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枸橼酸钠喷雾剂治疗非传导性嗅觉障碍的随机对照试验

A randomised controlled trial of sodium citrate spray for non-conductive olfactory disorders.

作者信息

Philpott C M, Erskine S E, Clark A, Leeper A, Salam M, Sharma R, Murty G E, Hummel T

机构信息

Norwich Medical School, University of East Anglia, Norfolk, UK.

The Smell & Taste Clinic, ENT Department, James Paget University Hospital NHS Foundation Trust, Gorleston, Norfolk, UK.

出版信息

Clin Otolaryngol. 2017 Dec;42(6):1295-1302. doi: 10.1111/coa.12878. Epub 2017 Apr 17.

Abstract

OBJECTIVES

Previous research has suggested that sodium citrate improves hyposmia by decreasing mucus calcium levels in the nose. This study aimed to confirm or refute this effect in a single application and assess potential side-effects.

DESIGN

Study design was a randomised double-blind controlled trial of sodium citrate nasal spray (intervention) vs sterile water (control). Fifty-five patients with non-conductive olfactory loss were randomised to receive the intervention or placebo.

SETTING

Tertiary care clinic.

MAIN OUTCOME MEASURES

The primary outcome measure was improvement in measured olfactory thresholds for phenyl ethyl alcohol (PEA) over 2 hours. Other outcome measures assessed were improvement in olfactory thresholds in 1-butanol, eucalyptol and acetic acid; number of responders with a clinically relevant response in each arm; and adverse effects.

RESULTS

A significant effect was seen in the intervention arm for PEA and for 1-butanol and eucalyptol when compared to the control arm (P<.05); 32% of the intervention arm responded in terms of improved sensitivity towards some of the odours. Minor adverse effects noted included sore throat, nasal paraesthesia, slight rhinorrhoea and itching. The duration of effect of the citrate is transient, peaking at 30-60 minutes after application.

CONCLUSIONS

Sodium citrate yields some potential as a treatment for non-conductive olfactory loss; however, these findings require corroboration in further clinical trials looking at longer term regular use of the spray as a viable therapeutic option for patients where it would be applied at frequent intervals such as before mealtimes.

摘要

目的

先前的研究表明,柠檬酸钠可通过降低鼻腔黏液中的钙水平来改善嗅觉减退。本研究旨在通过单次应用来证实或反驳这种效果,并评估潜在的副作用。

设计

研究设计为柠檬酸钠鼻喷雾剂(干预组)与无菌水(对照组)的随机双盲对照试验。55例非传导性嗅觉丧失患者被随机分配接受干预或安慰剂。

地点

三级护理诊所。

主要观察指标

主要观察指标是2小时内苯乙醇(PEA)嗅觉阈值的改善情况。评估的其他观察指标包括1-丁醇、桉叶油醇和乙酸嗅觉阈值的改善情况;每组中具有临床相关反应的应答者数量;以及不良反应。

结果

与对照组相比,干预组在PEA、1-丁醇和桉叶油醇方面有显著效果(P<0.05);干预组中有32%的患者对某些气味的敏感性有所提高。记录到的轻微不良反应包括喉咙痛、鼻感觉异常、轻微流涕和瘙痒。柠檬酸盐的作用持续时间是短暂的,在应用后30-60分钟达到峰值。

结论

柠檬酸钠作为非传导性嗅觉丧失的一种治疗方法具有一定潜力;然而,这些发现需要在进一步的临床试验中得到证实,该试验将着眼于长期定期使用喷雾剂,作为一种可行的治疗选择,适用于需要频繁应用(如饭前)的患者。

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