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颈动脉内膜切除术后预防中风及其他血管事件的抗血小板治疗。

Antiplatelet therapy for preventing stroke and other vascular events after carotid endarterectomy.

作者信息

Engelter S, Lyrer P

出版信息

Cochrane Database Syst Rev. 2003;2003(3):CD001458. doi: 10.1002/14651858.CD001458.

Abstract

BACKGROUND

Antiplatelet drugs are effective and safe in a wide variety of patients at high risk of vascular ischaemic events. Among patients undergoing vascular surgical procedures, these agents significantly reduce the risk of graft or native vessel occlusion. In this context we wished to examine their effects in patients after carotid endarterectomy (CEA).

OBJECTIVES

The objective of this review was to evaluate whether antiplatelet agents are safe and beneficial after endarterectomy of the internal carotid artery.

SEARCH STRATEGY

We searched the Cochrane Stroke Group Trials Register (last searched: 1 October 2002). In addition we performed comprehensive searches of the Cochrane Controlled Trials Register (Cochrane Library Issue 3, 2002), MEDLINE (January 1966 to September 2002) and EMBASE (January 1980 to September 2002), and checked all relevant papers for additional eligible studies.

SELECTION CRITERIA

We selected randomised, controlled, unconfounded trials comparing antiplatelet agents with control after carotid endarterectomy in symptomatic or asymptomatic carotid stenosis of different degrees. Treatment duration had to be at least 30 days after CEA. Follow-up should be at least three months.

DATA COLLECTION AND ANALYSIS

Two reviewers selected trials for inclusion, assessed trial quality, and extracted data independently from each other. From each trial we extracted, first the number of patients originally allocated to each treatment group, and, second the number of patients who met the criteria for each outcome (intention-to-treat analysis). We calculated a weighted estimate of the odds for each outcome event across studies using the Peto odds ratio method.

MAIN RESULTS

Six trials involving 907 patients were identified. For 'death (all causes)' the Peto odds ratio of 0.77 with a 95% confidence interval (CI) of 0.48-1.24 did not show a statistically significant difference between both treatment groups. For 'stroke (any)' the Peto odds ratio of 0.58 (95%CI: 0.34-0.98) indicated a statistically significant benefit in favour of antiplatelet drugs (p=0.04). Concerning the secondary outcome events 'vascular death', 'stroke or vascular death', 'serious vascular events', 'death or dependency', 'myocardial infarction', 'major extracranial haemorrhage', 'local haemorrhage requiring surgery', 'restenosis', 'TIA or amaurosis fugax', neither any benefit nor any hazard of antiplatelet drugs could be shown. For the outcome events 'intracranial haemorrhage', 'ischaemic stroke' and 'occurrence or progression of contralateral stenosis', data were either too sparse for meaningful analyses, or not available at all.

REVIEWER'S CONCLUSIONS: Our results may indicate that antiplatelet drugs did not significantly change the odds of 'death' but reduce the outcome 'stroke of any cause' in patients undergoing carotid endarterectomy. However, it can not be excluded that the beneficial effect in reducing stroke is due to chance. There is a suggestion that antiplatelets may increase the odds of haemorrhage, but there are currently too few data to quantify this effect.

摘要

背景

抗血小板药物在各类有血管缺血事件高风险的患者中有效且安全。在接受血管外科手术的患者中,这些药物能显著降低移植血管或自身血管闭塞的风险。在此背景下,我们希望研究其在颈动脉内膜切除术(CEA)后患者中的效果。

目的

本综述的目的是评估抗血小板药物在颈内动脉内膜切除术后是否安全且有益。

检索策略

我们检索了Cochrane卒中组试验注册库(最后检索时间:2002年10月1日)。此外,我们还对Cochrane对照试验注册库(Cochrane图书馆2002年第3期)、MEDLINE(1966年1月至2002年9月)和EMBASE(1980年1月至2002年9月)进行了全面检索,并检查所有相关论文以寻找其他符合条件的研究。

选择标准

我们选择了随机、对照、无混淆的试验,比较不同程度有症状或无症状颈动脉狭窄患者在颈动脉内膜切除术后抗血小板药物与对照的效果。治疗持续时间必须在CEA后至少30天。随访应至少三个月。

数据收集与分析

两名评价员选择纳入试验,评估试验质量,并相互独立地提取数据。从每个试验中,我们首先提取最初分配到每个治疗组的患者数量,其次提取符合每个结局标准的患者数量(意向性分析)。我们使用Peto比值比方法计算各研究中每个结局事件的加权比值比估计值。

主要结果

确定了6项涉及907例患者的试验。对于“全因死亡”,Peto比值比为0.77,95%置信区间(CI)为0.48 - 1.24,两个治疗组之间未显示出统计学显著差异。对于“任何卒中”,Peto比值比为0.58(95%CI:0.34 - 0.98),表明抗血小板药物具有统计学显著益处(p = 0.04)。关于次要结局事件“血管性死亡”“卒中或血管性死亡”“严重血管事件”“死亡或依赖”“心肌梗死”“重大颅外出血”“需要手术的局部出血”“再狭窄”“短暂性脑缺血发作或一过性黑矇”,未显示出抗血小板药物有任何益处或危害。对于结局事件“颅内出血”“缺血性卒中”和“对侧狭窄的发生或进展”,数据要么过于稀少无法进行有意义的分析,要么根本没有。

评价员结论

我们的结果可能表明,抗血小板药物在接受颈动脉内膜切除术的患者中未显著改变“死亡”的几率,但降低了“任何原因的卒中”这一结局。然而,不能排除降低卒中的有益效果是由于偶然因素。有迹象表明抗血小板药物可能增加出血几率,但目前数据太少无法量化这种效果。

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