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1.
CONTEXT: In most countries, the use of topical nasal decongestants is limited to a maximum of 10 days because of the risk of developing rebound mucosal swelling and rhinitis medicamentosa. OBJECTIVE: To determine whether topical nasal decongestants can be safely used for 10 days in patients with chronic inflammation of the nasal mucosa. DESIGN: Double-blind, randomized, controlled, parallel study. PATIENTS: Thirty-five patients with vasomotor rhinitis selected from our outpatient department. INTERVENTION: Eighteen patients received oxymetazoline hydrochloride (0.5 mg/mL) nasal spray containing the preservative benzalkonium chloride (0.1 mg/mL), and the other 17 were treated with oxymetazoline nasal spray without benzalkonium chloride. Before and after the treatment, recordings of the nasal mucosa and minimal cross-sectional area were made with rhinostereometry and acoustic rhinometry, followed by histamine hydrochloride challenge tests. Symptoms of nasal stuffiness were estimated on visual analog scales (0-100) in the morning and the evening, just before the nasal spray was used. RESULTS: No rebound swelling was found after the 10-day treatment in the 2 groups with either of the methods or as estimated by symptom scores. In the group receiving oxymetazoline containing benzalkonium chloride, but not in the other group, the histamine sensitivity was significantly reduced after treatment (P<.001). CONCLUSIONS: It is safe to use topical nasal oxymetazoline with or without benzalkonium chloride for 10 days in patients with vasomotor rhinitis. However, this study indicates that benzalkonium chloride in nasal decongestant sprays affects the nasal mucosa also after short-term use.  相似文献   

2.
Dorn M  Hofmann W  Knick E 《HNO》2003,51(10):794-799
BACKGROUND. Local alpha-sympathomimetics in hydrous solution are well known in the therapy of acute rhinitis and sinusitis. However, added preservatives like benzalkonium chloride have a negative effect on compatibility. PATIENTS AND METHOD. A total of 307 patients with acute rhinitis entered the study. The treatment with oxymetazoline with preservative, oxymetazoline without preservative and xylometazoline with preservative was evaluated. RESULTS. This randomised, double-blind, multi-centered, verum-controlled tolerance study confirmed that the local sympathomimetics oxymetazoline and xylometazoline are well tolerated in the treatment of acute rhinitis. When evaluated according to the parameters "feeling of dryness in nasal mucosa" and "burning sensation", the Nasivin sanft 0.05% spray, which contains the active agent oxymetazoline without preservatives, proved to be considerably superior to preparations containing the preservative benzalkonium chloride. CONCLUSION. Preparations without preservatives should be the preferred choice of treatment for acute rhinitis.  相似文献   

3.
Benzalkonium chloride is a preservative commonly used in nasal decongestant sprays. It has been suggested that benzalkonium chloride may be harmful to the nasal mucosa. Decongestion with the vasoconstrictor xylometazoline containing benzalkonium chloride has been shown to cause a significant reduction of the nasal mucosal temperature. The purpose of the present study was to determine the short-term influence of xylometazoline nasal spray with and without benzalkonium chloride on the nasal mucosal temperature. Healthy volunteers (30) were included in the study. Fifteen volunteers received xylometazoline nasal spray (1.0 mg/mL) containing benzalkonium chloride (0.1 mg/mL) and 15 age-matched subjects, received xylometazoline nasal spray without benzalkonium chloride. Using a miniaturized thermocouple the septal mucosal temperature was continuously measured at defined intranasal detection sites before and after application of the nasal spray. The mucosal temperature values did not significantly differ between the group receiving xylometazoline containing benzalkonium chloride and the group receiving xylometazoline spray without benzalkonium chloride before and after decongestion (P > 0.05). In both study groups septal mucosal temperatures significantly decreased after decongestion (P < 0.05) because of a reduction of the nasal mucosal blood flow following vasoconstriction. This study indicates that benzalkonium chloride itself does not seem to influence nasal blood flow and nasal mucosal temperature in topical nasal decongestants.  相似文献   

