Bismuth Tripotassium Dicitrate Research Articles

Effectiveness of eradication therapy for Hp infection of residents of Perm and the Perm region

Purpose: to evaluate the effectiveness of eradication therapy for Hp infection in Perm and the Perm region. Materials and methods: a retrospective analysis of 88 case histories of patients who underwent eradication of Hp infection was carried out at the Perm Medical Center (GASTROCENTER). Primary infection with H. pylori was confirmed by: serological blood test or determination of Hp antigen in feces, rapid urease test, and C13 urease breath test. Hp eradication therapy regimens, depending on the source of prescription, included standard triple therapy with the addition of bismuth preparations for a period of 14 days (main group) or 7-10-day triple therapy (control group). Results and discussion: the main indications for Hp eradication were: chronic gastritis and gastroesophageal reflux disease. In the main group, all patients received Hp eradication therapy with the inclusion of: esomeprazole (emanera) 40 mg, amoxicillin 1000 mg, clarithromycin (fromilid) 50 mg and bismuth tripotassium dicitrate (ulcavis) 240 mg twice a day for 14 days. The control group included patients who received Hp eradication schemes with various proton pump inhibitors, amoxicillin and clarithromycin or metronidazole or levofloxacin or even rifaximin for 7 or 10 days. Adverse events: abdominal pain and diarrhea occurred in both groups. Patients of the main group complained about bitterness in the mouth, where all patients received clarithromycin. Approximately the same small number of patients complained of nausea. With a differentiated assessment by groups, in the main group, Hp eradication was highly effective and reached 93%, while in the control group it was significantly lower and did not exceed 48% (p=0,00087) Conclusions: modern detection of Hp infection and its eradication is an effective approach to the prevention of atrophic gastritis, gastric cancer and peptic ulcer of the stomach and duodenum. The “gold” standard for diagnosing Hp infection is the 13C-urease breath test. For residents of Perm and the Perm Territory, it is recommended to use Hp eradication with the appointment of a 14-day regimen with the inclusion of esomeprazole (Emaner), clarithromycin (Fromilide), amoxicillin and bismuth tripotassium dicitrate (Ulkavis) as the first line of therapy.

Резолюция Экспертного совета «Необследованная диспепсия: краткосрочная и долгосрочная стратегии ведения пациента»

Purpose. To present the materials of the Expert Council, which was held on April 22, 2023 in Moscow and dedicated to modern approaches to the management of patients with unexplored dyspepsia, as well as the choice of the optimal Helicobacter pylori eradication therapy scheme in the Russian Federation. The main provisions of the resolution. An initial patient with recent dyspeptic symptoms who has not taken drugs that can cause gastric damage should be considered as a patient with undiagnosed dyspepsia. The first diagnosis to be excluded in a patient with unexplored dyspepsia is H. pylori-associated chronic gastritis. In order to alleviate or eliminate the symptoms of dyspepsia in the period before testing for H. pylori, the appointment of the prokinetic itopride hydrochloride is recommended, given the lack of influence on the results of the examination, proven efficacy and high safety profile, as demonstrated in studies on the original drug. The patient's presence of objective signs of gastrointestinal bleeding, unmotivated weight loss, aggravated family history of gastric cancer, as well as age over 50 years are indications for esophagogastroduodenoscopy with biopsy. An initial positive test for H. pylori is an indication for eradication therapy, as infection is a major etiological factor in gastric adenocarcinoma, including proximal gastric cancer and cancer of the gastroesophageal junction. Quadruple therapy with clarithromycin (amoxicillin + clarithromycin + proton pump inhibitor + bismuth tripotassium dicitrate) for 14 days can be defined as first-line therapy in the Russian Federation. In order to increase the effectiveness of eradication, the use of original preparations is recommended

Evaluation of the dynamics of symptoms of dyspepsia after eradication therapy in patients with Helicobacter pylori-associated gastritis

