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一项安慰剂对照、随机、双盲研究,评估丙酸氟替卡松鼻喷雾剂治疗嗅觉减退/嗅觉丧失患者的疗效。

Placebo-controlled, randomized, double-blind study evaluating the efficacy of fluticasone propionate nasal spray for the treatment of patients with hyposmia/anosmia.

作者信息

Blomqvist Ebba Hedén, Lundblad Lars, Bergstedt Hans, Stjärne Pär

机构信息

Department of Otorhinolaryngology, Karolinska Hospital, Stockholm, Sweden.

出版信息

Acta Otolaryngol. 2003 Sep;123(7):862-8. doi: 10.1080/00016480310002140.

Abstract

OBJECTIVE

To compare the effect on olfaction of topical glucocorticoid treatment versus placebo given for an extended period in addition to oral short-term glucocorticoids in patients with anosmia/hyposmia.

MATERIAL AND METHODS

This was a randomized, double-blind, placebo-controlled study. The criterion for inclusion in the blinded phase was an improvement of at least 2 steps in the butanol odor threshold test following open treatment for 10 days with oral and nasal corticosteroids. Forty patients were included: 20 were randomized to treatment with fluticasone propionate, 10 to placebo and 10 others as controls. The topical treatment was continued for 6 months.

RESULTS

The 3 groups showed similar improvements in their sense of smell after the initial 10-day treatment with combined oral and nasal corticosteroids. Patients who continued the local treatment maintained the same level of improvement throughout the study, whether or not they had been given nasal corticosteroids or placebo. We found no significant differences between the treatment groups.

CONCLUSIONS

In patients with anosmia/hyposmia partly caused by local inflammation, no further improvement in the olfactory threshold is achieved by continuing with a topical intranasal glucocorticoid after an initial combined topical and systemic glucocorticoid treatment.

摘要

目的

比较在嗅觉减退/嗅觉丧失患者中,除口服短期糖皮质激素外长期给予局部糖皮质激素治疗与安慰剂治疗对嗅觉的影响。

材料与方法

这是一项随机、双盲、安慰剂对照研究。进入盲法阶段的纳入标准是在口服和鼻用皮质类固醇开放治疗10天后,丁醇气味阈值测试至少改善2个等级。共纳入40例患者:20例随机接受丙酸氟替卡松治疗,10例接受安慰剂治疗,另10例作为对照。局部治疗持续6个月。

结果

在最初10天联合口服和鼻用皮质类固醇治疗后,3组患者的嗅觉改善情况相似。继续局部治疗的患者在整个研究过程中保持相同的改善水平,无论他们接受的是鼻用皮质类固醇还是安慰剂。我们发现治疗组之间无显著差异。

结论

在部分由局部炎症引起嗅觉减退/嗅觉丧失的患者中,在最初联合局部和全身糖皮质激素治疗后,继续鼻内局部使用糖皮质激素不能进一步改善嗅觉阈值。

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