Hyaluronan Plus Saline Nasal Washes in The Treatment of Rhino-sinusal Symptoms

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Hyaluronan Plus Saline Nasal Washes in The Treatment of Rhino-sinusal Symptoms in Patients Undergoing Functional Endoscopic Sinus Surgery for Rhino-Sinusal Remodeling

Article specifications

This Randomized Controlled Study was published in 2013 in international journal of immunopathology and pharmacology (IF 2013:2.04) by Italian specialist. This pilot study was aimed at evaluating the effects of nebulized 9 mg of sodium hyaluronate given for 15 days per months over 3 months in 46 patients aged> 4 years who underwent functional endoscopic sinus surgery (FESS) for rhino-sinusal remodeling. Eligible patients were randomized to receive nebulized 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 nebulization of particles with a median aerodynamic diameter> 10 micron, i.e., suitable for upper respiratory airways deposition. The efficacy variables included clinical (presence of nasal dyspnea), 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.

 

Results

Treatment with 9 mg of sodium hyaluronate was associated with significantly greater improvements compared to controls in nasal dyspnea, presence of mycetes, ciliary motility 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 dyspnea, normal mucosa at endoscopy ciliary motility and presence of bio film. Treatment with 9 mg sodium hyaluronate plus saline was well tolerated.

Tags: Italy international journal of immunopathology and pharmacology Clinical trial 2013

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