Multicenter, randomized, open-label, comparative study of the effectiveness of nasal spray Aqua Maris Extra Strong as a symptomatic therapy in the technology of delayed antibiotic prescription in the treatment of acute rhinosinusitis in children aged 6-11 years.

Antibacterial therapy in acute rhinosinusitis (ARS) is prescribed 4-9 times more often than recommended, while no >5 % of patients require such treatment. The main motive for the irrational antibiotic prescription is the presence of mucopurulent discharge and nasal congestion in combination with hyperthermia. The study objective was to determine the efficacy of hypertonic seawater solution in the technology of delayed antibiotic prescription in patients with ARS. METHODS: In a multicenter, randomized, open-label, comparative study, 100 children were randomized. 100 children with ARS aged 6-11 years, who received Aqua Maris Extra Strong irrigation therapy in addition to standard therapy or received standard therapy, completed the study. EVALUATION CRITERIA: decreased intensity of nasal congestion, rhinorrhea, postnasal drip, headache and facial pain, assessed by the physician using a 4-point scale at each visit compared to Visit 1, dynamics of self-scored symptoms using a 10-point visual analogue scale, frequency of antipyretic and antibiotic prescription. RESULTS: The use of hypertonic seawater solution in patients with ARS provides a clinically significant reduction in the severity of core or key symptoms: rhinorrhea, nasal congestion, postnasal drip and headache, assessed by the physician at V2 (p < 0.05). There are significant differences in the dynamics of these symptoms according to the patient's self-assessment from treatment Day 2 (p < 0.05). The use of irrigation therapy with Aqua Maris Extra Strong in the technology of delayed antibiotic prescription in patients with ARS allows to reduce the prescription of antibacterial drugs. No on-treatment side effects were observed in any patient. CONCLUSION: Hypertonic seawater solution Aqua Maris Extra Strong is a safe and effective medicinal product for the symptomatic treatment of acute rhinosinusitis in children aged 6-11 years/ It provides a significant therapeutic effect when prescribed in addition to standard therapy and helps to reduce the need for antibiotics.

FEATURES OF THE CONNECTIVE TISSUE COMPONENT OF THE PALATINE TONSILS IN PATIENTS WITH RECURRENT TONSILLITIS.

OBJECTIVE: The aim: To explore the morphological changes of palatine tonsil at the levels of the epithelial layer and connective tissue; to determine the relative area of the connective tissue component in the tonsillar tissue (fibrosis) in patients with recurrent tonsillitis compared to the control. PATIENTS AND METHODS: Materials and methods: This study presents a morphological assessment of the palatine tonsils of 10 people. Tonsils' material with surrounding tissue was fixed in 10% formalin solution. The samples were dehydrated in increasing ethanol concentrations, cleared in xylol, impregnated with paraffin. Microscopy was then performed with samples stained beforehand. RESULTS: Results: In the samples of patients with recurrent tonsillitis pericapsular sclerosis was noted, along with thickening of interlobular septa and pronounced subepithelial fibrosis. A ratio of the dense connective tissue surface area to the total surface area of tonsil tissue was determined. The control group showed a statistically significant decrease in the degree of sclerosis of the tonsil stroma. CONCLUSION: Conclusions: Multiple changes were found in the tonsils of patients with recurrent tonsillitis at the level of the epithelial layer that manifested in structural alterations. Significant and irreversible changes were also observed in the connective stroma of the tonsil - pericapsular sclerosis, thickening of interlobular septa, and pronounced subepithelial fibrosis. A statistically significant increase in the relative surface area of the connective tissue component of the tonsil (fibrosis) by a factor of 1,26 was noted in patients with recurrent tonsillitis compared to the results of the control group of patients.

Clinical efficiency of allergen-specific immunotherapy with fungal allergens in patients with chronic polypous rhinosinusitis against the background of fungal sensitization.

