Di Martino Mirko, Agabiti Nera, Cascini Silvia, Kirchmayer Ursula, Bauleo Lisa, Fusco Danilo, Belleudi Valeria, Pinnarelli Luigi, Voci Claudio, Patorno Elisabetta, Pistelli Riccardo, Davoli Marina
a Department of Epidemiology , Lazio Regional Health Service , Roma , Italy.
b Management Control Unit , Modena University Hospital , Modena , Italy.
COPD. 2016 Jun;13(3):293-302. doi: 10.3109/15412555.2015.1044861. Epub 2015 Oct 29.
Chronic therapy with long-acting bronchodilators (LB) is recommended to treat moderate-to-severe COPD. Although the benefits of adding inhaled corticosteroid (ICS) to LB are still unclear, patients who experience repeated exacerbations are suggested to add ICS to their LB treatment. The objective of this study is to analyze whether adding ICS to LB therapy reduces mortality.
We identified a cohort of patients discharged from hospital with COPD diagnosis between 2006 and 2009. The first prescription for LB or ICS following discharge was defined as the index prescription. Only new users were included (no use of any study drug in the 6 months before treatment). A 4-day time window was used to classify patients into "LB alone" or "LB plus ICS" initiators. We used propensity score to balance the study groups. Sensitivity analyses were performed in patients with recent out-of-hospital exacerbations.
Among the 18615 adults enrolled, 12207 initiated "LB plus ICS" therapy and 6408 "LB alone." Crude mortality rates were 110 and 143 cases per 1000 person-years in the "LB plus ICS" and "LB alone" groups, respectively. The adjusted hazard ratio (HR) was 0.83 (95% CI: 0.72-0.97; p-value: 0.024). When analyzing patients with recent out-of-hospital exacerbations, the benefit of the combination therapy was more pronounced, HR = 0.63 (95% CI: 0.44-0.90; p-value: 0.012).
Our findings showed a beneficial effect on mortality of adding inhaled corticosteroids to long-acting bronchodilators. The advantage was much more pronounced in patients with frequent exacerbations.
推荐使用长效支气管扩张剂（LB）进行长期治疗以治疗中重度慢性阻塞性肺疾病（COPD）。尽管在LB治疗中添加吸入性糖皮质激素（ICS）的益处仍不明确，但建议反复出现病情加重的患者在LB治疗中添加ICS。本研究的目的是分析在LB治疗中添加ICS是否能降低死亡率。
我们确定了一组在2006年至2009年间因COPD诊断而出院的患者队列。出院后首次开具的LB或ICS处方被定义为索引处方。仅纳入新使用者（治疗前6个月未使用任何研究药物）。使用4天的时间窗将患者分为“仅使用LB”或“LB加ICS”起始者。我们使用倾向评分来平衡研究组。对近期有院外病情加重的患者进行了敏感性分析。
在纳入的18615名成年人中，12207人开始“LB加ICS”治疗，6408人“仅使用LB”治疗。“LB加ICS”组和“仅使用LB”组的粗死亡率分别为每1000人年110例和143例。调整后的风险比（HR）为0.83（95%置信区间：0.72 - 0.97；p值：0.024）。在分析近期有院外病情加重的患者时，联合治疗的益处更为明显，HR = 0.63（95%置信区间：0.44 - 0.90；p值：0.012）。
我们的研究结果表明，在长效支气管扩张剂治疗中添加吸入性糖皮质激素对死亡率有有益影响。在频繁病情加重的患者中，这种优势更为明显。
