Ram F S, Brocklebank D M, White J, Wright J P, 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):CD002158. doi: 10.1002/14651858.CD002158.
BACKGROUND: A number of different inhaler devices are available to deliver beta2-agonist bronchodilators in asthma. These include hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)-free propelled pressurised metered dose inhalers (pMDIs) and dry powder devices. OBJECTIVES: To determine the clinical effectiveness of pMDI compared with any other available handheld inhaler device for the delivery of short-acting beta-2 agonist bronchodilators in non-acute asthma in children and adults. SEARCH STRATEGY: The Cochrane Collaboration Clinical Trials register was searched for studies as well as separate additional searches carried out on MEDLINE, EMBASE, CINAHL and also on the Current Contents Index as well as the Science Citation Index. In addition, 17 individual online respiratory journals and 12 electronically available clinical trial databases were also searched. The UK pharmaceutical companies who manufacture inhaled asthma medication were contacted in order to obtain details of any published or unpublished studies. SELECTION CRITERIA: - The full texts of all potentially relevant articles were reviewed independently by two reviewers. DATA COLLECTION AND ANALYSIS: Fixed and random effect models were used. Dichotomous outcomes were assessed using Odds Ratios or Relative Risks (RR) with 95% Confidence Intervals (95%CI). MAIN RESULTS: Eighty-four randomised controlled trials were included in this review, but few could be combined to assess a specific outcome for a given delivery device comparison. Only two studies required demonstration of adequate pMDI technique as an entry requirement. There were no difference between a standard CFC containing pMDI and any other device for most outcomes. Regular use of HFA-pMDI containing salbutamol reduced the requirement for short courses of oral corticosteroids (3 trials, 519 patients: RR 0.67; 95% CI 0.49, 0.91); however the total number of exacerbations were unchanged (3 trials, 1271 patients: RR 1.0; 95% CI 0.75, 1.33). REVIEWER'S CONCLUSIONS: In patients with stable asthma, short-acting beta-2 bronchodilators in standard CFC-pMDI's are as effective as any other devices. The effect of HFA-pMDI on requirement for oral corticosteroid courses to treat acute exacerbations should be confirmed. Effectiveness studies that use an intention-to-treat analysis are required.
背景:有多种不同的吸入装置可用于在哮喘治疗中递送β2-肾上腺素能支气管扩张剂。这些装置包括氢氟烷烃(HFA)或不含氯氟烃(CFC)的加压定量吸入器(pMDI)以及干粉装置。 目的:确定在儿童和成人非急性哮喘中,与其他任何可用的手持吸入装置相比,pMDI递送短效β2激动剂支气管扩张剂的临床效果。 检索策略:检索了Cochrane协作网临床试验注册库中的研究,并在MEDLINE、EMBASE、CINAHL以及当期目次索引和科学引文索引上进行了单独的额外检索。此外,还检索了17种在线呼吸专业期刊和12个可通过电子方式获取的临床试验数据库。联系了生产吸入性哮喘药物的英国制药公司,以获取任何已发表或未发表研究的详细信息。 选择标准:两位评审员独立审查了所有潜在相关文章的全文。 数据收集与分析:使用固定效应模型和随机效应模型。二分类结局使用比值比(OR)或相对危险度(RR)及95%置信区间(95%CI)进行评估。 主要结果:本综述纳入了84项随机对照试验,但很少有试验能合并起来评估特定递送装置比较的特定结局。只有两项研究要求将证明正确的pMDI使用技术作为纳入标准。对于大多数结局,含标准CFC的pMDI与任何其他装置之间没有差异。定期使用含沙丁胺醇的HFA-pMDI减少了口服糖皮质激素短期疗程的需求(3项试验,519例患者:RR 0.67;95%CI 0.49,0.91);然而,急性加重的总数未变(3项试验,1271例患者:RR 1.0;95%CI 0.75,1.33)。 综述作者结论:在稳定期哮喘患者中,标准CFC-pMDI中的短效β2支气管扩张剂与任何其他装置一样有效。HFA-pMDI对治疗急性加重时口服糖皮质激素疗程需求的影响应予以确认。需要开展采用意向性分析的有效性研究。
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