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丙酸氟替卡松治疗哮喘的临床经验:与布地奈德和二丙酸倍氯米松在半微克剂量或更低剂量下的疗效和全身活性的荟萃分析。

Clinical experience with fluticasone propionate in asthma: a meta-analysis of efficacy and systemic activity compared with budesonide and beclomethasone dipropionate at half the microgram dose or less.

作者信息

Barnes N C, Hallett C, Harris T A

机构信息

London Chest Hospital, U.K.

出版信息

Respir Med. 1998 Jan;92(1):95-104. doi: 10.1016/s0954-6111(98)90039-7.

DOI:10.1016/s0954-6111(98)90039-7
PMID:9519232
Abstract

The relative clinical efficacy and systemic effects of different inhaled corticosteroids is controversial. To obtain further information on this matter, the authors have performed meta-analysis of seven trials comparing fluticasone propionate (FP) with budesonide (Bud), and seven trials comparing FP with beclomethasone dipropionate (BDP) for the treatment of asthma of all severities in adult and paediatric patients. In all cases, the drugs were compared at clinically equivalent doses, i.e. FP was given at half (or less) the microgram dose. The total number of patients was 1980 (1000 treated with FP 200-800 micrograms day-1 and 980 with Bud 400-1600 micrograms day-1), and 1584 patients in the second analysis (780 treated with FP 200-1000 micrograms day-1 and 804 with BDP 400-2000 micrograms day-1). FP significantly improved mean morning peak expiratory flow rate (PEFR) compared with Bud, with an overall difference of +11 l min-1. Analysis of serum cortisols showed no differences between FP and Bud treatment at low doses, but at higher dosages, and overall, significant differences in favour of FP were observed. In the second meta-analysis, no significant differences in PEFR were observed between FP and BDP in any of the seven individual studies or in the pooled analysis. Analysis of serum cortisols showed a similar trend to the previous analysis, however, no overall difference in serum cortisol results were seen between FP and BDP. In conclusion, the pooled analysis shows that FP at half the dose (or less) is more effective than Bud and as effective as BDP in improving PEFR; in addition, these improvements were achieved with a reduction in cortisol suppression compared with BUD and with no greater degree of cortisol suppression compared with BDP. This demonstrates, in patients with asthma, that FP has an improved efficacy to safety ratio compared with older inhaled corticosteroids.

摘要

不同吸入性糖皮质激素的相对临床疗效和全身效应存在争议。为获取关于此事的更多信息,作者对七项比较丙酸氟替卡松(FP)与布地奈德(Bud)的试验,以及七项比较FP与二丙酸倍氯米松(BDP)治疗成人和儿童所有严重程度哮喘的试验进行了荟萃分析。在所有情况下,均以临床等效剂量比较药物,即FP的微克剂量为一半(或更低)。患者总数为1980例(1000例接受200 - 800微克/天的FP治疗,980例接受400 - 1600微克/天的Bud治疗),第二次分析中有1584例患者(780例接受200 - 1000微克/天的FP治疗,804例接受400 - 2000微克/天的BDP治疗)。与Bud相比,FP显著改善了平均晨起呼气峰值流速(PEFR),总体差异为 +11升/分钟。血清皮质醇分析显示,低剂量时FP与Bud治疗之间无差异,但在较高剂量时,总体上观察到有利于FP的显著差异。在第二次荟萃分析中,七项单独研究中的任何一项以及汇总分析中,FP与BDP之间在PEFR方面均未观察到显著差异。血清皮质醇分析显示出与先前分析相似的趋势,然而,FP与BDP之间在血清皮质醇结果上未观察到总体差异。总之,汇总分析表明,剂量减半(或更低)的FP在改善PEFR方面比Bud更有效,且与BDP效果相当;此外,与Bud相比,这些改善是在皮质醇抑制减少的情况下实现的,与BDP相比,皮质醇抑制程度没有更大。这表明,在哮喘患者中,与 older inhaled corticosteroids相比,FP具有更好的疗效与安全性比。

注

原文中“older inhaled corticosteroids”直译为“更老的吸入性糖皮质激素”,这里意译为“传统吸入性糖皮质激素”可能更符合语境,但按照要求未添加解释,保留了原文直译。

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