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长效β2受体激动剂用于可逆性差的慢性阻塞性肺疾病

Long-acting beta2-agonists for poorly reversible chronic obstructive pulmonary disease.

作者信息

Appleton S, Poole P, Smith B, Veale A, Lasserson T J, Chan M M

机构信息

Queen Elizabeth Hospital, Dept. of Medicine, Woodville Rd., Woodville, Adelaide, Australia 5011.

出版信息

Cochrane Database Syst Rev. 2006 Jul 19;2006(3):CD001104. doi: 10.1002/14651858.CD001104.pub2.

Abstract

BACKGROUND

Chronic obstructive pulmonary disease (COPD) is characterised by partially reversible airflow limitation. Many patients have little reversibility to short acting bronchodilators, but long acting bronchodilators are frequently advocated.

OBJECTIVES

To determine the effectiveness of long acting beta-2 adrenoceptor agonists (LABAs) in COPD patients demonstrating poor reversibility to short-acting bronchodilators.

SEARCH STRATEGY

The Cochrane Airways Group Specialised Register was searched ('all years' to 2005) along with the reference lists from identified randomised controlled trials (RCTs).

SELECTION CRITERIA

All RCTs comparing inhaled LABAs (salmeterol or formoterol) with placebo in the treatment of patients with stable, poorly reversible COPD. Studies were a minimum of four weeks in duration.

DATA COLLECTION AND ANALYSIS

Two authors independently performed data extraction and study quality assessment. If we required additional data, we contacted authors and pharmaceutical companies sponsoring the identified RCTs.

MAIN RESULTS

Twenty-three published and unpublished studies (6061 participants) were included in the review. There was a significant change in forced expiratory volume in 1 second (FEV1) in favour of salmeterol 50 mcg twice daily (BID) of 51 mls (95% confidence intervals (CI) 32 to 70), end of study morning peak expiratory flow (PEF) 14.89 L/min (95% CI 10.86 to 18.91). Supplemental short-acting bronchodilator usage was reduced by just under one puff per day. There were significant differences in the total, activity and impact domain scores of the St George's respiratory questionnaire in favour of salmeterol 50 mcg BID. Findings from other health status measurements and symptom scores were conflicting. There was no significant difference in exercise tolerance. The number of participants experiencing exacerbations was significantly reduced with salmeterol 50 mcg treatment compared with placebo (numbers needed to treat to benefit 21).

AUTHORS' CONCLUSIONS: This review shows that the treatment of patients with COPD with salmeterol 50 mcg produces modest increases in lung function. There were varying effects for other important outcomes such as health related quality of life or reduction in symptoms. However, there was a consistent reduction in exacerbations which may help people with COPD who suffer frequent deterioration of symptoms prompting healthcare utilisation. The strength of evidence for the use of salmeterol 100 mcg, formoterol 12 mcg, 18 mcg, 24 mcg was insufficient to provide clear indications for practice.

摘要

背景

慢性阻塞性肺疾病(COPD)的特征是气流受限部分可逆。许多患者对短效支气管扩张剂几乎没有可逆性,但长效支气管扩张剂经常被推荐使用。

目的

确定长效β2肾上腺素受体激动剂(LABAs)对短效支气管扩张剂反应不佳的COPD患者的有效性。

检索策略

检索Cochrane气道组专业注册库(截至2005年的所有年份)以及已识别的随机对照试验(RCTs)的参考文献列表。

选择标准

所有比较吸入LABAs(沙美特罗或福莫特罗)与安慰剂治疗稳定的、可逆性差的COPD患者的RCTs。研究持续时间至少为四周。

数据收集与分析

两位作者独立进行数据提取和研究质量评估。如果我们需要额外的数据,我们会联系作者和资助已识别RCTs的制药公司。

主要结果

本综述纳入了23项已发表和未发表的研究(6061名参与者)。每日两次吸入50μg沙美特罗组的1秒用力呼气容积(FEV1)有显著变化,增加了51ml(95%置信区间(CI)32至70),研究结束时早晨的呼气峰值流速(PEF)增加了14.89L/min(95%CI 10.86至18.91)。补充使用短效支气管扩张剂的量每天减少不到一剂。圣乔治呼吸问卷的总分、活动和影响领域得分有显著差异,有利于每日两次吸入50μg沙美特罗组。其他健康状况测量和症状评分的结果相互矛盾。运动耐力无显著差异。与安慰剂相比,每日两次吸入50μg沙美特罗治疗组经历病情加重的参与者数量显著减少(受益所需治疗人数为21)。

作者结论

本综述表明,每日两次吸入50μg沙美特罗治疗COPD患者可使肺功能适度增加。对于其他重要结局,如与健康相关的生活质量或症状减轻,有不同的影响。然而,病情加重的情况持续减少,这可能有助于频繁出现症状恶化并因此寻求医疗服务的COPD患者。使用100μg沙美特罗、12μg、18μg、24μg福莫特罗的证据强度不足以提供明确的实践指征。

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