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1.
In Vivo ; 38(4): 2058-2063, 2024.
Article in English | MEDLINE | ID: mdl-38936919

ABSTRACT

BACKGROUND/AIM: Postnasal drip may be related to several diseases, but not all patients are clearly diagnosed. Patients with chronic, idiopathic postnasal drip symptoms are easily overlooked, and their clinical features are yet to be identified. This study aimed to analyze the clinical features and response to first generation antihistamine-decongestant therapy in patients with chronic idiopathic postnasal drip, suggesting it as a distinct entity. PATIENTS AND METHODS: A retrospective cohort study involving 157 chronic idiopathic postnasal drip patients was conducted, analyzing demographics, symptoms, and treatment response to first-generation antihistamines and nasal decongestants. RESULTS: Mean age of patients was 55.4±17.0 years old. Median duration of symptom was 36 months (range=12-66 months) and severity in the visual analogue scale was 7 (range=5-8). Throat discomfort was the most frequently associated symptom (73.7%). Cough was recorded in 30.3% of patients. Viscosity of postnasal drip was associated with rhinorrhea and throat discomfort. Of the patients, 71.6% responded positively to 1st generation antihistamine-decongestant medication. However, 25.9% of patients presented symptom re-occurrence. Patients with nasal stiffness or persistent symptoms presented a higher re-occurrence rate compared to others. CONCLUSION: This study outlines the clinical features of patients with chronic idiopathic postnasal drip and suggests it as a distinctive entity., This proposal aims to enhance diagnostic precision and promote further research in the field.


Subject(s)
Histamine Antagonists , Nasal Decongestants , Humans , Female , Male , Middle Aged , Chronic Disease , Adult , Aged , Histamine Antagonists/therapeutic use , Nasal Decongestants/therapeutic use , Nasal Decongestants/administration & dosage , Retrospective Studies , Rhinitis/diagnosis , Rhinitis/drug therapy , Treatment Outcome
2.
J Allergy Clin Immunol Pract ; 12(7): 1865-1876.e6, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38677586

ABSTRACT

BACKGROUND: Little is known about rhinitis control in real-life, nor about the contribution of treatment-related and patient-related factors. OBJECTIVE: This study aimed to examine the level of rhinitis control and rhinitis medication utilization in patients with persistent rhinitis and to identify predictors of rhinitis control. METHODS: A cross-sectional observational study was conducted in patients with persistent rhinitis recruited in community pharmacies. Participants completed the Rhinitis Control Assessment Test, a questionnaire on patient/rhinitis characteristics, and rhinitis medication use. A visual analog scale for nasal symptoms was also completed. Pharmacy dispensing data were used to calculate adherence to intranasal glucocorticoids. Nasal spray technique was evaluated using a standardized checklist. Predictors of rhinitis control were explored using a linear regression model. RESULTS: A total of 1,514 patients, recruited in 215 pharmacies, participated in the study (mean age 48.7 y, 62% female). Almost 60% exhibited suboptimal rhinitis control (Rhinitis Control Assessment Test ≤ 21 of 30). A 50-mm cut-off on the visual analog scale yielded 78.1% sensitivity to identify suboptimal rhinitis control. Participants most frequently used intranasal glucocorticoids (55.6%) and intranasal decongestants (47.4%). Only 10.3% of current nasal spray users demonstrated perfect technique. More than half (54.8%) of glucocorticoid users were identified as underadherent. Female sex, self-reported nasal hyperreactivity, active asthma, and use of oral/intranasal decongestants or nasal saline were identified as predictors of worse rhinitis control. CONCLUSIONS: Suboptimal rhinitis control was common in this real-life sample of persistent rhinitis patients. Improving use of rhinitis medication may be key to increase disease control.