4.
The in vivo effects of benzalkonium chloride, which is a preservative in most nasal sprays and drops, have been investigated in normal human volunteers. Saccharin clearance time was slightly prolonged 10 min after 0.02% benzalkonium chloride was applied, compared to that following 0.9% saline (n = 27, P = 0.04, Wilcoxon test). Sixty-five normal volunteers were randomly assigned to receive saline, fluticasone propionate aqueous nasal spray or placebo (which contained all the ingredients of fluticasone aqueous spray incl. 0.02% benzalkonium chloride, minus the fluticasone propionate) for 2 weeks, two puffs twice a day on a double-blind basis. Symptom scores, acoustic rhinometry, saccharin clearance time and ciliary beat frequency were measured immediately prior to this study and again at 2 weeks. Fifty-eight individuals completed the study with >80% compliance. There was no significant difference between the three groups in any of the variables tested. Benzalkonium chloride causes slight prolongation of mucociliary clearance shortly after application but has no detectable effect on nasal mucosal function after 2 weeks regular use.  相似文献   

5.
BACKGROUND: The preservatives benzalkonium chloride and potassium sorbate are widely used in nasal drops and sprays. Recently, side effects resulting from mucosal damage caused by benzalkonium chloride and potassium sorbate were reported. METHODS: We investigated the toxicity of benzalkonium chloride and potassium sorbate on human nasal epithelial cells in vitro. Using primary human nasal epithelial cells, different concentrations of benzalkonium chloride, potassium sorbate, or phosphate-buffered saline (PBS; control group) solutions were cocultured with nasal epithelial cells for 15 minutes. Then, the viability of the cells and the cell morphology were assessed. RESULTS: Nasal epithelial cells were more severely damaged with use of clinical preparations or higher concentrations of benzalkonium chloride than in the control group. In addition, nasal epithelial cell membrane lysis was seen on electronic microscopy in the benzalkonium chloride groups. In contrast, there was no significant cell damage seen in the potassium sorbate groups compared with the control group, even with higher concentrations than clinically used. CONCLUSION: Potassium sorbate appears to be a relatively safer preservative than benzalkonium chloride for use in nasal sprays and drops in vitro study.  相似文献   

6.
OBJECTIVE: To measure the influence of topical steroids and the preservative potassium sorbate on the ciliary beat frequency (CBF) of human nasal mucosa in vitro. DESIGN: In vitro study of cultured ciliated cells of human nasal mucosa. METHODS: Human nasal mucosa was removed endoscopically and cultured for 10 days. Cell cultures with ciliated cells grown on an object slide were exposed to benzalkonium chloride and topical steroids in an exposure chamber. The CBF was measured with a photometer. RESULTS: The preservative potassium sorbate did not influence CBF in different concentrations. The glucocorticoid budesonide spray containing potassium sorbate did not affect CBF at 10% dilution and showed moderate reversible decrease of CBF at 50% dilution. The glucocorticoid sprays fluticasone propionate and mometasone fuorate containing the preservative benzalkonium chloride caused a reversible decrease of CBF at 10% dilution and a complete irreversible standstill at 50% dilution. CONCLUSIONS: In vitro, the steroid sprays containing fluticasone or mometasone, both with benzalkonium chloride, caused slowing or standstill of CBF depending on the concentration. The isolated preservative potassium sorbate and the budesonide nasal spray containing this preservative did not have negative influence on CBF in vitro. Potassium sorbate can therefore be considered harmless to the motility of ciliated cells.  相似文献   

