Alzayer Reem, Hughes Jeffery, Parsons Richard, Lee Ya Ping
Curtin University of Technology, Perth, Australia.
Qual Prim Care. 2010;18(3):189-99.
The aim of this study was to examine the risk of cardiovascular diseases among users of both inhaled (ipratropium bromide or tiotropium bromide) and oral (oxybutynin and propantheline, solifenacin, tolterodine) anticholinergics.
A retrospective study was undertaken on data obtained from the Food and Drug Administration (FDA) from subjects who had received either an inhaled or oral form of an anticholinergic drug and experienced some side effect during the period from 1988 to 2009. The recorded data included: patient's age, sex, list of drugs and side effects. Side effect rates for the anticholinergic drugs were compared using univariate (Chi-square) and multivariate (logistic regression) methods.
The files from the FDA held data for 36 491 different subjects, of whom 2610 (7.15%) experienced a cardiovascular or neurovascular side effect. Subjects were classified as taking the oral (45%) or inhaled (55%) class of the drug, with only 109 subjects (0.3%) taking drugs in both forms. Side effect rates differed between anticholinergic drugs. Stroke and hypertension were significantly more common for subjects taking oral anticholinergic drug compared with tiotropium, while other reported vascular side effects (cardiac ischaemia or arrhythmiascardiac failure, cardiac arrest) tended to be more commonly associated with the use of inhaled anticholingerics. These differences persisted after adjustment for age and gender.
This observational study of recorded side effects showed that, except for stroke and hypertension, patients who were treated with an inhaled anticholinergic drug appeared to be at higher risk of developing neurovascular or cardiovascular side effects, than those treated with an oral drug. However, physicians should also be aware that oral anticholinergic drugs may have similar adverse impacts on health. Further studies on the association between anticholinergic drugs and cardiovascular and neurovascular side effects are recommended.
本研究旨在探讨吸入性（异丙托溴铵或噻托溴铵）和口服（奥昔布宁、丙胺太林、索利那新、托特罗定）抗胆碱能药物使用者发生心血管疾病的风险。
对1988年至2009年期间从美国食品药品监督管理局（FDA）获取的数据进行回顾性研究，这些数据来自接受过吸入或口服抗胆碱能药物且出现过某些副作用的受试者。记录的数据包括：患者的年龄、性别、药物清单和副作用。使用单变量（卡方检验）和多变量（逻辑回归）方法比较抗胆碱能药物的副作用发生率。
FDA的档案中有36491名不同受试者的数据，其中2610名（7.15%）出现了心血管或神经血管副作用。受试者被分为服用口服药物（45%）或吸入药物（55%）两类，只有109名受试者（0.3%）同时服用两种形式的药物。不同抗胆碱能药物的副作用发生率有所不同。与噻托溴铵相比，服用口服抗胆碱能药物的受试者中风和高血压更为常见，而其他报告的血管副作用（心脏缺血或心律失常、心力衰竭、心脏骤停）往往更常与吸入性抗胆碱能药物的使用相关。在对年龄和性别进行调整后，这些差异仍然存在。
这项关于记录副作用的观察性研究表明，除中风和高血压外，接受吸入性抗胆碱能药物治疗的患者出现神经血管或心血管副作用的风险似乎高于接受口服药物治疗的患者。然而，医生也应意识到口服抗胆碱能药物可能对健康有类似的不良影响。建议进一步研究抗胆碱能药物与心血管和神经血管副作用之间的关联。