The treatment of functional dyspepsia remains a complex and incompletely resolved issue of gastroenterology. Subjective sensations of the patient, described as a feeling of fullness in the epigastrium after eating, early satiety, pain in the epigastrium, may be a manifestation of dyspepsia associated with Helicobacter pylori (H. pylori) infection. Aim was evaluation of the effectiveness of standard triple eradication therapy enhanced with bismuth tripotassium dicitrate for the relief of symptoms of dyspepsia in patients with H. pylori-associated chronic gastritis. Materials and Methods. The study involved 38 patients with H. pylori-associated chronic gastritis with symptoms of dyspepsia. The Questionnaire “7 × 7” was used to describe the dynamics of symptoms of dyspepsia. Results. At the initial examination, dyspeptic disorders in most patients corresponded the criteria for mild and moderate severity, respectively - 44.7% and 28.9% of patients. The severity of pain in the stomach area on average corresponded to a moderate pain syndrome, and the burning sensation was of low intensity. A feeling of fullness in the stomach after eating and/or early satiety was experienced by 76.3% of patients, pain disorders were observed in 92.1% of individuals. Two months after successful eradication treatment, complete relief of dyspepsia symptoms was noted in 57.9% of patients, and significant relief of symptoms of the combined form of dyspepsia in 23.7% of individuals. Conclusions: Successful standard triple eradication therapy enhanced with bismuth tripotassium dicitrate is effective for the treatment of dyspeptic symptoms in patients with H. pylori-associated chronic gastritis.

Combination of gastroprotectors and probiotics in the eradication of H. pylori infection: results of a randomized comparative clinical trial

Objective. To compare efficacy and safety of 14-day triple eradication therapy with the addition of methylmethionine sulfonium chloride and a probiotic complex and 14-day triple eradication therapy boosted with bismuth tripotassium dicitrate and a probiotic complex in a prospective comparative randomized clinical trial. Materials and Methods. A total of 70 patients with confirmed H. pylori infection were enrolled into the study. The first group (n = 35) received esomeprazole 20 mg 2 bid, clarithromycin 500 mg bid and amoxicillin 1000 mg bid for 14 days, methylmethionine sulfonium chloride 300 mg once a day for 1 month, probiotic complex (bifidobacteria [Bifidobacterium longum CBT BG7, Bifidobacterium lactis CBT BL3, Bifidobacterium bifidum CBT BF3], lactobacilli [Lactobacillus acidophilus CBT LA1, Lactobacillus rhamnosus CBT LR5], Streptococcus thermophilus CBT ST3) 1 capsule once a day for 1 month. The second group (n = 35) received esomeprazole 20 mg 2 bid, clarithromycin 500 mg 2 bid, amoxicillin 1000 mg 2 bid and bismuth tripotassium dicitrate 240 mg 2 bid for 14 days, probiotic complex (bifidobacteria [Bifidobacterium longum CBT BG7, Bifidobacterium lactis CBT BL3, Bifidobacterium bifidum CBT BF3], lactobacilli [Lactobacillus acidophilus CBT LA1, Lactobacillus rhamnosus CBT LR5], Streptococcus thermophilus CBT ST3) 1 capsule once a day for 1 month. Eradication of H. pylori was assessed using stool antigen test. Results. Eradication rates for the first and second groups in the intent-to-treat (ITT) population were 77.1% and 88.6% (p = 0.205), respectively. In the per-protocol (PP) population, eradication rates were 81.8% and 96.9% (p = 0.051), respectively. Adverse events were reported in 34.3% of patients in the first group and 34.3% of patients in the second group (p = 1). Conclusions. 14-day standard triple therapy boosted with bismuth tripotassium dicitrate and a probiotic complex demonstrates high efficacy and safety profile, and therefore can be recommended as first-line therapy for H. pylori infection in adults.

Second-line levofloxacin-based quadruple therapy versus bismuth-based quadruple therapy for Helicobacter pylori eradication and long-term changes to the gut microbiota and antibiotic resistome: a multicentre, open-label, randomised controlled trial

