Assessment of safety and intranasal neutralizing antibodies of HPMC-based human anti-SARS-CoV-2 IgG1 nasal spray in healthy volunteers.

An HPMC-based nasal spray solution containing human IgG1 antibodies against SARS-CoV-2 (nasal antibody spray or NAS) was developed to strengthen COVID-19 management. NAS exhibited potent broadly neutralizing activities against SARS-CoV-2 with PVNT50 values ranging from 0.0035 to 3.1997 µg/ml for the following variants of concern (ranked from lowest to highest): Alpha, Beta, Gamma, ancestral, Delta, Omicron BA.1, BA.2, BA.4/5, and BA.2.75. Biocompatibility assessment showed no potential biological risks. Intranasal NAS administration in rats showed no circulatory presence of human IgG1 anti-SARS-CoV-2 antibodies within 120 h. A double-blind, randomized, placebo-controlled trial (NCT05358873) was conducted on 36 healthy volunteers who received either NAS or a normal saline nasal spray. Safety of the thrice-daily intranasal administration for 7 days was assessed using nasal sinuscopy, adverse event recording, and self-reporting questionnaires. NAS was well tolerated, with no significant adverse effects during the 14 days of the study. The SARS-CoV-2 neutralizing antibodies were detected based on the signal inhibition percent (SIP) in nasal fluids pre- and post-administration using a SARS-CoV-2 surrogate virus neutralization test. SIP values in nasal fluids collected immediately or 6 h after NAS application were significantly increased from baseline for all three variants tested, including ancestral, Delta, and Omicron BA.2. In conclusion, NAS was safe for intranasal use in humans to increase neutralizing antibodies in nasal fluids that lasted at least 6 h.

Phase III study of Phlai capsules in the treatment of allergic rhinitis: A randomized, double-blind, placebo-controlled trial.

BACKGROUND: Preclinical studies demonstrated anti-inflammatory effects of Zingiber montanum (J.König) Link ex Dietr.(Phlai). However, its clinical effect on allergic rhinitis (AR) is not evident. OBJECTIVE: We sought to assess the efficacy and safety of Phlai for treating AR. METHODS: A phase 3, randomized, double-blind, placebo-controlled study was conducted. Patients with AR were randomized into three groups and received Phlai 100 mg or Phlai 200 mg or placebo once a day for four weeks. The primary outcome was a change in the reflective total five symptom score (rT5SS). The secondary outcomes were the change in the instantaneous total five symptom score (iT5SS), the reflective individual symptom scores (rhinorrhea, nasal congestion, sneezing, itchy nose, itchy eyes), Rhinoconjunctivitis Quality of Life-36 Questionnaire (RCQ-36) score, peak nasal inspiratory flow (PNIF), and adverse events. RESULTS: Two hundred and sixty-two patients were enrolled. Compared with placebo, Phlai 100 mg improved rT5SS [adjusted mean difference (aMD) -0.62; 95%CI -1.22, -0.03; p = 0.039], rhinorrhea (aMD -0.19; 95%CI -0.37, 0.002; p = 0.048), itchy nose (aMD -0.24; 95%CI -0.43, -0.05; p = 0.011), and itchy eyes (aMD -0.19; 95%CI -0.36, -0.02; p = 0.033) at week 4. Nasal obstruction, sneezing, iT5SS, overall RCQ-36 score, PNIF did not reach statistical significance. Phlai 200 mg did not bring additional benefits compared to 100 mg. Adverse events were similar among groups. CONCLUSIONS: Phlai was safe. At four weeks, there were small improvements in rT5SS, together with the individual symptoms of rhinorrhea, itchy nose, and itchy eyes.

Overall survival and prognostic factors in diabetic patients with invasive fungal rhinosinusitis.

BACKGROUND: Patients with diabetes mellitus (DM) are susceptible to invasive fungal rhinosinusitis (IFRS). The mortality rate of IFRS varies greatly among the patients with DM. OBJECTIVE: To identify the prognostic factors for the overall survival of patients with DM and IFRS. METHODS: A retrospective study was conducted in four tertiary hospitals in Thailand, Malaysia and Myanmar. Patients diagnosed with IFRS and DM from 2008 to 2019 were identified. The outcome was the overall survival. Variables analyzed for risk factors were age, HbA1C level, ketoacidosis, white blood cell count, hyperglycemia, duration of DM, current use of diabetic medications, serum creatinine level, and the extensions of IFRS to the orbit, the cavernous sinus and intracranial cavity. RESULTS: Sixty-five diabetic patients with IFRS (age 57.9 ± 13.4 years, male 60%) were identified. The mortality rate was 21.5%. The extensions of IFRS to the cavernous sinus (hazard ratio 5.1, 95% CI [1.4-18.2], p = 0.01) and intracranial cavity (hazard ratio 3.4, 95% CI [1.1-11.3, p = 0.05) predicted mortality. Current use of diabetic medications decreased the mortality risk (hazard ratio 0.2, 95% CI [0.1-0.9], p = 0.03). The 6-month overall survival of the patients with and without the cavernous sinus extension were 51.4% and 83.6%, (p = 0.001), with and without intracranial extension 53.3% and 88.9%, (p = 0.001), and with and without current diabetic medications 82.3% and 57.5%, respectively (p = 0.045). CONCLUSIONS: The extensions of IFRS to the cavernous sinus and intracranial cavity increased the risk of death in patients with DM. Survival was primarily related to current use of diabetic medications.