Subject(s)
Glucocorticoids , Rhinitis , Sinusitis , Humans , Female , Male , Rhinitis/drug therapy , Middle Aged , Sinusitis/drug therapy , Cross-Sectional Studies , Adult , Glucocorticoids/therapeutic use , Administration, Intranasal , Nasal Decongestants/therapeutic use , Pharmacies , Surveys and Questionnaires , Nasal Sprays , Medication Adherence , Aged , Rhinosinusitis
3.
Otolaryngol Head Neck Surg ; 170(6): 1696-1704, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38461407

ABSTRACT

OBJECTIVE: Mucosal decongestion with nasal sprays is a common treatment for nasal airway obstruction. However, the impact of mucosal decongestion on nasal aerodynamics and the physiological mechanism of nasal airflow sensation are incompletely understood. The objective of this study is to compare nasal airflow patterns in nasal airway obstruction (NAO) patients with and without mucosal decongestion and nondecongested healthy subjects. STUDY DESIGN: Cross-sectional study of a convenience sample. SETTING: Academic tertiary medical center. METHODS: Forty-five subjects were studied (15 nondecongested healthy subjects, 15 nondecongested NAO patients, and 15 decongested NAO patients). Three-dimensional models of the nasal anatomy were created from computed tomography scans. Steady-state simulations of airflow and heat transfer were conducted at 15 L/min inhalation rate using computational fluid dynamics. RESULTS: In the narrow side of the nose, unilateral nasal resistance was similar in decongested NAO patients and nondecongested healthy subjects, but substantially higher in nondecongested NAO patients. The vertical airflow distribution within the nasal cavity (inferior vs middle vs superior) was also similar in decongested NAO patients and nondecongested healthy subjects, but nondecongested NAO patients had substantially less middle airflow. Mucosal cooling, quantified by the surface area where heat flux exceeds 50 W/m2, was significantly higher in decongested NAO patients than in nondecongested NAO patients. CONCLUSION: This pilot study suggests that mucosal decongestion improves objective measures of nasal airflow, which is consistent with improved subjective sensation of nasal patency after decongestion.


Subject(s)
Nasal Decongestants , Nasal Mucosa , Nasal Obstruction , Humans , Pilot Projects , Nasal Obstruction/physiopathology , Male , Female , Nasal Decongestants/administration & dosage , Cross-Sectional Studies , Adult , Nasal Mucosa/physiology , Middle Aged , Tomography, X-Ray Computed , Nasal Sprays , Airway Resistance/physiology
4.
Ther Adv Respir Dis ; 18: 17534666241228927, 2024.
Article in English | MEDLINE | ID: mdl-38372128

ABSTRACT

BACKGROUND: The common cold is a frequent, acute, and mild upper respiratory human disease. Nasal congestion has been considered the most bothersome symptom in the common cold, impacting quality of life (QoL). Topical decongestants containing steroids benefit QoL in allergic rhinitis, but no published research has assessed the impact of topical decongestants on QoL in the common cold. OBJECTIVE: To evaluate the effects of xylometazoline hydrochloride 0.1% (Otrivin, GSK Consumer Healthcare SARL, Switzerland) for up to 7 days on QoL in participants with nasal congestion associated with the common cold. DESIGN: This was a decentralized, longitudinal, open-label study. METHODS: The study enrolled 136 participants (⩾18 years) with early symptoms of the common cold, of which 102 were included in the modified intention-to-treat (mITT) population. Within 24 h of study product receipt, participants confirmed a 'plugged nose' and ⩾1 other common cold symptom. Primary endpoints were Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) total score, total and individual symptom scores, and total QoL score. Secondary endpoints were additional QoL scores. Exploratory and post hoc analyses included median days to resolution for each QoL factor and analyses of five QoL categories. RESULTS: Consistent improvements in symptoms and QoL were seen in the mITT population. From day 1, improvements were seen in the 'plugged nose' symptom (p = 0.0023), WURSS-21 total QoL score, and all individual QoL scores (p < 0.0001 for all). After the last dose needed, significant improvements were seen in sleep quality (73%), vitality (76%), physical activity (71%), social activity (80%), and sensation (81%). No serious or unexpected adverse events were reported. CONCLUSION: This study is the first to demonstrate in a real-life setting that treating nasal congestion in adults with xylometazoline hydrochloride 0.1% during the common cold positively impacts QoL factors relevant to daily living [Otrivin: Quality of Life (QoL) Impact in a Real-World Setting; https://clinicaltrials.gov/study/NCT05556148].