Levofloxacin-based therapy or bismuth-based quadruple therapy are the recommended second-line regimens for Helicobacter pylori eradication after failure of clarithromycin-based therapy. However, resistance to levofloxacin has increased in the past decade. Furthermore, little is known about the long-term effects of H pylori eradication on the antibiotic resistome. In this study, we compared these second-line eradication therapies for efficacy, tolerability, and short-term and long-term effects on the gut microbiota, antibiotic resistome, and metabolic parameters. We did a multicentre, open-label, parallel group, randomised controlled trial at eight hospitals in Taiwan. Adult patients (age ≥20 years) with persistent H pylori infection after first-line clarithromycin-based therapy were randomly assigned (1:1, permuted block sizes of four) to receive levofloxacin-based sequential quadruple therapy for 14 days (EAML14; esomeprazole 40 mg and amoxicillin 1 g for 7 days, followed by esomeprazole 40 mg, metronidazole 500 mg, and levofloxacin 250 mg for 7 days, all twice-daily) or bismuth-based quadruple therapy for 10 days (BQ10; esomeprazole 40 mg twice daily, bismuth tripotassium dicitrate 300 mg four times a day, tetracycline 500 mg four times a day, and metronidazole 500 mg three times a day). All investigators were masked to the randomisation sequence. The primary endpoint was H pylori eradication rate measured by 13C urea breath test 6 weeks after second-line treatment according to both intention-to-treat (ITT) and per-protocol analysis. The microbiota composition and antibiotic resistome of faecal samples collected at baseline (before treatment) and at 2 weeks, 8 weeks, and 1 year after eradication therapy was profiled by shotgun metagenomic sequencing and 16S rRNA gene sequencing. The frequency of adverse effects and changes in the gut microbiota and antibiotic resistome were assessed in all participants with available data. The trial is complete and registered with ClinicalTrails.gov, NCT03148366. Between Feb 25, 2015, and Dec 11, 2020, 560 patients were randomly assigned to receive EAML14 or BQ10 (n=280 per group; 261 [47%] men and 299 [53%] women). Mean age was 55·9 years (SD 12·7) in the EAML14 group and 54·9 years (12·3) in the BQ10 group. Eradication of H pylori was achieved in 246 (88%) of 280 participants in the EAML14 group and 245 (88%) of 280 in the BQ10 group according to ITT analysis (risk difference -0·4%, 95% CI -5·8 to 5·1; p=0·90). In the per-protocol analysis, 246 (90%) of 273 participants in the EAML14 group and 245 (93%) of 264 participants in the BQ10 group achieved H pylori eradication (risk difference 2·7%, 95% CI -0·2 to 7·4; p=0·27). Transient perturbation of faecal microbiota diversity at week 2 was largely restored to basal state 1 year after EAML14 or BQ10. Diversity recovery was slower with BQ10, and recovery in species abundance was partial after both therapies. On shotgun sequencing, we observed significant increases in total resistome after EAML14 (p=0·0002) and BQ10 (p=4·3 × 10-10) at week 2, which were restored to pretreatment level by week 8. The resistance rates of Escherichia coli and Klebsiella pneumonia to levofloxacin, ciprofloxacin, ampicillin (ampicillin-sulbactam for K pneumonia), and various cephalosporins were significantly increased in the EAML14 group compared with in the BQ10 group at week 2, which were restored to pretreatment levels and showed no significant differences at week 8 and 1 year. The frequency of any adverse effects was significantly higher after BQ10 therapy (211 [77%] of 273 participants) than after EAML14 therapy (134 [48%] of 277; p<0·0001). We found no evidence of superiority between levofloxacin-based quadruple therapy and bismuth-based quadruple therapy in the second-line treatment of H pylori infection. The transient increase in the antibiotic resistome and perturbation of faecal microbiota diversity were largely restored to pretreatment state from 2 months to 1 year after eradication therapy. The Ministry of Science and Technology of Taiwan, the Ministry of Health and Welfare of Taiwan, National Taiwan University Hospital, Taipei Veteran General Hospital, and the Australian Federal Government through the St George and Sutherland Medical Research Foundation. For the Chinese translation of the abstract see Supplementary Materials section.

Clinical Recommendations of Russian Gastroenterological Association and RENDO Endoscopic Society on Diagnosis and Treatment of Gastritis and Duodenitis

