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Kamil Janeczek,1 Agnieszka Kaczyńska,1 Andrzej Emeryk,1 Cemal Cingi2 1Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, Lublin, Poland; 2Department of Otorhinolaryngology, Faculty of Medicine, Eskişehir Osmangazi University, Eskişehir, TurkeyCorrespondence: Kamil Janeczek, Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, Prof. A. Gębali 6, Lublin, 20-093, Poland, Tel +48817185477, Email kamil.janeczek@umlub.plAbstract: Bacterial lysates (BLs) are mixtures of bacterial antigens that have been used for many decades to minimize the risk of recurrent respiratory tract infections in both pediatric and adult populations. Research on the use of BLs is also conducted in allergology. Biomedical databases were searched for articles on the use of BLs in the treatment of allergic rhinitis (AR). After rejecting ineligible articles, six remaining reports were reviewed. Based on this review, it can be concluded that adding BL to standard therapy for seasonal or perennial AR reduces the severity of nasal symptoms and the need for antiallergic medications in both children and adults. Concurrently, these formulations have a high safety profile. An analysis of studies shows that the first effects of BLs therapy appear at the earliest 2– 6 weeks after the start of treatment and persist at least 3 months after treatment.Keywords: bacterial lysate, allergic rhinitis, immunostimulation, treatment

Summary: Background: Allergic rhinitis/rhinoconjunctivitis (AR/C) induced by house dust mites (HDM) often begins in childhood and negatively impacts a child’s quality of life. The daily burden can be further compounded by comorbid asthma. Allergen immunotherapy is the only available treatment targeting the underlying cause of allergic disease. Efficacy and safety of the SQ HDM sublingual immunotherapy (SLIT)-tablet has been demonstrated in adults and adolescents with HDM AR/C with or without asthma, but data are lacking for younger children. Methods: Phase III, randomised, double-blind, placebo-controlled trial in younger children (5–11 years) with HDM AR/C with or without asthma. Eligible subjects were randomised 1:1 to SQ HDM SLIT-tablet or placebo for ∼1 year and had free access to AR/C symptom-relieving medications. The primary outcome was the total combined rhinitis score (TCRS) during the final 8 weeks of the treatment period (∼1 year). Secondary outcomes included the rhinitis daily symptom score (DSS) and medication score (DMS), the rhinoconjunctivitis total combined score (TCS), and the Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) score. Efficacy analyses were conducted on the full analysis set (observed cases). Asthma-related outcomes were also explored. The trial was registered on ClinicalTrials.gov: NCT04145219 and EudraCT: 2019-000560-22. Findings: A total of 1460 subjects were randomised to SQ HDM SLIT-tablet (n = 729) or placebo (n = 731). The primary outcome, TCRS, was statistically significantly different for SQ HDM SLIT-tablet (n = 693) versus placebo (n = 706), with an absolute difference of 1.0 (95% CI: 0.5, 1.4; p

PURPOSE The advent of new medical devices allows patients with asthma to self- monitor at home, providing a more complete picture of their disease than occasional in- person clinic visits. This raises a pertinent question: which devices and parameters perform best in exacerbation detection? METHODS A total of 149 patients with asthma (90 children, 59 adults) participated in a 6-month observational study. Participants (or parents) regularly (daily for the first 2 weeks and weekly for the next 5.5 months, with increased frequency during exacerbations) performed self-examinations using 3 devices: an artificial intelligence (AI)-aided home stethoscope (providing wheezes, rhonchi, and coarse and fine crackles intensity; respiratory and heart rate; and inspiration-to-expiration ratio), a peripheral capillary oxygen saturation (Sp[O.sub.2]) meter, and a peak expiratory flow (PEF) meter and filled out a health state survey. The resulting 6,029 examinations were evaluated by physicians for the presence of exacerbations. For each registered parameter, a machine learning model was trained, and the area under the receiver operating characteristic curve (AUC) was calculated to assess its utility in exacerbation detection. RESULTS The best single-parameter discriminators of exacerbations were wheezes intensity for young children (AUC 84% [95% CI, 82%-85%]), rhonchi intensity for older children (AUC 81% [95% CI, 79%-84%]), and survey answers for adults (AUC 92% [95% CI, 89%- 95%]). The greatest efficacy (in terms of AUC) was observed for a combination of several parameters. CONCLUSIONS The AI-aided home stethoscope provides reliable information on asthma exacerbations. The parameters provided are effective for children, especially those younger than 5 years of age. The introduction of this tool to the health care system might enhance asthma exacerbation detection substantially and make remote monitoring of patients easier. Key words: asthma monitoring; asthma exacerbation; childhood asthma; AI-aided medical device; home health care, INTRODUCTION As defined in the Global Initiative for Asthma (GINA) annual report, asthma is a heterogeneous disease, usually characterized by chronic airway inflammation and a history of respiratory symptoms such [...]