7.
Topical decongestants are available over the counter and provide rapid relief of nasal obstruction for conditions of short duration, for example the common cold. Manufacturers' recommendations are that topical decongestants should not be used regularly for more than 1 week in view of the risk of rebound mucosal hyperaemia with persistent nasal obstruction and refractoriness to further effects of decongestants. For this reason we performed a randomised double-blind placebo-controlled trial in 30 normal adult subjects with 0.05% oxymetazoline nasal spray 2 sprays (0.1 ml/spray) to each nostril 3 times daily over an extended period of 4 weeks. Degree of nasal blockage was assessed before and after 4 weeks treatment and for 2 weeks following discontinuation of treatment. Outcome measures included diary symptom scores and measurements of nasal peak inspiratory flow, airway resistance (using posterior active rhinomanometry) and volume (using acoustic rhinometry). Nasal patency was assessed at baseline and 15 minutes after oxymetazoline challenge at each clinic visit. Results demonstrated no significant increases in subjective nasal blockage throughout the 6 weeks study period in either oxymetazoline- or placebo-treated subjects. No significant differences were observed between groups for baseline measurements of nasal peak inspiratory flow, airway resistance or volume at each clinic visit. A highly significant decongestant effect of oxymetazoline was observed at each clinic visit with changes in all 3 measurements for both treatment groups, again with no significant differences between groups. In summary, in normal subjects, we identified no significant nasal blockage or impaired decongestant response to oxymetazoline following 4 weeks treatment with oxymetazoline compared to matched placebo nasal spray.  相似文献   

8.
Objectives: The preservatives benzalkonium chloride (BZC) and potassium sorbate (PS) are widely used, not only for nasal drops, but also for eyedrops and cosmetics. However, there have been many case reports that consider lesions such as dermatitis or conjunctivitis to be the results of irritation induced by BZC or PS. Methods: We evaluated the histological changes after the long‐term administration of BZC or PS on rat nasal respiratory mucosa. Forty rats were used for the BZC group and 40 rats for PS group. Animals in each group were divided into four subgroups. The first subgroup received a low‐concentration preservative solution that was commonly used for nasal sprays. The second subgroup received a high‐concentration preservative solution that was reported to induce dermatitis in humans. The third and fourth subgroups received a steroid mixed preservative solution of low and high concentrations, respectively. The control group was administrated normal saline. After each group received 1, 2, and 4 weeks of topical administration, the symptomatic and histological changes on H&E stain were observed. Results: Sneezing and nasal rubbing with forelegs were observed in almost all subgroups by the seventh day of treatment. The preservatives induced nasal lesions, including intraepithelial glandular formation, inflammatory cell infiltration, vascular hyperplasia, and edematous change. The symptomatic and histological changes were pronounced with the prolonged duration of administration. Similar results were observed in the steroid mixed‐solution groups. In the PS steroid mixed‐solution group, however, symptoms and nasal lesions were reduced with the prolonged duration of administration. Conclusion: It is our finding that even a low‐concentration solution of preservative can lead to nasal lesion. Hence there is a strong need to develop both a preservative that can be safely and widely used and a nasal spray without preservatives.  相似文献   

9.
Use of sympathomimetic topical nasal decongestants to treat nasal obstruction is usually restricted to 3 to 5 days to avoid potential rebound swelling (rhinitis medicamentosa). In this study, 10 healthy volunteers used oxymetazoline (long-acting topical nasal decongestant) nightly for 4 weeks. Subjects who used antihistamines, oral or topical decongestants, or systemic steroids or who had active sinusitis were excluded from the study. Weekly history, physical examination, and anterior rhinomanometry revealed no adverse effects. Eight (80%) subjects developed nightly nasal obstruction a few hours before the evening dose; the obstruction resolved within 48 hours if no more decongestant was used. All subjects remained responsive to oxymetazoline 4 weeks and 8 weeks after the study began. This finding suggests that long-acting decongestants may be safely used for longer than the recommended 3 to 5 days without adverse effects if used once nightly.  相似文献   

10.
To evaluate the treatment of rhinitis medicamentosa, 10 consecutive patients discontinued their use of topical vasoconstrictors and were treated with budesonide nasal spray, 400 μg, daily for 6 weeks. The thickness of the nasal mucosa, the decongestive effect of oxymetazoline and the histamine sensitivity were measured with rhinostereometry. All patients were able to stop using the vasoconstrictors and objective variables showed that they needed treatment for at least 6 weeks. The results strongly support the theory that the rebound swelling is due to interstitial oedema rather than to vasodilatation. The presence of tachyphylaxis reflected by a reduction in both the decongestive effect of oxymetazoline and a reduction of drug duration was seen.  相似文献   

