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近期短暂性脑缺血发作或脑卒中后他汀类药物治疗:随机临床试验显示的有效性在日常临床实践中也能观察到吗?

Statin treatment after a recent TIA or stroke: is effectiveness shown in randomized clinical trials also observed in everyday clinical practice?

机构信息

Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands.

出版信息

Acta Neurol Scand. 2010 Jul;122(1):15-20. doi: 10.1111/j.1600-0404.2009.01247.x. Epub 2009 Dec 28.

Abstract

AIM AND BACKGROUND

The benefit of statin treatment in patients with a previous ischemic stroke or transient ischemic attack (TIA) has been demonstrated in randomized clinical trials (RCT). However, the effectiveness in everyday clinical practice may be decreased because of a different patient population and less controlled setting. We aim to describe statin use in an unselected cohort of patients, identify factors related to statin use and test whether the effect of statins on recurrent vascular events and mortality observed in RCTs is also observed in everyday clinical practice.

METHODS

In 10 centers in the Netherlands, patients admitted to the hospital or visiting the outpatient clinic with a recent TIA or ischemic stroke were prospectively and consecutively enrolled between October 2002 and May 2003. Statin use was determined at discharge and during follow-up. We used logistic regression models to estimate the effect of statins on the occurrence of vascular events (stroke or myocardial infarction) and mortality within 3 years. We adjusted for confounders with a propensity score that relates patient characteristics to the probability of using statins.

RESULTS

Of the 751 patients in the study, 252 (34%) experienced a vascular event within 3 years. Age, elevated cholesterol levels and other cardiovascular risk factors were associated with statin use at discharge. After 3 years, 109 of 280 (39%) of the users at discharge had stopped using statins. Propensity score adjusted analyses showed a beneficial effect of statins on the occurrence of the primary outcome (odds ratio 0.8, 95% CI: 0.6-1.2).

CONCLUSION

In our study, we found poor treatment adherence to statins. Nevertheless, after adjustment for the differences between statin users and non-statin users, the observed beneficial effect of statins on the occurrence of vascular events within 3 years, although not statistically significant, is compatible with the effect observed in clinical trials.

摘要

目的和背景

他汀类药物治疗在既往缺血性卒中和短暂性脑缺血发作(TIA)患者中的益处已在随机临床试验(RCT)中得到证实。然而,由于患者人群不同和治疗环境控制较差,其在日常临床实践中的有效性可能会降低。我们旨在描述未经选择的患者队列中他汀类药物的使用情况,确定与他汀类药物使用相关的因素,并检验 RCT 中观察到的他汀类药物对复发性血管事件和死亡率的影响是否也存在于日常临床实践中。

方法

在荷兰的 10 个中心,2002 年 10 月至 2003 年 5 月期间,前瞻性连续招募了因近期 TIA 或缺血性卒中来院或门诊就诊的患者。在出院和随访期间确定他汀类药物的使用情况。我们使用逻辑回归模型来估计他汀类药物对 3 年内血管事件(卒中和心肌梗死)和死亡率发生的影响。我们使用倾向评分调整混杂因素,该评分将患者特征与使用他汀类药物的概率相关联。

结果

在研究的 751 例患者中,252 例(34%)在 3 年内发生血管事件。年龄、胆固醇水平升高和其他心血管危险因素与出院时使用他汀类药物相关。3 年后,280 例出院时使用他汀类药物的患者中有 109 例(39%)停止使用他汀类药物。倾向评分调整分析显示,他汀类药物对主要结局(比值比 0.8,95%置信区间:0.6-1.2)的发生有有益影响。

结论

在我们的研究中,我们发现他汀类药物治疗的依从性较差。然而,在校正了他汀类药物使用者和非使用者之间的差异后,观察到他汀类药物对 3 年内血管事件发生的有益影响虽然没有统计学意义,但与临床试验中的观察结果一致。

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