Impact of xylometazoline hydrochloride 0.1% on quality of life in people with blocked nose associated with the common coldThe common cold is a widespread, mild respiratory illness for which a hallmark symptom is a blocked or stuffy nose, which makes breathing and sleeping difficult. This study focused on how a nasal spray called Otrivin (containing xylometazoline hydrochloride 0.1%) impacts the quality of life (QoL) of people suffering from nasal congestion due to the common cold.Participants answered a questionnaire called the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21), which helped understand how people experience respiratory symptoms and how different aspects of QoL were impacted. Participants also responded to eight additional QoL questions not covered in the WURSS-21.The results showed that from the first day of using the nasal spray, participants experienced significant relief from the blocked nose symptom and reported an overall improvement in their QoL and well-being, such as in sleep quality, energy levels, senses, and physical and social activities.In conclusion, this real-world study demonstrated that using xylometazoline hydrochloride 0.1% nasal spray during the common cold can significantly improve nasal congestion and various aspects of a person's daily life. These findings provide valuable evidence for using this nasal spray to relieve symptoms and enhance the overall well-being of individuals with the common cold.


Subject(s)
Common Cold , Imidazoles , Adult , Humans , Common Cold/diagnosis , Common Cold/drug therapy , Common Cold/chemically induced , Nasal Decongestants/adverse effects , Quality of Life , Administration, Intranasal
5.
Int Forum Allergy Rhinol ; 14(3): 630-638, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37449456

ABSTRACT

BACKGROUND: Limited treatment options exist for refractory Rhinitis Medicamentosa (RM). The role of surgery after failed medical management is not well defined. Mucosal contact points and restricted airflow often perpetuate decongestant use. This study assessed the long-term outcomes of nasal surgery in patients with refractory RM. METHODS: A prospective cohort study of refractory RM treated with nasal surgery was performed with ≥12 months follow-up. Refractory RM was defined as nasal decongestant use once per day continuously for ≥4 weeks despite medical therapy. Patients with concomitant sinus disease and nonrhinitis conditions were excluded. Sinonasal Outcome Test (SNOT22), Nasal Symptom Score (NSS), and nasal medication use were assessed. Patients who ceased decongestants were compared with ongoing users. RESULTS: A total of 56 patients (age 48.4 [5.0] years, 50% female) were assessed. Median follow-up was 3.4(1.6-6.2) years. Total cessation of decongestants was achieved in 91.1%, while 5.4% had intermittent use, and 3.6% reported daily use. Ongoing users had higher odds of concomitant asthma (40.0% vs. 3.9%; odds ratio [OR], 16.33 [1.7-159.75]; p = 0.036), reduced symptom improvement (ΔSNOT22, -4.6 [15.7] vs. 27.1 [17], p = 0.009 and ΔNSS, -1.0 [4.2] vs. -6.6 [5.1], p = 0.025), and greater ongoing use of nasal corticosteroid (60.0% vs. 5.9%; OR 24.0 [2.8-203.1]) and saline sprays (40% vs. 3.9%; OR 16.3 [1.7-159.8]) but showed no difference in allergy status (OR, 0.7[0.1-7.1]), previous surgery (OR, 1.0[0.1-10.2]), gastroesophageal reflux (OR 1.0[0.1-10.2], or underlying anxiety/depression (OR 6.1[0.8-45.9]) compared with those who ceased. CONCLUSION: Surgically re-establishing a nasal airway was associated with long-term decongestant cessation and symptom improvement in medically refractory RM.


Subject(s)
Nasal Surgical Procedures , Rhinitis , Humans , Female , Middle Aged , Male , Nasal Decongestants/therapeutic use , Prospective Studies , Rhinitis/drug therapy , Rhinitis/surgery , Rhinitis/complications , Treatment Outcome
6.
Int Forum Allergy Rhinol ; 14(1): 68-77, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37357822

