Lysozyme-Enzybiotic with Valuable Effects in Prevention and Treatment of Postoperative Complications in Adult Patients After Bilateral Tonsillectomy

摘要

Introduction: Enzybiotics are enzymes with antimicrobial and immunomodulatory activity. The aim of this study was to investigate the effectiveness and safety of enzy-biotic lysozyme in combination with pyridoxine for the prevention and treatment of postoperative complications after bilateral tonsillectomy. Materials and Methods: The study was designed as randomized controlled, parallel-group, open, prospective, multicenter clinical study in adult patients after bilateral tonsillectomy. 160 patients were randomized to the lysozyme + pyridoxine or control group. Efficacy was evaluated by: Visual analog scale (for pain), clinical signs (for wound healing and postoperative complications), and the need for treatment (with analgesics and systemic antimicrobials). Safety was evaluated by reporting adverse effects. Results: Lysozyme + pyridoxine was superior to control with respect to the pain reduction (starting already from the first day of treatment), the reduction of local fibrin deposits and the need for analgesics. No statistically significant difference was seen regarding local bleeding (less than 15% patients in both groups) and infection (less than 5% patients in both groups). Systemic antibiotics were used by 16 patients (19.1%) in lysozyme + pyridoxine group and 24 patients (31.6%) in control group (no statistical difference, P > 0.050). Conclusion: Lysozyme + pyridoxine showed beneficial effects in respect of suppression of pain with subsequent lower need for analgesics, as well as in the faster process of healing of postoperative scar. Moreover, next to its suitability for application, lysozyme + pyridoxine lozenges showed excellent tolerability and safety profile.