Kamal Ayeesha K, Naqvi Imama, Husain Muhammad R, Khealani Bhojo A
Stroke Service, Section of Neurology, Department of Medicine, Aga Khan University Hospital, Stadium Road, PO Box 3500, Karachi, Pakistan, 74800.
Cochrane Database Syst Rev. 2011 Jan 19;2011(1):CD008076. doi: 10.1002/14651858.CD008076.pub2.
Aspirin is widely used for secondary prevention after stroke. Cilostazol has shown promise as an alternative to aspirin in Asian people with stroke.
To determine the relative effectiveness and safety of cilostazol compared directly with aspirin in the prevention of stroke and other serious vascular events in patients at high vascular risk for subsequent stroke, those with previous transient ischaemic attack (TIA) or ischaemic stroke of arterial origin.
We searched the Cochrane Stroke Group Trials Register (last searched September 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, Issue 4), MEDLINE (1950 to May 2010) and EMBASE (1980 to May 2010). In an effort to identify further published, ongoing and unpublished studies we searched journals, conference proceedings and ongoing trial registers, scanned reference lists from relevant studies and contacted trialists and Otsuka Pharmaceutical Co Ltd.
We selected all randomised controlled trials (RCTs) comparing cilostazol with aspirin where participants were treated for at least one month and followed systematically for development of vascular events.
Data extracted from eligible studies included: (1) a composite outcome of vascular events (stroke, myocardial infarction or vascular death) during follow up (primary outcome); (2) separate outcomes of stroke (ischaemic or haemorrhagic, fatal or non-fatal), myocardial infarction (MI) (fatal or non-fatal), vascular death and death from all causes; and (3) main outcomes of safety including any intracranial, extracranial or gastrointestinal (GI) haemorrhage and other outcomes during treatment follow up (secondary outcomes). We computed an estimate of treatment effect and performed a test for heterogeneity between trials. We analysed data on an intention-to-treat basis and assessed bias for all included studies.
We included two RCTs with 3477 Asian participants. Compared with aspirin, cilostazol was associated with a significantly lower risk of composite outcome of vascular events (6.77% versus 9.39%, risk ratio (RR) 0.72, 95% confidence interval (CI) 0.57 to 0.91), and lower risk of haemorrhagic stroke (0.53% versus 2.01%, RR 0.26, 95% CI 0.13 to 0.55). In terms of outcome of safety compared with aspirin, cilostazol was significantly associated with minor adverse effects (8.22% versus 4.95%, RR 1.66, 95% CI 1.51 to 1.83).
AUTHORS' CONCLUSIONS: Cilostazol is more effective than aspirin in the prevention of vascular events secondary to stroke. Cilostazol has more minor adverse effects, although there is evidence of fewer bleeds.
阿司匹林广泛用于中风后的二级预防。在亚洲中风患者中，西洛他唑已显示出有望作为阿司匹林的替代药物。
直接比较西洛他唑与阿司匹林在预防后续中风血管风险高的患者、既往有短暂性脑缺血发作（TIA）或动脉源性缺血性中风患者中风及其他严重血管事件方面的相对有效性和安全性。
我们检索了Cochrane中风组试验注册库（最后检索时间为2010年9月）、Cochrane对照试验中心注册库（CENTRAL）（《Cochrane图书馆》2009年第4期）、MEDLINE（1950年至2010年5月）和EMBASE（1980年至2010年5月）。为了识别更多已发表、正在进行和未发表的研究，我们检索了期刊、会议论文集和正在进行的试验注册库，浏览了相关研究的参考文献列表，并联系了试验人员和大冢制药有限公司。
我们选择了所有比较西洛他唑与阿司匹林的随机对照试验（RCT），其中参与者接受治疗至少1个月，并对血管事件的发生进行系统随访。
从符合条件的研究中提取的数据包括：（1）随访期间血管事件的综合结局（中风、心肌梗死或血管性死亡）（主要结局）；（2）中风（缺血性或出血性、致命或非致命）、心肌梗死（MI）（致命或非致命）、血管性死亡和全因死亡的单独结局；（3）安全性的主要结局，包括治疗随访期间的任何颅内、颅外或胃肠道（GI）出血及其他结局（次要结局）。我们计算了治疗效果的估计值，并对试验间的异质性进行了检验。我们基于意向性分析对数据进行分析，并评估了所有纳入研究的偏倚。
我们纳入了两项RCT，共3477名亚洲参与者。与阿司匹林相比，西洛他唑的血管事件综合结局风险显著更低（6.77%对9.39%，风险比（RR）0.72，95%置信区间（CI）0.57至0.91），出血性中风风险也更低（0.53%对2.01%，RR 0.26，95%CI 0.13至0.55）。在与阿司匹林相比的安全性结局方面，西洛他唑与轻微不良反应显著相关（8.22%对4.95%，RR 1.66，95%CI 1.51至1.83）。
西洛他唑在预防中风继发血管事件方面比阿司匹林更有效。西洛他唑有更多轻微不良反应，尽管有证据表明出血较少。
