Топические этиотропные препараты в терапии инфекционно- воспалительных заболеваний глотки у детей дошкольного возраста. Результаты многоцентрового рандомизированного сравнительного клинического исследования

Abstract

In accordance with modern clinical guidelines, systemic antibiotic therapy for infectious and inflammatory diseases of the throat is recommended only when beta-hemolytic group A streptococcus is detected. In other cases, it is advisable to use topical drugs of etiotropic, pathogenetic and symptomatic action. The combined preparation Grammidin® has a wide spectrum of etiotropic activity (antiviral, antibacterial and antifungal). Objective of the study: to assess the safety and efficacy of the use of Grammidin® for children (dosage form – metered spray) in the treatment of inflammatory diseases of the pharynx in preschool children. Materials and methods. An open comparative multicenter randomized study was carried out in two parallel groups with the participation of 160 patients aged 3–5 years with an infectious-inflammatory disease of the pharynx of nonstreptococcal etiology. The disease was established clinically by the presence of: a symptom of «sore throat» according to the Wong-Baker (WB) scale, as well as two or more local signs of acute inflammation of the oropharynx (hyperemia of the pharyngeal mucosa, edema of the pharyngeal mucosa, edema of the soft tissues of the posterior and lateral pharyngeal walls, an increase in lymphoid granules of the posterior pharyngeal wall and lateral columns, swelling of the uvula) according to pharyngoscopy. The randomized patients received Grammidin® for children or Hexoral® for 7 days according to the instructions for medical use. Safety was assessed by the incidence of adverse events (AEs) and by monitoring vital signs (body temperature, blood pressure, respiration and heart rate) with monitoring of blood and urine tests. Efficacy was assessed by the decrease in mean disease severity (modified TSS) at visit 2 from baseline – the primary endpoint. Changes were used as secondary endpoints: the severity of the disease (TSS scale), the severity of the sore throat symptom (WB scale), the severity of each of the catarrhal symptoms initially identified according to pharyngoscopy data, the proportion of patients with no sore throat (WB scale), the proportion of patients with the absence of all catarrhal phenomena (pharyngoscopy) at visits 2 and 3. Results. Primary efficacy endpoint: change in mean disease severity on the TSS scale at Visit 2 from baseline in Group 1 was –1,80 (95% CI –1,98 – –1.61) points and –1,31 (95 % CI –1,50 – –1,12) points - in group 2 (p = 0.003). Secondary performance endpoints. According to the analysis of variance in Group 1, there was a statistically significant predominance of the therapeutic effect throughout the treatment in relation to the severity of the disease on the Total Symptoms Score (TSS) scale (p = 0,006), the severity of sore throat on the WB scale (p = 0,006), as well as the severity of individual signsof the disease: «Hyperemia of the pharyngeal mucosa» (p = 0,036) and «edema of the pharynx» (p = 0,037). The rates of relief of symptoms: «the severity of lymphoid granules of the posterior pharyngeal wall and lateral columns» and «uvula edema» were similar in both groups. The proportion of children with no sore throat at visit 2 was statistically significantly different: 46 and 29% for Group 1 and Group 2, respectively (p = 0,022). Safety assessment. In the course of the study, 1 child was registered in each group who developed 1 AE of mild severity, had a doubtful connection with the study drugs, did not require their cancellation and additional therapy, and spontaneously ended without consequences by visit 3. Conclusions. The combined drug Grammidin® for children in the form of a metered spray was well tolerated by children aged 3–5 years and according to a number of main criteria of efficacy (total severity of symptoms of the disease, sore throat, hyperemia and swelling of the pharyngeal mucosa) showed a pronounced and statistically significant advantage in speed and severity effect over a monocomponent preparation containing hexetidine in the form of an aerosol.