Risk factors of orbital complications in outpatients presenting with severe rhinosinusitis: A case-control study.

OBJECTIVES: We assessed associations of potential factors with orbital complications in acute rhinosinusitis (ARS) patients. DESIGN: An unmatched case-control study. SETTING: A tertiary referral hospital in Thailand. PARTICIPANTS: Consecutive outpatients of any age with severe ARS (visual analog scale ≥ 7) with and without orbital complications. MAIN OUTCOME MEASURES: Patients were enrolled from January 2013 to December 2018. Forty-three ARS patients (55.8% female, median age 45.6, (range 2.0-93.0) years) were included, with 19 patients in the complicated group and 24 in the uncomplicated group. Patient characteristics (gender, age, diabetes, immune status), symptoms and signs, site of infection and type of pathogenic bacteria were recorded and assessed their associations with orbital complications by univariable and multivariable logistic regression analyses. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: The most common orbital complication was subperiosteal abscess (42.1%), followed by orbital cellulitis (15.8%) and cavernous sinus thrombosis (10.5%). Multivariable logistic regression analysis demonstrated a positive association with orbital complications (pseudo R2 0.4) for ethmoid sinusitis (OR 31.1, 95% CI [2.3-430.6]) and a short duration of symptoms (OR 0.9, 95% CI [0.8-0.9]). CONCLUSIONS: Orbital complications were associated with ethmoid sinusitis with a short duration of ARS symptoms.

Decontamination and reuse of surgical masks and N95 filtering facepiece respirators during the COVID-19 pandemic: A systematic review.

OBJECTIVES: Surgical masks and N95 filtering facepiece respirators (FFRs) prevent the spread of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection and protect medical personnel. Increased demands for surgical masks and N95 FFRs during the coronavirus disease 2019 (COVID-19) pandemic has resulted in the shortage crisis. However, there is no standard protocol for safe reuse of the N95 FFRs. In this systematic review, we aimed to evaluate the effectiveness of existing decontamination methods of surgical masks and N95 FFRs and provide evidence-based recommendations for selecting an appropriate decontamination method. METHODS: We performed systematic searches of Ovid MEDLINE and Ovid EMBASE electronic databases. The last search was performed April 11, 2020. Any trials studying surgical masks and/or N95 FFRs decontamination were included. Outcomes were disinfections of virus and bacteria, restoration of the filtration efficiency, and maintenance of the physical structure of the mask. RESULTS: Overall, 15 studies and 14 decontamination methods were identified. A low level of evidence supported 4 decontamination methods: ultraviolet (UV) germicidal irradiation (9 studies), moist heat (5 studies), microwave-generated steam (4 studies), and hydrogen peroxide vapor (4 studies). Therefore, we recommended these 4 methods, and we recommended against use were given for the other 10 methods. CONCLUSIONS: A low level of evidence supported the use of UV germicidal irradiation, moist heat, microwave-generated steam, and hydrogen peroxide vapor for decontamination and reuse of N95 FFRs. These decontamination methods were effective for viral and bacterial disinfection as well as restoration of the filtration efficiency, and the physical structure of the FFRs.

Low-dose macrolides for treating pediatric rhinosinusitis: A retrospective study and literature review.

