the effectiveness of eradication of Hp.

The technical result by using the proposed invention is the improvement of eradication of Hp due to the impact of the overall therapeutic bioavailability of each drug on the background of constant alkaline environment of the stomach.

This technical result is achieved in that in the method of treatment of helicobacteriosis in patients with chronic atrophic gastritis, peptic ulcers of the stomach or duodenum scheme of eradication of Helicobacter populating, including reception twice a day proton pump inhibitor with one antibiotic when dual therapy of two antibiotics in triple therapy course of 7-10 days, according to the invention the eradication of Helicobacter populating spend separate time with medication, and a proton pump inhibitor taking two hours earlier antibiotic when dual therapy and four hours earlier than the second antibiotic in the triple therapy, the second medication is prescribed within 12 hours after the first, antibiotics take along with 250 ml of water. At the same time as proton pump inhibitor use omeprazole or pantoprazole, but the quality of the antibiotic clarithromycin, amoxicillin or f is milid.

The medication twice a day every 12 hours with split time taking PPIS and antibiotics provides maximum total therapeutic bioavailability of each drug with consistently effective eradication of Hp.

Note that both antibiotics are not destroyed in the acidic environment, for the 1st 2 hours, the second after 4 hours after administration of PPIS with an interval of 2 h are taken at the height of the maximum decrease in acidity (pH>4), which provides protection from destruction kislotoneustoichiv antibiotics in the acidic environment (pH<3). In addition, for efficiency, stable eradication of Hp increase additional bioavailability of each antibiotic 2.2 times in 3 hours using simultaneous reception of an antibiotic with 250 ml of water and additional increase the bioavailability of omeprazole in 2 times due to the maximum bioavailability of antibiotics. IPP fully retain the "gold standard" only if separate reception twice a day every 12 hours in total interaction with preserved most active properties of PPIS and antibiotics with positive compliance. In addition, when using the proposed method "night acid breakthrough will not happen because of the constant alkaline environment in the stomach, as the night the gap between medication with one antibiotic is 10 h, with d uma - 8 h to 16 h in the prototype.

The proposed method antihelicobacter therapy is carried out as follows. Designate separate receiving PPIS with one or with two a/b-mi 2 times a day every 12 hours, and PPIS take 2 hours before simultaneous reception of a/C-SC 250 ml of water with dual therapy and for 4 hours before simultaneous reception of the second a/b-SC 250 ml of water during triple therapy.

Dual therapy for 7-10 days:

1st technique: the IPP+ a/b it with 250 ml of water in;

after 12 h 2nd reception: the IPPa/b it with 250 ml of water in.

Triple therapy for 7-10 days:

1st technique:

The IPP+ 1 and/b-with 250 ml of water in+ 2nd a/C-with 250 ml of water inthrough 12 h 2-th receive:

The IPP+1 and/b-with 250 ml of water in+ 2nd a/C-with 250 ml of water in.

Examples of specific implementation of the method

Example 1. Patient B., 26 years old I went to the doctor with complaints of epigastric pain after meals and on an empty stomach at night, heartburn, bloating, frequent loose stools up to 6 times per day. It hurts for about 8 years, notes the seasonal exacerbation. In the period of exacerbation treated with folk remedies, which at the same time worsened the condition.

After the examination, including fibroesofagogastroduodenoscopia (peggs), biopsy and "urease" breath test, was diagnosed with chronic Subtotal atrophic gastritis caused by Hp infection.

The treatment was performed separate reception 2 times a day every 12 hours for double therapy:

omeprazole 20 mg

fromilid 500 mg with 250 ml of water

omeprazole 20 mg

fromilid 500 mg with 250 ml of water

throughout the 7 days.

Two days epigastric pain finally disappeared flatulence, normalized stool.

After 7 days of patient complaints is not present, considering themselves healthy.

After 10 days control faggs - the mucosa of the stomach without pathological changes, negative urease" breath test on Hp.

Re-control study after 4 weeks: faggs - the mucosa of the stomach in the normal range with crisp pleats, negative urease" breath test on Hp.

General conclusion: recovery, no recurrence after 4 months.

Example 2. Patient C., 57 years, is sick for more than 15 years, treated in the period of exacerbation in the spring time in 3 years. Complaints of pain in the epigastric region after eating and persistent constipation - stool for 2-3 day. Smoke on an empty stomach, smokes - 20 CIG./day.

After the examination, including faggs peptic pyloric localization round sores on the rear wall (1215 mm) and front wall (106 mm) in the active phase, chronic Subtotal atrophic gastritis, intestinal metaplasia, grade II positive for Hp.

The presence of Hp infection was determined using the research 5 biopsies and "urease" breath test.

Treatment for triple-pattern:

omeprazole 20 mg 30 minutes before meals

amoxicillin 500 mg with 250 ml of water

clarithromycin 500 mg with 250 ml of water

omeprazole 20 mg 30 minutes before meals

amoxicillin 500 mg with 250 ml of water

clarithromycin 500 mg with 250 ml of water for 10 days.