Aim.The clinical guidelines are intended to supplement specialty decision-making for improved aid quality in patients with gastritis and duodenitis though acknowledging the latest clinical evidence and principles of evidencebased medicine.Key points.Gastritis is an inflammatory disease of stomach mucosa, with a separate definition of acute and chronic gastritis. Chronic gastritis is a cohort of chronic diseases uniting a typical morphology of persistent inflammatory infiltration, impaired cellular renewal with emergent intestinal metaplasia, atrophy and epithelial dysplasia of gastric mucosa. Oesophagogastroduodenoscopy (OGDS) or high-resolution OGDS with magnified or non-magnified virtual chromoendoscopy, including targeted biopsy for atrophy and intestinal metaplasia grading and neoplasia detection, are recommended to verify gastritis and duodenitis, precancer states and/or gastric mucosal changes. All chronic gastritis patients positive for H. рylori should undergo eradication therapy as aetiological and subsidiary for gastric cancer prevention. Chronic gastritis patients with symptoms of dyspepsia (epigastric pain, burning and congestion, early satiety), also combined with functional dyspepsia, are recommended proton pump inhibitors, prokinetics, rebamipide and bismuth tripotassium dicitrate in symptomatic treatment. With focal restricted intestinal metaplasia, follow-up is not required in most cases, mainly when advanced atrophic gastritis is ruled out in high-quality endoscopy with biopsy. However, a familial history of gastric cancer, incomplete intestinal metaplasia and persistent H. pylori infection render endoscopy monitoring with chromoendoscopy and targeted biopsy desirable once in three years. Patients with advanced atrophic gastritis should have high-quality endoscopy every 3 years, and once in 1–2 years if complicated with a familial history of gastric cancer.Conclusion.The recommendations condense current knowledge on the aetiology and pathogenesis of gastritis and duodenitis, as well as laboratory and instrumental diagnostic techniques, main approaches to aetiological H. pylori eradication and treatment of dyspeptic states.

Dynamics of clinical manifestations of irritable bowel syndrome against the background of cytoprotector rebamipide intake: intermediate results of the SOKRAT program

BACKGROUND: Irritable bowel syndrome (IBS) is one of the most common diseases of the gastrointestinal tract, the detection rate of which in the general population is 9-23%, in the Russian Federation 8.3-19%. IBS is the cause of chronic pain which accompanies patients throughout their life, significantly reducing its quality and disrupting social adaptation. Insufficient effectiveness of modern methods of treating IBS dictates the need to search for new drugs, the pharmacological action of which is aimed at the pathogenetic mechanisms of IBS formation. Currently, more and more attention in the development of IBS is paid to the syndrome of increased epithelial permeability, in connection with which it is promising to include the universal cytoprotector rebamipide in the complex therapy of patients with IBS.&#x0D; AIM: To evaluate the effect of rebamipide on the course of irritable bowel syndrome.&#x0D; MATERIALS AND METHODS: This article presents the intermediate results of the SOCRAT study, which has assessed the effect of rebamipide on the course of IBS. For this purpose, 40 patients with IBS have been examined and subsequently randomized into two groups comparable in gender, age and type of IBS. The patients of the main group (n = 21) received cytoprotector rebamipide in addition to standard antispasmodic therapy, and the patients of the comparison group (n = 19) received cytoprotector bismuth tripotassium dicitrate. Patients gastroenterological complaints have been assessed before and after treatment using GSRS, 7x7, IBS-QOL questionnaires and a visual analogue scale.&#x0D; RESULTS: According to the study findings, the well-being of the patients has improved in the both study groups. However, more significant positive dynamics has been observed in the main group, as evidenced by a significant decrease in the frequency and severity of abdominal pain and symptoms caused by constipation, which, in turn, led to an increase in the quality of life of the studied patients.&#x0D; CONCLUSIONS: Thus, protective therapy of epithelium with rebamipide has not only a symptom-reducing effect, but also a positive effect on the course of IBS.

Diagnosing MALT Gastric Lymphoma in Gastroenterologist’s Practice, a Clinical Observation

Aim.A clinical case description to highlight challenges in diagnosing MALT lymphoma presented in infiltrative ulcer-ative lesions.Key points. A 60-yo patient was admitted to the Loginov Moscow Clinical Scientific Centre with epigastric pain and an 18 kg weight loss over past 4 months. A history of repeated outpatient endoscopic examinations revealing subse-quently ulcerative and infiltrative ulcerative gastric lesions of unestablished origin. A complex examination combin-ing oesophagogastroduodenoscopy (OGDS), endosonography (EUS), multislice computed tomography (MSCT), morphological and immunohistochemical (IHC) assays elicited the MALT gastric lymphoma IIE stage involving para-gastric and intraperitoneal lymph nodes. The first treatment stage included line-1 eradication therapy, rabeprazole 20 mg x 2 times a day, amoxicillin 1000 mg x 2 times a day, clarithromycin 500 mg x 2 times a day, bismuth tripotas-sium dicitrate 240 mg x 2 times a day — for 14 days. Accounting for the process prevalence and stage, six courses of R-CHOP polychemotherapy (PCT) were ordered by haematologist.Conclusion.This observation demonstrates a targeted-biopsy endoscopic examination followed by morphological, IHC, EUS (for invasion depth) and MSCT (for process advancement) assays to be decisive in differential diagnosis of ulcerative and infiltrative ulcerative gastric lesions.