The effects of low-dose macrolide (LDM) therapy on pediatric chronic rhinosinusitis (CRS) patients are unknown. This study aimed to assess the effectiveness of LDM for treating pediatric refractory CRS. A retrospective study was conducted by a medical chart review. Pediatric CRS patients (age <15 years) who received LDM after standard medical treatments failure between 2013 and 2019 were identified. The LDM treatments with any macrolide agents, doses, and regimens were included. Any co-interventions were allowed. Duration of the LDM therapy was ≥6 weeks. Outcomes were the total nasal symptoms by the visual analogue scale (TNS), presence of individual symptoms, physician-assessment nasal discharge and adverse events. Six patients (67% male, mean age 7±3.4 years) were assessed. All patients had failed to intranasal steroids and nasal saline irrigation but continued. The addition of LDM significantly improved TNS (mean difference ± standard deviation 5.83 ± 1.33; 95% confidence interval 4.44-7.23, p< 0.001). At the end of treatment, the numbers of patients with individual symptoms were decreased: nasal obstruction (100%-67%), rhinorrhea (83%-50%), hyposmia (50%-0%), cough (100%-33%), and physician-assessment thick mucoid discharge (33%-0%). No patients had facial pain. One patient reported mild tolerable nausea. Preliminary findings of this study showed some beneficial effects of LDM added to intranasal steroids and nasal saline irrigation in pediatric CRS after standard treatments failure. The beneficial effects included the improvements of the TNS and individual nasal symptoms and decrease in thick mucoid discharge.

Olfactory and gustatory dysfunctions in COVID-19 patients: A systematic review and meta-analysis.

Olfactory and gustatory dysfunctions (OGD) are pathognomonic symptoms in patients with Coronavirus Disease 2019 (COVID-19). This study reviews the associations of OGD with COVID-19 which will be useful for early diagnosis and self-isolation. Systematic searches of PubMed, Ovid Medline, Scopus, and EMBASE electronic databases were performed. Studies reporting OGD in COVID-19 patients were included. Data were pooled for meta-analysis. The outcomes were odds ratios (OR) of OGD in COVID-19 patients. Proportions of smell and/or taste dysfunctions in the COVID-19 patients were assessed. Fourteen studies (21,515 participants, age 49.12 years, 26% male) were included. The OR of olfactory and/or gustatory dysfunctions in COVID-19 patients were 11.26 (95% confidence interval (CI) 5.41 to 23.4) when compared with acute respiratory infection (ARI) without detectable virus and 6.46 (95% CI 2.79 to 14.97) in patients with other respiratory viruses. The OR of olfactory dysfunction in COVID-19 patients were 11.67 (95% CI 6.43 to 21.17) when compared with the ARI patients without detectable virus and 4.17 (95% CI 1.34 to 12.98) with other respiratory viruses. The OR of gustatory dysfunction in COVID-19 patients were 12.70 (95% CI 7.9 to 20.44) when compared with the ARI patients without detectable virus and 4.94 (95%CI 1.59 to 15.31) with other respiratory viruses. Fifty percent (95% CI 36.7 to 63.3%) of COVID-19 patients had olfactory and/or gustatory dysfunctions. In summary, there are associations between OGD and COVID-19 patients. Patients presenting with ARI should be assessed for olfactory and gustatory functions.

Smell and taste dysfunction in patients with SARS-CoV-2 infection: A review of epidemiology, pathogenesis, prognosis, and treatment options.

During the initial pandemic wave of COVID-19, apart from common presenting symptoms (cough, fever, and fatigue), many countries have reported a sudden increase in the number of smell and taste dysfunction patients. Smell dysfunction has been reported in other viral infections (parainfluenza, rhinovirus, SARS, and others), but the incidence is much lower than SARS-CoV-2 infection. The pathophysiology of post-infectious olfactory loss was hypothesized that viruses may produce an inflammatory reaction of the nasal mucosa or damage the olfactory neuroepithelium directly. However, loss of smell could be presented in COVID-19 patients without other rhinologic symptoms or significant nasal inflammation. This review aims to provide a brief overview of recent evidence for epidemiology, pathological mechanisms for the smell, and taste dysfunction in SARS-CoV-2 infected patients. Furthermore, prognosis and treatments are reviewed with scanty evidence. We also discuss the possibility of using "smell and taste loss" as a screening tool for COVID-19 and treatment options in the post-SARS-CoV-2 infectious olfactory loss.

Predicting bacteria causing acute bacterial rhinosinusitis by clinical features / Predição de bactérias causadoras de rinossinusite bacteriana aguda por características clínicas

