Cupido Gian Franco, Gelardi Matteo, La Mantia Ignazio, Aragona Salvo Emanuele, Vicini Claudio, Ciprandi Giorgio, Otorhinolaryngological Disorders Italian Study Group On Inflammatory
ENT Department, University of Palermo, Palermo, Italy.
Acta Biomed. 2019 Jul 10;90(7-S):30-35. doi: 10.23750/abm.v90i7-S.8655.
Inflammation and infection are common pathogenic mechanisms involved in many otorhinolaryngological (ORL) chronic diseases. Broncalt® is a class II Medical Device containing: thermal water (Medesano, PR, Italy), hyaluronic acid, and grapefruit seed extract. It could exert a safe and effective anti-inflammatory, washing, and antimicrobial activity by virtue of these components. Therefore, the aim of the current survey, conducted in clinical practice of 84 Italian ORL centers, was to evaluate its safety and efficacy in the treatment of patients with chronic upper airways disease. The 1,817 (958 males, mean age 49 years) patients were evaluated at baseline (T0) and after one (T1) and two (T2) weeks of treatment, they were treated or not treated with Broncalt®. Signs and symptoms severity were measured by visual analogue scale. Broncalt® significantly, quickly, and safely diminished the clinical features in all sub-groups (p<0.001 for all). In conclusion, Broncalt® is a class II Medical Device able to exert a safe, quick, and effective activity in patients with chronic ORL disorders.
炎症和感染是许多耳鼻咽喉科（ORL）慢性疾病常见的致病机制。Brocalt®是一种II类医疗器械，含有：温泉水（意大利普拉亚德梅德萨诺）、透明质酸和葡萄柚籽提取物。凭借这些成分，它可以发挥安全有效的抗炎、清洗和抗菌活性。因此，本次在意大利84个ORL中心的临床实践中进行的调查旨在评估其在治疗慢性上呼吸道疾病患者中的安全性和有效性。1817名患者（958名男性，平均年龄49岁）在基线（T0）以及治疗1周（T1）和2周（T2）后进行评估，他们接受或未接受Brocalt®治疗。通过视觉模拟量表测量体征和症状的严重程度。Brocalt®在所有亚组中均显著、快速且安全地减轻了临床症状（所有p<0.001）。总之，Brocalt®是一种II类医疗器械，能够在慢性ORL疾病患者中发挥安全、快速且有效的作用。
