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This is a phase III, randomized, double-blind, clinical trial with two parallel groups of 50 patients to assess the efficacy of ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]ethyl ] amino]methylene]-4-bromo-benzenesulfonamide, CAS 100981-43-9, FI-3542) 800 mg and ranitidine 300 mg as a single evening dose in the treatment of benign gastric peptic ulcer. Prior to treatment, an endoscopy was performed to detect ulcer lesions and to discard malignancies. Clinical and endoscopic examinations were performed at 6, 9 and 12 weeks. Healing rates were significant for both treatments at week 6, while at week 12 there was statistical significance for ebrotidine as compared to ranitidine (96% vs 88% in the intention-to-treat analysis and 98% vs 87.5% in the per protocol analysis). Decrease in ulcer diameter was significant for both treatments at week 6, and for ebrotidine versus ranitidine at weeks 9 and 12. The overall improvement of symptoms was higher with ebrotidine, which was already significant at week 6. Safety was considered to be excellent, since no significant adverse events were reported for the patients included in the study.

A new method of estimation of trauma victim risk is presented. This new score--UWR--trauma risk score is created by multiplication product of LSO value and logarithmic age index. The influence of age of trauma patient on all stages of "trauma disease" is proved in two groups of trauma victims, contain 2485 and 3407 patients. Frequency of accidents, localisation and severity of injuries, and on results of treatment depends on age. This is the cause to consider an age into trauma scale. The new UWR is correlated not only with mortality, but a LSO with percentage and severity of disability.

Microstructural, endo- and exocrine changes in gastric mucosa of Non-Ulcer Dyspepsia patients with H. pylori infection in the course of eradication has been studied. Before, during and after anti H. pylori therapy plasma gastrin and somatostatin levels, EGF and somatostatin concentration in gastric juice and basal and pentagastrin stimulated gastric acid secretion were measured. Moreover microstructure of gastric mucosa specimens has been studied. Maximal Acid Output initially higher in NUD patients than in healthy volunteers increased slightly in the course of eradication. Plasma gastrin decreased while EGF and somatostatin concentration in gastric juice increased. After treatment the ratio of patients with pronounced features (activity) of gastritis was significantly reduced.

We designed this study to follow exocrine, endocrine and microstructural changes in duodenal ulcer patients with H. pylori infection in the course and after quadruple eradication regimen. Quadruple therapy appeared to be highly effective method of both ulcer healing and H. pylori eradication. We observed enhanced regeneration of gastric mucosa in the course of treatment. Almost immediate decrease of plasma gastrin and increase of plasma somatostatin and EGF concentration in gastric juice were noticed.

Epidermal growth factor (EGF) is secreted by salivary and Brunner's glands and shows a potent inhibitory effect on gastric acid and stimulatory influence on mucosal growth and protection but little is known about the effect of the Helicobacter pylori (Hp) infection on the release of EGF. In this study the salivary and gastric concentrations of EGF have been measured and gastric mucosal expression of EGF has been determined in 25 Hp positive duodenal ulcer (DU) patients before and after the eradication of Hp (using triple therapy with omeprazole, 20 mg bd, amoxycillin, 500 mg qd and metronidazole, 500 mg bd for 2 weeks) and in 10 healthy controls under basal conditions and following pentagastrin (2 micrograms/kg-h) stimulation. Basal salivary and gastric concentrations of EGF were similar and no significant difference was found between DU patients and healthy controls. Pentagastrin infusion (2 micrograms/kg-h) caused a significant increase in EGF release into saliva and gastric juice both in healthy controls and DU patients but in DU patients the Hp eradication resulted in several folds higher basal and pentagastrin-induced gastric EGF content than that before the anti-Hp therapy, whereas such Hp eradication had no significant influence on basal and pentagastrin-induced salivary EGF. Antral mucosal expression of EGF in Hp-positive DU patients was significantly higher than that in healthy Hp-negative controls and this elevation persisted after eradication of Hp. Basal and pentagastrin-induced gastric acid outputs in Hp-positive DU patients were significantly higher than in healthy controls and they were slightly reduced after the triple therapy. In all DU patients, 4 weeks after termination of anti-Hp therapy, a complete ulcer healing occurred. We conclude that (1) the stomach is capable of secreting large amounts of EGF and pentagastrin appears to be a potent stimulus of salivary and gastric EGF release; (2) the Hp infection reduces the release of gastric EGF and the eradication of Hp results in the augmentation of basal and pentagastrin-induced EGF release into the stomach but not into the saliva and (3) since the eradication of Hp infection in DU patients resulted in DU healing and this was accompanied by an increase in EGF release, we conclude that EGF plays a crucial role in the DU healing process.