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氟替卡松与倍氯米松或布地奈德用于成人和儿童慢性哮喘的比较。

Fluticasone versus beclomethasone or budesonide for chronic asthma in adults and children.

作者信息

Adams N, Lasserson T J, Cates C J, Jones P W

机构信息

Worthing & Southlands NHS Trust, Respiratory Medicine, Worthing, UK.

出版信息

Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD002310. doi: 10.1002/14651858.CD002310.pub4.

Abstract

BACKGROUND

Beclomethasone dipropionate (BDP) and budesonide (BUD) are commonly prescribed inhaled corticosteroids for the treatment of asthma. Fluticasone propionate (FP) is newer agent with greater potency in in-vitro assays.

OBJECTIVES

To compare the efficacy and safety of Fluticasone to Beclomethasone or Budesonide in the treatment of chronic asthma.

SEARCH STRATEGY

We searched the Cochrane Airways Group trial register (January 2007) and reference lists of articles. We contacted trialists and pharmaceutical companies for additional studies and searched abstracts of major respiratory society meetings (1997 to 2006).

SELECTION CRITERIA

Randomised trials in children and adults comparing Fluticasone to either Beclomethasone or Budesonide in the treatment of chronic asthma.

DATA COLLECTION AND ANALYSIS

Two reviewers independently assessed articles for inclusion and methodological quality. One reviewer extracted data. Quantitative analyses were undertaken using RevMan analyses 1.0.1.

MAIN RESULTS

Seventy-one studies (14,602 participants) representing 74 randomised comparisons met the inclusion criteria. Methodological quality was fair. Dose ratio 1:2: FP produced a significantly greater end of treatment FEV1 (0.04 litres (95% CI 0 to 0.07 litres), end of treatment and change in morning PEF, but not change in FEV1 or evening PEF. This applied to all drug doses, age groups, and delivery devices. No difference between FP and BDP/BUD were seen for trial withdrawals. FP led to fewer symptoms and less rescue medication use. When given at half the dose of BDP/BUD, FP led to a greater likelihood of pharyngitis. There was no difference in the likelihood of oral candidiasis. Plasma cortisol and 24 hour urinary cortisol was measured frequently but data presentation was limited. Dose ratio 1:1: FP produced a statistically significant difference in morning PEF, evening PEF, and FEV1 over BDP or BUD. The effects on exacerbations were mixed. There were no significant differences incidence of hoarseness, pharyngitis, candidiasis, or cough.

AUTHORS' CONCLUSIONS: Fluticasone given at half the daily dose of beclomethasone or budesonide leads to small improvements in measures of airway calibre, but it appears to have a higher risk of causing sore throat and when given at the same daily dose leads to increased hoarseness. There are concerns about adrenal suppression with Fluticasone given to children at doses greater than 400 mcg/day, but the randomised trials included in this review did not provide sufficient data to address this issue.

摘要

背景

二丙酸倍氯米松(BDP)和布地奈德(BUD)是常用于治疗哮喘的吸入性糖皮质激素。丙酸氟替卡松(FP)是一种新型药物,在体外试验中具有更强的效力。

目的

比较氟替卡松与倍氯米松或布地奈德治疗慢性哮喘的疗效和安全性。

检索策略

我们检索了Cochrane Airways Group试验注册库(2007年1月)以及文章的参考文献列表。我们联系了试验研究者和制药公司以获取更多研究,并检索了主要呼吸学会会议(1997年至2006年)的摘要。

入选标准

比较氟替卡松与倍氯米松或布地奈德治疗慢性哮喘的儿童和成人随机试验。

数据收集与分析

两名 reviewers 独立评估文章是否纳入及方法学质量。一名 reviewer 提取数据。使用RevMan分析1.0.1进行定量分析。

主要结果

71项研究(14,602名参与者)代表74项随机对照符合纳入标准。方法学质量为中等。剂量比1:2:氟替卡松在治疗结束时的第一秒用力呼气容积(FEV1)显著增加(0.04升(95%可信区间0至0.07升)),治疗结束时及早晨呼气峰流速(PEF)有变化,但FEV1或夜间PEF无变化。这适用于所有药物剂量、年龄组和给药装置。在试验退出方面,氟替卡松与二丙酸倍氯米松/布地奈德之间无差异。氟替卡松导致的症状更少,急救药物使用更少。当以二丙酸倍氯米松/布地奈德一半的剂量给药时,氟替卡松导致咽炎的可能性更大。口腔念珠菌病的可能性无差异。经常测量血浆皮质醇和24小时尿皮质醇,但数据呈现有限。剂量比1:1:氟替卡松在早晨PEF、夜间PEF和FEV1方面与二丙酸倍氯米松或布地奈德相比有统计学显著差异。对病情加重的影响不一。在声音嘶哑、咽炎、念珠菌病或咳嗽的发生率方面无显著差异。

作者结论

以二丙酸倍氯米松或布地奈德每日剂量的一半给予氟替卡松,在气道口径测量方面有小幅改善,但似乎引起喉咙痛的风险更高,且以相同每日剂量给药时会导致声音嘶哑增加。对于每日剂量大于400微克给予儿童的氟替卡松,存在肾上腺抑制的担忧,但本综述纳入的随机试验未提供足够数据来解决此问题。

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