A Real-World Observational Study to Evaluate the Safety and Effectiveness of Fluticasone Furoate-Oxymetazoline Fixed Dose Combination Nasal Spray in Patients with Allergic Rhinitis.

BACKGROUND: Allergic rhinitis (AR) has shown an increasing prevalence leading to a considerable medical and social burden. Nasal congestion is the cardinal symptom of AR, and the upper respiratory tract is most affected by this long-lasting ailment. Intranasal corticosteroids alleviate nasal congestion, along with other symptoms of AR, but their effect is not evident immediately. Oxymetazoline has a rapid onset of action, but its use should be limited to 3-5 days. OBJECTIVE: The study aimed to evaluate the safety and effectiveness of the fixed-dose combination nasal spray containing fluticasone furoate and oxymetazoline hydrochloride (FF + OXY) 27.5/50 mcg once daily in patients with AR in a real-world clinical setting. METHODS: The study was a prospective, open-label, single-arm, multicenter, real-world observational study conducted in patients with AR for a period of 28 days. Patients (n = 388) with a diagnosis of AR were treated with a combination of FF + OXY nasal spray. Total nasal symptom score (TNSS), total ocular symptom score (TOSS) and total symptom score (TSS) were documented at baseline and at the end of study period. The overall effectiveness of treatment with FF + OXY was rated by the investigators as very good/good/satisfactory/poor (4-point Likert scale) for each patient. RESULTS: Treatment with FF + OXY resulted in significant reduction in the TNSS, TOSS and TSS, from 7.18 ± 3.38 at baseline to 0.20 ± 0.84 (p < 0.001), from 2.34 ± 2.29 at baseline to 0.09 ± 0.53 (p < 0.001), from 9.51 ± 4.94 at baseline to 0.29 ± 1.32 (p < 0.001) at 28 days respectively. With respect to effectiveness, the investigators reported very good effectiveness in 52.12% of patients. No serious adverse events were reported. CONCLUSION: The fixed-dose combination of once-daily fluticasone furoate and oxymetazoline hydrochloride nasal spray 27.5/50 mcg was effective in relieving the nasal congestion and reduction of TNSS, TOSS and TSS in patients suffering from AR. The combination was safe and well tolerated with no rebound congestion throughout the treatment period.

Efficacy of Normal Saline Nasal Spray Added to Standard Treatment Regimen of Chronic Rhinosinusitis: A Randomised Controlled Trial.

Chronic Rhinosinusitis is characterized by inflammation of lining of nose and paranasal sinuses leading to nasal blockage/discharge, facial pressure/pain and loss of smell sensation, generally treated with medical therapy initially. Nasal saline irrigation is one of the treatment modalities commonly used to improve symptoms. The aim was to evaluate efficacy of adding normal saline nasal spray to standard treatment regimen of chronic rhinosinusitis. A randomized, controlled, single blinded study with 40 chronic rhinosinusitis patients. Study group was prescribed Normal Saline nasal spray (1 puff in each nostril, thrice daily) along with topical corticosteroids (Mometasone furoate nasal spray, 1 puff in each nostril, twice daily; 1 puff = 50 µg), and oral antibiotics (Amoxicillin + Clavulanic acid, 30 mg/kg, twice daily), and the control group was only prescribed topical corticosteroids and oral antibiotics. Patients were evaluated using Lund-Kennedy endoscopic scores and Sino-Nasal Outcome Test before and after treatment. There was a significant improvement in LKES, with pre-treatment and post-treatment scores for control group being 5.35 ± 2.43 vs 3.70 ± 1.95 respectively (p = 0.0116), whereas for test group, pre-treatment and post-treatment scores were 8.15 ± 2.62 vs 6.05 ± 2.04 respectively (p = 0.0037). Improvement in SNOT-22 scores were observed as well, with pre-treatment and post-treatment scores for control group being 38.90 ± 12.01 vs 25.70 ± 9.21 respectively (p = 0.0002), whereas for test group, pre-treatment and post-treatment scores were 49.85 ± 11.38 vs 31.55 ± 9.91 respectively (p < 0.0001). The study suggests that there is additional benefit in usage of normal saline in form of symptomatic relief as well as clinical improvement.

A Cadaveric Study of Anatomical and Radiological Correlation of Mastoid Air Cells System in Relation to its Morphology.

A cadaveric study to know the anatomical and radiological correlation between the mastoid air cell system in relation to its volume and morphology. This is a rare and one of its kind of cadaveric study on temporal bone in which comparison of pre dissection and post cortical mastoidectomy dissection on x-ray mastoid in relation to their dimensions. To study the anatomical and radiological correlation of mastoid air cell system in relation to its morphology using pre and post dissection x-ray measurements and dissection method. 30 adult cadaveric, temporal bone cortical mastoidectomy dissections were performed and X-ray mastoid with a pre and post mastoid dissection measurements using vernier caliper was done. Further 3-D analysis of volume of mastoid cavity compared with a post dissection digital radiographic measurements was carried out. On statistical analysis, mean surface area of MACS, shortest length between sigmoidsinus and posterior wall of EAC, also shortest distance between dural plate and mastoid tip, in pre and post dissection x-ray mastoid and in direct mastoid cavity measurements were not found to be significant. Mastoidectomy being the treatment of choice in day to day practise in many cases this study hopes to add up to the present understanding for the MACS dynamics and assesses the possible anatomical variations that can exist. This study helps us to find the approximate time required for surgery to perform cortical mastoidectomy.