ABSTRACT

BACKGROUND: Pathophysiology of rhinitis in older adults is largely unknown. We tested whether air pollution is associated with this condition and how immune mechanisms may play a role in this relationship. METHODS: We analyzed cross-sectional data from the National Social Life, Health, and Aging Project, a nationally representative study of older adults born between 1920 and 1947. Particulate matter ≤2.5 µm (PM2.5 ) air pollution exposure estimates were generated using validated spatiotemporal models. Presence of rhinitis was defined based on medication use (≥1: intranasal medications: steroids, antihistamines, lubricants, and/or decongestants, and/or oral medications: antihistamines and/or decongestants). K-means cluster analysis (Jaccard method) was used to group 13 peripheral blood cytokines into 3 clusters to facilitate functional determination. We fitted multivariate logistic regressions to correlate PM2.5 exposure with presence of rhinitis, controlling for confounders, and then determined the role of cytokines in this relationship. RESULTS: Long- (but not short-) term exposure to PM2.5 was associated with presence of rhinitis: 3-year exposure window, odds ratio (OR) = 1.32, 95% confidence interval (CI): 0.98, 1.80, per 1 standard deviation (SD) PM2.5 increase. Inclusion of cytokine cluster in the model led to a modestly stronger effect of PM2.5 exposure on rhinitis (OR = 1.37; 95% CI: 1.00, 1.87; 3-year exposure window). The particular immune profile responsible for this result was composed of elevated IL-3, IL-12, and IFN-γ (OR = 4.86, 95% CI: 1.10, 21.58, immune profile-PM2.5 exposure interaction term). CONCLUSION: We show for the first time that IL-3, IL-12, and IFN-γ explain in part the relationship between PM2.5 exposure and rhinitis in older US adults. If confirmed, these immune pathways may be used as therapeutic targets.


Subject(s)
Air Pollutants , Air Pollution , Rhinitis , Humans , Aged , Adult , Middle Aged , Air Pollutants/adverse effects , Air Pollutants/analysis , Cross-Sectional Studies , Interleukin-3/analysis , Nasal Decongestants , Environmental Exposure/adverse effects , Air Pollution/adverse effects , Particulate Matter/adverse effects , Particulate Matter/analysis , Rhinitis/epidemiology , Interleukin-12/analysis , Histamine Antagonists
7.
Rhinology ; 62(2): 143-151, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-37942998

ABSTRACT

Topical anaesthesia and decongestion of the sinonasal mucosa are used commonly in rhinology practice to facilitate nasal endoscopy, as well as debridement and biopsies. Topical agents used for sinonasal anaesthesia include lignocaine, tetracaine and cocaine. Unlike lignocaine and tetracaine, cocaine also has a decongestant effect. Phenylephrine, oxymetazoline, xylometazoline or adrenaline are usually added to lignocaine and tetracaine to provide decongestion. Several studies have been performed seeking to identify the optimal nasal preparation for nasal endoscopy in the clinic setting. However, there remains no clear consensus in the literature resulting in ongoing wide variation between anaesthetic-decongestant preparations used in clinical practice. Indeed, some authors have argued that no anaesthetic is required at all for flexible nasendoscopy despite the apparent consensus that nasal instrumentation is generally uncomfortable, inferred by the persistence of ongoing research in this area. This review provides a practical summary of local anaesthetic and decongestant pharmacology as it relates to rhinologic practice and summarises the literature to date, with the goal of identifying current gaps in the literature and guiding future research efforts.


Subject(s)
Cocaine , Nasal Decongestants , Humans , Tetracaine , Anesthesia, Local/methods , Lidocaine
8.
J Forensic Sci ; 69(1): 359-364, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37919943

ABSTRACT

An increase in the use of over-the-counter medications has been observed in recent years. This also concerns xylometazoline, approved for the treatment of allergic rhinitis or upper respiratory tract infections. We present the fatal case of a 40 year-old-woman with a massive hemorrhagic stroke. Initial toxicology tests of biological material collected during autopsy revealed the presence of xylometazoline. No other significant toxicology findings were noted. LC-MS/MS method has been developed to determine xylometazoline concentration, which was 18.6 ng/mL in blood and 498.9 ng/mL in urine. The macroscopically detected hemorrhagic focus was confirmed by histopathological which confirmed hemorrhagic infarcts in the brain tissue, especially in the subarachnoid area. No other pathological changes were found. Based on findings from autopsy and toxicological analyses, the direct cause of death was concluded to be hemorrhagic stroke resulting from xylometazoline intoxication. Although xylometazoline products are regarded as relatively safe and are available over the counter, the risk of adverse effects, in particular stroke leading to death, should be considered. If adverse effects are observed, it is reasonable to measure the concentration of the drug in blood and urine. With such data, it will be possible to assess the actual exposure to this xenobiotic and draw firmer conclusions.


