Efficacy and safety of the use of rebamipide in the scheme of triple eradication therapy of Helicobacter pylori infection: a prospective randomized comparative study.

AIM: To evaluate the effectiveness and safety of the use of rebamipide as part of the triple eradication therapy (ET) scheme of Helicobacter pylori infection. MATERIALS AND METHODS: A prospective, randomized comparative study included 94 patients with uncomplicated H. pylori-associated stomach / duodenal ulcer. In the process of randomization, patients are divided into three groups depending on the intended therapy. The first group (n=36) received a classical triple scheme of the first-line ET (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day) for 10 days. Patients of the second group (n=33) were assigned a classical triple scheme of ET with the inclusion of rebamipide (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day, rebamipide 100 mg 3 times a day day) for 10 days. Patients of the third group (n=25) were assigned a classical triple scheme of ET with the inclusion of rebamipide (omeprazole 20 mg twice a day, amoxicillin 1000 mg twice a day, clarithromycin 500 mg twice a day, rebamipide 100 mg 3 times a day) in for 10 days, with the prolongation of the administration of rebamipide for the next 20 days. The effectiveness of ET was determined by the respiratory test after 6 weeks after the end of treatment. Adverse events were recorded by patients in specially developed diaries. All patients with gastric ulcer at the 6th week underwent a histological examination of the biopsy specimens of the antrum and the body of the stomach, assessing the inflammatory activity of the process on a point system in accordance with the updated Sydney system. RESULTS: Efficiency of H. pylori eradication in the first group was 77.7% (ITT), 82.3% (PP), in the second group - 81.8% (ITT), 84.4% (PP), and in the third group - 84% (ITT), 87.5% (PP). The use of rebamipide in the triple ET regimen was associated with an increase in H. pylori eradication efficiency, both with simultaneous use with the scheme [odds ratio (OR) 1.16; 95% confidence interval (CI) 0.32-4.24], and with subsequent prolonged admission (OR 1.5, 95% CI 0.34-6.7). A somewhat more pronounced dynamics of the epithelization of erosive and ulcerative changes in the mucous membrane of the stomach and duodenum to the 21st and 28th days in the third group of patients was noted. The incidence of adverse events between the groups was comparable: 22.2% in the first group, 24.2% in the second group and 20% in the third group. In the pathomorphological evaluation of biopsy specimens of patients with gastric ulcer at the 6th week after the treatment, significant differences were revealed between the first and third groups in terms of the inflammatory activity in the antrum stomach (2±0.63 vs. 1.4±0.52; p=0,0399). CONCLUSION: The inclusion of rebamipide in the classical triple scheme of H. pylori ET increases the effectiveness of treatment and does not affect the safety profile. In the post-eradication period, it is advisable to continue the use of rebamipide to potentiate the repair of the gastric mucosa and regress the inflammatory processes.

[MENETRIER DISEASE].

Menetrier disease (MD) is a very rare stomach pathology of unknown etiology characterized by manifest hypertrophy of gastric mucosa. The main causes of MD are believed to be Helicobacter pylori and cytomegalovirus infections. The most frequent symptom is epigastric pain. Also common are peripheral oedema due to hypoalbuminemia and increased permeability of gastric mucosa. The main diagnostic signs of MD include diffusive enhancement of mucosal folds, foveolar hyperplasia and glandular atrophy with a decrease in the number of main and parietal cells, hypoalbuminemia and peripheral oedema. MD being a very rare condition, the optimal methodfor its treatment is unknown.

[Pharmacoeconomic evaluation of treatment in patients with Helicobacter pylori-associated diseases].

