Lopatin A S, Ivanchenko O A, Soshnikov S S, Mullol J
Policlinic N. 1, Medical Department, Business Administration of the President of the Russian Federation, Moscow, Russia.
Consultative and Diagnostic Policlinic N. 121, Moscow Healthcare Department, Moscow, Russia.
Acta Otorhinolaryngol Ital. 2018 Apr;38(2):115-123. doi: 10.14639/0392-100X-1342.
Chronic rhinosinusitis (CRS) is an inflammatory disease of the nose and paranasal sinuses affecting 11% of the European population. Cyclamen europaeum plant extract (CE) has demonstrated efficacy in treating acute rhinosinusitis, but its role in CRS exacerbations remains unknown. In this real-life, prospective, epidemiological, observational study, a total of 317 patients with exacerbations of CRS without nasal polyps (CRSsNP) of moderate severity were treated using three different options: oral antibiotics, CE extract nasal spray, or the combination of oral antibiotic with CE extract. The main outcomes were the effect of treatment on sinonasal symptoms and endoscopic appearance after 6 weeks of therapy, and the number of recurrences of CRS exacerbations after 6 months of follow-up. On the top of oral antibiotics, CE extract significantly improved sinonasal symptoms and endoscopic findings and caused a 4-fold reduction of CRS recurrences. When administered in monotherapy, CE extract was at least as effective as antibiotic in monotherapy on relief of both symptoms and reduction of CRS recurrences. In patients with CRS exacerbation of moderate severity, CE extract nasal spray in monotherapy or added to standard antibiotic treatment significantly reduces sinonasal symptoms and CRS recurrences compared to antibiotics in monotherapy.
慢性鼻-鼻窦炎(CRS)是一种影响11%欧洲人口的鼻和鼻窦炎性疾病。欧洲仙客来植物提取物(CE)已证明在治疗急性鼻-鼻窦炎方面有效,但其在CRS加重期的作用尚不清楚。在这项真实、前瞻性、流行病学观察研究中,共有317例中度严重程度的无鼻息肉慢性鼻-鼻窦炎(CRSsNP)加重期患者接受了三种不同治疗方案:口服抗生素、CE提取物鼻喷雾剂,或口服抗生素与CE提取物联合治疗。主要结局为治疗6周后对鼻窦症状和内镜表现的影响,以及随访6个月后CRS加重期的复发次数。在口服抗生素基础上,CE提取物显著改善了鼻窦症状和内镜检查结果,并使CRS复发率降低了4倍。当单独使用时,CE提取物在缓解症状和降低CRS复发率方面至少与单独使用抗生素一样有效。在中度严重程度的CRS加重期患者中,与单独使用抗生素相比,单独使用CE提取物鼻喷雾剂或添加到标准抗生素治疗中可显著减轻鼻窦症状和CRS复发率。