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用于变应性鼻炎的每日一次布地奈德水性鼻喷雾剂:一项综述

Once-daily budesonide aqueous nasal spray for allergic rhinitis: a review.

作者信息

Stanaland Brett E

机构信息

Division of Allergy and Immunology, University of South Florida Health Sciences Center, Tampa, Florida, USA.

出版信息

Clin Ther. 2004 Apr;26(4):473-92. doi: 10.1016/s0149-2918(04)90050-1.

Abstract

BACKGROUND

Allergic rhinitis (AR) is a highly prevalent inflammatory condition with substantial direct and indirect costs. Intranasal corticosteroids are recommended as first-line therapy for moderate to severe persistent AR. Intranasal budesonide is effective and well tolerated; budesonide aqueous nasal spray (BANS) offers several advantages of potential importance to patients, including once-daily dosing at a low volume of spray in a formulation that is free of chlorofluorocarbon propellants, alcohol, benzalkonium chloride, and scents.

OBJECTIVE

This article reviews the findings of randomized, blinded studies assessing the efficacy, safety profile, quality-of-life effects, patient preference, and cost-effectiveness of once-daily BANS in the treatment of AR.

METHODS

A MEDLINE search (1966-April 2003) was conducted to identify potentially relevant English-language articles. Pertinent abstracts from recent allergy society meetings were also identified. The search strategy employed the medical subject heading terms budesonide, intranasal corticosteroid, or nasal steroid and allergic rhinitis. Selected studies were randomized, controlled clinical trials of once-daily BANS in patients with AR.

RESULTS

Based on the results of randomized, double-blind, controlled trials, once-daily BANS is an effective treatment for both seasonal and perennial AR at doses as low as 64 microg (one 32-microg spray per nostril). BANS was well tolerated in these studies, with an adverse-event profile similar to that of placebo, and caused no clinically meaningful suppression of hypothalamic-pituitary-adrenal axis function at doses 4-fold higher than the recommended starting dose. Once-daily administration of BANS 64 microg was similar in efficacy to mometasone furoate nasal spray 200 microg once daily; comparable doses of BANS and fluticasone propionate nasal spray (FPNS) were similar in efficacy as well. Based on specific sensory attributes, patients preferred BANS to FPNS at the recommended once-daily starting doses. BANS was associated with more days of treatment per prescription at a lower cost per day compared with other intranasal corticosteroids.

CONCLUSIONS

Based on the studies reviewed, BANS administered once daily is an effective and well-tolerated treatment for seasonal and perennial AR in both children and adults. Due to its sensory attributes, efficacy, safety profile, and relatively low cost, BANS may help improve patient adherence.

摘要

背景

变应性鼻炎(AR)是一种高度流行的炎症性疾病,会产生大量直接和间接费用。鼻用糖皮质激素被推荐作为中重度持续性AR的一线治疗药物。鼻用布地奈德有效且耐受性良好;布地奈德水性鼻喷雾剂(BANS)具有一些对患者可能具有重要意义的优点,包括每日一次给药,喷雾量少,且制剂不含氯氟烃推进剂、酒精、苯扎氯铵和香料。

目的

本文综述了评估每日一次BANS治疗AR的疗效、安全性、生活质量影响、患者偏好和成本效益的随机、盲法研究结果。

方法

进行了MEDLINE检索(1966年 - 2003年4月)以识别潜在相关的英文文章。还识别了近期过敏学会会议的相关摘要。检索策略使用医学主题词布地奈德、鼻用糖皮质激素或鼻用类固醇以及变应性鼻炎。选定的研究是对AR患者每日一次BANS的随机对照临床试验。

结果

基于随机、双盲、对照试验的结果,每日一次BANS在低至64微克(每侧鼻孔一次32微克喷雾)的剂量下对季节性和常年性AR均为有效治疗。在这些研究中,BANS耐受性良好,不良事件谱与安慰剂相似,并且在比推荐起始剂量高4倍的剂量下未引起下丘脑 - 垂体 - 肾上腺轴功能的临床意义上的抑制。每日一次给予64微克BANS的疗效与每日一次给予200微克糠酸莫米松鼻喷雾剂相似;BANS和丙酸氟替卡松鼻喷雾剂(FPNS)的相当剂量疗效也相似。基于特定的感官属性,在推荐的每日一次起始剂量下,患者更喜欢BANS而非FPNS。与其他鼻用糖皮质激素相比,BANS每张处方的治疗天数更多,且每天成本更低。

结论

基于所综述的研究,每日一次给予BANS对儿童和成人的季节性和常年性AR是一种有效且耐受性良好的治疗方法。由于其感官属性、疗效、安全性和相对较低的成本,BANS可能有助于提高患者的依从性。

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