Department of Pneumology and Intensive Care Medicine, RWTH Aachen University Hospital, Aachen, Germany.
Institute for Clinical Pharmacology, University Hospital RWTH Aachen, Aachen, Germany.
Eur J Clin Pharmacol. 2023 Feb;79(2):219-227. doi: 10.1007/s00228-022-03433-9. Epub 2022 Dec 9.
Inhaled drugs have been cornerstones in the treatment of chronic obstructive pulmonary disease (COPD) for decades and show a high prescription volume. Due to the local application, drug safety issues of these therapies are often underestimated by professionals and patients. Data about adverse drug reactions (ADRs) caused by inhaled therapy in patients with COPD and polypharmacy are rare. We aimed to analyze the use and relevance of inhaled therapies in those patients in relation to ADR complaints, which were severe enough to warrant presentation to the emergency department.
Emergency department cases due to suspected ADRs of the ADRED database (n = 2939, "Adverse Drug Reactions in Emergency Departments"; DRKS-ID: DRKS00008979, registration date 01/11/2017) were analyzed for inhaled drugs in patients with COPD. ADRs in cases with overdosed inhaled drugs were compared to non-overdosed cases. ADRs, potentially caused by inhaled drugs, were evaluated, clustered into complexes, and assessed for association with inhaled drug classes.
Of the 269 included COPD cases, 67% (n = 180) received inhaled therapy. In 16% (n = 28), these therapies were overdosed. Overdosed cases presented the complexes of malaise and local symptoms more frequently. Related to the use of inhaled anticholinergics, local (dysphagia-like) and related to inhaled beta-2 agonists, local (dysphagia-like) and sympathomimetic-like ADRs presented more frequently.
Overdosed inhaled therapies in patients with COPD lead to relevant ADRs and impact on emergency room presentations. These are rarely associated to inhaled therapy by healthcare professionals or patients. Due to the high volume of inhaled drug prescriptions, pharmacovigilance and patient education should be more focused in patients with COPD. German Clinical Trial Register: DRKS-ID: DRKS00008979.
吸入性药物数十年来一直是治疗慢性阻塞性肺疾病(COPD)的基石,处方量很大。由于局部应用,这些治疗方法的药物安全性问题经常被专业人员和患者低估。关于 COPD 合并多种药物治疗患者因吸入治疗引起的不良反应(ADR)的数据很少。我们旨在分析与因吸入治疗引起的严重不良反应(ADR)而导致需急诊就诊的 ADR 投诉相关的这些患者中吸入治疗的使用情况和相关性。
对 ADRED 数据库(DRKS-ID:DRKS00008979,注册日期为 2017 年 11 月 1 日)中因疑似 ADR 而就诊于急诊科的病例(n=2939,“急诊中的药物不良反应”)进行分析,以确定 COPD 患者中使用的吸入性药物。比较了吸入药物过量和未过量病例的 ADR。评估了可能由吸入性药物引起的 ADR,将其聚类为复合物,并评估与吸入性药物类别之间的相关性。
在纳入的 269 例 COPD 病例中,67%(n=180)接受了吸入性治疗。在 16%(n=28)的病例中,这些治疗药物过量。药物过量病例更常出现不适和局部症状的复合物。与吸入性抗胆碱能药物相关的局部(类吞咽困难)和与吸入性β2 受体激动剂相关的局部(类吞咽困难)和拟交感神经样 ADR 更常出现。
COPD 患者中过量使用吸入性治疗药物会导致相关的 ADR,并影响急诊科就诊。这些很少被医疗保健专业人员或患者与吸入性治疗联系起来。由于吸入性药物处方量很大,因此应更关注 COPD 患者的药物警戒和患者教育。德国临床试验注册处:DRKS-ID:DRKS00008979。