Dupilumab (REGN668/SAR231893), produced by a collaboration between Regeneron and Sanofi, is a monoclonal antibody currently in phase III for moderate-to-severe asthma. Dupilumab is directed against the α-subunit of the interleukin (IL)-4 receptor and blocks the IL-4 and IL-13 signal transduction. Areas covered: Pathophysiological role of IL-4 and IL-13 in asthma; mechanism of action of dupilumab; pharmacology of IL-4 receptor; phase I and phase II studies with dupilumab; regulatory affairs. Expert opinion: Patients with severe asthma who are not sufficiently controlled with standard-of-care represent the target asthma population for dupilumab. If confirmed, efficacy of dupilumab in both eosinophilic and non-eosinophilic severe asthma phenotype might represent an advantage over approved biologics for asthma, including omalizumab, mepolizumab, and reslizumab. Head-to-head studies to compare dupilumab versus other biologics with different mechanism of action are required. Pediatric studies with dupilumab are currently lacking and should be undertaken to assess efficacy and safety of this drug in children with severe asthma. The lack of preclinical data and published results of the completed four phase I studies precludes a complete assessment of the pharmacological profile of dupilumab. Dupilumab seems to be generally well tolerated, but large studies are required to establish its long-term safety and tolerability.
Objective: The aim of this study was to present some cases of acute vertigo potentially related to the coronavirus disease 2019 (COVID-19) vaccine and review the available literature about cochleovestibular dysfunction after the COVID-19 vaccination.Methods: In the period from May to July 2021, we evaluated 33 patients (mean age 54.3 ± 14.1) with “acute vertigo” post COVID-19 vaccination. A detailed medical history was taken on comorbidities, types of vaccines received, and symptoms associated. All patients underwent otoneurological evaluation, such as head impulse test, nystagmus evaluation, test of skew (HINTS) examination. Head shaking test-induced nystagmus, hyperventilation-induced nystagmus, and parossistic positional nystagmus were studied to search for vestibular impairment.Results: Symptoms included 16 patients (48.5%) with objective vertigo, 14 patients (42.4%) with subjective vertigo, and 3 patients (9.1%) with dizziness. Of the associated ear, nose, and throat (ENT) symptoms, the most expressed was tinnitus (18.2%). Bedside examination showed absent nystagmus in 7 patients (21.2%), 9 patients (27.3%) had horizontal or rotatory nystagmus, 17 patients (51.5%) had a vertical or oblique nystagmus, negative HST, or “central HINTS.”Discussion and Conclusions: The 9 patients had an evoked nystagmus pathognomonic for benign paroxysmal positional vertigo; in the remaining 17 cases, peripheral vestibular dysfunction could be excluded and central disorder may be suggested. Due to the prevalence of nystagmus of non-peripheral origin, a central nervous system involvement could not be excluded. However, due to the small sample size, a definite cause–effect relationship between vaccination and vertigo cannot be inferred. In light of expected third dose, large-scale and well-designed studies are needed to better define possible adverse reactions of the COVID-19 vaccine.
The purpose of this study was to evaluate the benefits of unilateral cochlear implant (CI) in patients over 60 on speech perception and quality of life, comparing the results obtained with a control group of younger CI recipients. Twenty CI users (mean age 72 years), postlingually deafened, were included in this study. Audiological performance was evaluated using bisyllabic words and sentences recognition tests in a quiet and a noise environment. Moreover, we administered two questionnaires to evaluate the health status (SF-36), CI-related effects on daily activities and personal satisfaction (Questionnaire for self-evaluation of CI benefit with SADL scale modification). Performance measures of the geriatric population showed a significant benefit on speech recognition tests compared to pre-implantation condition, even if younger CI users scored significantly better in both bisyllabic words and sentences recognition test. All study patients reported being able to have a normal conversation with an acquaintance. No significant difference was found between the study and control group in physical and mental health status, conversation with an outsider, use of TV and phone. A significant difference (p < 0.05) was noticed, instead, between elderly and younger adult patients about the overall satisfaction derived from CI. Our findings confirm the indisputable utility of CI and provide evidence that elderly patients derive a substantial benefit from it on quality of life, as demonstrated by health status, success in the common activities of daily living and perceived satisfaction after this procedure.