Changing Scenario in Tympanoplasty: Endoscopic Versus Microscopic Approach.

Tympanoplasty is the most common surgery performed for Chronic Otitis Media. Here we have compared the minimally invasive endoscopic tympanoplasty with the conventional microscopic tympanoplasty. It's a comparative prospective study, involving cases of Chronic otitis media with dry perforation analysed from January 2009 to October 2019. Equally 312 patients were divided into two groups, 156 in each group and subjected for Endoscopic and Microscopic Tympanoplasty. Various parameters were studied. Graft success rate of 98.08% and 93.58% in group A and B respectively were comparable, hearing improvement in both groups was not statistically significant with p-value > 0.05, whereas the postoperative hearing improved significantly to preoperative in both groups. Endoscopic and Microscopic tympanoplasty has similar outcomes, in terms of graft success rate, hearing and duration of surgery. Cosmetic results were better in Endoscopic group whereas canalplasty rates were evident in Microscopic group.

Changing Clinical Scenario of Tuberculous Otitis Media: A Case Series.

Tuberculosis is a global health problem. Extrapulmonary tuberculosis remains to be a challenge in the diagnosis and treatment. Tuberculous otitis media being not so commonly diagnosed due to its varied presentation, early diagnosis and treatment remains to be a challenge. The aim of this study is to present the varied and unusual presentations and the importance of histopathological confirmation and new diagnostic tools like CBNAAT (cartridge based nucleic acid amplification test) which aids in the confirmation and to start anti-tubercular treatment (ATT). Five cases of tuberculous otitis media within a period of two years were included in the study. Among the five cases three cases presented with discharging sinuses, one with mastoid abscess and one with tuberculous otitis media with pulmonary origin. All five cases were confirmed with proper histopathological examination and two cases with CBNAAT (cartridge based nucleic acid amplification test) confirmation. Anti-tubercular treatment (ATT) was started and the patients were disease free. Tuberculous otitis media remains to be a rare complication of chronic suppurative otitis media and it has to be kept in mind while treating chronic suppurative otitis media. Classical presentations of tuberculous otitis media are not seen nowadays and the disease extending to the mastoid is the changing trend as the initial presentation. A proper suspicion with confirmation of the disease remains to be the gold standard for diagnosis and for treatment with anti-tubercular therapy.

Disparate Presentations of Retropharyngeal Abscess: An Experience From a Tertiary Care Centre.

To discuss the varied presentations, diagnosis, and prompt management of retropharyngeal abscess for academic importance. A retrospective study was conducted in the Department of Otorhinolaryngology and Head and Neck Surgery in Belagavi district of Karnataka. Six cases of varied age group with diagnosis of retropharyngeal abscess were studied during two-year period from January 2019 to January 2021. Thorough assessment of all cases was done which included symptoms at the time of presentation, clinical examination findings, imaging studies and laboratory results, medical and surgical interventions. Six patients (4 males, 2 females) were diagnosed as having Retropharyngeal abscess. Youngest age of presentation was 2 month infant. The most common symptoms at presentation included fever and odynophagia seen in all six patients. The clinical examination revealed bulge in posterior pharyngeal wall in all cases, cervical lymphadenopathy in one case, drooling of saliva in three and stridor in one patient, diffuse neck swelling in two ptatients, and trismus in two patients. Contrast Enhanced Computerized Tomographic (CECT) scanning was performed in five patients and one patient underwent Magnetic Resonance Imaging (MRI). The abscess was surgically drained in all patients and received intravenous antibiotics after which there was significant improvement. Retropharyngeal space infection if left untreated, they carry the potential to cause life-threatening complications and death. Although with availability of broad-spectrum antibiotics, the mortality rate is low, appropriate and successful management requires a thorough understanding of the anatomy of the neck, knowledge of usual causative organisms and appropriate medical and surgical management.

A Study of JCIH (Joint Commission on Infant Hearing) Risk Factors for Hearing Loss in Babies of NICU and Well Baby Nursery at a Tertiary Care Center.

