High risks adverse events associated with usage of aspirin in chronic obstructive pulmonary disease

Despite potential benefits and widespread prescription of aspirin among chronic obstructive pulmonary disease (COPD) patients, limited research has investigated its adverse effects (AEs) in COPD population. We conducted a retrospective analysis of adverse drug events (ADEs) reported in the US Food and Drug Administration Adverse Event Reporting System (FAERS) between Q1 2013 and Q2 2022. COPD patients were categorized into two groups based on aspirin use. ADEs related to aspirin use were identified using combined reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC) methods. A total of 56,660 ADEs reports associated with COPD patients were included in the study. Among these reports, 144 adverse events were linked to aspirin use in COPD patients, including fatigue (4.12%), diarrhea (3.13%), dyspnea exertional (2.03%), rhinorrhea (1.99%), weight increased (1.89%) and vomiting (1.84%), muscle spasms (1.79%), cardiac disorder (1.74%), heart rate increased (1.69%) and peripheral swelling (1.59%). Subgroup analysis indicates that age and gender might affect the AEs frequency in COPD patients using aspirin. Our findings identify 10 most frequently reported ADEs associated with aspirin use in COPD patients, thus offer valuable insights into the AEs of aspirin for safer clinical utilization in COPD management.

尽管阿司匹林在慢性阻塞性肺疾病（chronic obstructive pulmonary disease, COPD）患者中具备潜在获益且被广泛处方，但针对该人群中阿司匹林不良反应（adverse effects, AEs）的相关研究仍较为匮乏。本研究针对2013年第一季度至2022年第二季度美国食品药品监督管理局不良事件报告系统（U.S. Food and Drug Administration Adverse Event Reporting System, FAERS）收录上报的药品不良事件（adverse drug events, ADEs）开展回顾性分析。研究根据阿司匹林使用情况将COPD患者划分为两组，采用联合报告比值比（reporting odds ratio, ROR）、比例报告比值比（proportional reporting ratio, PRR）及信息成分（information component, IC）三种方法，识别与阿司匹林使用相关的药品不良事件。本研究共纳入56660例与COPD患者相关的药品不良事件报告，其中共计144例不良事件与COPD患者使用阿司匹林相关，涉及的不良事件包括疲劳（4.12%）、腹泻（3.13%）、劳力性呼吸困难（2.03%）、鼻漏（1.99%）、体重增加（1.89%）、呕吐（1.84%）、肌肉痉挛（1.79%）、心脏疾病（1.74%）、心率增快（1.69%）及外周水肿（1.59%）。亚组分析结果显示，年龄与性别可能会影响使用阿司匹林的COPD患者的不良事件发生频率。本研究明确了COPD患者中与阿司匹林使用相关的10种上报频次最高的不良事件，可为阿司匹林在COPD管理中的安全临床应用提供具有参考价值的科学依据。