Ram F S, Brocklebank D M, Muers M, Wright J, Jones P W
Department of Physiological Medicine, St George's Hospital Medical School, Level 0, Jenner Wing, Cranmer Terrace, London, UK, SW17 0RE.
Cochrane Database Syst Rev. 2002;2002(1):CD002170. doi: 10.1002/14651858.CD002170.
BACKGROUND: Bronchodilator therapy for COPD may be delivered by a number of different inhaler devices. OBJECTIVES: To determine the efficacy of pressurised metered dose inhalers (pMDI) compared to any other handheld inhaler device for the delivery of bronchodilators in non-acute COPD. SEARCH STRATEGY: The Cochrane Collaboration, Asthma and Wheeze Randomised Controlled Clinical Trials register was searched for studies. The UK pharmaceutical companies who manufacture inhaled COPD medication were also contacted. SELECTION CRITERIA: Two reviewers independently reviewed the results of computerised search and any potentially relevant articles were obtained in full. DATA COLLECTION AND ANALYSIS: One reviewer extracted details of each trial and a second reviewer checked all extracted data. Dichotomous outcomes such as exacerbation rate were assessed using relative risk, with 95% confidence interval (CI). MAIN RESULTS: Fourteen studies appeared potentially relevant but only three studies (61 patients) met the entry criteria. Two studies compared a dry powder device (Turbuhaler or Rotahaler) with a pMDI for beta2-agonist delivery, and one (36 patients cross-over design) the Respimat (soft mist device for ipratropium) vs a pMDI. For the Turbuhaler and Rotahaler, none of the reported outcome measures were significantly different. The Rotahaler study used a high and low dose of medication with or without large volume spacer. The study using the Respimat showed significant increases in FEV1 when compared to a pMDI (difference in change from base line 70 ml, 95% CI 10, 130 ml). The effect on change in FVC was of similar size. There were no differences between these two devices for any other reported outcomes. Although none of the included studies required prior patient ability to use any of the inhalers (and no study mentioned device training), it was assumed that all patients randomised into the study would have undergone training in use of the study inhalers and were capable of using those devices. REVIEWER'S CONCLUSIONS: In patients with stable COPD, pMDI produced similar outcomes to a dry powder device for delivering beta2-agonists, but the very small number of studies and included patients does not permit firm conclusions to be drawn. The soft mist device for ipratropium was more effective than a pMDI, but the data come from one small study. There need to be further well designed randomised controlled trials to define the role of inhaler devices using bronchodilators in stable COPD.
背景:慢性阻塞性肺疾病(COPD)的支气管扩张剂治疗可通过多种不同的吸入装置进行。 目的:确定在非急性COPD患者中,与其他任何手持吸入装置相比,压力定量吸入器(pMDI)在递送支气管扩张剂方面的疗效。 检索策略:检索Cochrane协作网、哮喘与喘息随机对照临床试验注册库以查找研究。还联系了生产吸入性COPD药物的英国制药公司。 入选标准:两名评价员独立审查计算机检索结果,并获取所有可能相关文章的全文。 数据收集与分析:一名评价员提取每个试验的详细信息,另一名评价员检查所有提取的数据。使用相对危险度及95%置信区间(CI)评估诸如急性加重率等二分法结局。 主要结果:14项研究似乎可能相关,但只有3项研究(61例患者)符合纳入标准。两项研究比较了干粉装置(都保或准纳器)与pMDI递送β2受体激动剂的情况,一项研究(36例患者的交叉设计)比较了思力华(异丙托溴铵软雾吸入装置)与pMDI。对于都保和准纳器,所报告的任何结局指标均无显著差异。准纳器研究使用了高剂量和低剂量药物,有或没有大容量储雾罐。使用思力华的研究显示,与pMDI相比,第1秒用力呼气容积(FEV1)显著增加(与基线相比的变化差值为70 ml,95%CI为10至130 ml)。对用力肺活量(FVC)变化的影响大小相似。这两种装置在任何其他报告结局方面均无差异。尽管纳入的研究均未要求患者事先具备使用任何一种吸入器的能力(且没有研究提及装置培训),但假定所有随机分组进入研究的患者都接受了研究吸入器使用培训,并且能够使用这些装置。 评价员结论:在稳定期COPD患者中,pMDI在递送β2受体激动剂方面产生的结局与干粉装置相似,但研究数量和纳入患者数量极少,无法得出确切结论。异丙托溴铵软雾吸入装置比pMDI更有效,但数据来自一项小型研究。需要进一步开展设计良好的随机对照试验,以明确吸入装置在稳定期COPD中使用支气管扩张剂的作用。
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