Fungal flora is one of the causes of inflammatory, including polypous, processes in the nasal cavity. In this regard, studies aimed at reducing the effect of fungal sensitization (FS) on the course of chronic polypous rhinosinusitis (CPRS) are relevant. The objective of the study was to evaluate the effect of various treatment options on the clinical course of the disease in patients with chronic polypous rhinosinusitis against the background of sensitization to fungi. The study included 90 patients with chronic polypous rhinosinusitis in combination with FS. The patients were divided into two groups - the first clinical group (G1) and the second clinical group (G2). G1 patients received allergen-specific immunotherapy (ASIT) according to the scheme. G2 patients received basic treatment. Evaluation of the clinical efficiency of ASIT was made based on complaints, assessment of symptom severity on a visual analog scale (VAS), and rhinoendoscopic examination. The treatment outcomes were evaluated on a 4-point scale, with excellent results (4 points) - complete remission of the disease during the follow-up period (6-12 months); good (3 points) - exacerbation of the disease 1-2 times a year, in mild form and removed by expectant treatment; satisfactory (2 points) - the number of exacerbations did not decrease. The use of ASIT therapy is pathogenetically justified and leads to a significant improvement in the clinical condition of patients with CPRS with FS.

CLINICAL AND LABORATORY JUSTIFICATION FOR USE OF POLYVALENT BACTERIOPHAGE IN TECHNIQUE OF DELAYED PRESCRIBING OF ANTIBIOTICS IN PATIENTS WITH ARS.

OBJECTIVE: The aim: Of research was to evaluate the effectiveness of bacteriophage in patients with acute rhinosinusitis in respect of technique of delayed prescribing of antibiotics. PATIENTS AND METHODS: Materials and methods: There were examined 155 patients who were given irrigation therapy with isotonic solution of sea water 4 times a day and mometasone furoate of 100 mg twice a day for 10 days. The patients of intervention group (n - 80) were additionally prescribed the polyvalent bacteriophage endonasally, in drops of 2-10 ml 3 times a day. RESULTS: Results: The patients in the control group were observed the decrease in intensity of rhinorrhea, nasal congestion and post-nasal drip on the third day of supervision (p < 0.05), the reduction in bacterial load with Staphylococcus aureus, S. pneumoniae, Haemophilus influenza and M. Catarrhalis (р <0,005), the increase of IgА and sIgA levels (p<0,005) and the reduction in prescription of antibacterial medications by 20%. CONCLUSION: Conclusions: Adding of polyvalent bacteriophage contributes to reducing the use of antibiotics and is recommended in the framework of the strategy of delayed prescribing of antibiotics.

An open-label, multicentre, randomized comparative study of efficacy, safety and tolerability of the 5 plant - extract BNO 1012 in the Delayed Antibiotic Prescription Method in children, aged 6 to 11 years with acute viral and post-viral rhinosinusitis.

Acute rhinosinusitis (ARS) can be characterized as bacterial (ABRS) and require antibiotic therapy only in 0.5-5% of cases. In most cases, the disease is in a viral and post-viral form, which requires pathogenetic and symptomatic treatment. The study objective was to determine the efficacy of BNO 1012 extract in the technology of delayed antibiotic prescribing in children with acute rhinosinusitis. METHODS: 292 children aged 6 to 11 years with ARS were randomized in the multicenter, comparative study. They received an extract of five medicinal plants in addition to standard symptomatic therapy or standard therapy only. EVALUATION CRITERIA: reduction of the sinusitis severity according to a 4-point medical assessment scale (nasal congestion, severity of anterior and posterior rhinorrhea) at each visit, dynamics of self-scoring of rhinorrhea and headache (according to a 10-point visual analogue scale), "therapeutic benefit" in days, frequency of antibiotic prescriptions due to the use of an extract of five plants. RESULTS: The use of the 5-plant extract BNO 1012 in addition to the standard symptomatic treatment of acute rhinosinusitis provides a clinically significant, adequate reduction in the severity of rhinorrhea, nasal congestion and post-nasal drip, assessed by a physician at V2 (p < 0.005). Significant differences are noted in the patient's self-scoring of rhinorrhea on the second or third day in viral RS, and from the fourth to the eighth day in post-viral RS. Symptoms of similar intensity in control group were observed at V3. Thus, in the first week of treatment, the treatment group compared to the control one showed a "therapeutic benefit" of three days. The use of BNO 1012 in patients with acute rhinosinusitis can 1.81-fold reduce the prescription of antibacterial drugs. CONCLUSION: The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years. Its use provides a significant "therapeutic benefit" when administered in addition to standard symptomatic therapy, reducing the need for antibiotic use.

