吸入皮质类固醇与 COPD 患者全因死亡率的相关性：60 项随机对照试验的荟萃分析。
Association of Inhaled Corticosteroids With All-Cause Mortality Risk in Patients With COPD: A Meta-analysis of 60 Randomized Controlled Trials.
机构信息
Department of Respiratory and Critical Care Medicine, Chengdu Second People's Hospital, Chengdu, China.
Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Chengdu Medical College, Chengdu, China.
出版信息
Chest. 2023 Jan;163(1):100-114. doi: 10.1016/j.chest.2022.07.015. Epub 2022 Jul 31.
BACKGROUND
Inhaled corticosteroids (ICSs) have been used widely in the maintenance therapy of COPD. However, whether inhaled therapy containing ICSs can reduce the all-cause mortality risk and the possible benefited patient subgroups is unclear.
RESEARCH QUESTION
Does inhaled therapy containing ICSs reduce the all-cause mortality risk in patients with COPD compared with other inhaled therapies not containing ICSs?
STUDY DESIGN AND METHODS
We searched PubMed, Cochrane Library, Embase, and ClinicalTrials.gov for relevant randomized clinical trials (RCTs). Pooled results were calculated using Peto ORs with corresponding 95% CIs.
RESULTS
Sixty RCTs enrolling 103,034 patients were analyzed. Inhaled therapy containing ICSs (Peto OR, 0.90; 95% CI, 0.84-0.97), especially triple therapy (Peto OR, 0.73; 95% CI, 0.59-0.91), was associated with a reduction in the all-cause mortality risk among patients with COPD when compared with inhaled therapy without ICSs. Subgroup analyses revealed that treatment duration of > 6 months (Peto OR, 0.90; 95% CI, 0.83-0.97), medium-dose ICSs (Peto OR, 0.71; 95% CI, 0.56-0.91), low-dose ICSs (Peto OR, 0.88; 95% CI, 0.79-0.97), and budesonide (Peto OR, 0.75; 95% CI, 0.59-0.94) were involved in this association. The predictors of this association included eosinophil counts of ≥ 200/μL or percentage of ≥ 2%, documented history of ≥ 2 moderate and severe exacerbations in the previous year, Global Initiative for Chronic Obstructive Lung Disease stages III or IV, age younger than 65 years, and BMI of ≥ 25 kg/m, among which eosinophil counts of ≥ 200/μL (Peto OR, 0.58; 95% CI, 0.36-0.95) were the strongest predictor.
INTERPRETATION
Inhaled therapy containing ICSs, especially triple therapy, of longer than 6 months was associated with a reduction in the all-cause mortality risk in patients with COPD. The predictors of this association included medication factors and patient characteristics, among which eosinophil counts of ≥ 200/μL were the strongest predictor.
TRIAL REGISTRY
PROSPERO; No.: CRD42022304725; URL: https://www.crd.york.ac.uk/prospero/.
背景
吸入性皮质类固醇（ICSs）已广泛用于 COPD 的维持治疗。然而，含有 ICS 的吸入疗法是否能降低全因死亡率以及可能受益的患者亚组尚不清楚。
研究问题
与不含有 ICS 的其他吸入疗法相比，含有 ICS 的吸入疗法是否能降低 COPD 患者的全因死亡率？
研究设计和方法
我们在 PubMed、Cochrane 图书馆、Embase 和 ClinicalTrials.gov 上检索了相关的随机临床试验（RCTs）。使用 Peto OR 及其相应的 95%CI 计算汇总结果。
结果
共分析了 60 项 RCTs，纳入了 103034 名患者。与不含有 ICS 的吸入疗法相比，含有 ICS 的吸入疗法（Peto OR，0.90；95%CI，0.84-0.97），特别是三联疗法（Peto OR，0.73；95%CI，0.59-0.91），与 COPD 患者的全因死亡率降低相关。亚组分析显示，治疗时间大于 6 个月（Peto OR，0.90；95%CI，0.83-0.97）、中剂量 ICSs（Peto OR，0.71；95%CI，0.56-0.91）、低剂量 ICSs（Peto OR，0.88；95%CI，0.79-0.97）和布地奈德（Peto OR，0.75；95%CI，0.59-0.94）均与该关联有关。与这种关联相关的预测因素包括嗜酸性粒细胞计数≥200/μL 或百分比≥2%、前一年记录≥2 次中度和重度加重、慢性阻塞性肺疾病全球倡议 III 或 IV 期、年龄小于 65 岁和 BMI≥25 kg/m，其中嗜酸性粒细胞计数≥200/μL（Peto OR，0.58；95%CI，0.36-0.95）是最强的预测因素。
解释
含有 ICS 的吸入疗法，特别是三联疗法，持续时间超过 6 个月与 COPD 患者的全因死亡率降低相关。与这种关联相关的预测因素包括药物因素和患者特征，其中嗜酸性粒细胞计数≥200/μL 是最强的预测因素。
试验注册
PROSPERO；编号：CRD42022304725；网址：https://www.crd.york.ac.uk/prospero/。
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