Appleton S, Poole P, Smith B, Veale A, Bara A
Department of Medicine, The Queen Elizabeth Hospital, Woodville Rd., Woodville, Adelaide, Australia.
Cochrane Database Syst Rev. 2002(3):CD001104. doi: 10.1002/14651858.CD001104.
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.
To determine the effectiveness of long acting beta-2 adrenoceptor agonists in COPD patients with low reversibility to short-acting bronchodilators.
The Cochrane Airways Group register was searched. Bibliographies of identified randomised controlled trials (RCTs) were also searched. Authors of identified RCTs were contacted for other published and unpublished studies and unpublished studies were obtained from pharmaceutical companies.
All RCTs over four weeks in duration comparing treatment with long-acting beta-2 adrenoceptor agonists (salmeterol or formoterol) with placebo in patients with stable poorly-reversible COPD.
Data extraction and study quality assessment was performed independently by two reviewers. Where further or missing data were required, authors of studies were contacted.
Eight RCTs met the inclusion criteria review. Six were parallel group studies of 12-16 weeks in duration and two were cross-over studies with four week treatment arms. All eight assessed the efficacy of salmeterol in COPD compared to placebo. Few of the results could be combined in meta-analyses because of differences in methods of reporting data. Isolated trials reported an improvement in one or other outcome in favour of salmeterol, but the only possible meta-analysis of FEV1 showed no overall benefit (Standardised mean difference 0.14 (95% Confidence Interval -0.16, 0.44, n=4). There was no consistent effect on Health Related Quality of LIfe or symptoms scores. Overall, breathlessness was not reduced, but in one study more subjects in the salmeterol group had low Borg dyspnoea scores compared to placebo (Peto Odds Ratio = 0.60, 95% CI: 0.40; 0.88). There was no effect on COPD exacerbations over the short period of the studies.
REVIEWER'S CONCLUSIONS: In the few studies that could be included in this review, treatment of patients with COPD with long acting beta-2 agonists produces only small increases in FEV1. The improvement in airways function does not seem to be associated with a consistent effect on other outcomes such as health related quality of life or reductions in breathlessness.
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的可逆性很小,但长效支气管扩张剂经常被提倡使用。
确定长效β2肾上腺素能受体激动剂对短效支气管扩张剂反应性低的COPD患者的有效性。
检索Cochrane Airways Group登记册。还检索了已识别的随机对照试验(RCT)的参考文献。联系已识别RCT的作者以获取其他已发表和未发表的研究,并从制药公司获取未发表的研究。
所有持续时间超过四周的RCT,比较长效β2肾上腺素能受体激动剂(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。
由两名评价者独立进行数据提取和研究质量评估。如果需要进一步的数据或缺失数据,则联系研究的作者。
八项RCT符合纳入标准综述。六项是为期12 - 16周的平行组研究,两项是为期四周治疗组的交叉研究。所有八项研究均评估了沙美特罗与安慰剂相比在COPD中的疗效。由于报告数据的方法不同,很少有结果可以合并进行荟萃分析。个别试验报告沙美特罗在一项或其他结果上有改善,但对FEV1唯一可能的荟萃分析显示没有总体益处(标准化均数差0.14(95%置信区间-0.16,0.44,n = 4))。对健康相关生活质量或症状评分没有一致影响。总体而言,呼吸困难没有减轻,但在一项研究中,与安慰剂相比,沙美特罗组更多受试者的Borg呼吸困难评分较低(Peto比值比 = 0.60,95% CI:0.40;0.88)。在研究的短时间内对COPD急性加重没有影响。
在本综述中可以纳入的少数研究中,用长效β2激动剂治疗COPD患者仅使FEV1略有增加。气道功能的改善似乎与对其他结果如健康相关生活质量或呼吸困难减轻没有一致影响。