Wilterdink J L, Easton J D
Department of Neurology, Rhode Island Hospital, Providence 02903, USA.
Arch Neurol. 1999 Sep;56(9):1087-92. doi: 10.1001/archneur.56.9.1087.
The second European Stroke Prevention Study (ESPS-2) recently reported a substantial benefit of dipyridamole combined with aspirin over aspirin alone in the prevention of stroke. This appears to be at odds with previous studies suggesting that dipyridamole adds nothing to aspirin alone.
To review and compare the results of ESPS-2 and previous studies of dipyridamole plus aspirin and aggregate them in a meta-analysis.
We combined the detailed data provided by the Antiplatelet Trialists' Collaboration on the previous studies of dipyridamole plus aspirin with the results from ESPS-2. The data on the previous trials were listed in the appendix of the 1994 publication of the Antiplatelet Trialists' Collaboration.
The results of our meta-analysis demonstrate that for the outcome of nonfatal stroke, ESPS-2 overwhelms previous data, which, even in the aggregate, did not include enough patients or outcome events to exclude efficacy for the combination of dipyridamole and aspirin. Differences between ESPS-2 and previous studies, which may have contributed to different results, include the doses and preparations of aspirin and dipyridamole.
The ESPS-2 showed that dipyridamole alone prevents stroke. More importantly, it showed a substantial benefit for dipyridamole combined with aspirin over aspirin alone. When the ESPS-2 data are aggregated with the 14 previous trials of dipyridamole combined with aspirin over aspirin alone, the combination reduces the risk of stroke by 23% over aspirin alone. Nevertheless, important questions remain unanswered. We conclude that another randomized clinical trial showing a significant benefit of the combination of dipyridamole plus aspirin over aspirin alone may be needed before the addition of dipyridamole to aspirin is widely accepted for prevention of stroke.
第二项欧洲卒中预防研究（ESPS - 2）最近报告，双嘧达莫联合阿司匹林在预防卒中方面比单用阿司匹林有显著益处。这似乎与之前的研究结果相矛盾，之前的研究表明双嘧达莫单用阿司匹林并无额外益处。
回顾并比较ESPS - 2以及之前关于双嘧达莫加阿司匹林的研究结果，并进行荟萃分析汇总这些结果。
我们将抗血小板试验协作组提供的关于双嘧达莫加阿司匹林之前研究的详细数据与ESPS - 2的结果相结合。之前试验的数据列于抗血小板试验协作组1994年出版物的附录中。
我们的荟萃分析结果表明，对于非致命性卒中这一结局，ESPS - 2的数据超过了之前的数据，之前的数据即便汇总起来，纳入的患者或结局事件数量也不足以排除双嘧达莫与阿司匹林联合使用的疗效。ESPS - 2与之前研究之间可能导致结果不同的差异包括阿司匹林和双嘧达莫的剂量及制剂。
ESPS - 2表明单用双嘧达莫可预防卒中。更重要的是，它表明双嘧达莫联合阿司匹林比单用阿司匹林有显著益处。当将ESPS - 2的数据与之前14项双嘧达莫联合阿司匹林对比单用阿司匹林的试验数据汇总时，联合用药比单用阿司匹林可使卒中风险降低23%。然而，重要问题仍未得到解答。我们得出结论，在双嘧达莫加至阿司匹林用于预防卒中被广泛接受之前，可能需要另一项随机临床试验来证明双嘧达莫联合阿司匹林比单用阿司匹林有显著益处。