Abstract Introduction: Clinicians rely on clinical presentations to select therapeutic agents for acute bacterial rhinosinusitis. Streptococcus pneumoniae and Haemophilus influenzae are common in acute bacterial rhinosinusitis. Drug resistant Streptococcus pneumoniae and Haemophilus influenzae require different antibiotics. Objective: This study aimed to evaluate the associations between clinical features of acute bacterial rhinosinusitis and pathogenic bacteria. Methods: Sixty-four patients with acute bacterial rhinosinusitis were enrolled. Clinical features including nasal obstruction, discolored discharge, facial pain, smell disturbance, fever and laboratory findings of patients with acute bacterial rhinosinusitis were collected. The bacterial cultures of endoscopic middle meatal swabs were used as a reference. Results: Serum C-reactive protein level elevation correlated with the bacterial species (p = 0.03), by which was increased in 80.0% of Haemophilus influenzae rhinosinusitis and 57.1% of Streptococcus pneumoniae rhinosinusitis. The elevated C-reactive protein was the significant predictor for Haemophilus influenzae rhinosinusitis with the Odds Ratio of 18.06 (95% CI 2.36-138.20). The sensitivity of serum C-reactive protein level elevation for diagnosing Haemophilus influenzae rhinosinusitis was 0.80 (95% CI 0.49-0.94). Conclusion: Elevation of serum C-reactive protein level was associated with and predicted acute bacterial rhinosinusitis caused by Haemophilus influenzae.

Resumo: Introdução: Os médicos se baseiam nas características clínicas para a escolha dos agentes terapêuticos para o tratamento da rinossinusite bacteriana aguda. Streptococcus pneumoniae e Haemophilus influenzae são agentes comuns na rinossinusite bacteriana aguda. Streptococcus pneumoniae e Haemophilus influenzae resistentes a antibióticos requerem medicamentos diferentes. Objetivo: Avaliar as associações entre as características clínicas da rinossinusite bacteriana aguda e bactérias patogênicas. Método: O estudo incluiu 64 pacientes com rinossinusite bacteriana aguda. Foram coletadas e registradas as características clínicas, inclusive obstrução nasal, secreção com cor alterada, dor facial, distúrbios do olfato, febre e achados laboratoriais de pacientes com rinossinusite bacteriana aguda. As culturas bacterianas obtidas por swab endoscópico do meato médio foram usadas como referência. Resultados: A elevação do nível sérico de proteína C-reativa estava correlacionada com a espécie bacteriana (p = 0,03); ela estava aumentada em 80,0% das rinossinusites por Haemophilus influenzae e em 57,1% das rinossinusites por Streptococcus pneumoniae. A proteína C-reativa elevada foi um significativo fator preditor de rinossinusite por Haemophilus influenzae, com razão de probabilidade de 18,06 (IC 95% 2,36-138,20). A sensibilidade da elevação dos níveis séricos de proteína C-reativa para o diagnóstico de rinossinusite por Haemophilus influenzae foi de 0,80 (IC 95% 0,49 ± 0,94). Conclusão: A elevação dos níveis séricos de proteína C-reativa é um preditor de rinossinusite bacteriana aguda causada por Haemophilus influenzae.

Predicting bacteria causing acute bacterial rhinosinusitis by clinical features.

INTRODUCTION: Clinicians rely on clinical presentations to select therapeutic agents for acute bacterial rhinosinusitis. Streptococcus pneumoniae and Haemophilus influenzae are common in acute bacterial rhinosinusitis. Drug resistant Streptococcus pneumoniae and Haemophilus influenzae require different antibiotics. OBJECTIVE: This study aimed to evaluate the associations between clinical features of acute bacterial rhinosinusitis and pathogenic bacteria. METHODS: Sixty-four patients with acute bacterial rhinosinusitis were enrolled. Clinical features including nasal obstruction, discolored discharge, facial pain, smell disturbance, fever and laboratory findings of patients with acute bacterial rhinosinusitis were collected. The bacterial cultures of endoscopic middle meatal swabs were used as a reference. RESULTS: Serum C-reactive protein level elevation correlated with the bacterial species (p=0.03), by which was increased in 80.0% of Haemophilus influenzae rhinosinusitis and 57.1% of Streptococcus pneumoniae rhinosinusitis. The elevated C-reactive protein was the significant predictor for Haemophilus influenzae rhinosinusitis with the Odds Ratio of 18.06 (95% CI 2.36-138.20). The sensitivity of serum C-reactive protein level elevation for diagnosing Haemophilus influenzae rhinosinusitis was 0.80 (95% CI 0.49-0.94). CONCLUSION: Elevation of serum C-reactive protein level was associated with and predicted acute bacterial rhinosinusitis caused by Haemophilus influenzae.

Intranasal corticosteroids for non-allergic rhinitis.