AIM: To estimate the pharmacoeconomic parameters of treatment in patients with Helicobacter pylori-associated diseases when using 6 eradication therapy (ET) regimens. SUBJECTS AND METHODS: The investigation enrolled a total of 231 patients who received anti-Helicobacter pylori therapy according to the intention-to-treat (ITT) principle, including 229 patients who met the protocol requirements, i.e. who completed the prescribed per-protocol (PP) treatment: 106 patients with duodenal bulb ulcer disease, 2 with gastric ulcer, 90 with erosive gastritis, and 31 patients with non-atrophic gastritis. In an outpatient setting, the patients received one of the 6 ET regimens: OAC, RBMA, RBCA, EBCA, sequential OACM therapy, and modified sequential OACMB therapy (O--omeprazole; A--amoxicillin; C--clarithromycin; B--bismuth tripotassium dicitrate, R--rabeprazole; M--metronidazole; E--esomeprazole). Treatment costs were calculated only from direct drug expenditures. The effective cost coefficient (K(eff)) was determined from the cost/ treatment efficiency ratio: K(eff) = cos/eff, where the cost was the average total costs; the eff was efficiency (%). RESULTS: The modified sequential OACMB therapy has proven to be more cost-efficient than the other regimens as it has a lower K(eff), (14). The RBMA regimens can overcome an 80% ET barrier (82.4%); however, in this case the K(eff) is 21.5. the sequential OACM therapy can also overcome an 80% ET barrier (84.8%); the K(eff) being 10.8. Incorporation of the bismuth preparation can achieve a more noticeable therapeutic effect up to 95.4%. The EBCA regimen has turned out to be most expensive with the highest K(eff) of 36.9. The RBCA regimen is most effective with the least K(eff) of 29; the therapeutic effect is 96.7%. CONCLUSION: The clinical cost-efficiency of ET is enhanced by the incorporation of the bismuth preparation for the treatment of patients with H. pylori-associated diseases. The modified sequential OACMB therapy can overcome resistance to clarithromycin and metronidazole with a good cost-efficiency.

[Drug interaction of proton pump inhibitors and clopidogrel taken together].

Current clinical practice lays special emphasis on drug interactions. High rates of cardiovascular morbidity and acid-dependent diseases dictates the necessity of antiaggregation and antisecretory therapy. The former uses a variety of medicines with acetylsalicylic acid (ASA) and clopidogrel being the most popular ones. Therapy using drugs with different mechanisms of action on the thrombocytic component of homeostasis appears to be especially promising as having synergic antiplatelet effect. The most common variant of antiplatelet therapy is a combination of ASA and clopidogrel usually referred to as double antiplatelet therapy (DAP). Current consensus recommends intake of proton pump inhibitors (PPI) during DAP to reduce the risk of gastrointestinal complications. However, recent studies showed that this approach is fraught with severe cardiovascular disorders, such as myocardial infarction, stroke, unstable angina, necessity of repeat coronary interventions, and coronary death. Hence, the importance of differential application of PPI in patients treated with ASA and clopidogrel. A comprehensive review of this problem is presented along with results of investigations of PPI action on clinical outcome of clopidrogel therapy.

[Current recommendations for the diagnosis of chronic pancreatitis in general clinical practice].

The paper gives practical recommendations based on the provisions of a number of foreign national guidelines for the diagnosis of chronic pancreatitis (CP). There is virtually no evidence for Class I database for its diagnosis. Despite an inadequate scientific rationale, the review of these international guidelines has brought together the basic available data in the context of the current global standards for the diagnosis of CP.

[The role of respiratory tests in diagnostics of Helicobacter pylori infection].

The clinical significance and potential of respiratory tests for diagnostics of Helicobacter pylori infection was estimated in 76 patients. Results of 13C and 14C-urease tests were in especially good agreement with those oh histological studies. The 13C-urease test should be preferred in the examination of both in-patients and out-patients whereas NH3-urease test is much inferior to 13C and 14C-urease tests in terms of informative value.

[Difficulties and errors in the management tactics of patients with chronic pancreatitis].

The paper deals with the difficulties and errors that are most commonly used in clinical practice to manage patients with chronic pancreatitis (CP). The higher interest in CP is inspired by the wide prevalence of this disease with its constant upward trend. At the same time, a variety of the etiological forms of CP, from generically determined to infectious and autoimmune ones, in combination with a weak theoretical basis in a number of practitioners gives rise to a broad spectrum of tactical errors in the management of patients with CP. The paper summarizes and analyzes the most common defects and errors in the management tactics of patients with this nosological entity, including the aspects of diagnosis and medical treatment. Ways to solve the set optimization problems in management protocols for patients with CP are proposed in the context of evidence-based medicine.

[Clinical significance of Helicobacter pylori infection].