Management of risk factors for gastrointestinal bleeding in patients receiving anticoagulant therapy

Direct oral anticoagulants (DOACs) are used to prevent and treat thrombosis and thromboembolic events in patients with various diseases. Despite its high efficacy and safety, DOAC therapy is accompanied by increased risk of hemorrhage, including gastrointestinal bleeding. Bleeding risk depends on individual patient profile and their risk factors. An increased risk of bleeding is associated with manifesting effect of DOACs on existing mucosal defects, active Helicobacter pylori infection. To reduce the risk of gastrointestinal bleeding in clinical practice, changing of following modifiable risk factors is required: H. pylori eradication; dose-adjusted DOAC therapy; prophylactic proton pump inhibitors (PPIs) administration to patients with HAS-BLED score ≥3, receiving dual or triple antithrombotic therapy, taking DOACs in combination with non-steroidal antiinflammatory drugs, to those with upper gastrointestinal diseases. In addition to PPIs, patients may be prescribed with rebamipide, bismuth tripotassium dicitrate, ursodeoxycholic acid. DOAC rivaroxaban (Xarelto®) has pharmacokinetic and pharmacodynamic advantages, a convenient single dosing regimen and a favorable safety profile, which provides effective protection against thrombosis and thromboembolic events in combination with low risk of gastrointestinal bleeding.

Study of Antiulcer activity of a hydrogel based on chitosan

In this study, the antiulcer activity of a gel based on high-viscosity chitosan was studied in models of NSAID and ethanol-induced ulcerogenesis. To simulate damage to the gastric mucosa in the NSAID model, diclofenac sodium was administered to experimental animals at a dose of 50mg/kg. An antiseptic intestinal and astringent agent was chosen as reference drug: bismuth tripotassium dicitrate at a dose of 0.017g/kg. The studied gel was used in 3 doses (0.08, 0.16 and 0.24ml/100g of body weight). In ethanol model, ulcers were induced by a single administration of ethanol 96% at a dose of 5ml/kg. Omeprazole at a dose of 20mg/kg was used as reference drug in this model. Chitosan-based gel was administrated in this model at a dose of 0.16ml per 100g of animals, which corresponds to the minimum available dose with antiulcer activity in the NSAID model. All investigated substances were injected intragastrically using a gastric tube. As a result of this research, it was found that the chitosan-based gel is effective in the NSAID gastropathy model but not effective in the ethanol model. In the NSAID gastropathy model, after a single oral administration of chitosan-based gel at doses of 0.16 and 0.24ml/ 100g, sufficient antiulcer activity was revealed, which was 2.4 and 4.694, respectively, and exceeded the effect of the reference drug, bismuth tripotassium dicitrate. In the ethanol model, the results of experimental studies showed that the reference drug, omeprazole, provides antiulcer activity with a calculated value of the antiulcer activity index of 2.18. After the administration of a chitosan-based gel at a dose of 0.16 ml per 100g of body weight of animals, compared with the control, the calculated value of antiulcer activity was 1.18, which characterizes the absence of an antiulcer effect.

BISMUT-INDUCED ONSET OF ACUTE TUBULOINTERSTICIAL NEPHRITIS: А СLINICAL CASE

This article presents a clinical case of drug-induced acute TIN that developed in response to self-administered intake of bismuth tripotassium dicitrate. This clinical case was characterized by an acute onset, presence of urinary syndrome (low specific gravity of the urine and proteinuria), occurrence of azotemia in the setting of preserved diuresis, lack of hyperkaliemia, and quick and complete restoration of renal functioning after the discontinuation of a bismuth-containing drug. It can be suggested that the presented clinical case will allow for a better understanding of the causes and clinical features of acute TIN and the choice of the management tactics for patients with this pathology.