A randomized, open-label, multicenter, comparative study of therapeutic efficacy, safety and tolerability of BNO 1030 extract, containing marshmallow root, chamomile flowers, horsetail herb, walnut leaves, yarrow herb, oak bark, dandelion herb in the treatment of acute non-bacterial tonsillitis in children aged 6 to 18 years.

Seventy to 95% of acute tonsillitis episodes are caused by viral infection, therefore why antibiotic therapy is not indicated in majority of cases. In such cases, acetaminophen or ibuprofen are used to alleviate the symptoms. The objective of this study was assessment of efficacy of phytoneering extract BNO 1030 (Imupret®) in patients with acute non-bacterial tonsillitis. METHODS: This randomized, open-label, multicenter, comparative study randomised 238 outpatients aged 6-18 years to receive either BNO 1030 (Imupret®) as a supplement to standard symptomatic therapy, or standard therapy. Assessment criteria were as follows: sore throat dynamics at rest and at swallowing, throat irritation associated with cough, general condition, day of withdrawal of antipyretics, the share of treatment responders, as well as assessment of "therapeutic benefit" from the use of BNO 1030. RESULTS: Decreased intensity of acute tonsillitis symptoms to 1 point and lower, assessed using 4-point scale starting from the day 5 of treatment (p < 0.005), alleviation of local symptoms and general condition starting from day 2 of the disease (р < 0.001), withdrawal of antipyretics starting from day 4 of treatment (p < 0.005), increase of the number of treatment responders to 81.6% (p < 0.005) versus the control were reported. "Therapeutic benefit" was 4.2 days. All patients tolerated phytotherapy well, and no adverse reactions were seen. CONCLUSION: BNO 1030 (Imupret®) is a safe and effective product for treatment of acute non-bacterial tonsillitis in children aged 6-18 years, assuring therapeutic benefit when prescribed additionally to the standard symptomatic therapy.

Effectiveness of betahistine (48 mg/day) in patients with vestibular vertigo during routine practice: The VIRTUOSO study.

BACKGROUND: Vestibular vertigo is associated with substantially reduced quality of life. Betahistine is effective in improving vertigo-associated symptoms, with longer treatment periods leading to greater improvements; however, it is not known whether these effects persist after treatment cessation. METHODS: VIRTUOSO was a prospective, multinational, non-comparative, post-marketing observational programme investigating the effectiveness of betahistine (48 mg/day) and the course of vertigo after the discontinuation of treatment. Patients with vestibular vertigo who were prescribed 48 mg/day betahistine were enrolled in Russia and Ukraine. Treatment duration was up to 2 months, and patients were followed up for 2 months after discontinuation of betahistine. Efficacy endpoints included clinical response (assessed by change in vertigo severity), monthly attack frequency, and physician and patient grading of overall clinical response and improvement of vertigo-associated symptoms. RESULTS: Overall, 309 patients were enrolled and 305 completed the study. Clinical response was rated as good, very good or excellent in 74.1% of patients at end of treatment, with vertigo severity significantly decreased from baseline (p < 0.001). Monthly vertigo attack frequency decreased significantly during the 2 months of treatment (p < 0.001 from baseline) and further decreased during the 2-month follow-up (p < 0.001 from end of treatment). Overall, clinical response was graded as good or excellent by 94.4% of physicians and 95.4% of patients. Clinical improvement was considered either good or excellent by 82.6-90.5% of physicians and patients for nausea, vomiting and faintness. Only one adverse event was reported, with no serious adverse events. CONCLUSION: Our findings suggest that betahistine (48 mg/day) therapy is effective in treating vertigo in routine clinical settings. The observed effects persisted for 2 months after treatment cessation, suggesting that betahistine may facilitate lasting vestibular compensation.