This article deals with modern concepts of H. pylori infection and its role in the development of gastric and extragastic pathology. The currently available algorithms of diagnostics and treatment of this infection are presented Recommendations of recent Maastricht consensuses (7MC-3, 2005; MC-4, 2010) on diagnostics and treatment of H. pylori infection are considered. The data on resistance of H .pylori to antibiotics, mechanisms of its development and methods of control are summarized.

[Helicobacter pylori: what schemes of eradication are essential today?].

Current approaches to treatment of Helicobacter pylori infection, basic international recommendations, problems of growing H. pylori resistance to antibiotics are reviewed. Much attention is given to prospects of new eradication schemes, for example combinations based on bismuth tripotassium dicitrate and successive treatment schedules.

[Tension-free plasty in the surgery of abdominal wall hernias].

The article presents an experience with application of tension-free plasty of the anterior abdominal wall using reticular endoprostheses. New endoprostheses of Reperen are developed and applied, a method of sutureless fixation of polypropylene net in the abdominal wall tissues is proposed when performing plasty for great ventral hernias. Advantages of new methods are shown compared with analogs both in selective and in emergency surgery, in different age groups of patients. The direct and long-term postoperative results and parameters of quality of life are investigated.

[Experimental-clinical reasons for application of endoprostheses of reperen for plasty of the abdominal wall].

The work presents results of a morphological investigation of tissues in the zone of implantation of synthetic material in creation of experimental model of ventral hernia. A comparative characteristic of a reaction of tissues on reperen and polypropylene is given. A number of principal advantages of reperen as compared with polypropylene were detected in plasty of hernial hilus. An analysis of the first experience of operative treatment of hernias by nonstrain methods using reperen in clinic is made.

[The quality of life dynamics in patients with gastroesophageal reflux disease during rabeprazol therapy].

The present article represents findings of quality of life index dynamics for 100 patients with gastroesophageal reflux disease under pressure of proton pump inhibitor therapy. The degree of clinical evidence was measured by Likert scale, quality of life appraisal was made on the bases of SF-36, GSRS checklists, psychoemotional component of patients' health was analyzed with the help of the V.M. Bekhterev Institute personal enquirer. Treatment with Rabeprazole helps efficiently jugulate reflux disease symptoms and accurately improve quality of life index.

[Combined therapy of acid-dependent gastrointestinal disorders with the use of antacidic drug Relcer].

The aim of the study was to evaluate clinical efficiency of antacidic drug Relcer included in combined therapy of gastroesophagal reflux disease (GERD) and ulcer disease (UD). Group 1 comprised 47 patients with GERD and group 2 49 patients with gastric and duodenal UD. Each group was divided into study (A) and control (B) subgroups. All GERD patients were given rabeprazole and metoclopramide, patients with UD received rebaprazole, clarithromycin and amoxicillin. Relcer was additionally prescribed to 24 patients in group 1A and 26 in 2A. Duration of therapy in all groups was 14 days. By the end of the study, all symptoms of GERD were eliminated in 100% of the patients in group 1A and in 78.3% in 1B. Pain and heartburn in group 1A were reduced or eliminated within 5 and 7.8 min respectively after the first dose of Relcer. The same complaints in 69.9% of 1B patients were resolved by the end of the first day. The remaining ones benefited from combined treatment on day 2 Rapid and complete elimination of UD symptoms was finally achieved in 21.7-26.1% of 2A patients whereas moderate dyspeptic syndrome persisted in those of subgroup 2B. Ulcer scarring completed by day 14 in 88.5 and 87% of the patients in subgroups 2A and 2B respectively. Eradication of H. pylori was achieved in 92.3 and 87% of the patients in these groups. It is concluded that introduction of Relcer into combined therapy of GERD and UD improves its results and accelerates elimination of clinical symptoms.

[The use of prokinetics for the correction of motor and tonic digestive disorders].