11.
It has been reported that skin-test reactivity and rhinitis symptom severity weaken in the course of time. A corresponding weakening might also be seen in non-specific nasal hyper-reactivity, but the relationships of these responses are poorly understood. Our aim was to measure nasal responsiveness to histamine in a series of patients with long-continuing allergic rhinitis and to compare these measurements with skin test responses, allergen provocation and changes in severity of allergic rhinitis symptoms. A total of 73 patients in whom allergic rhinitis had been verified over 20 years earlier were re-interviewed and re-investigated. Skin prick tests with common allergens were performed and the presence of nasal allergy was confirmed by allergen provocation. Non-specific nasal hyper-reactivity was determined with nasal histamine challenge using four concentrations of histamine phosphate. The response was registered by counting sneezes, recording changes in nasal discharge and mucosal swelling and measuring nasal airway resistance. Sneezing and discharge scores showed that milder non-specific nasal hyper-reactivity was associated with lack of reactivity in skin prick tests and nasal allergen challenge. No association was observed between allergy test results and changes in nasal airway resistance during the histamine provocation. In most patients the symptoms of rhinitis had become milder or disappeared during the follow-up, but the results of the histamine challenge showed no relationship with the changes in symptom severity. In patients with allergic rhinitis, reactivity to histamine is associated with a concomitant change in skin and nasal mucosal reactivity to allergens.  相似文献   

12.
《Acta oto-laryngologica》2012,132(1):67-71
It has been reported that skin-test reactivity and rhinitis symptom severity weaken in the course of time. A corresponding weakening might also be seen in non-specific nasal hyper-reactivity, but the relationships of these responses are poorly understood. Our aim was to measure nasal responsiveness to histamine in a series of patients with long-continuing allergic rhinitis and to compare these measurements with skin test responses, allergen provocation and changes in severity of allergic rhinitis symptoms. A total of 73 patients in whom allergic rhinitis had been verified over 20 years earlier were re-interviewed and re-investigated. Skin prick tests with common allergens were performed and the presence of nasal allergy was confirmed by allergen provocation. Non-specific nasal hyper-reactivity was determined with nasal histamine challenge using four concentrations of histamine phosphate. The response was registered by counting sneezes, recording changes in nasal discharge and mucosal swelling and measuring nasal airway resistance. Sneezing and discharge scores showed that milder non-specific nasal hyper-reactivity was associated with lack of reactivity in skin prick tests and nasal allergen challenge. No association was observed between allergy test results and changes in nasal airway resistance during the histamine provocation. In most patients the symptoms of rhinitis had become milder or disappeared during the follow-up, but the results of the histamine challenge showed no relationship with the changes in symptom severity. In patients with allergic rhinitis, reactivity to histamine is associated with a concomitant change in skin and nasal mucosal reactivity to allergens.  相似文献   

13.
《Acta oto-laryngologica》2012,132(7):837-842
Phenylpropanolamine (PPA) is widely used as a nasal decongestant administered orally in sustained release preparations and, in Sweden, the recommended dose nowadays is 50 mg twice daily for adults. The aim of this placebo-controlled, cross-over study was to determine the onset and duration of the decongestive effect of 50 and 100 mg PPA in 15 healthy subjects. All subjects arrived at the laboratory at 07.30 h. After an acclimatisation, the nasal mucosal baseline was established with rhinostereometry and the minimal cross-sectional area was measured using acoustic rhinometry. The systolic and diastolic blood pressures were also determined. Then all subjects were given their study drugs for the day and the measurements were repeated every hour for 8 h. This procedure was repeated for 3 days at 48 h intervals between the days. For purposes of comparison, the decongestive effect of oxymetazoline nasal spray was studied on a separate day. The decongestive effect of 100 mg PPA was similar to that of topical oxymetazoline. It develops after 1 h and lasts for approximately 6 h. The decongestive effect of oxymetazoline was significantly greater than that of 50 mg PPA and that of 100 mg PPA was significantly greater than that of 50 mg PPA using rhinostereometry, but not when using acoustic rhinometry. However, 50 mg PPA had no significant decongestive effect, compared with placebo, with rhinostereometry or acoustic rhinometry. In the first 3 h after administration of PPA, there was a dose-response increase in the systolic and diastolic blood pressures, which then returned to baseline. In conclusion, this study shows that PPA in double the recommended dose, i.e. 100 mg, has a significant decongestive effect on the nasal mucosa in healthy subjects. However, when the dose of PPA is increased the systolic and diastolic blood pressures also increase.  相似文献   

