哮喘联盟

   摘要
   吸入性皮质类固醇激素及长效β受体激动剂（ICS/LABA）联合治疗哮喘和慢性阻塞性肺疾病（COPD）的疗效已经广受认可。虽然ICS/LABA的两种代表性产品（布地奈德/福莫特罗和氟替卡松/沙美特罗）的药理性质不同，多项随机临床试验（RCTs）及荟萃分析结果显示其在RCT研究中疗效类似。但是，近期报道的疗效比较研究结果显示，不同的ICS/LABA联合方案治疗哮喘或COPD患者，所得到的临床表现及医疗保健结局存在明显差异。本文简要回顾疗效比较研究（CER）在哮喘及COPD治疗领域中的优点和局限性。我们对目前关于ICS/LABA治疗哮喘及COPD的CER研究进行了系统性文献回顾。通过文献分析体现CER研究中存在的独特挑战，并总结研究结果及研究局限性。我们着重分析治疗开始前、中、后中的偏差及混杂因素。除了提供关于两种ICS/LABA联合方案的综述外，本研究也希望有助于对哮喘及COPD领域的CER发表研究进行质量评估，或用以指导研究者进行慢性呼吸道疾病治疗相关CER的研究设计。
 

（刘国梁 审校）
Drugs. 2014 May 6. [Epub ahead of print]

 

Management of Asthma and Chronic Obstructive Pulmonary Disease with Combination Inhaled Corticosteroids and Long-Acting β-Agonists: A Review of Comparative Effectiveness Research.
 

Mapel DW1, Roberts MH.
 

ABSTRACT
The value of combination therapy with inhaled corticosteroids and long-acting β-agonists (ICS/LABA) is well recognized in the management of asthma and chronic obstructive pulmonary disease (COPD). Despite differences in the pharmacological properties between two well-established ICS/LABA products (budesonide/formoterol and fluticasone/salmeterol), data from randomized clinical trials (RCTs) and meta-analyses suggest that these two products perform similarly under RCT conditions. In contrast, a few recently reported real-world comparative effectiveness studies have suggested that there are substantial differences between ICS/LABA combination treatments in terms of clinical and healthcare outcomes in patients with asthma or COPD. The purpose of this article is to provide a brief review of the benefits, as well as the limitations, of comparative effectiveness research (CER) in the therapeutic area of asthma and COPD. We conducted a structured literature review of the current CER studies on ICS/LABA combinations in asthma and COPD. These articles were then used to illustrate the unique challenges of CER studies, providing a summary of study results and limitations. We focus particularly on difficult biases and confounding factors that may be introduced before, during, and after the initiation of therapy. Beyond being a review of these two ICS/LABA combination treatments, this article is intended to help those real-world comparative effectiveness studies who wish to assess the quality of CER published projects in asthma and COPD, or guide investigators who wish to design new CER studies for chronic respiratory disease treatments.
 

Drugs. 2014 May 6. [Epub ahead of print]