Babies in Neonatal Intensive Care Units (NICU) have an additional risk for hearing loss due to various risk factors like, prematurity, low birth weight, mechanical ventilation, hyperbillirubinemia, ototoxic drugs, low APGAR score etc. as compared to the babies from well baby nursery (WBN) who, poses risk factors mostly family history, syndromic deafness. So the present study was aimed know the risk factors responsible for hearing loss in NICU and WBN babies and to assess the incidence of deafness. A total of 800 babies from NICU (n = 402) and WBN (n = 398) underwent hearing screening from a tertiary care center. Hearing screening was done using two staged screening protocol as per JCIH guidelines with Distortion product Evoked Otoacoustic Emissions (DPOAE) and Automated Auditory Brainstem Responses (A-ABR). According to DPOAE test, 311 from NICU and 383 from WBN passed the test and during second screening, 80 out of 91 from NICU and 11 out of 13 from WBN passed the DPOAE test. Further BERA was done at the 3rd month of corrected age where 6 out of 11 showed positive responses from NICU and 3 babies from WBN had profound hearing loss. Data analysis revealed that family history of deafness, anemia and hypertension in ANC, TORCH in mother, low Apgar score and hyperbillirubinemia in newborns were a major risk factor for hearing impairment. We conclude that the diagnoses of auditory disorders at early stage due to various risk factors are important since appropriate therapeutic intervention and rehabilitation would help in better development of children.

Prevalence of Olfactory and Gustatory Dysfunction in Coronavirus Disease (COVID-19): A Cross Sectional Study in Our Tertiary Care Hospital.

COVID-19 pandemic is affecting millions of people all across the globe. Along with other clinical features, anosmia and dysgeusia are important symptoms being seen. This study evaluates the prevalence of olfactory and gustatory dysfunction in patients with SARS CoV-2 infection in a tertiary care centre and the severity and duration of altered taste and smell sensation in COVID positive patients. A total number of 167 patients that had tested positive for COVID 19 KLES Dr. Prabhakar Kore hospital in the study period of 3 months were assessed for presence and severity of olfactory and gustatory sensations. The prevalence of alteration of sense in COVID 19 patients in our tertiary care centre was found to be 62.87% and alteration of taste was 58.68%. This study shows that smell and taste loss has a high prevalence in patients of COVID 19 and health care workers should keep high degree of suspicion for COVID 19 when patients present with these symptoms. The early identification may help to reduce the risk of spread.

Intraoperative Classification of Cholesteatoma Using ChOLE Classification and Evaluating its Treatment Outcomes Using Inside Out Approach Mastoidectomy.

The primary objective is to classify acquired cholesteatoma according to the ChOLE classification system based on the preoperative and intraoperative findings, and to describe prevalence of each stage. The secondary objective is to correlate the extent of inside out approach mastoidectomy required with the staged extent of cholesteatoma. A non-randomized Prospective Observational study conducted in 67 patients in a tertiary care hospital. Each case was categorized according to the ChOLE classification system including cholesteatoma extension, ossicular chain status, life threatening complications and eustachian tube dysfunction. Based on the extent of disease, inside out approach mastoidectomy was done and results analysed. Most patients presented with stage 2 disease [67%]. Canal wall was preserved for all stage I, and in stage II cholesteatoma canal wall was either kept intact, reconstructed or lowered based on the extent of erosion of posterior meatal wall and cholesteatoma extension. All stage III underwent canal wall down mastoidectomy. Staging of cholesteatoma by ChOLE classification allows standardization in reporting gravity of disease and surgical outcomes. Inside out approach mastoidectomy contributes to the successful surgical management of cholesteatoma by eradicating the disease with the creation of a smaller cavity.

Ancient Schwannoma: A Rare Intramural Intra-lingual Lesion.

Ancient schwannoma is an uncommon schwannoma variant which is a benign tumour of Schwann cell origin. It is relatively a rare tumour (25%) in the head and neck region. It is encapsulated and well demarcated from the surrounding tissues. A 35 years old patient in this case presented with painless swelling of the tongue. Trans-oral excision of the intramural lesion was performed. Histopathological and immuno-histochemistry confirmed the diagnosis of schwannoma. This case is of interest on account of the complexity of its diagnosis and the atypical site, that is, intra-mural, of appearance of a schwannoma.

Eagle's Syndrome: An Underdiagnosed Condition-Case Series in a Tertiary Care Hospital.

To evaluate all the cases of chronic neck pain thoroughly to diagnose eagle's syndrome. Hospital based prospective study done in the department of otorhinolaryngology at our tertiary care hospital from January 2017 to December 2018. We selected 60 subjects in our study who presented to us with complaints of chronic neck pain associated with referred otalgia, along with aggravation of pain with neck movements, odynophagia, throat pain and foreign body sensation in the throat. After thorough clinical examination an orthopantomogram has been done which revealed elongated styloid process. Conservative management with carbamazepine was tried but only temporary relief was noticed in these patients. Hence intra oral tonsillo-styloidectomy was done and patients were followed up to 3 months. Out of 10 patients, 9 were female and 1 was male. 8 patients had bilateral elongated styloid process and 2 patients had unilateral elongation. Orthopantomogram revealed an average elongation of styloid process of 3.5-5 cm and the average length of the removed styloid process ranged from 0.6-3 cm. All patients showed significant improvement post operatively. Eagle's syndrome is not a rarity, but underdiagnosed and missed most of the times. Hence all cases of chronic neck pain should be evaluated thoroughly by taking complete history and proper clinical examination, along with radiological investigations.