BACKGROUND: Non-allergic rhinitis is defined as dysfunction and non-infectious inflammation of the nasal mucosa that is caused by provoking agents other than allergens or microbes. It is common, with an estimated prevalence of around 10% to 20%. Patients experience symptoms of nasal obstruction, anterior rhinorrhoea/post-nasal drip and sneezing. Several subgroups of non-allergic rhinitis can be distinguished, depending on the trigger responsible for symptoms; these include occupation, cigarette smoke, hormones, medication, food and age. On a cellular molecular level different disease mechanisms can also be identified. People with non-allergic rhinitis often lack an effective treatment as a result of poor understanding and lack of recognition of the underlying disease mechanism. Intranasal corticosteroids are one of the most common types of medication prescribed in patients with rhinitis or rhinosinusitis symptoms, including those with non-allergic rhinitis. However, it is unclear whether intranasal corticosteroids are truly effective in these patients. OBJECTIVES: To assess the effects of intranasal corticosteroids in the management of non-allergic rhinitis. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 7); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 July 2019. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing intranasal corticosteroids, delivered by any means and in any volume, with (a) placebo/no intervention or (b) other active treatments in adults and children (aged ≥ 12 years). DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. The primary outcomes were patient-reported disease severity and a significant adverse effect - epistaxis. Secondary outcomes were (disease-specific) health-related quality of life, objective measurements of airflow and other adverse events. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 34 studies (4452 participants); however, only 13 studies provided data for our main comparison, intranasal corticosteroids versus placebo. The participants were mainly defined as patients with perennial rhinitis symptoms and negative allergy tests. No distinction between different pheno- and endotypes could be made, although a few studies only included a specific phenotype such as pregnancy rhinitis, vasomotor rhinitis, rhinitis medicamentosa or senile rhinitis. Most studies were conducted in a secondary or tertiary healthcare setting. No studies reported outcomes beyond three months follow-up. Intranasal corticosteroid dosage in the review ranged from 50 µg to 2000 µg daily. Intranasal corticosteroids versus placebo Thirteen studies (2045 participants) provided data for this comparison. These studies used different scoring systems for patient-reported disease severity, so we pooled the data in each analysis using the standardised mean difference (SMD). Intranasal corticosteroid treatment may improve patient-reported disease severity as measured by total nasal symptom score compared with placebo at up to four weeks (SMD -0.74, 95% confidence interval (CI) -1.15 to -0.33; 4 studies; 131 participants; I2 = 22%) (low-certainty evidence). However, between four weeks and three months the evidence is very uncertain (SMD -0.24, 95% CI -0.67 to 0.20; 3 studies; 85 participants; I2 = 0%) (very low-certainty evidence). Intranasal corticosteroid treatment may slightly improve patient-reported disease severity as measured by total nasal symptom score change from baseline when compared with placebo at up to four weeks (SMD -0.15, 95% CI -0.25 to -0.05; 4 studies; 1465 participants; I2 = 35%) (low-certainty evidence). All four studies evaluating the risk of epistaxis showed that there is probably a higher risk in the intranasal corticosteroids group (65 per 1000) compared to placebo (31 per 1000) (risk ratio (RR) 2.10, 95% CI 1.24 to 3.57; 4 studies; 1174 participants; I2 = 0%) (moderate-certainty evidence). The absolute risk difference (RD) was 0.04 with a number needed to treat for an additional harmful outcome (NNTH) of 25 (95% CI 16.7 to 100). Only one study reported numerical data for quality of life. It did report a higher quality of life score in the intranasal corticosteroids group (152.3 versus 145.6; SF-12v2 range 0 to 800); however, this disappeared at longer-term follow-up (148.4 versus 145.6) (low-certainty evidence). Only two studies provided data for the outcome objective measurements of airflow. These data could not be pooled because they used different methods of outcome measurement. Neither found a significant difference between the intranasal corticosteroids and placebo group (rhinomanometry SMD -0.46, 95% CI -1.06 to 0.14; 44 participants; peak expiratory flow rate SMD 0.78, 95% CI -0.47 to 2.03; 11 participants) (very low-certainty evidence). Intranasal corticosteroids probably resulted in little or no difference in the risk of other adverse events compared to placebo (RR 0.99, 95% CI 0.87 to 1.12; 3 studies; 1130 participants; I2 = 0%) (moderate-certainty evidence). Intranasal corticosteroids versus other treatments Only one or a few studies assessed each of the other comparisons (intranasal corticosteroids versus saline irrigation, intranasal antihistamine, capsaicin, cromoglycate sodium, ipratropium bromide, intranasal corticosteroids combined with intranasal antihistamine, intranasal corticosteroids combined with intranasal antihistamine and intranasal corticosteroids with saline compared to saline alone). It is therefore uncertain whether there are differences between intranasal corticosteroids and other active treatments for any of the outcomes reported. AUTHORS' CONCLUSIONS: Overall, the certainty of the evidence for most outcomes in this review was low or very low. It is unclear whether intranasal corticosteroids reduce patient-reported disease severity in non-allergic rhinitis patients compared with placebo when measured at up to three months. However, intranasal corticosteroids probably have a higher risk of the adverse effect epistaxis. There are very few studies comparing intranasal corticosteroids to other treatment modalities making it difficult to draw conclusions.

