STUDI CLINICI
Sezione riservata ai signori medici
Otorinolaringoiatri e pediatri, nella loro pratica clinica, spesso raccomandano i lavaggi nasali nelle patologie infiammatorie acute e croniche del distretto naso-sinusale; il loro utilizzo infatti è associato a un netto miglioramento dei segni e sintomi, a un minore consumo di farmaci, come antibiotici, corticosteroidi locali e sistemici, decongestionanti, e a un minor tasso di riacutizzazioni nelle forme croniche.
Cinque recenti studi clinici effettuati su adulti e bambini, utilizzando una soluzione salina arricchita con 9 mg di Acido Ialuronico, hanno dimostrato che Otosan® Nasal Wash velocizza la guarigione ed è significativamente più efficace rispetto ai lavaggi a base di sola soluzione salina.
STUDIO 1
Studio su pazienti adulti sottoposti ad operazione chirurgica: 23 trattati con soluzione salina+Acido Ialuronico; 23 con sola soluzione salina
Gruppo soluzione salina+Acido Ialuronico 9 mg
|
STUDIO IN DOPPIO CIECO |
Baseline: nr. pazienti riportanti problema |
Conclusione: nr. pazienti riportanti problema |
% di guarigione |
|---|---|---|---|
|
Dispnea nasale |
23 | 0 | 100% |
|
Apertura seni paranasali |
19 | 4 | 79% |
|
Motilità ciliare |
23 | 3 | 87% |
|
Biofilm batterico |
11 | 0 | 100% |
Gruppo sola soluzione salina
|
STUDIO IN DOPPIO CIECO |
Baseline: nr. pazienti riportanti problema |
Conclusione: nr. pazienti riportanti problema |
% di guarigione |
|---|---|---|---|
|
Dispnea nasale |
22 | 18 | 18% |
|
Apertura seni paranasali |
17 | 8 | 53% |
|
Motilità ciliare |
23 | 12 | 47% |
|
Biofilm batterico |
8 | 4 | 50% |
Abstract: “Hyaluronic acid is a major component of many extracellular matrices and plays a central role in the homeostasis of physiology in upper and lower airways. When topically administered following endoscopic sinus surgery, hyaluronic acid may be effective in functional recovery and in the prevention of recurrence of chronic rhinosinusistis. This pilot study was aimed at evaluating the effects of nebulised 9 mg of sodium hyaluronate given for 15 days per months over 3 months in 46 patients aged greater than 4 years who underwent functional endoscopic sinus surgery (FESS) for rhino-sinusal remodelling. Eligible patients were randomized to receive nebulised 9 mg sodium hyaluronate nasal washes plus saline solution or 5 ml saline alone (23 patients in each group), according to an open-label, parallel group design, with blind observer assessment. Treatment was administered by means of a nasal ampoule that allows nebulisation of particles with a median aerodynamic diameter greater than 10 micron, i.e. suitable for upper respiratory airways deposition. The efficacy variables included clinical (presence of nasal dyspnoea), endoscopical (ostium of paranasal sinuses, oedema, respiratory patency, synechiae, and appearance of nasal mucosa) and cytological (ciliary motility and presence of neutrophils, eosinophils, mast cells, bacteria, mycetes and bio film) measures. At the end of the study, patients expressed an opinion on the overall tolerability of treatment. The two treatment groups were comparable at baseline. Treatment with 9 mg of sodium hyaluronate was associated with significantly greater improvements compared to controls in nasal dyspnoea (p less than 0.001), presence of mycetes (p = 0.044), ciliary motility (p less than 0.001) and abnormalities in nasal secretions. A univariate logistic model, in which the odd ratio (OR) indicates the probability of success in the 9 mg sodium hyaluronate group compared to the control group, showed that the highest OR was observed for presence of nasal dyspnoea (OR = 21.36; 95 percent CI: 1.07 to 426.56), normal mucosa at endoscopy (OR: 9.62; 95 percent CI: 1.82 to 50.89), ciliary motility (OR: 7.27; 95 percent CI: 1.68 to 31.42) and presence of bio film (OR: 4.41; 95 percent CI: 1.26 to 15.40). Treatment with 9 mg sodium hyaluronate plus saline was well tolerated. A 3-month intermittent treatment with 9 mg sodium hyaluronate plus saline solution nasal washes following FESS for rhino-sinusal remodelling was associated with significant improvements in nasal dyspnoea, appearance of nasal mucosa at endoscopy and ciliary motility compared to saline alone.”