Pain disappeared on the 2nd day, the chair was normalized after 2 days. The patient quit Smoking on an empty stomach, does not violate diet, alcohol is not used.

After treatment, after 4 weeks and 3 months follow-up research: faggs - inflammatory changes in the mucosa no, no erosion; the ulcers is determined by pink scar (3 m Central white scar). Diagnostic tests: biopsy - negative, "urease" breath test is negative.

Conclusion: the recovery is toika remission after 3 months.

Example 3. Patient D., 41. Ill more than a year. Complaints about aching, hungry night pain in the epigastric region, liquid stool 3-4 times/day, aggravated by improper feeding: after fried and spicy foods, alcohol abuse. The average weight of the stream.

After examination of the patient, including faggs, biopsy and "urease" breath test diagnosed: a peptic ulcer is localized on the back of the bulb DNA 0,90,12 cm, fresh, active, chronic antral gastritis, Hp negative.

The mucosa of the stomach is thickened in the antrum. Onion DNA slightly deformed, thickened folds, slimy pale pink, on the back wall of the active ulcer 912 mm oval shape, the edges with clear boundaries, hypermonogenic, swollen. The bottom of the ulcer is covered with a fibrinous overlays yellow, at the bottom of ulcer dark inclusions.

The patient is assigned a dual scheme:

pantoprazole 40 mg

amoxicillin 1000 mg + 250 ml water

pantoprazole 40 mg

amoxicillin 1000 mg + 250 ml water

throughout the 7 days.

The pain was gone the next day, the chair was normalized on the third day.

On the 9th day and after 4 weeks the patient underwent a second examination, in the absence of clinical signs.

With sista stomach and DNA pink, on the ground ulcer pink scar, inflammatory changes in the mucous no, "urease" breath test negative.

Conclusion: complete remission, Hp negative.

1. The treatment method helicobacteriosis in patients with chronic atrophic gastritis, peptic ulcers of the stomach or duodenum scheme of eradication of Helicobacter populating, including reception twice a day proton pump inhibitor with one antibiotic when dual therapy of two antibiotics in triple therapy course of 7-10 days, characterized in that the eradication of Helicobacter populating spend separate time with medication, and a proton pump inhibitor taking two hours earlier antibiotic when dual therapy and four hours earlier than the second antibiotic in the triple therapy, the second medication is prescribed within 12 hours after the first, antibiotics, take along with 250 ml of water.

2. The method according to p. 1, comprising receiving as a proton pump inhibitor omeprazole or pantoprazole, but the quality of the antibiotic clarithromycin, amoxicillin or fromilid.



 

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FIELD: medicine.

SUBSTANCE: preventive agent is presented by one of phenylthioacetamide derivatives of the general formula: wherein R1=H, Me; R2=H; R3=CH2COOMe, CH(Me)COOMe, CH(Et)COOMe, CH(CH2CH2SMe)COOMe, CH2COOH, CH(Me)COOH, CH(Et)COOH, CH(CH2CH2SMe)COOH, CH2CH2CH2CH2CH(NH2)COOH, CH2CH2CH2CH(NH2)COOH; R2, R3=CH2CH2CH2CH(COOMe); R2, R3=CH2CH2CH2CH(COOH). The above compounds are administered parenterally in a dose of 0.5-90 mg/kg, particularly in a dose of 1-3 mg/kg 10-120 minutes before administering nonsteroidal anti-inflammatory agents (e.g. aspirin or indomethacin), particularly 30 minutes before administering the nonsteroidal anti-inflammatory agents (e.g. aspirin or indomethacin) that enables reducing an area of erosions and ulcers of the gastric mucosa by 2-4 times as compared to a reference group receiving the nonsteroidal anti-inflammatory agents and receiving no declared compounds. The above phenylthioacetamides are applicable for preventing and treating the gastric ulcer caused by administering the therapeutic agents containing the nonsteroidal anti-inflammatory preparations of salycylates and acetic acid derivatives. The areas of the ulcer formation caused by the action of the nonsteroidal anti-inflammatory agents of salycylates (e.g. aspirin-containing) and acetic acid derivatives (e.g. indomethacin-containing) decrease after administering the phenylthioacetamide derivatives in the mammalian gastric mucosa.

EFFECT: higher clinical effectiveness.

6 cl, 12 ex, 9 dwg

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to gastroenterology and infectious diseases, and concerns the prevention of developing thrombocytopenia in the patients suffering chronic hepatitis C (CHC) in a combination with Helicobacter pylori infection and receiving a combined antiviral therapy (CAVT). For this purpose, the beginning of the CAVT is preceded by a 10-14-day eradication therapy according to the schedule: a proton pump inhibitor in a standard dose twice a day + amoxicillin 500 mg 4 times a day or 1000 mg twice a day + clarithromycin 500 mg twice a day. The CAVT starts 2 weeks after the completion of the eradication therapy.

EFFECT: method provides reducing a risk of developing or progressing thrombocytopenia in the patients with chronic hepatitis C with underlying CAVT.

4 cl, 1 dwg

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