Histopathology of ethmoid mucosa versus polyp tissue in diagnosing eosinophilic mucin rhinosinusitis.

BACKGROUND: This study aims to compare histopathology of nasal polyp and ethmoid mucosa for diagnosing eosinophilic mucin rhinosinusitis (EMRS). METHODOLOGY: Patients with chronic rhinosinusitis with polyps (CRSwNP) were enrolled. Using eosinophilic mucin as a reference, histopathology of polyp apex, polyp pedicle and ethmoid mucosa was compared for density of tissue eosinophil and sensitivity for diagnosing EMRS. Associations with asthma were assessed for each site. RESULTS: Thirty patients with CRSwNP were enrolled. When polyp apex, polyp pedicle and ethmoid mucosa were assessed for tissue eosinophilia, consistent results were reported in 16 patients (53%). Median tissue eosinophil was greater in polyp apex (58, IQR: 7-100) than ethmoid mucosa (10, IQR: 2-21), but not different from polyp pedicle (22, IQR: 1-96). Sensitivity for diagnosing EMRS were 100% (95%CI: 47.8 - 100) for polyp apex, 60% (95%CI: 14.7 - 94.7) for polyp pedicle, 80% (95%CI: 28.4 â€" 99.5) for ethmoid mucosa. Associations with asthma were significant for polyp pedicle, and ethmoid mucosa but not polyp apex. CONCLUSION: Density of tissue eosinophil was greater in nasal polyp than in ethmoid mucosa. Histopathology of polyp apex had good sensitivity for diagnosing EMRS. Polyp pedicle and ethmoid mucosal eosinophilia associated with asthma.

Does Heating up Saline for Nasal Irrigation Improve Mucociliary Function in Chronic Rhinosinusitis?

Background Mucociliary function is affected by temperature. Exposure to cold air may impair ciliary beat frequency. While saline nasal irrigation improves in ciliary beat activity, there is no evidence supporting the use of heated saline irrigation in treating patients with chronic rhinosinusitis. Objective To compare the effects of heated saline to room-temperature saline nasal irrigation on mucociliary clearance in chronic rhinosinusitis patients. Methods Adult patients with chronic rhinosinusitis were randomized into two groups receiving either heated saline or room-temperature saline nasal irrigation. Healthy subjects were included as control. Saccharin transit time was measured before and after nasal irrigation. Nasal patency was assessed by peak nasal inspiratory flow, anterior rhinomanometry, acoustic rhinometry, nasal obstruction score, and breathe-comfort score. Any adverse events were reported. Results Twenty-three patients with chronic rhinosinusitis and nine healthy subjects were enrolled. Saccharin transit time was decreased after nasal irrigation in both heated saline subgroup (baseline 12.3 ± 4.5 min vs. postirrigation 8.4 ± 4.9 min, p = 0.05) and room-temperature subgroup (baseline 12.8 ± 5.0 min vs. postirrigation 8.9 ± 4.2 min, p = 0.01). The saccharin transit time improvement was not different between heated saline (3.8 ± 6.2 min) and room-temperature saline (3.8 ± 4.0 min), p = 0.13. Postheated saline irrigation saccharin transit time of chronic rhinosinusitis patients (8.4 ± 4.9 min) was not different to healthy subjects (9.2 ± 3.7 min), p = 0.69. Nasal patency was not different between groups. There was no adverse event reported. Conclusion Nasal saline irrigation is beneficial to patients with chronic rhinosinusitis on mucociliary improvement. Warming saline is not necessary and adds no additional benefit to room-temperature saline irrigation.

Burden of respiratory disease in Thailand: Results from the APBORD observational study.

Asia-Pacific Burden of Respiratory Diseases (APBORD) was a cross-sectional, observational study examining the burden of respiratory disease in adults across 6 Asia-Pacific countries.This article reports symptoms, healthcare resource utilization (HCRU), work impairment and cost burden associated with allergic rhinitis (AR), asthma, chronic obstructive pulmonary disease (COPD), and rhinosinusitis in Thailand.Consecutive participants aged ≥18 years with a primary diagnosis of AR, asthma, COPD, or rhinosinusitis were enrolled at 4 hospitals in Thailand during October 2012 and October 2013. Participants completed a survey detailing respiratory symptoms, HCRU, work productivity, and activity impairment. Locally sourced unit costs were used in the calculation of total costs.The study enrolled 1000 patients. The most frequent primary diagnosis was AR (44.2%), followed by rhinosinusitis (24.1%), asthma (23.7%), and COPD (8.0%). Overall, 316 (31.6%) of patients were diagnosed with some combination of the 4 diseases. Blocked nose or congestion (17%) and cough or coughing up phlegm (16%) were the main reasons for the current medical visit. The mean annual cost for patients with a respiratory disease was US$1495 (SD 3133) per patient. Costs associated with work productivity loss were the principal contributor for AR and rhinosinusitis patients while medication costs were the highest contributor for asthma and COPD patients.The study findings highlight the burden associated with 4 prevalent respiratory diseases in Thailand. Thorough investigation of concomitant conditions and improved disease management may help to reduce the burden of these respiratory diseases.

