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[大学生论坛]:一项随机、开放标签、第三阶段的优势试验(抗血小板疗法)

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zyf950201 发表于 2017-12-31 22:12:55 | 显示全部楼层 |阅读模式
本帖最后由 zyf950201 于 2017-12-31 22:14 编辑

Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial.
抗血小板疗法与阿司匹林、氯吡格雷、双嘧达莫同用和氯吡格雷单独使用或阿司匹林和双嘧达莫治疗急性脑缺血(TARDIS):一项随机、开放标签、第三阶段的优势试验


Summary
摘要


Background
背景
Intensive antiplatelet therapy with three agents might be more effective than guideline treatment for preventing recurrent events in patients with acute cerebral ischaemia. We aimed to compare the safety and efficacy of intensive antiplatelet therapy (combined aspirin, clopidogrel, and dipyridamole) with that of guideline-based antiplatelet therapy.
三种药物与强化抗血小板疗法共同使用可能比指导治疗用于防止急性脑缺血患者复发更有效。我们的目的是比较强化抗血小板疗法(联合阿司匹林、氯吡格雷和双嘧达莫)与基于指导的抗血小板疗法的安全性和有效性。


Methods
方法
We did an international, prospective, randomised, open-label, blinded-endpoint trial in adult participants with ischaemic stroke or transient ischaemic attack (TIA) within 48 h of onset. Participants were assigned in a 1:1 ratio using computer randomisation to receive loading doses and then 30 days of intensive antiplatelet therapy (combined aspirin 75 mg, clopidogrel 75 mg, and dipyridamole 200 mg twice daily) or guideline-based therapy (comprising either clopidogrel alone or combined aspirin and dipyridamole). Randomisation was stratified by country and index event, and minimised with prognostic baseline factors, medication use, time to randomisation, stroke-related factors, and thrombolysis. The ordinal primary outcome was the combined incidence and severity of any recurrent stroke (ischaemic or haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days, as assessed by central telephone follow-up with masking to treatment assignment, and analysed by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN47823388.
我们做了一个国际的,前瞻性的,随机的,开放标签的,盲端的预试验。被试在48小时内发作过缺血性中风或短暂的缺血发作(TIA)。参与者被分配到一个1:1的比例,使用计算机随机接受注射剂量,然后用30天的强化抗血小板治疗(联合阿司匹林75 mg,氯吡格雷75 mg,和双嘧达莫 200 mg,每天两次)或基于指导的治疗(包括单独使用氯吡格雷或联合阿斯匹林和双嘧达莫)。随机化由国家和指数事件分层,并将预后基线因素、用药时间、随机时间、中风相关因素和溶栓率降至最低。最主要的结果是任何复发性卒中的合并发生率和严重程度(缺血性或出血热;用改良Rankin量表,或在90天内缺血发作进行评估,由中央电话随访对治疗任务的掩蔽进行评估,并通过意向治疗进行分析。本次试验在ISRCTN注册中心注册,编号ISRCTN47823388。



Findings
发现
3096 participants (1556 in the intensive antiplatelet therapy group, 1540 in the guideline antiplatelet therapy group) were recruited from 106 hospitals in four countries between April 7, 2009, and March 18, 2016. The trial was stopped early on the recommendation of the data monitoring committee. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy (93 [6%] participants vs 105 [7%]; adjusted common odds ratio [cOR] 0·90, 95% CI 0·67–1·20, p=0·47). By contrast, intensive antiplatelet therapy was associated with more, and more severe, bleeding (adjusted cOR 2·54, 95% CI 2·05–3·16, p<0·0001).
3096名参与者(1556人在强化抗血小板疗法组,1540在指导抗血小板治疗组)于2009年4月7日至2016年3月18日从四个国家的106家医院招募。在数据监测委员会的建议下,实验提前结束。复发性卒中或TIA的发生率和严重程度与高强度和指导治疗无差异(93[6%]参与者vs 105[7%];调整后的常见优势比[cOR]0·90,95% CI 0·67 - 1·20,p = 0·47。相比之下,强化抗血小板疗法与更多、更严重的出血有关(调整后的cOR 2·54,95% CI 2·05 - 3·16,p < 0·0001)。

Interpretation
解释
Among patients with recent cerebral ischaemia, intensive antiplatelet therapy did not reduce the incidence and severity of recurrent stroke or TIA, but did significantly increase the risk of major bleeding. Triple antiplatelet therapy should not be used in routine clinical practice.
在最近的脑缺血患者中,强化抗血小板治疗并没有降低复发性卒中或TIA的发生率和严重程度,但显著增加了大出血的风险。三抗血小板治疗不应在常规临床实践中使用。

本文来自:http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32849-0/fulltext
作者:Prof Philip M Bath等
日期:20 December 2017

2014级商务英语 张远峰 3141204012


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