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新型口服抗凝药物的临床试验。间接比较也称为网络荟萃分析的附加价值。

Clinical trials with new oral anticoagulants. Additive value of indirect comparisons also named network meta-analyses.

机构信息

Department of Clinical Pharmacology, Medical Faculty Mannheim, University of Heidelberg, Maybachstr. 14, 68169 Mannheim, Germany.

出版信息

Hamostaseologie. 2013;33(1):62-70. doi: 10.5482/HAMO-12-11-0021. Epub 2013 Jan 24.

DOI:10.5482/HAMO-12-11-0021
PMID:23344716
Abstract

To compare the efficacy and safety of the new oral anticoagulants (NOAC), ideally head-to-head clinical trials should be performed. Given the expense of such an undertaking, it is highly unlikely that such a comparison would be performed. Therefore, there is a need for an unbiased comparative assessment of the benefits and risks of the NOACs, based on the available trial data. Indirect or mixed treatment comparisons may be an useful tool to overcome these limitations also known as network meta-analysis (NMA). The aim of this paper is to give an overview on published NMAs for dabigatran, rivaroxaban and apixaban, each assessed against warfarin in patients with atrial fibrillation, and against enoxaparin in patients undergoing total knee and total hip replacement surgery, in order to obtain insights into the comparability of the adopted methodological techniques.

摘要

为了比较新型口服抗凝药物(NOAC)的疗效和安全性,理想情况下应进行头对头的临床试验。鉴于进行此类研究的费用高昂,这种比较极不可能进行。因此,需要根据现有试验数据,对 NOAC 的获益和风险进行无偏倚的比较评估。间接或混合治疗比较可能是克服这些限制的有用工具,也称为网络荟萃分析(NMA)。本文的目的是概述已发表的关于达比加群、利伐沙班和阿哌沙班的 NMA,分别评估了房颤患者使用华法林、膝关节和髋关节置换手术患者使用依诺肝素的疗效,以便深入了解所采用的方法学技术的可比性。

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引用本文的文献

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Adherence to oral anticoagulants in patients with atrial fibrillation-a population-based retrospective cohort study linking health information systems in the Valencia region, Spain: a study protocol.西班牙巴伦西亚地区心房颤动患者口服抗凝药依从性——一项基于人群的回顾性队列研究,该研究连接了健康信息系统:研究方案
BMJ Open. 2015 Oct 19;5(10):e007613. doi: 10.1136/bmjopen-2015-007613.
2
Systematic review and network meta-analysis comparing antithrombotic agents for the prevention of stroke and major bleeding in patients with atrial fibrillation.比较抗血栓药物预防心房颤动患者中风和大出血的系统评价与网状Meta分析。
BMJ Open. 2014 Jun 2;4(6):e004301. doi: 10.1136/bmjopen-2013-004301.
3
[New oral anticoagulants: who really needs them?].
[新型口服抗凝药:究竟谁需要它们?]
Internist (Berl). 2014 Jan;55(1):93-101. doi: 10.1007/s00108-013-3409-2.
4
Rivaroxaban: a review of its use in the prevention of stroke and systemic embolism in patients with atrial fibrillation.利伐沙班:用于预防房颤患者中风和全身性栓塞的综述。
Drugs. 2013 May;73(7):715-39. doi: 10.1007/s40265-013-0056-9.