[Experimental and clinical evaluation of the safety and efficacy of Polydexa spray with phenylephrine in acute rhinosinusitis].

Abstract

Relevance: Acute rhinosinusitis is one of the most common ENT diseases. Topical complex nasal spray Polydexa with phenylephrine (PE), which includes an aminoglycoside antibiotic, is effective as a local therapy. There are no data on the toxic effects of Polydexa with PE in the medical literature. However, additional evidence will help remove restrictions on the use of Polydexa with PE spray, will help reduce the uncontrolled use of systemic antibiotics and reduce the growth of antibiotic resistance.

Objective: To improve the treatment results for patients with acute rhinosinusitis through the use of Polydexa with PE nasal spray, taking into account the experimental and clinical assessment of its safety and efficacy.

Material and methods: For the experimental part, 20 linear male mice aged 10 weeks were used. For 10 days, 3 times a day, 8 individuals were intranasally administered Polydexa with PE at a dose of 30 μl. To evaluate the experimental results, histological and morphometric studies of the olfactory structure tissues on the 10th day were used. The clinical part of the study included 70 patients (38 (54%) women, 32 (45%) men) with acute sinusitis aged 18 to 60 years, half of whom (n=35) used the intranasal spray Polydexa with PE at 1 dose 5 times a day for 7 days. To evaluate the clinical results, a visual analogue scale, endoscopic examination of the nasal cavity and assessment of olfactory thresholds using the RVSS test were used.

Results and discussion: According to the experimental study, there were no direct toxic and destructive lesions of the olfactory structures in mice against the background of local administration of Polydexa with PE. In addition, the results confirm the role of inflammation in olfactory impairment and the importance of olfactometry in the diagnosis of acute sinusitis. The clinical study data showed that local therapy with nasal spray Polydexa with PE compared to the control allowed to reduce the intensity of complaints by 2.8 times and the inflammatory picture in the nasal cavity by 1.7 times, which contributed to a 4.5-fold decrease in the frequency of systemic antibiotic use. The use of nasal spray Polydexa with PE led to the restoration of the sense of smell in 94.3% of patients, which confirms the absence of a neurotoxic effect on the olfactory nerve and olfactory epithelium.

Conclusion: As a result of the experimental and clinical study, the safety and efficacy of the complex nasal spray Polydexa with PE in acute rhinosinusitis were reliably proven, which allows its wider use as monotherapy and as part of a combined treatment for inflammation of the nose and paranasal sinuses.