(1) Background: This systematic review was designed to analyze adenotonsillectomy’s role in treating behavioural disorders and sleep-related quality of life in pediatric OSAS. (2) Methods: Papers that report pre-operative and post-operative outcomes by using the Epworth sleepiness scale, OSA-18, NEPSY, Conners’ rating scale, BRIEF, PSQ-SRBD, PedsQL and CBCL. We performed a comprehensive review of English papers published during the last 20 years regarding behavioural disorders in OSAS patients and adenotonsillectomy. (3) Results: We included 11 studies reporting behavioral outcomes and sleep related quality of life after surgery. We investigated changes in behavior and cognitive outcomes after AT, and we found significant improvements of the scores post-AT in almost all studies. After comparing the AT group and control group, only one study had no difference that reached significance at one year post-AT. In another study, it did not show any significant improvement in terms of all behavioural and cognitive outcomes. The questionnaires on sleep-related quality of life after AT (PSQ-SRBD or ESS or OSA-18 or KOSA) may improve with positive changes in sleep parameters (AHI, ODI and SpO2). Furthermore, there is a significantly higher decrease in OSAS symptoms than the pre-AT baseline score. (4) Conclusion: Future studies should pay more attention to characterizing patient populations as well as rapid surgical treatments through existing criteria.
Objective Recent literature has shown a growing interest in the relationship between presbycusis and cognitive decline, but significant evidence about the long-term benefit of rehabilitation on cognitive functions has not been reported yet. The aim of the study was to analyze audiological and neuropsychological performances in patients with cochlear implant (CI) or hearing aids (HAs) over time. Materials and Method Forty-four bilaterally deaf patients aged more than 60 years (25 with CI candidacy and 19 with HA candidacy) were enrolled. Patients were subjected to audiological evaluation, to a battery of neuropsychological tests (Mini-Mental State Examination [MMSE], Rey Auditory Verbal Learning Task [RAVLT], Rey–Osterreith Complex Figure Test, Digit/Corsi Span Forward and Backward, Multiple Features Target Cancellation, Trail-Making Test, Stroop Test, and Phonological and Semantic Word Fluency), and to a quality of life assessment (Short Form 36, Glasgow Benefit Inventory, Glasgow Health Status Inventory) at the baseline and after a long-term follow-up (6–12 months). Results Speech recognition scores in quiet and in noise were significantly improved even 6 months after auditory rehabilitation. Significant differences between pre- and post-rehabilitation scores were reported in physical and emotional impacts in life, general global health, vitality, and social activities. MMSE and RAVLT scores were significantly improved in both groups after 6 months of follow-up, suggesting a global involvement of memory domain. Mnesic performances remained unchanged between the first and second follow-up, but a further significant improvement in executive functions (Stroop Test) was detected in patients with CI reevaluated 12 months after implantation. A significant correlation of the RAVLT with signal-to-noise ratio at +10 dB speech-in-noise scores and the MMSE with signal-to-noise ratio at 0 dB speech-in-noise scores suggests the pivotal role of executive functions in recognition in noisy environment. Conclusions Our preliminary data confirm that hearing deprivation in aged patients represents a truly modifiable risk factor for cognitive decline, which can be positively faced by acoustic rehabilitation. The improvement of short- and long-term memory performances and the amelioration of executive and attentive functions suggest that hearing restoration with both HAs and CI may provide a recovery of superior cognitive domains probably through a reallocation of cortical resources altered by hearing deprivation.
Objective The aim of our study was to analyze the montelukast effectiveness in improving oculonasal symptoms, patient‐reported outcomes (PROs), and eosinophilic biomarkers in patients with nonallergic rhinitis eosinophilic syndrome (NARES). Methods We enrolled prospectively 80 symptomatic patients treated with 10 mg once a day of montelukast in monotherapy for 2 months. All patients were investigated before and after treatment. Nasal symptoms (nasal obstruction, rhinorrhoea, sneezing, nasal itching), ocular symptoms (redness/puffiness, watery eyes), and other PROs (olfactory dysfunction, difficulty going to sleep, nighttime awakenings, and nasal congestion on awakening) were scored by visual analogic scale. The following clinical scores were assessed: Total Nasal Symptom Score (T4NSS), Total Ocular Symptom Score (T2OSS), Total Symptom Score of Patient‐Reported Outcomes (TSS‐PROs), and a Composite Symptoms Score (CSS). Patients were classified as responders when a reduction of at least 50% of the CSS was observed. Before and after treatment, the eosinophilic biomarkers in nasal lavage were analyzed: nasal eosinophilia (number of eosinophils per high power field), eotaxin‐1 and eotaxin‐2. Results After treatment, significant reductions were observed for all the symptom scores. Forty‐two of 78 patients were considered responders. A significant reduction of eosinophils in nasal mucosa and of levels of eotaxin‐1 and eotaxin‐2 in nasal lavage were observed after treatment in responder patients. Patients with asthma had an increased probability to be responders. Conclusion NARES patients may benefit from treatment with montelukast. In particular, the presence of concomitant asthma may be predictive of a greater efficacy. Level of Evidence 2 Laryngoscope, 129:551–557, 2019
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