14.
Objective: In patients with nasal allergy, antigen challenge on the unilateral nasal mucosa results in nasal secretion not only in the ipsilateral but also in the contralateral nasal cavities that can be inhibited almost completely by premedication with atropine sulfate. The present study was performed to elucidate if centrally mediated vascular reflex induced by antigen challenge plays a role in nasal mucosal swelling in subjects with nasal allergy. Methods: Variations of mucosal swelling and mucosal blood flow in the ipsilateral and the contralateral nasal cavities after unilateral antigen challenge were evaluated by acoustic rhinometry and laser Doppler flowmetry in 20 patients with perennial nasal allergy. Results: Unilateral antigen challenge caused ipsilateral and contralateral nasal mucosal swelling in 17 and 13 patients, respectively. Incidence of contralateral nasal mucosal swelling after unilateral antigen challenge was significantly higher compared with that after control disc challenge (P < .001). In 10 patients in whom unilateral antigen challenge caused bilateral nasal mucosal swelling, significant swelling of the nasal mucosa lasted for more than 30 minutes in the ipsilateral nasal cavity after antigen challenge compared with only 15 minutes in the contralateral nasal cavity. Peak values of contralateral mucosal swelling were 45.3% of those of ipsilateral nasal mucosa. Conclusions: Centrally mediated vascular reflex is partially involved in the onset of nasal mucosal swelling observed after antigen challenge in subjects with nasal allergy. However, nasal mucosal swelling that persists and proceeds even 20 minutes after antigen challenge is caused by the direct effects of chemical mediators on the nasal vasculature.  相似文献   

15.
CONCLUSION: Fluticasone propionate (FP) aqueous nasal spray was objectively found to be effective and safe for the treatment of lower turbinate enlargement in patients with vasomotor rhinitis. OBJECTIVE: To assess the efficacy of FP aqueous nasal spray treatment in lower turbinate hypertrophy due to vasomotor rhinitis using CT. MATERIAL AND METHODS: Of 35 patients with hypertrophic lower turbinates due to vasomotor rhinitis, 20 were treated twice daily with FP aqueous nasal spray (200 microg/day) for 3 months continuously and 15 were treated with placebo vehicle as a control group. The local effect of the nasal spray was studied using CT and visual analog scales. RESULTS: Treatment with FP provided significantly greater relief from the symptom of nasal obstruction compared with placebo over the entire 3-month treatment period (p < 0.001). When the change from baseline was compared between the two groups, FP produced statistically significant reductions in the mucosal area of the lower turbinates and in the thickness of the nasal mucosa after 3 months (p < 0.05).  相似文献   

16.
Posterior rhinometric measurements of nasal resistance were conducted on two groups of patients with perennial rhinitis: those whose symptom of nasal stuffiness responded to a topical steroid spray and those in whom it did not. The anterior ends of the inferior turbinates in 48 patients were treated with either cryosurgery or cautery, and in half of the subjects the erectile tissue of the septum was also thermally ablated. Measurements were made before and 10-16 weeks after therapy. It is concluded from statistical comparison that there is no benefit to treating the septum, and that cryosurgery is more effective in those whose symptoms respond to topical steroids, while cautery works better in those who do not. Histology showed no change in the capacitance vessels (sinusoids) after either modality, and xylometazoline caused a marked decrease in nasal resistance, suggesting that vascular smooth muscle function was intact. Irrespective of the change in airway resistance, most subjects felt that there had been an improvement. The mechanism is discussed.  相似文献   

17.
The nasal mucosal blood flow was determined by means of the 133Xe wash-out method in an early stage of acute rhinitis and in health and the effect of a topical decongestant (oxymetazoline) was evaluated. During an early stage of acute rhinitis, a statistically significant increase of blood flow was found. The topical decongestant in therapeutically recommended doses decreased the blood flow significantly in acute rhinitis as well as in healthy subjects. The effect was more pronounced in acute rhinitis. The effect of oxymetazoline was dose dependent and a statistically significant decrease was found in doses of about 1/50 of the therapeutically recommended. The clinical implication is that it might be possible to reduce the dose of the decongestant in order to minimize the negative side effect of a decreased blood flow.  相似文献   