Subject(s)
Hemorrhagic Stroke , Female , Humans , Adult , Hemorrhagic Stroke/chemically induced , Hemorrhagic Stroke/drug therapy , Chromatography, Liquid , Nasal Decongestants/adverse effects , Tandem Mass Spectrometry
9.
Oral Health Prev Dent ; 21(1): 347-356, 2023 Sep 27.
Article in English | MEDLINE | ID: mdl-37916545

ABSTRACT

PURPOSE: To evaluate the use of concomitant medication in combination with a mouthwash of delmopinol HCl 0.2% based on data from 8 phase III efficacy studies on the mouthwash. MATERIALS AND METHODS: Clinical data obtained from 8 previously performed phase III studies, carried out to document the clinical efficacy of a mouthwash of delmopinol HCl 0.2% with respect plaque and gingivitis, were used to analyse the use of concomitant medication. In these 8 randomised double-blind clinical phase III studies the patients were - in addition to their normal oral hygiene measures - treated for 2-6 months with mouthwashes containing delmopinol HCl 0.2%, delmopinol HCl 0.1%, chlorhexidine digluconate 0.2% or placebo. The number of visits in each study was three. Each time the patients visited the dentist for efficacy determinations, other data were also recorded. One of these was whether the patient had used any other medication during the study. In this paper, the number of treatments of different types of concomitant medication (antibiotics, nasal decongestants and others) was used as a basis for statistical comparisons between the different test groups. RESULTS: For antibiotics (all indications), a 27% lower number of treatments was obtained in the delmopinol 0.2% group in comparison with the placebo group, and a 41% decrease was observed for treatments with antibiotics for respiratory infections. For nasal decongestants, the number of treatments was 53% lower in the delmopinol 0.2% group. CONCLUSIONS: The delmopinol HCl 0.2% solution in patients with gingivitis provided a statistically significant reduction of concomitant use of antibiotics and nasal decongestants.


Subject(s)
Gingivitis , Mouthwashes , Humans , Mouthwashes/therapeutic use , Nasal Decongestants/therapeutic use , Anti-Bacterial Agents/therapeutic use , Dental Plaque Index , Chlorhexidine/therapeutic use , Double-Blind Method , Gingivitis/drug therapy
10.
Eur Ann Otorhinolaryngol Head Neck Dis ; 140(6): 305-308, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37980265

ABSTRACT

INTRODUCTION: We illustrate the diagnostic method for chronic nasal dysfunction by an observation in which the clinical history was compared to preoperative responses on the DyNaChron self-administered questionnaire, with ENT interpretation of the sinonasal CT scan preceding and guiding nasal endoscopy. CASE REPORT: The initial suspicion of rhinitis medicamentosa was transformed by the radiological and endoscopic findings of chronic respiratory rhinitis signs. Prick tests showing sensitivity to dust mites then suggested an allergic origin of the mucosal inflammation, which affected neither the olfactory nose nor the paranasal sinuses. A septal deviation hampering visualization of the right ethmoidal reliefs completed the clinical picture. Inferior turbinate hypertrophy secondary to allergic inflammation could have been aggravated by prolonged daily use of nasal vasoconstrictors. Failure of medical treatment combining nasal lavage, topical corticosteroids and an attempt at weaning led to effective medical and surgical management combining septoplasty, bilateral inferior turbinoplasty, continuation of topical corticosteroids and initiation of allergen immunotherapy. In addition to complete relief of nasal obstruction and abandonment of nasal vasoconstrictors, improved sense of smell completed the restoration of nasal comfort. DISCUSSION: It is helpful to conceive the nose as being anatomically and pathophysiologically a triple organ and to evaluate therapy in terms of improvement in each symptom.


