Department of Pharmacy, University College London Hospitals NHS Foundation Trust, London, UK.
Br J Clin Pharmacol. 2009 Nov;68(5):731-6. doi: 10.1111/j.1365-2125.2009.03517.x.
A recent communication from the United States Food and Drug Administration highlighted a possible increased risk of stroke associated with use of the relatively new inhaled anticholinergic drug, tiotropium bromide. Using the United Kingdom General Practice Research Database, we set out to assess the risk of stroke in individuals exposed to inhaled tiotropium bromide and two other inhaled treatments for airways disease.
We used the self-controlled case-series that reduces confounding and minimizes the potential for biases in the quantification of risk estimates.
Of 1043 people with a diagnosis of incident stroke who had had at least one prescription for tiotropium bromide, 980 satisfied inclusion criteria. The age-adjusted incidence rate ratio for all-cause stoke in individuals exposed to tiotropium bromide (n = 980), ipratropium bromide (n = 4181) and fluticasone propionate/salmeterol xinafoate (n = 1000) was 1.1 [95% confidence interval (CI) 0.9, 1.3], 0.8 (95% CI 0.7, 0.9) and 1.0 (95% CI 0.9, 1.2), respectively.
We found no evidence of an increased risk of all-cause stroke for individuals exposed to commonly prescribed inhaled treatments for chronic obstructive pulmonary disease.
美国食品和药物管理局最近的一份通报强调了使用相对较新的吸入性抗胆碱能药物噻托溴铵可能增加中风风险。我们利用英国全科医生研究数据库，旨在评估吸入噻托溴铵以及另外两种用于气道疾病的吸入治疗药物对中风风险的影响。
我们使用了自我对照病例系列研究，这种方法可以减少混杂因素并最大限度地减少风险估计量化中的偏倚。
在 1043 名有确诊中风病史且至少有一次噻托溴铵处方的患者中，有 980 名符合纳入标准。暴露于噻托溴铵（n = 980）、异丙托溴铵（n = 4181）和氟替卡松丙酸/沙美特罗替卡松（n = 1000）的个体的全因中风年龄调整发生率比分别为 1.1（95%置信区间 0.9，1.3）、0.8（95%置信区间 0.7，0.9）和 1.0（95%置信区间 0.9，1.2）。
我们没有发现暴露于慢性阻塞性肺疾病常用吸入治疗药物的个体全因中风风险增加的证据。