18.
The correlation between the subjective sensation of nasal stuffiness and nasal mucosal swelling measured with rhinostereometry during histamine challenge was studied in 13 healthy subjects. To permit a study of the entire range from decongestion to maximal congestion, the mucosa was pre-treated with a local vasoconstrictor 1 h before it was challenged with eight doses of increasing concentrations of histamine applied to one side of the nose. Ten minutes after each application, the subject estimated stuffiness on the challenged side, using a 100 mm visual analogue scale. The amount of mucosal swelling was measured with rhinostereometry. In 12 of 13 individuals and in the group as a whole, there was a strong positive correlation between a feeling of nasal stuffiness and the degree of mucosal swelling with this nasal provocation model (R = 0.59; P <0.001).  相似文献   

19.
The H(1) antagonist azelastine is used in nasal sprays for the treatment of allergic rhinitis, but its therapeutic efficacy in vasomotor rhinitis is unknown. We performed a multicenter randomized double-blind placebo-controlled study of the efficacy and tolerance of azelastine nasal spray in 89 adult patients with vasomotor rhinitis (confirmed by negative Phadiatop). Following a washout period, patients were treated for 15 days with one puff three times daily per nostril of azelastine (n = 44) or placebo (n = 45) nasal spray. Efficacy was evaluated by the reduction in symptomatology and by rhinoscopy. Intent-to-treat analysis revealed better results in the azelastine group for all assessed symptoms; the significance level was reached for nasal obstruction on day 15 (p = 0.042). Using per protocol analysis (in 85 patients complying with the protocol), the significance level was reached for nasal obstruction on day 15 (p = 0.017) and for the percentage of success in rhinorrhea (p = 0.023). In the azelastine group, rhinoscopy examination showed a significantly higher reduction in the inflammatory level and edema of the nasal mucosa (p = 0.03 and 0.02 for VAS on day 15 respectively, per protocol analysis). General efficacy assessment by the physician and the patient was in favor of azelastine (with significance levels <0.01). No drowsiness or serious adverse event was reported, and the frequency of mouth dryness and headaches was similar in the two treatment groups. The present study demonstrates the efficacy of azelastine nasal spray in the treatment of vasomotor rhinitis. The best achieved results were a decrease in nasal obstruction and mucosal edema. Further studies are required to investigate if this therapeutic benefit results from H(1) antagonism or from another, not well-characterized pharmacological action of azelastine.  相似文献   

20.
An important function of the healthy nose is the ability to adjust nasal patency in response to stimuli such as a change in posture between sitting and supine. We hypothesised that the regulation of nasal patency would be impaired in patients with asthma and mild rhinitis and that it could be improved by reducing nasal inflammation with a topical nasal steroid. This is a randomised, placebo-controlled, double-blind, cross-over study comprising 19 subjects with well-controlled asthma and a history of rhinitis without current treatment. The subjects were randomised to fluticasone propionate aqueous nasal spray (Beconase®), 200 μg daily, or placebo (FESS® saline nasal spray), for 6 weeks in a cross-over design with a 4-week wash-out between treatments. Nasal patency was measured with acoustic rhinometry, while sitting and supine and with peak nasal inspiratory flow (PNIF). Treatment response was also monitored with spirometry, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Short Form-36 (SF-36), and The Pittsburgh Sleep Quality Index. The minimal cross-sectional area remained unchanged between sitting and supine at baseline and after placebo but after fluticasone propionate there was a significant decrease. PNIF, RQLQ and SF-36 improved after fluticasone propionate, whereas sleep quality did not change. In well-controlled asthma and mild rhinitis, nasal steroid treatment normalised the neurovascular response to posture in the nasal mucosa and improved health-related quality of life. An impaired ability to regulate nasal patency could be a marker of upper airway inflammation in patients with asthma that can be measured non-invasively.  相似文献   

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