Pharmaceutical excipients with potential to cause adverse effects in paediatric nasal medicines.

Some pharmaceutical excipients may cause adverse reactions, excipient-related interactions and/or contraindications. Due to the unique characteristics of the paediatric population, adverse effects may occur to substances generally thought safe. The proportion of topical nasal medicines approved for paediatric use and the prevalence and labelling of excipients with known effect (EKE) in these products were compared in Serbia as a non-EU country and Croatia and Slovenia as EU countries. The study was designed as a post-authorization safety study and safety of excipients was considered in accordance with recommendations of the European Medicines Agency (EMA). More than 90% of topical nasal medicines registered in the three countries were approved for paediatric use and more than half of these paediatric medicines contained EKE that may cause adverse effects. Benzalkonium chloride was found in 52.38%, 55.81% and 59.09% of these products in Serbia, Croatia and Slovenia, respectively. Propylene glycol, benzyl alcohol, ethanol, methyl paraben, propyl paraben and boric acid were also present in a few analysed preparations. A significant number of EKE labelling deficiencies were detected in all three countries, hindering healthcare professionals' access to information needed for adequate patient counselling. A revision of the nasal paediatric medicines' PLs and SmPCs is recommended.

Prevalence of and factors affecting otitis media with effusion in children in the region from Balkans to Caspian basin; A multicentric cross-sectional study.

OBJECTIVE: The aim of our study was to contribute to the literature about the prevalence of OME by conducting a research in a wide geography examining most of the associating factors together with a questionnaire. Additionally, possible effects of altitudes and latitudes, concordance between the otoscopic examination findings and tympanometric and acoustic reflex test results were evaluated in 4-7 years old children in the same season in different countries. METHODS: In the randomly sampled schools from different regions of different cities where people of different scoioecomonic statuses live, 4-7 year-old children were included in the study. The results of the questionnaire covering the potential factors in OME etiology were evaluated together with the results of the otoscopic examination and tympanometry findings, and also the acoustic reflex findings to direct the interpretation in cases of low amplitude - blunted peak tympanograms which can be interpreted as a "Type B" or "Type As". All the results were gathered in the same season. RESULTS: Ten centers from nine countries participated in the study. A total of 4768 children were evaluated. The frequency of OME diagnosed by otosopic examination was 22.48% (n=1072) and the diagnosis rate when otoscopic examination plus type B tympanometry were taken into account was found as 11.3% (n=539) in general population. Factors increasing the prevalence of OME were found as; mother's educational level (p=0.02), child's age (p=0.006), history of upper respiratory tract infection (p=0.001), smoking father (p=0.01), mother being a housewife or laborer (p=0.01), history of allergy (p=0.001), asthma (p=0.04), or allergy symptoms (p=0.02). No direct relationship was found between altitudes or latitudes and prevalence of OME. CONCLUSION: The important affecting factors found after analyzing all of the potential risk factors in the same model are secondhand smoke exposure, low level of mother's education, mother's occupation, positive history of URTI, and age of the child being less than 7. By paying attention to the factors that increase the prevalence of OME, putting particular emphasis on the preventable ones such as smoking, education, and fighting with allergies could decrease the prevalence of this public health issue.

Basal ganglia shrinkage without remarkable hippocampal atrophy in chronic aviremic HIV-positive patients.

Conventional magnetic-resonance (MR) imaging is not sensitive enough in depicting subtle neurodegenerative changes that occur during chronic HIV infection with good peripheral viral suppression. The aim of this study was to compare brain volumes in HIV-positive subjects with age- and education-matched healthy controls with regard to influence of aging and immunologic parameters. An overall of 65 subjects (40 HIV-positive and 25 age-, gender-, and education-matched healthy subjects) underwent conventional MR imaging with three-dimensional sequence adequate for volumetric measurements. Volumes of specific brain regions were measured and compared between HIV-positive and healthy subjects using Student t test. Correlations between obtained brain volumes and immunologic parameters were determined using Pearson's correlation test. Influence of age as a covariate was determined using ANCOVA test. Statistical value was set at p < 0.05. Volumes of nucleus accumbens (p = 0.003), putamen (p = 0.003), and thalamus (p = 0.046) were significantly decreased in HIV-positive subjects compared with healthy, while volumes of lateral ventricles were significantly increased (p = 0.043). However, influence of age on atrophy was greater than presence of HIV infection in all observed volumes. Positive correlation of nadir CD4+ count and nucleus accumbens volume was obtained, as well as of therapy with lateral ventricle volumes. Volumes of putamen correlated negatively with duration of therapy. HIV-associated atrophic changes are visible in nucleus accumbens, putamen, and thalamus in neurocognitively asymptomatic stage, while no changes can be observed in the hippocampus, affected by other types of dementias. Under therapy, the influence of physiological aging on HIV-associated atrophy is greater than the presence of HIV infection per se.