Objective — to evaluate the clinical efficacy of the addition of Gyalera emulsion (Alpiflor SRL, Italy) to the standard therapy of patients with gastroesophageal reflux disease (GERD) and to study the effects of such treatment on the state of the esophagus epithelium.Materials and methods. A multicenter, randomized, open, comparative study with the parallel control has been carried out. It involved 60 patients with GERD aged 18 to 65 years, from them 25 women (42 %), and 35 men (58 %). The inclusion criteria included the presence of GERD symptoms (primarily heartburn), confirmed endoscopically and morphologically. The participants were divided into two groups of 30 subjects in each. Omeprazole in a dose of 20 mg 2 times a day and domperidone at a dose of 10 mg 3 times a day were used as basic therapy in both groups. In the first group, an additional «Gyalera» emulsion of 15 ml sticks was administered in a dose of 1 stick after a meal 3 times a day.Results. After the treatment, heartburn frequency in the first group was almost three times lower than in the comparison group (p = 0.035). This group did not suffer from nighttime heartburn and dysphagia, whereas in the second group it was observed in almost 7 % of patients. The incidence of belching after the treatment was 17 % and 20 % respectively. Esophagitis was detected endoscopically in 4.5 times more often in the second group than in the first, in one patient it was erosive. In the patients of the first group, morphologically significant positive dynamics was defined.Conclusions. In patients with GERD, the addition of Gyalera emulsion to the standard therapy with proton pump inhibitor and prokinetics promoted significant (in comparison with the control group) reduction of the heartburn frequency and severity, the degree of esophagus damage as per the esophagoscopy data, and elimination of dysphagia and nocturnal heartburn. Morphological analysis of esophageal mucosa demonstrated a decrease in the degree of epithelial inflammation and degeneration, and increase in the synthesis of protective mucus and epithelial integration on account of claudine 1 in tight junctions.
Relevance. Although monotherapy with a gluten-free diet (BGD) for celiac disease is highly effective, it does not in all cases achieve complete remission of the disease. Therefore, an additional comprehensive examination of patients for the purpose of prescribing reasonable therapy is relevant. Objective: to study the causes of the persistence of clinical symptoms in patients with celiac disease who are on a gluten-free diet for 6 months. Materials and methods. Patients with celiac disease (n = 41) who were on a gluten-free diet (GFD) for 6 months were studied. The average age is 35.42 ± 0.45 years. Group 1 (n = 17) – patients who subjectively noted a positive dynamics of treatment and with a significant improvement in general condition, but without complete clinical remission. Group 2 (n = 24) – patients with unsatisfactory treatment results, no clinical effect from treatment, or weak positive dynamics on the background of GFD. The study included two stages: 1) assessment of patients' compliance and their diet (through the analysis of food diaries) in order to identify disorders of a gluten-free diet as the main cause of the persistence of clinical symptoms; 2) identification of other causes of the persistence of symptoms: exocrine pancreas insufficiency (EPI), lactase deficiency (LD) and the syndrome of increase bacterial growth (SIBR). A C13 triglyceride breath test (IRIS analyzer) was performed to diagnose EPI. To diagnose LD and SIBR in the small intestine, hydrogen breath tests (Micro H2-meter analyzer) were used – a test with lactose and D-xylose, respectively. Also, the titer of antibodies to tissue transglutaminase (TTG) to deaminated gliadin peptides (DPG) was determined in all patients, and their DPG/TTG ratio was calculated. Results. The main reason for the ineffectiveness of treatment is a violation of a gluten-free diet, found in 63.4% of subjects (incompletely formed mushy stool, polyfaeces, steatorrhea; recurrent abdominal pain, bloating, flatulence). Revision of food intake and elimination of sources of latent gluten from the diet of patients with celiac disease allowed to achieve complete serological remission (normalization of titers specific for celiac disease antibodies) in all patients, but complete clinical remission was achieved in only 34.6%. Therefore, it is concluded that there are other causes of incomplete remission of celiac disease associated with concomitant diseases of the digestive tract. Using carbon and hydrogen breath tests, it was found that, in addition to diet, the reasons for the lack of complete remission in patients with celiac disease are EPI (19%), SIBR in the small intestine (16%), LD (47%) and a combination of EPI with SIBR. Conclusion. The inclusion of respiratory tests (C13-triglyceride, hydrogen with lactose, and D-xylose) in a comprehensive examination of patients with celiac disease can significantly improve treatment outcomes and reduce the duration of clinical remission.
В статье приведены собственные данные исследования современных возможностей повышения эффективности лечения больных целиакией (n = 41). Все пациенты находились на аглиадиновой диете, тем не менее эффективность лечения расценивалась как неудовлетворительная. Благодаря использованию современных углеродных и водородных дыхательных тестов и диагностике синдрома чрезмерного бактериального роста, лактазной недостаточности и внешнесекреторной недостаточности поджелудочной железы, которые оказались причинами персистенции клинической симптоматики, были получены основания для их коррекции и достигнута полная ремиссия основного заболевания.
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