Changes in local immune status in tonsillopharyngitis under pathogenic therapy with the BNO 1030 extract: a randomized, comparative, parallel-group, single-center study.

Aim of studyThe present study aimed to evaluate anti-inflammatory and immunomodulating properties of BNO 1030 (Tonsilgon(R) N) and its direct effect on the indicators of the local immunity of oropharyngeal mucosa in patients with acute tonsillopharyngitis (TP) or exacerbation of chronic TP without evident systemic inflammatory syndrome. Materials and methodsA total of 60 adult patients with acute TP or exacerbation of chronic TP without severe systemic inflammatory syndrome were randomly divided into 2 groups: Group 1 L 30 patients took BNO 1030 (Tonsilgon(R) N), Group 2 L 30 patients took sage tablets according to the summary of product characteristics during 7 days. During 3 visits (day 1, day 3, day 7) symptoms and oropharyngeal mucosa condition were evaluated using a 10-point visual analogue scale (VAS). Local immunity parameters of oropharyngeal mucosa (cytokines: IL-1{beta}, IL-6, IL-8, IL-10, IL-17, TNF-, and lysozyme, lactoferrin, sIgA) were determined by ELISA and by real time polymerase chain reaction. ResultsReduction of the main symptoms was significantly faster under BNO 1030 therapy than under sage therapy. In BNO 1030 group reduction of clinical symptoms correlated with the onset of action and the local immunological parameters. During BNO 1030 treatment IL-1{beta}, IL-6, and IL-8 mRNA levels decreased below the levels in healthy controls, while, the immune factors lysozyme, lactoferrin and sIgA increased. Therapy with sage tablets did not affect local immunity parameters. ConclusionBoth treatment regimens resulted in elimination of clinical signs and mucosal pharyngeal barrier regeneration. In contrast to the sage tablets, BNO 1030 can also affect local mucosal immunity via regulating the balance of pro- and anti-inflammatory factors. Study highlightsO_LIThis study can answer the question regarding influence on main local immunity parameters of subjects with tonsillitis C_LIO_LIThe one of main task of this study is to evaluate what local immune parameters of oral cavity are most changeable C_LIO_LITonsilgon N usage is not decrease main local immunity parameters such as IL-1{beta}, IL-8, lysozyme and lactoferrin C_LIO_LIThis study evaluated the functional condition of mucosal immunity of oral cavity in subjects with tonsillopharingitis C_LI