Pressurized metered dose inhalers (pMDIs) contain propellants with high Global Warming Potential. This paper compares six pMDI products from the Polish market in terms of their contribution to environmental burden by analyzing the release and residuals of greenhouse gases during use and disposal. The results show that these similar medical products have markedly different carbon footprint values (12-22.5 kg CO2e), which might be mitigated by certain measures involving technical and legal actions.

Introduction Eosinophilic granulomatosis with polyangiitis (eGPA) is a rare type of vasculitis. We described the case of the patient who was admitted to our Department due to haemoptysis, in whom the model-based clinical reasoning and quick diagnostic process led to the diagnosis and referral of the patient to specialists dealing with the treatment of this disease. We wanted to emphasize the fact that the patient developed symptoms of the disease many years before diagnosis. However, these clinical problems were treated individually. A broader reflection of the patient’s symptoms may have led to earlier diagnosis and implementation of adequate treatment Objective The aim of the study is to underline the importance of clinical reasoning on the example of eGPA model diagnostics. The combination of several clinical findings led to the correct diagnosis, which enabled the patient to obtain treatment and improved further prognosis.

BackgroundThere are many drugs for allergic rhinitis (AR), however, these drugs show variable clinical effectiveness and some side effects. Therefore, new methods of AR pharmacotherapy are being sought.ObjectivesThe objectives of this study were to evaluate the efficacy of polyvalent mechanical bacterial lysate (PMBL) therapy in improving the clinical course of grass pollen-induced AR (seasonal AR, SAR) in children and its effect on changes in the blood level of the γδT, iNKT and cytotoxic T cell subsets.MethodsFifty children with SAR were enrolled in this study and were randomly assigned to either the PMBL group or the placebo group. The severity of SAR symptoms was assessed using the total nasal symptom score (TNSS) and visual analogue scale (VAS). During two visits (V1, V2), peak nasal inspiratory flow (PNIF) was measured and peripheral blood was collected for immunological analyses. The study also included 2 telephone contacts (TC1, TC2).ResultsThe severity of the nasal symptoms of SAR on the TNSS scale was revealed to have a significantly lower impact in the PMBL group vs the placebo group at measuring points TC1 and V2 (p = 0.01, p = 0.009, respectively). A statistically significantly lower mean severity of nasal symptoms of SAR on the VAS scale was recorded for children in the PMBL group compared to the placebo group at measuring points TC1, V2 and TC2 (p = 0.04, p = 0.04, p = 0.03, respectively). The compared groups do not show significant differences in terms of PNIF values at individual measuring points. There were no statistically significant changes in immune variables. For both groups, there was a statistically significant association between the level of Th1-like γδT cells and the severity of SAR symptoms expressed on the TNSS scale (p = 0.03) – the lower the level of Th1-like γδT cells, the higher the TNSS value.ConclusionAdministration of sublingual PMBL tablets during the grass pollen season proves to have a high efficacy in alleviating SAR symptoms in children sensitized to grass pollen allergens. Th1-like γδT cells may be used as potential markers for SAR severity in children.Clinical trial registrationClinicalTrials.gov, identifier (NCT04802616).

