Ann Clin Otolaryngol | Volume 6, Issue 1 | Research Article | Open Access

Multicenter, Randomized, Open-Label, Comparative Study of Therapeutic Efficacy, Safety and Tolerability of BNO 1030 Application in the Technology of Delayed Prescription of Antibiotics in Patients with Severe Acute Tonsillitis

Popovych VI*, Koshel IV, Malofiichuk OM, Pyletska LI, Semeniuk OO, Martynnyk OV, Orlovska RM and Leta OI

Department of Ivano-Frankivsk National Medical University, Ukraine

*Correspondance to: Popovych VI 

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Abstract

Acute bacterial tonsillitis occurs in 20% to 30 % of children; however, the frequency of antibacterial drug prescriptions reaches up to 90%. Delayed antibiotic prescription is recommended by current guidelines. The study objective was to determine the efficacy of phytoneering extract BNO 1030 in the technology of delayed antibiotic prescription in patients with severe acute tonsillitis. Materials and Methods: In the multicenter, randomized, open-label, interventional comparative study, 182 children with acute tonsillitis aged 6 to 12 years completed the study. Evaluation Criteria: Dynamics of sore throat when swallowing and at rest, throat irritation at rest, hyperemia of the tonsils according to a 4-point scale compared to visit 1, dynamics of selfassessment of general well-being, sore throat and difficulty swallowing according to a 10 point VAS, frequency of antibiotic prescriptions, “therapeutic benefit” from BNO 1030 in days. Results: The use of BNO 1030 in addition to the standard treatment of severe acute tonsillitis provides a clinically significant, adequate reduction in the symptom severity assessed by a physician at V2 and in accordance to the patient’s self-assessment of the symptoms from treatment Day 2. This allows to reduce the duration of antipyretic administration. In the first days of treatment, when a decision on delay of antibiotic prescription is made, a “therapeutic gain?” in two days in patients of the treatment group was observed compared to the control group. The use of BNO 1030 in patients with severe acute tonsillitis significantly reduces, by 43.7% or 2.3 times, the need for antibiotic therapy as part of the technology of delayed antibiotic prescription (p<0.005). Conclusion: BNO 1030 is safe and effective for the treatment of severe acute tonsillitis in children aged 6 to 12 years. It provides a significant “therapeutic benefit” when administered in addition to standard symptomatic therapy and reduces the irrational antibiotic prescription.

Keywords:

Severe acute tonsillitis; Delayed antibiotic therapy; BNO 1030

Citation:

Popovych VI, Koshel IV, Malofiichuk OM, Pyletska LI, Semeniuk OO, Martynnyk OV, et al. Multicenter, Randomized, Open-Label, Comparative Study of Therapeutic Efficacy, Safety and Tolerability of BNO 1030 Application in the Technology of Delayed Prescription of Antibiotics in Patients with Severe Acute Tonsillitis. Ann Clin Otolaryngol. 2021; 6(1): 1049..

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