Ebbens Fenna A, Scadding Glenis K, Badia Lydia, Hellings Peter W, Jorissen Mark, Mullol Joaquim, Cardesin Alda, Bachert Claus, van Zele Thibaut P J, Dijkgraaf Marcel G W, Lund Valerie, Fokkens Wytske J
Department of Otorhinolaryngology, Head and Neck Surgery, Academic Medical Center, Amsterdam, The Netherlands.
J Allergy Clin Immunol. 2006 Nov;118(5):1149-56. doi: 10.1016/j.jaci.2006.07.058.
Chronic rhinosinusitis (CRS) is one of the most common chronic diseases. Recently, it has been suggested that an exaggerated immune response to fungi is crucial in the pathogenesis of the disease. On the basis of this hypothesis, intranasal treatment with amphotericin B should benefit patients with CRS. Data from 2 uncontrolled and 2 controlled trials are conflicting, however.
To clarify the role of intranasal antifungal drugs in the treatment of CRS, we conducted a large, double-blind, placebo-controlled, multicenter study comparing the effectiveness of amphotericin B nasal lavages with placebo.
A total of 116 randomly selected patients with CRS were instructed to instill 25 mL amphotericin B (100 microg/mL) or placebo to each nostril twice daily for 3 months. Primary outcomes included a reduction in total visual analog scale (VAS) score and nasal endoscopy score. Secondary outcome measures included peak nasal inspiratory flow, polyp score, quality of life (Short Form-36, Rhinosinusitis Outcome Measure-31), and individual VAS scores.
Analysis was based on intention to treat and involved all patients randomly assigned. Mean VAS scores, Short Form-36 and Rhinosinusitis Outcome Measure-31 data, peak nasal inspiratory flow values, nasal endoscopy scores, and polyp scores were similar in both treatment groups at the time of randomization, and no significant differences were observed after 13 weeks of treatment.
Amphotericin B nasal lavages in the described dosing and time schedule do not reduce clinical signs and symptoms in patients with CRS.
Amphotericin B nasal lavages in the described dosing and time schedule are ineffective and therefore not advised in the treatment of patients with CRS.
慢性鼻-鼻窦炎（CRS）是最常见的慢性疾病之一。最近，有人提出对真菌的过度免疫反应在该疾病的发病机制中起关键作用。基于这一假设，两性霉素B鼻内治疗应对CRS患者有益。然而，来自2项非对照试验和2项对照试验的数据相互矛盾。
为阐明鼻内抗真菌药物在CRS治疗中的作用，我们进行了一项大型、双盲、安慰剂对照、多中心研究，比较两性霉素B鼻腔灌洗与安慰剂的疗效。
总共116例随机选择的CRS患者被指导每天两次向每个鼻孔滴入25 mL两性霉素B（100μg/mL）或安慰剂，持续3个月。主要结局包括视觉模拟量表（VAS）总分及鼻内镜评分降低。次要结局指标包括鼻吸气峰流量、息肉评分、生活质量（简明健康状况调查量表-36、鼻窦炎结局测量量表-31）以及个体VAS评分。
分析基于意向性治疗原则，纳入所有随机分组的患者。随机分组时，两个治疗组的VAS平均分、简明健康状况调查量表-36和鼻窦炎结局测量量表-31数据、鼻吸气峰流量值、鼻内镜评分及息肉评分相似，治疗13周后未观察到显著差异。
按所述给药剂量和时间安排进行两性霉素B鼻腔灌洗并不能减轻CRS患者的临床体征和症状。
按所述给药剂量和时间安排进行两性霉素B鼻腔灌洗无效，因此不建议用于CRS患者的治疗。
