Safety and tolerability of surfactant nasal irrigation
Safety and tolerability of surfactant nasal irrigation
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DOI：
10.1002/alr.21959
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发表时间：
2017-08-01
影响因子：
6.4
通讯作者：
Chandra, Rakesh K.
中科院分区：
文献类型：
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作者：
Turner, Justin H.;Wu, Jeffanie;Chandra, Rakesh K.
背景：异常的粘液成分和细菌生物膜被认为是鼻窦炎的病理生理学原因。假设向盐水冲洗液中添加粘液活性表面活性剂可解决这些因素。我们在正常受试者样本中评估了重新配制的表面活性剂的安全性和耐受性。方法：在对照交叉研究设计中，共有33名志愿者被随机分配在基线时接受表面活性剂溶液或缓冲盐水。每名受试者都接受了内窥镜检查和通过40个问题的气味识别测试（SIT）进行的办公室气味测试。排除了非正常嗅觉结果或活动性鼻炎症状的患者。指导受试者每天用所选溶液冲洗两次，持续1周，同时记录每日日记。第2周，停止治疗。在第3周期间，每组转换为另一种治疗。考试，SIT，和充血程度进行了评估后，每个phase.Results：使用表面活性剂导致边际减少平均SIT评分为1.5分，这是统计学显著（p = 0.012）。在表面活性剂组18%（6/33）的受试者中观察到SIT评分有临床意义的降低（定义为>= 4分），而在生理盐水组3%（1/33）的受试者中观察到SIT评分有临床意义的降低（p = 0.046）。在表面活性物质治疗期，29%（8/28）完成日志的受试者报告中度或重度充血。相比之下，只有6%（2/32）的受试者报告中度充血后，盐水阶段（p = 0.021）。结论：在正常志愿者，表面活性剂鼻腔冲洗可能与耐受性问题，由于充血。一个子集可能会出现嗅觉敏锐度下降，这似乎是可逆的。(C)2017 ARS-AAOA，LLC.
Background: Abnormal mucus composition and bacterial biofilms are thought to contribute to the pathophysiology of rhinosinusitis. Addition of a mucoactive surfactant to saline irrigation solution has been hypothesized to address these factors. We evaluated the safety and tolerability of a reformulated surfactant in a sample of normal subjects.Methods: A total of 33 volunteers were randomly assigned to receive either surfactant solution or buffered saline at baseline in a controlled crossover study design. Each subject underwent rhinoscopic exam and in-office smell testing via the 40-question smell identification test (SIT). Those with non-normosmic results or active rhinitis symptoms were excluded. Subjects were instructed to irrigate twice daily with the selected solution for 1 week while keeping a daily diary. For week 2, treatment was stopped. During week 3, each group switched to the other treatment. Exam, SIT, and degree of congestion were assessed after each phase.Results: Use of surfactant led to a marginal reduction in mean SIT score of 1.5 points, which was statistically significant (p = 0.012). A clinically meaningful reduction in SIT score, defined as >= 4 points, was observed in 18% (6/33) of subjects after surfactant vs 3% (1/33) after saline (p = 0.046). During the surfactant phase, moderate or severe congestion was reported in 29% (8/28) of subjects completing the diary. In contrast, only 6% (2/32) of subjects reported moderate congestion after the saline phase (p = 0.021).Conclusion: In normal volunteers, surfactant nasal irrigation may be associated with tolerability issues due to congestion. A subset may experience reduction in olfactory acuity that appears reversible. (C) 2017 ARS-AAOA, LLC.