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丙酸氟替卡松水鼻喷雾剂与二丙酸倍氯米松治疗常年性鼻炎的安慰剂对照研究:对变应性和非变应性常年性鼻炎的疗效

A placebo-controlled study of fluticasone propionate aqueous nasal spray and beclomethasone dipropionate in perennial rhinitis: efficacy in allergic and non-allergic perennial rhinitis.

作者信息

Scadding G K, Lund V J, Jacques L A, Richards D H

机构信息

Royal National Throat, Nose and Ear Hospital, London, UK.

出版信息

Clin Exp Allergy. 1995 Aug;25(8):737-43. doi: 10.1111/j.1365-2222.1995.tb00011.x.

Abstract

BACKGROUND

Fluticasone propionate is a new potent, topically active corticosteroid with negligable oral bioavailability. Data on its comparative efficacy in perennial allergic and non-allergic rhinitis are limited.

OBJECTIVE

To compare the efficacy and safety of fluticasone propionate aqueous nasal spray (FPANS) 200 micrograms once or twice daily with beclomethasone dipropionate aqueous nasal spray (BPD) 200 micrograms twice daily and placebo in patients with allergic and non-allergic perennial rhinitis.

METHODS

The 12-week study had a multicentre, double-blind, randomized, parallel group design. Efficacy was assessed from symptom scores recorded on daily diary cards.

RESULTS

FPANS 200 micrograms once or twice daily was significantly better than placebo but not better than BDP in relieving the nasal symptoms of rhinitis. FPANS at either dose was equally effective in the treatment of allergic and non-allergic perennial rhinitis. There were few adverse events and no treatment-related abnormalities in laboratory measurements in either FPANS-treated group. Comparison between treatment groups indicated that FPANS was as well tolerated as placebo and BDP at the doses studied.

CONCLUSIONS

In the majority of patients FPANS 200 micrograms once daily in as effective as BDP 200 micrograms twice daily in the relief of perennial allergic rhinitis.

摘要

背景

丙酸氟替卡松是一种新型强效局部活性皮质类固醇,口服生物利用度可忽略不计。关于其在常年性变应性和非变应性鼻炎中比较疗效的数据有限。

目的

比较每日一次或两次使用200微克丙酸氟替卡松水性鼻喷雾剂(FPANS)、每日两次使用200微克二丙酸倍氯米松水性鼻喷雾剂(BPD)和安慰剂对变应性和非变应性常年性鼻炎患者的疗效和安全性。

方法

这项为期12周的研究采用多中心、双盲、随机、平行组设计。根据每日日记卡记录的症状评分评估疗效。

结果

每日一次或两次使用200微克FPANS在缓解鼻炎鼻症状方面显著优于安慰剂,但不优于BDP。两种剂量的FPANS在治疗变应性和非变应性常年性鼻炎方面同样有效。两个FPANS治疗组的不良事件很少,实验室检查中也没有与治疗相关的异常。治疗组之间的比较表明,在所研究的剂量下,FPANS与安慰剂和BDP的耐受性相当。

结论

在大多数患者中,每日一次使用200微克FPANS缓解常年性变应性鼻炎的效果与每日两次使用200微克BDP相当。

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