Место препаратов висмута в лечении кислотозависимых заболеваний у детей

The article deals with the current problems of the prevalence, diagnosis and treatment of acid-related disorders in children. The administrative and legal aspects of the state regulation of measures aimed at diagnosing Helicobacter pylori infection, procurement of drugs for its treatment in the Russian Federation are discussed. The article also focuses on the standards of treatment of H. pylori infection in children with regard to age restrictions for the administration of the recommended drugs. A detailed account of the mechanisms of the developing H. pylori resistance to modern antibacterial drugs is given. The above problems necessitate the use of highly effective and safe drugs with low H. pylori resistance and approved for administration in children. The article indicates the already established and hypothesised factors of the pathogen’s low resistance to bismuth preparations. The multifactor, predominantly local, pharmacodynamic effect of bismuth tripotassium dicitrate in children ≥ 4 years of age is described. Data on the clinical effectiveness and high safety of this compound in H. pylori eradication therapy in paediatric population are also presented. Key words: acid-related disorders, Helicobacter pylori, standards for diagnosis and treatment of H. pylori in children, antibiotic resistance, bismuth tripotassium dicitrat

Differentiated approach to eradication therapy in patients with chronic pancreatitis

Purpose of the study. Compare the effectiveness of different eradication therapy regimens in patients with chronic pancreatitis with concomitant gastritis associated with various genetic variants of H. pylori.Materials and methods: 63 patients with chronic pancreatitis and concomitant Helicobacter pylori-associated gastritis were examined. The control group consisted of 45 patients with chronic gastritis. Diagnosis of chronic pancreatitis was based on anamnestic, clinical data, instrumental studies (MSCT). Diagnosis of H. pylori infection was carried out by the morphological method, 13C urease breath test, and immunoblotting. Statistical processing was carried out using application packages SPSS Statistic 17.0.Results. In patients with chronic pancreatitis, CagA-positive H. pylori strains were found 19.3% less often compared with the control group (p &lt;0.05), VacA-positive—21.9% less often (p &lt;0.05). In the study group, H. pylori genes encoding urease A production and genes encoding the synthesis of H. pylori outer membrane proteins (p33, p30, p29, p26, p19, p17) were significantly more frequently met. In the group of patients with chronic pancreatitis, the standard triple therapy of the 1st line with the inclusion of bismuth tripotassium dicitrate was 86.8% more effective (p &lt;0.01) compared to the standard triple therapy of the 1st line, and the maximum increase in efficiency was observed among owners of H. pylori strains, expressing urease A and with the representation on the outer membrane of the proteins p30, p33, p26, p19, p17 (p &lt;0.01).Conclusion. Eradication therapy in patients with chronic pancreatitis in the presence of pathogenicity complex p30, p33, urease A, p26, p19, p17 in H. pylori according to the standard line triple therapy protocol with the inclusion of bismuth tripotassium dicitrate has advantages compared to the standard triple therapy protocol 1 line (p &lt;0.001).

European registry on Helicobacter pylori management (Hp-EuReg) as a tool to evaluate and improve clinical practice in Moscow

to evaluate the effectiveness of the standard triple therapy (amoxicillin, clarithromycin, a proton pump inhibitor) and the standard triple therapy plus bismuth tripotassium dicitrate. Observational, prospective, multicenter study, carried out in one single Russian centre A.S. Loginov Moscow Clinical Scientific Center as part of the Hp-EuReg. Patients were included from 2013 to November 2019 by Russian gastroenterologists. A total of 647 patients were collected and 330 were administered either standard triple therapy ((amoxicillin, clarithromycin, a proton pump inhibitor) or standard triple therapy plus bismuth tripotassium dicitrate. Invasive methods is dominates in the initial diagnosis of H. pylori: the frequency of use of the quick urease test decreased from 50% in 2013 to 31% in 2019. Serology was used in 27.9%. There has been an increase in the use of the13C-urea breath test from 13% in 2013 to 31% in 2019. The histological method (7.5%) and the stool antigen test (3.2%) were used less frequently. For eradication control non-invasive methods are mostly used:13C-UDT (82.7%) and the stool antigen test (14.4%). The effectiveness of standard triple therapy (mITT) was 68% with a 7-day course, 79% with a 10-day course, and 70% with a 14-day course. Combination of bismuth and standard triple therapy eradicates H. pylori (mITT) in 63%, 75% and 89%, respectively. An improvement in the clinical practice of managing patients with H. pylori infections has been noted. The standard triple therapy in combination with bismuth tripotassium dicitrate, prescribed for 14 days, is more effective.

