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):24-29. doi: 10.23750/abm.v90i7-S.8654.
Inflammation is a common pathogenic mechanism involved in many otorhinolaryngological (ORL) disorders. Broncalt® is a class II Medical Device containing: thermal water (Medesano, PR, Italy), hyaluronic acid, and grapefruit seed extract. It has been reported that it exerted 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 acute upper airways disease. The 3,533 (1,797 males, mean age 43.5 years) patients were evaluated at baseline (T0) and after a 2-week treatment (T1) with or without Broncalt®. Signs and symptoms severity were measured by visual analogue scale. Broncalt® significantly and safely diminished the clinical features in all sub-groups (p<0.001 for all). Interestingly, Broncalt® significantly induced a faster symptom relief already within 3 days after the start of the treatment. In conclusion, Broncalt® is a class II Medical Device able to exert a safe and effective activity in patients with acute ORL disorders.
炎症是许多耳鼻咽喉科（ORL）疾病常见的致病机制。Broncalt®是一种二类医疗器械，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。据报道，由于这些成分，它具有安全有效的抗炎、冲洗和抗菌活性。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急性上呼吸道疾病患者中的安全性和有效性。对3533名患者（1797名男性，平均年龄43.5岁）在基线（T0）以及接受或未接受Broncalt®治疗2周后（T1）进行评估。通过视觉模拟量表测量体征和症状的严重程度。Broncalt®在所有亚组中均显著且安全地减轻了临床症状（所有p<0.001）。有趣的是，Broncalt®在治疗开始后3天内就显著加快了症状缓解速度。总之，Broncalt®是一种二类医疗器械，能够在急性ORL疾病患者中发挥安全有效的作用。
