[Efficacy and distribution pattern of the medical device Prima Difesa on rhinosinusal area]. / Efficacia e modalità di distribuzione del presidio medico Prima Difesa sul distretto rinosinusale.

AIM: Common cold is the commonest form of acute rhinitis and the first pathology of the upper airways. Viruses, the main responsible of this pathology, carry out their cytopathic effect on the ciliated cells of the airways mucosa. Mucociliary transport shows their dangerous effect. The aim of our study is to evaluate the effect of the medical device Prima Difesa on the functioning of the mechanism thanks to its composition and its distribution modality in the nasal cavities. MATERIALS AND METHODS: The present study has been performed on three groups of subjects with their informed consent: Group A (30 healthy subjects: 19 M, 11 F; 18-36 yrs, mean age: 29.1 yrs), Gruppo B (30 patients affected by rhinosinusal pathology: 7 M, 13 F; 19-38 yrs, mean age 30.7 yrs) and Group C (20 healthy subjects: 12 M, 8 F; 20-40 yrs, mean age: 32.2 yrs). The protocol of administration for the Group A and B, in order to evaluate the efficacy of Prima Difesa, consisted of 2 puff per nostril of Prima Difesa 4 times a day over 15 days. The follow-up of patients belonging to Grup A and Group B was articulated in three consecutive visits, each consisting of: anterior rhinoscopy, active anterior rhinomanometry, measurement of mucociliary transport (TMCt). The C patients underwent only one administration of the device to the extent of evaluating through endoscopy its distribution modality in the nasal cavities. RESULTS: The results show that clinical effects, evaluated in term of improvement of MCTt and in term of decreasing of nasal resistance, are particularly clear in patients with alterations of these parameters caused by rhinosinusal pathologies. The device can reach the "key" areas of rhinosinusal pathologies that are: middle turbinate and osteomeatal complex. Beside, the percentage of diffusion, about 30% of the middle turbinate head, justifies its clinical effect. CONCLUSIONS: The medical device Prima Difesa has resulted to be able in interfering with the correct maintenance and performance of the Mucociliary Transport mechanism, that represents an important aspecific machinery for the local defence of nasal mucosa by microbial injuries.

Do tryptase, ECP and specific IgE measurement by nasal incubation increase the specific nasal provocation test sensitivity?

The specific Nasal Provocation Test (sNPT) is a third level diagnostic tool. Fitted to reproduce natural exposure condition to pick the responsible allergen for nasal symptoms out, it is applied when prick test and RAST responses are doubtful. SNPT results have been evaluated measuring nasal resistance (anterior rhinomanometry) and nasal symptoms (clinical score), reaching 50% of sensitivity. This study focused on the determination of allergic response markers, triggered by nasal challenge: tryptase levels in the nose, specific IgE and ECP (Eosinophil Cationic Protein). The aim was to increase sNPT sensitivity. Twenty patients suffering from allergic rhinitis and 16 age-matched-nonallergic subjects were enrolled in the study. Tryptase, specific IgE and ECP were determined in nasal mucosa applying a new method, based on in situ incubation, before and after sNPT. The latter was performed following a standardized method. Tryptase levels increased in 13 patients (65%), were unchanged in four patients (20%), and slightly decreased in three patients (15%). The increase recorded was significant in mite allergic patients (p=0.005), but not significant (p> 0.05) in pollen allergic patients. ECP values increased in 13 patients (65%), were unchanged in two patients (10%), and highly decreased in five patients (25%). ECP increase was not significant (p> 0.05). Specific IgE levels increased in seven patients (35%), were unchanged in 11 patients (55%) and decreased in two patients (10%). The IgE increase was significant in pollen-allergic patients (p<0.05), while it was not significant in mite-allergic patients (p>0.05). Tryptase, ECP, and specific IgE were not detected in the control group. The data obtained showed a positive sNPT response in 12 patients (60%). Comparing our results with those derived from classical-parameter employment, we gathered an improvement of 10%. On the basis of the usual parameters, in fact, we recorded 50% positivity, while the use of mediators provided an additional 10% improvement in sNPT sensitivity: taking together the usual parameters and nasal allergic mediators values, we reached an sNPT over-all sensitivity of 85%.

[Specific nasal provocative test in allergic rhinitis diagnosis: reliability and standardization]. / Il test di provocazione nasale specifico nella diagnosi di rinite allergica: attendibilità e standardizzazione.

Specific vasomotorial rhinopathy, or allergic rhinitis is to be seen as a systemic pathology characterized by a condition of hyperactivity, the target organ of which is the nose. Particular attention, among the diagnostic tests, should be reserved to the specific nasal provocative test (sNPT), which has been part of the clinical routine for years but has nonetheless failed to achieve a suitable level of standardization. With this intent, we have devoted the present work to the assay of several phlogosis mediators (tryptase, specific IgE and ECP) before and after performing the sNPT. We have studied 20 patients affected by allergic rhinitis, aged between 13 and 61, with single or multiple allergen sensitivities, but in any case with a predominant sensitization, who underwent sNPT between October 2000 and July 2001. In every patients we performed ECP, tryptase and specific IgE assay via direct incubation in the nasal mucosa, before and after specific nasal provocation. The results of the sNPT (rhinomanometry and symptoms score) were compared with the variations in the phlogosis mediators assayed at nasal level. On the basis of the variations in the rhinomanometric resistance and symptoms score, the sNPT was positive in 10 patients (50%). Tryptase and specific IgE increased to a statistically significant degree (respectively, p = 0.01 and p < 0.05) in all of the patients; the ECP variations, instead, were not significant (p > 0.05). Overall, the simultaneous assay of ECP, tryptase and specific IgE, increasing the sensibility of the sNPT, enabled a positive result to be ascertained in 60% of the subjects examined. The method is furthermore based on the principle of local reactivity in that it assays the phlogosis mediators not at systemic level, but directly in the target organ, showing itself to be more specific than level I and II tests.