Subject(s)
Nasal Polyps , Rhinitis , Sinusitis , Humans , Rhinitis/diagnosis , Rhinitis/etiology , Rhinitis/therapy , Sinusitis/complications , Nasal Polyps/complications , Nasal Polyps/diagnosis , Nasal Polyps/therapy , Nasal Decongestants/therapeutic use , Endoscopy , Adrenal Cortex Hormones/therapeutic use , Inflammation/complications , Chronic Disease
12.
Eur J Pharm Biopharm ; 192: 136-146, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37804998

ABSTRACT

Acute viral rhinosinusitis (viral ARS), or commonly referred to as the "common cold", is caused by respiratory viruses that cause disruption of the airway epithelial barrier and mucociliary dysfunction. Treatment of ARS is mainly symptomatic, with xylometazoline, a direct-acting α-adrenoceptor agonist, commonly used as a nasal decongestant. Unfortunately, this treatment does not resolve the epithelial dysfunction observed in ARS, and its use might negatively impact the nasal mucosa causing issues such as dryness, stinging, burning, rebound congestion, as well as atrophy. In light of this, a novel nasal spray formulation containing both xylometazoline and hyaluronic acid (HA) was developed to provide a more effective and safer treatment for viral ARS. HA is a natural polysaccharide known to hydrate and moisturise the upper respiratory tract, maintain the integrity of the nasal mucosa, and promote mucociliary clearance and wound healing. To investigate the potential of this combination, this study was conducted using the nasal MucilAirTMin vitro model and high-speed phase-contrast microscopy to examine the effect of xylometazoline and HA on ciliary function by measuring ciliary beat frequency and their cytotoxicity by morphological, histological and ultrastructural analysis. This research is the first to assess the effects of a specific dose and molecular weight of HA as an active pharmaceutical ingredient in nasal spray formulations. The combination of a fast-acting decongestant and an additional active agent targeting nasal epithelial dysfunction has the potential to provide an improved, reliable and safe treatment for viral ARS, and may serve as the basis for future clinical studies.


Subject(s)
Hyaluronic Acid , Nasal Sprays , Imidazoles/pharmacology , Nasal Decongestants/pharmacology , Nasal Decongestants/therapeutic use , Nasal Mucosa
14.
Stomatologiia (Mosk) ; 102(4): 31-36, 2023.
Article in Russian | MEDLINE | ID: mdl-37622298

ABSTRACT

OBJECTIVE: Development and implementation in practice of a technique for applying a postoperative decongestant kinesiological bandage. MATERIALS AND METHODS: A comparative analysis of the effectiveness of the developed methodology was carried out. Three groups of patients were formed, consisting of 20 people. The first group of patients received a kinesiological bandage after surgery. The second group used a pressure bandage, while the third group used a chilotherapeutic cooling mask. RESULTS: The average value of the volume of postoperative edema (in cm) on the 5th day after surgery was 10.9 in the first group; 11.4 in the second group; 11.1 in the third group. On the 10th day the corresponding values were 10.7, 11.2 and 11 cm in the third group. CONCLUSIONS: The revealed indicators of average values in the three studied groups proved that the proposed method of applying the decongestant kinesiology dressing has the most pronounced effectiveness in the postoperative period.


Subject(s)
Deafness , Orthognathic Surgical Procedures , Humans , Nasal Decongestants , Bandages , Postoperative Period
15.
Clin Pharmacokinet ; 62(9): 1315-1328, 2023 09.
Article in English | MEDLINE | ID: mdl-37402024

ABSTRACT

BACKGROUND AND OBJECTIVES: Nasal esketamine is indicated for the treatment of adults with treatment-resistant depression and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Primary objectives of this study were to evaluate the effect of nasal decongestant pretreatment in patients with allergic rhinitis and the impact of daily nasal corticosteroid administration by healthy subjects on nasal esketamine pharmacokinetics. METHODS: Patients with allergic rhinitis self-administered 56 mg of nasal esketamine after pretreatment with nasal oxymetazoline (0.05%) at 1 h before esketamine and without oxymetazoline pretreatment. They were exposed to grass pollen in an allergen challenge chamber to induce allergic rhinitis symptoms at approximately 2 h before each esketamine administration until 1 h after. Healthy subjects self-administered esketamine (56 mg) before and after administration for 16 consecutive days of mometasone (200 µg), with the second esketamine dose administered 1 h after the last mometasone dose. The plasma pharmacokinetics of esketamine and noresketamine were assessed after each esketamine administration. The tolerability of esketamine, including effects on dissociative and potential psychotomimetic symptoms and level of sedation and suicidal ideation and behavior, was evaluated. RESULTS: The rate of esketamine absorption was slightly greater in patients exhibiting symptoms of allergic rhinitis (decrease in median tmax from 32 min to 22 min). Increases in esketamine Cmax and AUC were also small (mean, ≤ 21%). The pharmacokinetics of esketamine was not affected by oxymetazoline or mometasone pretreatment. Esketamine was well tolerated when it was administered with or without pretreatment of oxymetazoline or mometasone. CONCLUSIONS: Patients exhibiting symptoms of rhinitis may receive nasal esketamine spray without dose adjustment. In addition, esketamine may be administered 1 h after using a nasal decongestant or corticosteroid. TRIAL REGISTRATION: The study was registered in the Clinical Trials (NCT02154334) and EudraCT (2014-000534-38) registries.


