Objective: To confirm the efficacy and safety of AM-111 (brimapitide), a cell-penetrating c-Jun N-terminal Kinase (JNK) inhibitor, in patients suffering from severe to profound acute unilateral idiopathic sudden sensorineural hearing loss (ISSNHL). Study design: Prospective, double-blind, randomized, placebo-controlled phase 3 study with follow-up visits on Days 3, 7, 28, and 91. Setting: Fifty-one European and Asian sites (tertiary referral centers, private ENT practices). Patients: Two hundred fifty-six patients aged 18 to 65 years presenting within 72 hours following ISSNHL onset with mean hearing loss ≥ 40 dB and mean threshold ≥ 60 dB at the 3 worst affected contiguous test frequencies. Interventions: Single-dose intratympanic injection of AM-111 (0.4 or 0.8 mg/ml) or placebo; oral prednisolone as reserve therapy if hearing improvement < 10 dB at Day 7. Main outcome measures: Hearing improvement to Day 28 was the primary efficacy endpoint; complete hearing recovery, frequency of reserve therapy used, complete tinnitus remission, improvement in word recognition were secondary endpoints. Safety was evaluated by the frequency of clinically relevant hearing deterioration and adverse events. Results: While the primary efficacy endpoint was not met in the overall study population, post-hoc analysis showed a clinically relevant and nominally significant treatment effect for AM-111 0.4 mg/ml in patients with profound ISSNHL. The study drug and the administration procedure were well tolerated. Conclusions: AM-111 provides effective otoprotection in case of profound ISSNHL. Activation of the JNK stress kinase, AM-111's pharmacologic target, seems to set in only following pronounced acute cochlear injury associated with large hearing threshold shifts.
Background It has become clear that healthcare workers are at high risk, and otolaryngology has been theorized to be among the highest risk specialties for coronavirus disease 2019 (COVID‐19). The purpose of this study was to detail the international impact of COVID‐19 among otolaryngologists, and to identify instructional cases. Methods Country representatives of the Young Otolaryngologists–International Federation of Otolaryngologic Societies (YO‐IFOS) surveyed otolaryngologists through various channels. Nationwide surveys were distributed in 19 countries. The gray literature and social media channels were searched to identify reported deaths of otolaryngologists from COVID‐19. Results A total of 361 otolaryngologists were identified to have had COVID‐19, and data for 325 surgeons was available for analysis. The age range was 25 to 84 years, with one‐half under the age of 44 years. There were 24 deaths in the study period, with 83% over age 55 years. Source of infection was likely clinical activity in 175 (54%) cases. Prolonged exposure to a colleague was the source for 37 (11%) surgeons. Six instructional cases were identified where infections occurred during the performance of aerosol‐generating operations (tracheostomy, mastoidectomy, epistaxis control, dacryocystorhinostomy, and translabyrinthine resection). In 3 of these cases, multiple operating room attendees were infected, and in 2, the surgeon succumbed to complications of COVID‐19. Conclusion The etiology of reported cases within the otolaryngology community appear to stem equally from clinical activity and community spread. Multiple procedures performed by otolaryngologists are aerosol‐generating procedures (AGPs) and great care should be taken to protect the surgical team before, during, and after these operations.
The objective of the present work was to evaluate the effectiveness of the combination of azelastine hydrochloride and mometasone furoate for the intranasal application to treat the patients presenting with seasonal allergic rhinitis. A total of 60 subjects suffering from seasonal allergic rhinitis were available for the observation. All the patients were allocated to three groups comprised of 20 individuals each. The patients of the first group received the fixed combination of azelastine hydrochloride and mometasone furoate for the intranasal application, those in the second group were given mometasone furoate administered intranasally together with an oral antihistamine preparation of the third generation, and the patients of the third group were treated with intranasal mometasone furoate alone. The effectiveness of the treatment was evaluated on days 7 and 14 after its initiation. It was found that the treatment with the use of the combination of azelastine hydrochloride and mometasone furoate resulted in a more pronounced alleviation of rhinological symptoms and improvement of the quality of life at the early stages of therapy in comparison with mometasone furoate monotherapy. It is concluded that the patients with moderate and severe seasonal allergic rhinitis can be recommended to use the combination of azelastine hydrochloride and mometasone furoate as качестве the initial treatment.
Objectives/Hypothesis The objective of this study was to compare the efficiency and safety of endonasal endoscopic maxillary surgery and the Caldwell‐Luc approach in children. Study Design Case series. Methods A total of 121 children aged 9 to 17 years with chronic rhinosinusitis were included in the study. The patients were operated on using Caldwell‐Luc (n = 36) and endoscopic maxillary surgery (n = 85) procedures. Efficiency and safety of the surgeries were assessed using pre‐ and postoperative endoscopic evaluation of the mucosa of the nasal cavity, 20‐item Sino‐Nasal Outcome Test (SNOT‐20), and subjective (both children's and parents') evaluation of the outcomes. Results Endoscopic investigation of the mucosa of the nasal cavity demonstrated a significant improvement after both Caldwell‐Luc and endoscopic surgery, although the Caldwell‐Luc procedure did not result in significant improvement in mucosal color. However, no significant group difference was observed. Both techniques resulted in a significant improvement of mucosal edema and fluid characteristics. Based on the results of the SNOT‐20, endoscopic maxillary surgery was characterized by a significant improvement in headache frequency, waking up at night, reduced concentration, ear pain, and emotional suppression as compared to Caldwell‐Luc surgery. Although no significant group difference in efficiency between the Caldwell‐Luc approach and endoscopic surgery was observed, the latter was characterized by a lower rate of scar formation, and reduced sensitivity, local painfulness, lacrimation, and psychologic discomfort. Conclusions The obtained data demonstrate the higher efficiency and safety of endoscopic sinus surgery as compared to the Caldwell‐Luc approach in children. Level of Evidence 4 Laryngoscope, 130:1056–1063, 2020
Aim: This multicenter study was focused on the identification of the microorganisms inhabiting the maxillary sinus and middle nasal meatus in chronic rhinosinusitis. Methodology: 112 middle meatus swabs and 112 maxillary sinus aspirates from 103 patients were available for culture. Results: A total of 244 strains of microorganisms representing more than 50 families were identified in the maxillary sinus and middle nasal meatus (164 and 80, respectively). These included 154 (63.0%) strains of aerobic bacteria from 32 species and 90 (37.0%) strains of anaerobic bacteria from 23 species. Aerobes were more common than anaerobes in both the nasal cavity (78.7% vs. 21.3%) and in the maxillary sinus (55.2% vs. 44.8%). Species of Streptococci (28.8%) and Prevotella (17.8%) were the most common findings in the maxillary sinus aspirates. S. pneumonia, H. influenza, and S. aureus were relatively rare, and found in only 6.7%, 5.4%, and 8.9% of the samples, respectively. Conclusions: The results obtained suggest that common upper airway pathogens do not play a major role in the pathogenesis of chronic rhinosinusitis. The microbiome of inflamed sinonasal mucosa is extremely diverse and involves exotic species of bacteria that, to date, have not been considered as potential inhabitants of the paranasal sinuses.
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