The efficiency of lung drug delivery of nebulized drugs is governed by aerosol quality, which depends both on the aerosolization process itself but also on the properties of aerosol precursors. This paper determines physicochemical properties of four analogous micro-suspensions of a micronized steroid (budesonide, BUD) and seeks relationships between these properties and the quality of the aerosol emitted from a vibrating mesh nebulizer (VMN). Despite the same BUD content in all tested pharmaceutical products, their physicochemical characteristics (liquid surface tension, viscosity, electric conductivity, BUD crystal size, suspension stability, etc.) are not identical. The differences have a weak influence on droplet size distribution in the mists emitted from the VMN and on theoretical (calculated) regional aerosol deposition in the respiratory system but, simultaneously, there is an influence on the amount of BUD converted by the nebulizer to aerosol available for inhalation. It is demonstrated that the maximum inhaled BUD dose is below 80–90% of the label dose, depending on the nebulized formulation. It shows that nebulization of BUD suspensions in VMN is sensitive to minor dissimilarities among analogous (generic) pharmaceutics. The potential clinical relevance of these findings is discussed.

In pediatrics, acceptability has emerged as a key factor for compliance, and consequently for treatment safety and efficacy. Polyvalent mechanical bacterial lysate (PMBL) in 50-mg sublingual tablets is indicated in children and adults for the prophylaxis of recurrent respiratory tract infections. This medication may be prescribed in children over 3 years of age; the appropriateness of this sublingual formulation should thus be demonstrated amongst young children. Using a multivariate approach integrating the many aspects of acceptability, standardized observer reports were collected for medication intake over the course of treatment (days 1, 2, and 10) in 37 patients aged 3 to 5 years, and then analyzed in an intelligible model: the acceptability reference framework. According to this multidimensional model, 50-mg PMBL sublingual tablets were classified as “positively accepted” in children aged 3 to 5 years on all three days of evaluation. As the acceptability evaluation should be relative, we demonstrated that there was no significant difference between the acceptability of these sublingual tablets and a score reflecting the average acceptability of oral/buccal medicines in preschoolers. These results highlight that sublingual formulations could be appropriate for use in preschoolers.

Pressurized metered dose inhalers (pMDIs) contain propellants with high Global Warming Potential. This paper compares six pMDI products from the Polish market in terms of their contribution to environmental burden by analyzing the release and residuals of greenhouse gases during use and disposal. The results show that these similar medical products have markedly different carbon footprint values (12-22.5 kg CO2e), which might be mitigated by certain measures involving technical and legal actions. [ABSTRACT FROM AUTHOR]

Allergic bronchopulmonary aspergillosis (ABPA) is a consequence of hypersensitivity reaction to Aspergillus fumigatus that can chronically colonize the air ways of patients with abnormalities in their airway mucosal defenses, including mucociliary clearance and epithelial cell function, such as patients with bronchial asthma and cystic fibrosis. We present an interesting case of a 62-year-old woman who presented with purulent cough, subfebrile temperature and chest pain. She was ineffectively treated for a month with standard antibiotics and was finally diagnosed with ABPA.

We present a rare case of a patient operated due to a lung tumor, which was ultimately diagnosed as malignant peripherial nerve sheath tumor (MPNST). MPNSTs are rare tumors of soft tissue with mesenchymal origin. The World Health Organization has distinguished this group in order to unify terms in mesenchymal heterogeneous malignant tumors, e.g. neurofibrosarcomas, malignant schwannomas and malignant neurilemmoma [1]. They can occur as a result of neoplastic expansion of peripheral nerves’ branches, peripheral nerve fibers’ sheaths or Schwann cells, although many researchers believe that these tumors can derive not only from one, but several cell lines. MPNSTs are very rare in thorax, where they show aggressive pattern of growth [2] and stem from pleural cells rather than lung tissue.

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