Comparative evaluation of efficacy of 10-day regimens of helicobacter pylori infection eradication (triple and triple with the addition bismuth tripotassium dicitrate)

The article presents the results of a comparative study of the efficacy and tolerability of two 10-day eradication therapy regimens of Helicobacter pylori (HP) infection (triple and triple with the addition of bismuth tripotassium dicitrate (BTD). The study involved 158 patients with HP-associated pathology (dispepsia, erosive and ulcerative lesions of the gastroduodenal mucosa) from 18 to 65 years of age (mean age=44,6±13,5 years): 57 men (36,1 %), 101 women (63,9 %). The diagnostics of HP-infection performed using a rapid urease test (Helpil test St'Petersburg) in the course fibrogastroduodenoscopy (FGDS). The patients were divided randomly into two groups. In the group 1, 75 patients received classical first-line triple therapy: esomeprazole 20 mg twice a day, amoxicillin 1 000 mg twice a day, clarithromycin 500 mg twice a day. In the group 2, 83 patients received treatment using a similar regimen, but with the addition of BTD 240 mg twice a day. The duration of treatment in both groups was 10 days. The effectiveness of the eradication therapy was evaluated after 6-8 weeks of the end of the treatment course by means of qualitative rapid determination of fecal HP antigens using the method of immunochromatography with monoclonal antibodies (Vegal Farmaceutica, Spain). Out of the 75 patients in group 1, 60 (80 %) showed eradication of HP infection was achieved. Out of 83 patients in group 2, the eradication of HP infection was achieved in 76 patients (92,5 %). The difference in the effectiveness of eradication therapy in patients in group 1 and group 2 is statistically significant (p&lt;0,05). Thus, the classical 10-day regimen of triple antihelicobacter therapy is not effective enough and is not recommended for use in clinical practice in Khabarovsk. A 10-day triple therapy with the addition of BTD is highly effective in the Far Eastern region (Khabarovsk) and recommended as a first-line therapy. A significant reduction in the adverse events frequency in the form of bitter taste in the mouth and diarrhea is an additional advantage of the regimen using bismuth tripotassium dicitrate in comparison with the classical regimen of the triple antihelicobacter therapy.

Bismuth tripotassium dicitrat: from pharmaceutical characteristics to clinical efficacy

There are pharmacodynamics, pharmacokinetics, clinical aspects of the use of bismuth tripotassium dicitrate and comparative analysis of the physicochemical and structural properties of tableted forms of preparations containing bismuth tripotassium dicitrate - the original drug De-Nol® (Astellas) and the generic drug Ulcavis® (KRKA) in the article. Demonstrated similar physical and chemical properties, the similarity of the disintegration rate of the two tablets of bismuth tripotassium dicitrate suggests a similar clinical effectiveness of the reproduced and reference drug.

Сравнительное исследование двух схем эрадикации Helicobacter pylori (с висмутом трикалия дицитратом и без него)

Сравнительное исследование двух схем эрадикации Helicobacter pylori (с висмутом трикалия дицитратом и без него)

The ways of antihelicobacter therapy in Ukraine (based on the data of analysis of the Ukrainian Registry Hp-EuReg — UKRAINE)

