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双嘧达莫预防复发性缺血性中风和其他血管事件:来自随机对照试验的个体患者数据的荟萃分析

Dipyridamole for preventing recurrent ischemic stroke and other vascular events: a meta-analysis of individual patient data from randomized controlled trials.

作者信息

Leonardi-Bee Jo, Bath Philip M W, Bousser Marie-Germaine, Davalos Antoni, Diener Hans-Christoph, Guiraud-Chaumeil Bernard, Sivenius Juhani, Yatsu Frank, Dewey Michael E

机构信息

University of Nottingham, Nottingham, UK.

出版信息

Stroke. 2005 Jan;36(1):162-8. doi: 10.1161/01.STR.0000149621.95215.ea. Epub 2004 Nov 29.

Abstract

BACKGROUND AND PURPOSE

Results from randomized controlled trials of dipyridamole, given with or without aspirin, for secondary prevention after ischemic stroke or transient ischemic attack (TIA) have given conflicting results. We performed a meta-analysis using individual patient data from relevant randomized controlled trials.

METHODS

Randomized controlled trials involving dipyridamole in patients with previous ischemic stroke or TIA were sought from searches of the Cochrane Library, other electronic databases, references lists, earlier reviews, and contact with the manufacturer of dipyridamole. Individual patient data were merged from 5 of 7 relevant trials involving 11 459 patients. Results were adjusted for age, gender, qualifying event, and history of previous hypertension.

RESULTS

Recurrent stroke was reduced by dipyridamole as compared with control (OR, 0.82; 95% CI, 0.68 to 1.00), and by combined aspirin and dipyridamole versus aspirin alone (OR, 0.78; 95% CI, 0.65 to 0.93), dipyridamole alone (OR, 0.74; 95% CI, 0.60 to 0.90), or control (OR, 0.61; 95% CI, 0.51 to 0.71). The point estimates obtained for the comparisons of aspirin and dipyridamole versus control (OR, 0.63; significant) or versus aspirin (OR, 0.88; nonsignificant) were similar if the data from the largest trial, ESPS II (which provided 57% of data), were excluded. Similar findings were observed for nonfatal stroke. The combination of aspirin and dipyridamole also significantly reduced the composite outcome of nonfatal stroke, nonfatal myocardial infarction, and vascular death as compared with aspirin alone (OR, 0.84; 95% CI, 0.72 to 0.97), dipyridamole alone (OR, 0.76; 95% CI, 0.64 to 0.90), or control (OR, 0.66; 95% CI, 0.57 to 0.75). Vascular death was not altered in any group.

CONCLUSIONS

Dipyridamole, given alone or with aspirin, reduces stroke recurrence in patients with previous ischemic cerebrovascular disease. The combination of aspirin and dipyridamole also reduces the composite of nonfatal stroke, nonfatal myocardial infarction, and vascular death as compared with aspirin alone.

摘要

背景与目的

双嘧达莫联合或不联合阿司匹林用于缺血性卒中或短暂性脑缺血发作(TIA)二级预防的随机对照试验结果相互矛盾。我们使用相关随机对照试验的个体患者数据进行了一项荟萃分析。

方法

通过检索Cochrane图书馆、其他电子数据库、参考文献列表、早期综述以及与双嘧达莫制造商联系,寻找涉及双嘧达莫用于既往缺血性卒中和TIA患者的随机对照试验。从7项相关试验中的5项纳入了11459例患者的个体患者数据。结果根据年龄、性别、合格事件和既往高血压病史进行了调整。

结果

与对照组相比,双嘧达莫可降低复发性卒中(比值比[OR],0.82;95%置信区间[CI],0.68至1.00),联合阿司匹林和双嘧达莫组与单独使用阿司匹林组相比(OR,0.78;95%CI,0.65至0.93)、单独使用双嘧达莫组(OR,0.74;95%CI,0.60至0.90)或对照组相比(OR,0.61;95%CI,0.51至0.71)。如果排除最大试验ESPS II(提供了57%的数据)的数据,阿司匹林和双嘧达莫与对照组相比(OR,0.63;有统计学意义)或与阿司匹林相比(OR,0.88;无统计学意义)的点估计值相似。非致命性卒中也观察到类似结果。与单独使用阿司匹林相比,阿司匹林和双嘧达莫联合使用还显著降低了非致命性卒中、非致命性心肌梗死和血管性死亡的复合结局(OR,0.84;95%CI,0.72至0.97)、单独使用双嘧达莫组(OR,0.76;95%CI,0.64至0.90)或对照组相比(OR,0.66;95%CI,0.57至0.75)。任何组的血管性死亡均未改变。

结论

单独使用或与阿司匹林联合使用双嘧达莫可降低既往缺血性脑血管疾病患者的卒中复发率。与单独使用阿司匹林相比,阿司匹林和双嘧达莫联合使用还可降低非致命性卒中、非致命性心肌梗死和血管性死亡的复合结局。

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