The orbital floor is a surgical landmark for the Asian anterior skull base.

BACKGROUND: Surgical landmarks for defining the level of the skull base during endoscopic sinus and skull base surgery (ESBS), e.g., the middle turbinate, may be distorted by tumor or previous surgery. The orbital floor is a valid fixed anatomic landmark for the white population, but it is not known if its use is useful for an Asian population. OBJECTIVES: To define fixed anatomic landmarks for ESBS in an Asian population and to compare the level of the skull base and its relation with anatomic landmarks between Asian and white populations. METHODS: Computed tomographies performed on paranasal sinuses of Thai patients were retrospectively assessed. The distance between the nasal floor to four structures, the orbital floor, sphenoid planum, cribriform, and ethmoid roof, were measured. The level of skull base related to the orbital floor of an Asian population was compared with data of a white population from a previously published study. RESULTS: A total of 150 Thai patients (300 paranasal sinus systems) were assessed and compared with 150 white patients. The orbital floor was always below the skull base (600 sides [100%]). When compared with white patients, the Asian patients had significantly higher mean (standard deviation [SD]) values: orbital floor (35.2 ± 3.4 mm versus 33.9 ± 3.0 mm; p < 0.001), ethmoid roof (49.3 ± 3.8 mm versus 48.4 ± 4.5 mm; p = 0.01), cribriform (46.4 ± 3.6 mm versus 44.0 ± 3.7 mm; p < 0.001), and sphenoid roof (45.7 ± 3.7 mm versus 44.9 ± 3.7 mm; p = 0.01). The Asian population had a mean (SD) longer distance from the orbital floor to the cribiform (11.2 ± 2.5 mm versus 10.1 ± 2.7 mm; p < 0.001), a shorter distance to the sphenoid roof (10.5 ± 3.3 mm versus 11.0 ± 2.9 mm; p = 0.03), and a similar distance to the ethmoid roof (14.1 ± 3.1 mm versus 14.5 ± 3.5 mm; p = 0.09). CONCLUSION: Although a statistical difference exists between racial groups, clinically, the orbital floor is a useful fixed anatomic landmark for ESBS for both Asian and white populations.

A Surveillance Bacteriological Study of Acute Bacterial Rhinosinusitis in Thailand and the Clinical Responses to the Culture-directed Antibiotics.

OBJECTIVE: To examine: 1) types of bacteria and antimicrobial sensitivity of commonly used antibiotics for acute bacterial rhinosinusitis (ABRS) in Thailand, 2) the effectiveness of using antibiotics according to antimicrobial sensitivity, and 3) the effectiveness of using antibiotics according to the Thai clinical practice guidelines (CPG) of ABRS. MATERIAL AND METHOD: Descriptive & experimental studies were conducted in seven tertiary hospitals in Thailand. The specimens from maxillary sinuses were taken for bacterial cultures either by maxillary sinus tap or endoscopically directed middle meatus swabs in patients with clinically diagnosed ABRS. Antimicrobial sensitivity was performed and antibiotics were prescribed according to the results of antimicrobial sensitivity or the Thai CPG of ABRS. RESULTS: A total of 113 patients were enrolled between August 2006 and April 2007, 104 cases of which were performed for bacteriological study. The incidence of bacterial growth was 60.6% (95% CI 51.0-69.4%). The most common bacteria was H. influenzae (25.0%, 95% CI 16.9-35.3%), followed by S. pneumoniae (14.3%, 95% CI 8.2-23.5%) and S. aureus (9.5%, 95% CI 4.7-17.9%), respectively, whilst M. catarrhalis was found only in 2.4% (95% CI 0.5-7.3%). Eight in 12 S. pneumoniae isolates were tested for the minimal inhibitory concentration of penicillin and found to be penicillin resistant strain in five specimens. Beta-lactamase producing H. influenzae was found in eight out of 20 isolates. H. influenzae had a tendency to be sensitive to amoxicillin/clavulanate, cefuroxime, cefpodoxime, azithromycin, clarithromycin, ofloxacin, levofloxacin and gatifloxacin, whilst S. pneumoniae had a tendency to be sensitive to amoxicillin/clavulanate, cefaclor ampicillin/sulbactam, cefuroxime, ofloxacin, levofloxacin, gatifloxacin, cefpodoxime, cefixime and cefdinir. The effectiveness of antibiotics prescription according to the Thai CPG of ABRS and antimicrobial sensitivity were comparable, 88.5% (95% CI 69.8-97.6%) and 82.2% (95% CI 67.9-92%), respectively. CONCLUSION: H. influenzae is found to be the most common bacteria in Thai ABRS, followed by S. pneumoniae and S. aureus. There is a high incidence of beta-lactamase producing H. influenzae and penicillin non-susceptible S. pneumoniae.