Subject(s)
Depressive Disorder, Major , Rhinitis, Allergic , Adult , Humans , Administration, Intranasal , Adrenal Cortex Hormones , Double-Blind Method , Healthy Volunteers , Mometasone Furoate , Nasal Decongestants , Nasal Sprays , Oxymetazoline/pharmacokinetics , Rhinitis, Allergic/drug therapy
16.
Am J Otolaryngol ; 44(4): 103842, 2023.
Article in English | MEDLINE | ID: mdl-36989755

ABSTRACT

OBJECTIVE: Radiofrequency ablation (RFA) reliefs nasal obstruction and improves quality of life (QoL) in patients suffering from inferior turbinate hypertrophy (ITH). A substantial benefit was noted among patients suffering from Rhinitis Medicamentosa (RM), enabling ending decongestant spray abuse. Our aim was to establish the benefit from RFA with respect to QoL in patients suffering from ITH, due to the presence of RM. STUDY DESIGN: Prospective cohort study. METHODS: Prospective Cohort study, including patients suffering from ITH undergoing RFA between 9.2017 and 9.2019 in Tel Aviv Medical Center. The cohort was divided to RM and non-RM (including allergic, non-allergic) patients. The differences between the groups were compared before and after RFA, and included patients' complaints, clinical findings and QoL questionnaires (SNOT-22 & NOSE). In the RM group, the ability to wean from decongestants was also described. RESULTS: Our data demonstrated subjective QoL improvement following RFA (88.9 %, N = 90). All RM patients withdrawaled from nasal decongestant spray. NOSE questionnaire demonstrated a significant improvement in QoL after RFA in the RM group (PV = 0.025). SNOT-22 did not demonstrate significant difference in QoL between RM and the reference group (PV = 0.1). Rates of MCID>8.3 were high, without significant difference between the groups (PV = 0.2). CONCLUSION: RFA demonstrated effectiveness in achieving of withdrawal from decongestant spray in RM patients and may be a possible definitive treatment option for this group. The nasal obstruction component in SNOT-22 questionnaire & NOSE questionnaire showed improved QoL in comparison to controls. High QoL after RFA was established in our entire cohort.


Subject(s)
Nasal Obstruction , Radiofrequency Ablation , Rhinitis , Humans , Rhinitis/surgery , Rhinitis/chemically induced , Nasal Decongestants , Quality of Life , Turbinates/surgery , Nasal Obstruction/etiology , Nasal Obstruction/surgery , Prospective Studies , Hypertrophy/surgery , Treatment Outcome
17.
J Dermatol ; 50(6): 739-745, 2023 Jun.
Article in English | MEDLINE | ID: mdl-36806298