STUDIO 2
Studio su bambini con ricorrenti infezioni respiratorie: 38 trattati con soluzione salina+Acido Ialuronico; 37 con sola soluzione salina
Gruppo soluzione salina+Acido Ialuronico 9 mg
|
STUDIO IN DOPPIO CIECO |
Baseline: nr. pazienti riportanti problema |
Conclusione: nr. pazienti riportanti problema |
% di guarigione |
|---|---|---|---|
|
Dispnea nasale |
37 | 25 | 33% |
|
Apertura seni paranasali |
38 | 17 | 55% |
|
Motilità ciliare |
29 | 19 | 35% |
|
Biofilm batterico |
19 | 4 | 79% |
Gruppo sola soluzione salina
|
STUDIO IN DOPPIO CIECO |
Baseline: nr. pazienti riportanti problema |
Conclusione: nr. pazienti riportanti problema |
% di guarigione |
|---|---|---|---|
|
Dispnea nasale |
32 | 28 | 12% |
|
Apertura seni paranasali |
34 | 30 | 11% |
|
Motilità ciliare |
30 | 27 | 10% |
|
Biofilm batterico |
16 | 14 | 12% |
Abstract: “Hyaluronic acid is a major component of many extracellular matrices that plays a role in the regulation of vasomotor tone and mucous gland secretion, and in the modulation of the inflammatory process in upper and lower airways. This pilot study was aimed at evaluating the effects of nasal washes with 9 mg nebulised sodium hyaluronate given for 15 days per month over 3 months in 75 paediatric patients with recurrent upper respiratory tract infections (URTI). Eligible patients were randomized to treatment with nasal washes containing 9 mg sodium hyaluronate plus saline solution or saline alone, according to an open-label, parallel group design, with blind observer assessment. Ciliary motility, which was assessed based on a 0–3 point rating scale (0 = absent, 1 = < 5 minutes, 2 = ≥ 5 and ≤ 10 minutes, 3 = > 10 minutes) was the primary study endpoint. The secondary efficacy variables included cytological (presence of neutrophils, eosinophils and mast cells), microbiological (presence of bacteria and mycetes), endoscopical (presence of adenoid hypertrophy and biofilm) and clinical (presence of rhinitis, post-nasal drip, nasal dyspnoea) parameters. The two treatment groups (mean age 7.5 years, 53% of males) were comparable for baseline data, except a higher mean age in the control group than in the treated group. Treatment with 9 mg sodium hyaluronate was associated with significantly greater improvements (p<0.001 between groups) in primary outcome ciliary motility [odds ratio (OR) 13.61; 95% CI 4.51–41.00 in the univariate regression analysis that examined the probability of improvement]. Treatment with 9 mg sodium hyaluronate was also significantly superior to saline alone in adenoid hypertrophy (p<0.001; OR 14.72; 95% CI 4.74–45.68), presence of bacteria (p = 0.026; OR 2.95; 95% CI 1.15–7.55), neutrophils (p = 0.002; OR 4.51; 95% CI 1.75–11.62), rhinitis (p = 0.040; OR 10.47; 95% CI 3.10–35.31), nasal dyspnoea (p = 0.047; OR 3.80; 95% CI 1.09–13.19) and biofilm (p = 0.049; OR 9.90; 95% CI 2.61–37.47). Advantages of 9 mg of sodium hyaluronate over control on postnasal drip and presence of mycetes (although evident) did not reach the level of statistical significance. The superiority of the treated group over saline alone was confirmed in a multivariate logistic regression analysis that took into account age as confounding factor. The number of days of absence from school was significantly lower in the 9 mg sodium hyaluronate group compared to controls (p<0.001 between groups). A 3-month intermittent treatment with 9 mg sodium hyaluronate with nasal washes plus saline solution was associated with significant improvements in ciliary motility and in cytological, microbiological, endoscopic and clinical outcomes compared to saline, in children with recurrent URTI.”