Comparison of buffered and nonbuffered nasal saline irrigations in treating allergic rhinitis.

OBJECTIVES/HYPOTHESIS: We aimed to study the effect of alkalinity of isotonic nasal saline irrigation on nasal symptoms, mucociliary clearance, nasal patency, and patient's preference in patients with allergic rhinitis (AR). STUDY DESIGN: A double-blind, randomized, three-arm crossover study. METHODS: Patients with AR were enrolled. Three kinds of isotonic nasal saline irrigations: nonbuffered (pH 6.2-6.4), buffered with mild alkalinity (pH 7.2-7.4), and buffered with alkalinity (pH 8.2-8.4) were given one at a time, in different orders. Patients rinsed their nose with 240 ml of one solution twice daily for 10 days and then swapped to the others. The washout period was at least 5 days. Primary outcomes were nasal symptoms, mucociliary clearance time, and nasal patency. Outcomes were compared between baseline and posttreatment and also between various kinds of solution. Secondary outcomes were patients' preference and adverse events. RESULTS: Thirty-six subjects entered the study, and there were no dropouts. Overall nasal symptom was significantly improved from baseline (P = 0.03) only by buffered solution with mild alkalinity. Sneezing was significantly improved from baseline (P = 0.04) only by buffered solution with alkalinity. No other significant improvements were achieved by any solution. When comparing between the three nasal irrigations, there were no differences in all parameters. The patients significantly preferred the buffered solution with mild alkalinity (P = 0.02). CONCLUSIONS: Buffered isotonic saline with some degree of alkalinity may improve nasal symptoms. Isotonic saline irrigations, regardless of alkalinity, may not improve mucociliary function and nasal patency. Buffered isotonic saline with mild alkalinity is the most preferred.

The validity of peak nasal inspiratory flow as a screening tool for nasal obstruction.

BACKGROUND: The peak nasal inspiratory flow (PNIF) is used as an outcome measure in post-treatment clinical and research evaluation. It is simple and cost effective. The validity of the use as a screening tool has never been assessed OBJECTIVE: To assess its validity and to define the cut-off point of determining the nasal obstruction MATERIAL AND METHOD: The nasal patency of 141 ambulatory subjects with or without sino-nasal diseases was measured by the PNIF and active anterior rhinomanometry. Inclusion criteria was all subjects aged 18 to 75-years-old, sinonasal diseases/ symptoms(nasal congestion, nasal discharge, nasal polyp, deviated nasal septum, nasal tumor inferior turbinate hypertrophy, sinusitis, and allergic rhinitis), instant sensation of nasal obstruction, and nasal endoscopy finding were recorded. All subjects signed written consent. Compared with the active anterior rhinomanometry as the gold standard, the sensitivity, specificity, likelihood ratio, positive predictive value, and negative predictive value of the PNIF was analyzed. The cut-off point of nasal obstruction was defined from the Receiver Operating Characteristic curve analysis. The agreement between the PNIF and the stuffiness and between the PNIF and the presence of sino-nasal diseases were assessed by using Kappa. RESULTS: With the cut-off point of 90 L/min, the sensitivity of the peak nasal inspiratory flow was 0.87 (0.753-0.989). The specificity was 0.52 (0.429-0.617). The negative predictive value was 0.93 (0.872-0.997). The positive predictive value was 0.34 (0.237-0.446). The likelihood ratio was 1.81 (1.438-2.318). The mean of the PNIF in normal subjects was 97.11 +/- 31.15. The agreement between the PNIF and the instant sensation of nasal blockage was 0.14 (-0.024-0.321) and the agreement between the PNIF and the sino-nasal diseases was 0.09 (-0.083-0.265). CONCLUSION: The PNIF regarding the cut-off point of 90 L/min, revealed good sensitivity and high negative predictive value but it had low specificity and low positive predictive value. The nasal peak flow did not agree well with the subjects' symptoms of blockage and sino-nasal diseases.