ABSTRACT

Post-acne erythema (PAE) is one of the most common sequelae of acne inflammation. Unfortunately, the treatment of PAE remains challenging due to limited effective topical treatments. The objectives of this study were to evaluate the efficacy and safety of topical oxymetazoline hydrochloride (OxH) 0.05% solution for PAE. This study was a split-face, participants-and investigators-blinded, randomized, placebo-controlled trial conducted between December 2021 and March 2022 in Bangkok, Thailand. Healthy adults aged from 18 to 45 years with mild to severe PAE, according to the Clinician's Erythema Assessment (CEA), on both sides of the face were eligible. After randomization, each participant applied the OxH to one side of their face and a placebo to the contralateral face twice daily for 12 weeks. The primary outcome was PAE lesion counts. The secondary outcomes were erythema index, clinical response rate at week 12 ("clear," "almost clear," or "at least two-grade improvement" by CEA), and patient satisfaction scores. A total of 30 participants were enrolled. The OxH-treated skin showed a significantly greater mean difference (MD) reduction in PAE lesion counts than the placebo after 8 weeks of treatment (4.30, 95% confidence interval [CI] 1.42-7.18). Similarly, the MD reduction of the erythema index was higher in the OxH-treated skin from the second week (11.82, 95% CI 8.48-15.15). Additionally, the OxH-treated side also achieved a higher clinical response rate after 8 weeks of treatment (40.00% vs. 6.67%; p = 0.002) and rated higher satisfaction than those using the placebo at the end of the study (mean [standard deviation] satisfaction score 8.30 [0.18] vs 7.40 [0.18], P < 0.001). There were no serious adverse events or flares of erythema during the study. In conclusion, our study demonstrated that the topical OxH 0.05% solution was effective, well-tolerated, and safe for reducing PAE without a rebound effect. It could be a choice of PAE management. Trial Registration: Thai Clinical Trials Registry No. TCTR20211207004.


Subject(s)
Acne Vulgaris , Oxymetazoline , Adult , Humans , Oxymetazoline/adverse effects , Nasal Decongestants/adverse effects , Thailand , Acne Vulgaris/drug therapy , Erythema/diagnosis , Erythema/drug therapy , Double-Blind Method , Treatment Outcome
20.
Int J Clin Pharmacol Ther ; 61(2): 59-66, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36594656

ABSTRACT

BACKGROUND: Dysbiosis (also called dysbacteriosis) is characterized by a disruption of the microbiome, resulting in an imbalance in the microbiota, changes in their functional composition and metabolic activities, and a shift in their local distribution. Dysbiosis is most commonly reported as a condition affecting the gastrointestinal tract, for example with bacterial or fungal overgrowth in the small intestine. Known causes of dysbiosis include antibiotic use, liver disease, and alcohol misuse. AIMS: To determine those variables associated with the diagnosis of dysbiosis using a national database containing data supplied by general practitioners in Germany. MATERIALS AND METHODS: Patient data for the period January 2005 to December 2018 were obtained from the Disease Analyzer database (IQVIA) based on data from 1,193 general practices in Germany. Inclusion criteria were all adult patients (≥ 18 years) with an initial diagnosis of dysbiosis documented anonymously. Data for variables such as drug treatment, other diseases etc. associated with the diagnosis were analyzed using multivariable logistic regression analyses. RESULTS: A total of 4,013 patients diagnosed with dysbiosis and a comparative control cohort of 4,013 patients without such a dysbiosis were included in the study. The mean age in both groups was ~ 50 years where 65.2% of subjects were women. Decongestants and other nasal preparations for topical use (OR: 1.45, 95% CI: 1.14 - 1.85), proton pump inhibitors (OR: 1.39; 95% CI: 1.21 - 1.61), and systemic antibiotics (OR: 1.28, 95% CI: 1.13 - 1.47) were significantly associated with an increased occurrence of dysbiosis, whereas non-steroidal antirheumatic drugs (OR: 0.78, 95% CI: 0.69 - 0.87), lipid-lowering drugs (OR: 0.76, 95% CI: 0.63 - 0.93), and ACE inhibitors (OR: 0.64, 95% CI: 0.53 - 0.77) were associated with a decreased occurrence of dysbiosis. CONCLUSION: The study provides evidence that treatment with decongestants and other nasal preparations is strongly associated with an increased occurrence of dysbiosis. Although the pathophysiology of dysbiosis is multifactorial and confounding factors cannot be ruled out, the close correlation seen may have clinical significance.


Subject(s)
Dysbiosis , Proton Pump Inhibitors , Adult , Humans , Female , Middle Aged , Male , Proton Pump Inhibitors/adverse effects , Dysbiosis/chemically induced , Dysbiosis/epidemiology , Dysbiosis/drug therapy , Nasal Decongestants , Anti-Bacterial Agents/adverse effects , Germany/epidemiology
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