Objective — to assess the state of affairs in the diagnosis and treatment of Helicobacter pylori infection in Ukraine and their conformity with the modern international recommendations. Materials and methods. The performed analysis included data of 500 patients with H. pylori-associated gastrointestinal diseases, registered in the period of the year 2013 to 26.10.2018 in the Ukrainian Registry «gfadeenko» within the frameworks of the multicentre prospective trial Hp-EuReg — UKRAINE, initiated by the European Group on the investigation H. pylori infection and microbiota (EHMSG). All patients were administered antihelicobacter therapy (AHBT). Results. The predominated nosological units, for which AHBT was prescribed, were chronic gastritis (73.7 %) and duodenal ulcer 23.3 %. The mostly prevailed methods of primary H. pylori diagnosis were histological (50.8 %), serologic (26.7 %) and fast urease test (19.5 %). The AHBT duration was 7 days in 15.4 % of cases, 10 days in 37.6 %, and 14 days in 47.0 % of cases. The proton pump inhibitor pantoprazole was administered in the AHBT schemes most frequently (80.5 %). For the eradication control, stool test with H. pylori antigen identification in feces was actively used (90.5 %), and not actively the histological method (5.7 %) and urease breast test (1.9 %). Serological test was used in 2.9 % cases, and this was a significant diagnostic error. The eradication efficacy at the administration of the standard triple therapy was 53.5 % at 7-days course, 68.2 %, at 10-days course and 75.0 % at 14-days treatment. The use of triple therapy with addition of bismuth tripotassium dicitrate (VTD), the eradication level at 7-days course reached 71.4 %, at 10-days 92.6 %, and at 14-days 94.1 %. Conclusions. The non-compliance of the Maastricht-V recommendations regarding the duration of AHBT and eradication control has been revealed. Pantoprazole was administered in the AHBT schemes most frequently, that was stipulated by the comorbidity presence in the most of patients and risk of the inter-medication interactions. The insufficient efficacy of 7-days triple therapy has been established, as well as sub-optimal efficacy of 10- and 14-days schemes of triple AHBT and 7-days of triple AHBT with VTD addition. The VTD addition in 10- and 14-days schemes of triple therapy promoted the increase of eradication efficacy (more than 90 %), thus making this method of AHBT optimization actual for Ukraine.

The Role of the Pathoanatomical Diagnosis «Chronic Gastritis» in the System of Personified Cancer Prevention

Aim.The aim of the review is to systematize the principles of interpretation of morphological and molecular-cellular signs underlying the biopsy diagnosis of chronic gastritis from the standpoint of personified prevention of gastric cancer.Background. The chronicle of cancer prevention is presented as an evolution of views on the possibility of clinical interpretation of structural changes in the gastric mucosa such as early (inflammation, metaplasia, atrophy) and pronounced (intraepithelial neoplasia/dysplasia) precancerous changes. The protocols of taking gastric bioptates and their violations, the principles of formulating the pathoanatomical conclusion (Updated Sydney system, OLGA system) and a personalized forecast of the risk of gastric cancer are discussed. Molecular classification of gastric cancer is considered from the standpoint of carcinogenesis cascade and WHO 2010 histological classification. New molecular and cellular targets for the preparation of bismuth tripotassium dicitrate and practical steps of its use in the prevention of gastric cancer in chronic inflammation of the mucosa of various etiologies are conceptually described.Conclusion. Biopsy diagnosis of chronic gastritis combined with the evaluation of gene structure (genetic polymorphism) and epigenomic mechanisms (microRNA) allows the risk of gastric cancer to be ranked in a particular patient even with early precancerous changes in the gastric mucosa. The activity of gastritis (infiltration of the mucosa with neutrophilic leukocytes) of any etiology is the theoretical justification for the use of bismuth tripotassium dicitrate pharmacological preparation to protect the genome of stem cells of the gastric epithelium as a secondary prevention of gastric cancer.

Роль препаратов висмута в повышении эффективности эрадикации инфекции Helicobacter pylori

Aim of review. To demonstrate modern potential of bismuth agents administration for increasing of Helicobacter pylori (H. pylori) eradication efficacy. Summary. Prevention of peptic ulcer and stomach cancer makes eradication of H. pylori infection more and more important. At the same time efficacy of some eradication modes, first of all - that of standard triple therapy, steadily decreases because of growing antibiotic resistance of H. pylori strains, first of all - clarithromycin resistance. The concept that empirical prescription of standard triple therapy should be abandoned in favor of initial H. pylori clarithromycin-resistance testing by culture or real-time polymerase chain reaction became widely accepted. Bismuth-based quadrotherapy mainly - with bismuth tripotassium dicitrate (BTD) is alternative to standard triple mode therapy nowadays. Potential of BTD combination not only to tetracycline but to other antibiotics as well was demonstrated. Addition of BTD to triple therapy containing clarithromycin, levofloxacin, metronidazole allows to increase eradication efficacy for 30-40% at H. pylori-resistant strains. Absence of H. pylori resistance development to BTD, combined antibacterial and cytoprotective effects as well as good tolerance are important advantages of the drug. Conclusion. Addition of BTD to triple H. pylori eradication modes, that include different antibiotics (clarithromycin, levofloxacin and metronidazole) provide significant increase in efficacy of eradication at antibioticresistant Helicobacter pylori strains.