Emberlin J C, Lewis R A
National Pollen and Aerobiology Research Unit, University of Worcester, Worcester, UK.
Curr Med Res Opin. 2009 Jul;25(7):1635-44. doi: 10.1185/03007990903024699.
The objective was to investigate the effect of intranasal phototherapy delivered by a phototherapy device (allergy reliever SN-206) on symptoms of hay fever (seasonal rhinitis) due to grass pollen in adults. This registered class IIA medical device had been on sale for 15 months with no adverse effects reported but there had been no assessment of efficacy. Previous research had indicated that phototherapy could alleviate symptoms of allergic rhinitis but no double-blind, placebo-controlled trails had been done.
The trial is a double-blind, placebo-controlled grass pollen challenge conducted out of the pollen season, on 101 adult male and female hay fever sufferers. Subjects were assigned to placebo or active groups by stratified random sampling using responses to a baseline questionnaire. All subjects used active or placebo devices three times a day for 14 days before pollen challenge. Subjects were monitored for 2.5 h after challenge.
Primary outcome measures were observed severity scores for sneezing, running eyes, running nose, and the amount of eosinophil cationic proteins (ECP) in nasal secretions. Secondary outcome measures were symptom scores by subject report (itching eyes, itching nose, itching throat, itching mouth/palate), and nasal peak inspiratory flow (PIFn) and peak expiratory flow (PEFn).
Significant reductions in severity of symptom scores were found for sneezing, running nose, running eyes and itchy mouth/palate (p < or = 0.05). No significant differences were found in the results for itchy eyes, itchy nose, itchy throat, ECPs, PIFn and PEFn. No adverse events occurred.
The results show that the device significantly reduced some hay fever symptoms. The study would have been improved if compliance was monitored electronically and if nasal congestion was monitored by report. The mode of action is unclear. The study does not consider long-term implications of the therapy.
本研究旨在探讨一款光疗设备（过敏缓解仪SN - 206）经鼻光疗对成年患者因草花粉引起的花粉症（季节性鼻炎）症状的影响。这款已注册的IIA类医疗器械已上市销售15个月，尚无不良反应报告，但尚未进行疗效评估。此前的研究表明光疗可能缓解过敏性鼻炎症状，但尚未开展双盲、安慰剂对照试验。
本试验是一项在花粉季节之外进行的双盲、安慰剂对照草花粉激发试验，受试对象为101名成年花粉症男女患者。根据对基线问卷的回答，通过分层随机抽样将受试者分配到安慰剂组或治疗组。在花粉激发试验前，所有受试者每天使用治疗设备或安慰剂三次，持续14天。激发试验后对受试者进行2.5小时的监测。
主要观察指标包括观察到的打喷嚏、流眼泪、流鼻涕的严重程度评分，以及鼻分泌物中嗜酸性粒细胞阳离子蛋白（ECP）的含量。次要观察指标包括受试者报告的症状评分（眼睛瘙痒、鼻子瘙痒、喉咙瘙痒、口腔/上颚瘙痒），以及鼻吸气峰流速（PIFn）和呼气峰流速（PEFn）。
打喷嚏、流鼻涕、流眼泪和口腔/上颚瘙痒的症状严重程度评分显著降低（p≤0.05）。眼睛瘙痒、鼻子瘙痒、喉咙瘙痒、ECP、PIFn和PEFn的结果未发现显著差异。未发生不良事件。
结果表明该设备能显著减轻一些花粉症症状。如果通过电子方式监测依从性，并通过报告监测鼻塞情况，本研究将会得到改进。作用机制尚不清楚。本研究未考虑该疗法的长期影响。