STUDIO 3
Studio osservazionale su 20 pazienti adulti trattati con Otosan® Nasal Wash: 10 affetti da rino-sinusite; 10 sottoposti ad intervento chirurgico
Otosan® Nasal Wash si è dimostrato un efficace trattamento delle rino-sinusiti e nel postoperatorio, in quanto favorisce un’adeguata pulizia delle cavità nasali rimuovendo le secrezioni in eccesso e stimolando il rispristino del trasporto mucociliare. La pressione del getto, modulabile, permette di disgregare il biofilm batterico.
Significativa riduzione di bruciore e gonfiore, buon grado di cicatrizzazione
Naso libero da secrezioni e significativa riduzione del gonfiore.
Miglioramento sia in caso di rino-sinusiti sia nel postoperatorio
Revello F., VALUTAZIONE CLINICA OTOSAN NASAL WASH, Torino, Italia, 2018.
Altri studi
ABSTRACT
Background: To determine the effect of intranasal sodium hyaluronate on mucociliary clearance time following functional endoscopic sinus surgery in patients with nasal polyposis.
Study design: Randomized, controlled, blinded study.
Methods: Thirty-six patients with grade II nasal polyposis undergoing functional endoscopic sinus surgery received intranasal sodium hyaluronate 9 mg twice daily or saline for 30 days commencing on the second day after surgery. Ciliary mucous transport time was assessed using charcoal powder and saccharin administered during rhinoscopy. Other outcomes included changes in symptoms, endoscopic appearance of the nasal mucosa, and tolerability.
Results: Patients receiving sodium hyaluronate had a significantly faster mucociliary clearance time at 1 month compared with controls (14.3 +/- 2.5 vs. 23.6 +/- 3.3 minutes; p = 0.000). Furthermore, sodium hyaluronate recipients experienced a lower incidence of rhinorrhea, less nasal obstruction and a lower incidence of exudate on endoscopy than control subjects at 1 month (all p < 0.05). Sodium hyaluronate was well tolerated in patients following functional endoscopic sinus surgery.
Conclusion: The use of intranasal sodium hyaluronate in patients undergoing functional endoscopic sinus surgery for nasal polyposis augmented the improvement in mucociliary clearance observed following this procedure and improved several clinical and endoscopic parameters. These data provide encouraging evidence of the beneficial effects of sodium hyaluronate in the care of patients undergoing functional endoscopic sinus surgery with which to continue the development of the product for this indication.
Clicca per leggere lo studio completo.
Gelardi M. et al., EFFECT OF SODIUM HYALURONATE ON MUCOCILIARY CLEARANCE AFTER FUNCTIONAL ENDOSCOPIC SINUS SURGERY, Eur Ann Allegri Clin Immunol, Vol 45, N 3, 103-108, 2013.
ABSTRACT
Hyaluronan, a ubiquitous naturally occurring glycosaminoglycan, is a major component of the extracellular matrix, where it participates in biological processes that include water homeostasis, cell-matrix signaling, tissue healing, inflammation, angiogenesis, and cell proliferation and migration. There are emerging data that hyaluronan and its degradation products have an important role in the pathobiology of the respiratory tract. We review the role of hyaluronan in respiratory diseases and present evidence from published literature and from clinical practice supporting hyaluronan as a novel treatment for respiratory diseases. Preliminary data show that aerosolized exogenous hyaluronan has beneficial activity against airway inflammation, protects against bronchial hyperreactivity and remodeling, and disrupts the biofilm associated with chronic infection. This suggests a role in airway diseases with a predominant inflammatory component such as rhinosinusitis, asthma, chronic obstructive pulmonary disease, cystic fibrosis, and primary ciliary dyskinesia. The potential for hyaluronan to complement conventional therapy will become clearer when data are available from controlled trials in larger patient populations.
Clicca per leggere lo studio completo.
Garantziotis S., Brezina M., Castelnuovo P., Drago L., THE ROLE OF HYALURONAN IN TREATMENT OF RESPIRATORY DISEASES, Am J Physiol Lung Cell Mol Physiol 310: L785–L795, 2016.
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