Gartlehner Gerald, Hansen Richard A, Carson Shannon S, Lohr Kathleen N
Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.
Ann Fam Med. 2006 May-Jun;4(3):253-62. doi: 10.1370/afm.517.
We wanted to review systematically the efficacy, effectiveness, and safety of inhaled corticosteroids with respect to health outcomes in patients with chronic obstructive pulmonary disease (COPD).
We searched MEDLINE, EMBASE, The Cochrane Library, and the International Pharmaceutical Abstracts to identify relevant articles. We limited evidence to double-blinded randomized controlled trials (RCTs) for efficacy, but we also reviewed observational evidence for safety. Outcomes of interest were overall mortality, exacerbations, quality of life, functional capacity, and respiratory tract symptoms. When possible, we pooled data to estimate summary effects for each outcome.
Thirteen double-blinded RCTs determined the efficacy of an inhaled corticosteroid compared with placebo; 11 additional studies assessed the safety of inhaled corticosteroid treatment in patients with asthma or COPD. Overall, COPD patients treated with inhaled corticosteroids experienced significantly fewer exacerbations than patients taking placebo (relative risk [RR] = 0.67; 95% CI, 0.59-0.77). No significant difference could be detected for overall mortality (RR = 0.81; 95% CI, 0.60-1.08). Evidence on quality of life, functional capacity, and respiratory tract symptoms is mixed. Adverse events were generally tolerable; pooled discontinuation rates did not differ significantly between inhaled corticosteroid and placebo treatment groups (RR = 0.92; 95% CI, 0.74-1.14). Observational evidence, however, indicates a dose-related risk of cataract and open-angle glaucoma. Severe adverse events, such as osteoporotic fractures, are rare; the clinical importance of the additional risk is questionable.
Overall, the risk-benefit ratio appears to favor inhaled corticosteroid treatment in patients with moderate to severe COPD. Existing evidence does not indicate a treatment benefit for patients with mild COPD.
我们旨在系统回顾吸入性糖皮质激素对慢性阻塞性肺疾病（COPD）患者健康结局的疗效、有效性及安全性。
我们检索了MEDLINE、EMBASE、Cochrane图书馆及国际药学文摘数据库以识别相关文章。我们将疗效证据限定为双盲随机对照试验（RCT），但也回顾了安全性的观察性证据。感兴趣的结局包括全因死亡率、急性加重、生活质量、功能能力及呼吸道症状。如有可能，我们汇总数据以估计各结局的汇总效应。
13项双盲RCT确定了吸入性糖皮质激素与安慰剂相比的疗效；另有11项研究评估了吸入性糖皮质激素治疗哮喘或COPD患者的安全性。总体而言，接受吸入性糖皮质激素治疗的COPD患者急性加重次数显著少于服用安慰剂的患者（相对危险度[RR]=0.67；95%可信区间[CI]，0.59 - 0.77）。全因死亡率未发现显著差异（RR = 0.81；95% CI，0.60 - 1.08）。生活质量、功能能力及呼吸道症状方面的证据不一。不良事件一般可耐受；吸入性糖皮质激素治疗组与安慰剂治疗组的汇总停药率无显著差异（RR = 0.92；95% CI，0.74 - 1.14）。然而，观察性证据表明存在与剂量相关的白内障和开角型青光眼风险。严重不良事件，如骨质疏松性骨折，较为罕见；额外风险的临床重要性存疑。
总体而言，中重度COPD患者使用吸入性糖皮质激素治疗的风险效益比似乎有利。现有证据未表明轻度COPD患者能从治疗中获益。
