慢性阻塞性肺疾病（COPD）合并2型糖尿病患者中吸入性糖皮质激素（ICS）相关的代谢效应：一项历史匹配队列研究
Metabolic Effects Associated with ICS in Patients with COPD and Comorbid Type 2 Diabetes: A Historical Matched Cohort Study.
作者信息
Price David B, Russell Richard, Mares Rafael, Burden Anne, Skinner Derek, Mikkelsen Helga, Ding Cherlyn, Brice Richard, Chavannes Niels H, Kocks Janwillem W H, Stephens Jeffrey W, Haughney John
机构信息
Academic Primary Care, University of Aberdeen, Aberdeen, United Kingdom.
Observational and Pragmatic Research Institute, Singapore, Singapore.
出版信息
PLoS One. 2016 Sep 22;11(9):e0162903. doi: 10.1371/journal.pone.0162903. eCollection 2016.
BACKGROUND
Management guidelines for chronic obstructive pulmonary disease (COPD) recommend that inhaled corticosteroids (ICS) are prescribed to patients with the most severe symptoms. However, these guidelines have not been widely implemented by physicians, leading to widespread use of ICS in patients with mild-to-moderate COPD. Of particular concern is the potential risk of worsening diabetic control associated with ICS use. Here we investigate whether ICS therapy in patients with COPD and comorbid type 2 diabetes mellitus (T2DM) has a negative impact on diabetic control, and whether these negative effects are dose-dependent.
METHODS AND FINDINGS
This was a historical matched cohort study utilising primary care medical record data from two large UK databases. We selected patients aged ≥40 years with COPD and T2DM, prescribed ICS (n = 1360) or non-ICS therapy (n = 2642) between 2008 and 2012. The primary endpoint was change in HbA1c between the baseline and outcome periods. After 1:1 matching, each cohort consisted of 682 patients. Over the 12-18-month outcome period, patients prescribed ICS had significantly greater increases in HbA1c values compared with those prescribed non-ICS therapies; adjusted difference 0.16% (95% confidence interval [CI]: 0.05-0.27%) in all COPD patients, and 0.25% (95% CI: 0.10-0.40%) in mild-to-moderate COPD patients. Patients in the ICS cohort also had significantly more diabetes-related general practice visits per year and received more frequent glucose strip prescriptions, compared with those prescribed non-ICS therapies. Patients prescribed higher cumulative doses of ICS (>250 mg) had greater odds of increased HbA1c and/or receiving additional antidiabetic medication, and increased odds of being above the Quality and Outcomes Framework (QOF) target for HbA1c levels, compared with those prescribed lower cumulative doses (≤125 mg).
CONCLUSION
For patients with COPD and comorbid T2DM, ICS therapy may have a negative impact on diabetes control. Patients prescribed higher cumulative doses of ICS may be at greater risk of diabetes progression.
TRIAL REGISTRATION
ENCePP ENCEPP/SDPP/6804.
背景
慢性阻塞性肺疾病（COPD）管理指南建议，应给症状最严重的患者开具吸入性糖皮质激素（ICS）。然而，这些指南并未得到医生的广泛执行，导致ICS在轻度至中度COPD患者中广泛使用。尤其令人担忧的是，使用ICS可能存在使糖尿病控制恶化的潜在风险。在此，我们调查COPD合并2型糖尿病（T2DM）患者使用ICS治疗是否会对糖尿病控制产生负面影响，以及这些负面影响是否具有剂量依赖性。
方法与结果
这是一项历史性匹配队列研究，利用来自两个大型英国数据库的初级医疗记录数据。我们选取了年龄≥40岁、患有COPD和T2DM且在2008年至2012年间开具了ICS（n = 1360）或非ICS治疗（n = 2642）的患者。主要终点是基线期和结局期之间糖化血红蛋白（HbA1c）的变化。经过1:1匹配后，每个队列由682名患者组成。在12 - 18个月的结局期内，与接受非ICS治疗的患者相比，接受ICS治疗的患者HbA1c值显著升高；所有COPD患者的校正差异为0.16%（95%置信区间[CI]：0.05 - 0.27%），轻度至中度COPD患者为0.25%（95% CI：0.10 - 0.40%）。与接受非ICS治疗的患者相比，ICS队列中的患者每年与糖尿病相关的全科医生就诊次数也显著更多，并且接受血糖试纸处方的频率更高。与接受较低累积剂量（≤125 mg）ICS的患者相比，接受较高累积剂量（>250 mg）ICS的患者HbA1c升高和/或接受额外抗糖尿病药物治疗的几率更高，且HbA1c水平高于质量与结果框架（QOF）目标的几率也增加。
结论
对于COPD合并T2DM的患者，ICS治疗可能会对糖尿病控制产生负面影响。接受较高累积剂量ICS治疗的患者糖尿病进展风险可能更高。
试验注册
ENCEPP ENCEPP/SDPP/6804
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