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抗血栓剂量:来自已发表临床试验的一些观察结果。

Antithrombotic dose: Some observations from published clinical trials.

机构信息

Division of Internal Medicine, Medical School, Faculty of Health and Medical Sciences, University of Western Australia, Crawley, Australia.

School of Medicine & Public Health, University of Newcastle, UK.

出版信息

Br J Clin Pharmacol. 2019 Oct;85(10):2194-2197. doi: 10.1111/bcp.13968. Epub 2019 Jul 1.

Abstract

The clinical doses of antithrombotics-antiplatelet and anticoagulant agents-need to balance efficacy and safety. It is not clear from the published literature how the doses currently used in clinical practice have been derived from preclinical and clinical data. There are few large randomised controlled trials (RCTs) that compare outcomes with different doses vs placebo. For newer antithrombotics, RCT doses appear to have been chosen to maximise the probability of demonstrating noninferiority when compared to established agents such as warfarin or clopidogrel. Data from RCTs show that aspirin is an effective antithrombotic at doses below 75 mg daily, and that direct oral anticoagulants reduce the risk of stroke in patients with coronary disease at doses 1/4 of those recommended in atrial fibrillation. Lower doses than those currently recommended are safer and still maintain substantial efficacy.

摘要

抗血栓形成药-抗血小板和抗凝药物的临床剂量需要平衡疗效和安全性。目前在临床实践中使用的剂量是如何从临床前和临床数据中得出的,这在已发表的文献中尚不清楚。很少有大型随机对照试验(RCT)比较不同剂量与安慰剂的结果。对于较新的抗血栓形成药物,RCT 剂量似乎是为了在与华法林或氯吡格雷等已确立的药物相比时最大限度地提高显示非劣效性的可能性而选择的。RCT 数据表明,阿司匹林在每日低于 75mg 的剂量下是一种有效的抗血栓形成药物,而直接口服抗凝剂可降低冠心病患者中风的风险,剂量为房颤推荐剂量的 1/4。低于目前推荐剂量的药物更安全,并且仍然保持着相当大的疗效。

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