Abnormal tonic-motor activity is a key component in pathogenesis of many digestive disorders. Secondary disturbance of tonic-motor activity of digestive organs and the accompanying symptoms are known to develop in conjunction with diseases of other organs and systems, diabetes mellitus, Parkinson's disease, myotonic muscular dystrophy, amyloidosis, hyper- and hypothyroidism, hypoparathyroidism, etc. Disturbed motor activity in the gastro-duodenal region most frequently underlies functional dyspepsia, i.e. a group of symptoms unrelated to organic, systemic and metabolic diseases. Prokinetics are an important class of medicinal products for the treatment of all clinical forms of dyspepsia. One of the new ones is itopride hdrochloride having combined mechanism of action. Clinical studies of this drug revealed its high efficiency in patients with functional dyspepsia, chronic gastritis, and diabetic gastroparesis. It is well tolerated by the patients and produces no serious side effects. Inclusion of this drug in therapy improves the outcome of the treatment of disturbed motor activity of the gastrointestinal tract.

[Helicobacter pylori infection as additional risk factor of the development of NSAID-gastropatia effects at the patients with osteoarthritis].

Prevalence of osteoartrosis disease is high among the population. The main places in treatment of this pathology occupy NSAID. Intake of NSAID is lead to the development of NSAID-gastropatia. During last years H. pylori infection was numbered with risk factors of the NSAID-gastropatia development. In this review considered researches which are devoted to studying ties between H. pylori and NSAID. Data of the using eradication therapy with purpose of prevention and treatment of NSAID-gastropatia associated with H. pylori are shown in this review.

[Bismuth preparations in the treatment of patients with gastric and duodenal ulcer disease].

Studies of the role of H. pylori (Hp) in etiopathogenesis of a number of common diseases of the upper gastrointestinal tract changed traditional approaches to their management with emphasis on antibiotic therapy. Positive effect of Hp eradication was confirmed in numerous randomized clinical studies. Bismuth-containing drugs have been used for a long time to treat gastrointestinal disorders. To-day, bismuth tri-potassium di-citrate (de---nol) is considered to be an optimal tool for different schemes of eradication therapy (triple and quadruple therapy of the first and second lines) and recommended to improve its efficiency by overcoming resistance of Hp to antibiotics. The overall efficacy of anti-helicobacterial therapy using bismuth tri-potassium di-citrate amounts to 81-98%. This compound has cytoprotective effect on gastric and duodenal mucosa, besides antibacterial action. All these properties characterize de-nol as a single universal preparation for the treatment of erosive ulcers in the gastrointestinal tract.

[Features of combined (HBV/HCV-infection) viral lesion of the liver].

AIM: To study clinical, biochemical features, course of combined viral hepatitides, dominant viral activity in combination HBV/HCV infection. MATERIAL AND METHODS: A total of 37 patients with HbsAg and anti-HCV, 23 patients with chronic hepatitis C and 48 patients with chronic hepatitis B were examined (the study and comparison groups, respectively). 67 HbsAg carriers with normal,hepatic parameters (no clinical symptoms, normal transaminase activity) served controls. RESULTS: In patients with parallel detection of HbsAg and anti-HCV detectability of HBV-DNA was 8.1% while HCVrNA was detected in 84% cases. Half the patients with HbeAg positive HBV had seroconversion 1.5-2 years after HCV infection. Documented HCV infection in HBV patients leads to elimination of one of the viruses (HBV more frequently) in more than 50% cases. HCV infection may induce seroconversion of HbeAg. Biochemical parameters (bilirubin, AIAT, AP, gamma HTP of blood) in patients with mixed infection compared with those with mono-infection were 1.5 times higher. In mixed infection cytokines (TNF-alpha, IL-1 beta, IL-6, IL-8, TGF-lbeta) levels were also higher, the diameter of the portal vein was larger (16.9 +/- 0.5 mm). Conclusion. In mixed viral infection there are marked changes in clinico-biochemical, morphological and hemodynamic indices with a clear trend to early formation of portal hypertension with significant alterations in the esophago-gastroduodenal zone.

[Early symptoms of hepatic encephalopathy in patients with chronic diffuse hepatic diseases].

Four hundred and twenty-three patients with chronic diffuse hepatic diseases (hepatitis and viral hepatic cirrhosis) underwent complex clinico-instrumental examination; the control group consisted of 30 healthy individuals. Hepatic encephalopathy syndrome was a much more frequent finding in patients with hepatic cirrhosis. Association of chronic viral hepatic lesion with alcohol abuse increased the frequency of latent central nervous system lesions.