Roaldsen Melinda B, Lindekleiv Haakon, Mathiesen Ellisiv B, Berge Eivind
Brain and Circulation Research Group, Department of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, Norway.
Cochrane Database Syst Rev. 2018 Aug 21;8(8):CD010995. doi: 10.1002/14651858.CD010995.pub2.
About one in five strokes occur during sleep (wake-up stroke). People with wake-up strokes have traditionally been considered ineligible for thrombolytic treatment because the time of stroke onset is unknown. However, some studies suggest that these people may benefit from recanalisation therapies.
To assess the effects of intravenous thrombolysis and other recanalisation therapies versus control in people with acute ischaemic stroke presenting on awakening.
We searched the Cochrane Stroke Group Trials Register (last search: 9 January 2018). In addition, we searched the following electronic databases in December 2017: Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 11) in the Cochrane Library, MEDLINE, Embase, US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), the ISRCTN registry, and Stroke Trials Registry. We also screened references lists of relevant trials, contacted trialists, undertook forward tracking of relevant references, and contacted manufacturers of relevant devices and equipment.
Randomised controlled trials of intravenous thrombolytic drugs or intra-arterial therapies in people with acute ischaemic stroke presenting upon awakening.
Two review authors applied the inclusion criteria, extracted data, and assessed trial quality and risk of bias using the GRADE approach. We obtained both published and unpublished data.
We included one pilot trial with nine participants. The trial was a feasibility trial that included participants with an unknown onset of stroke and signs on perfusion computed tomography of ischaemic tissue at risk of infarction, who were randomised to alteplase (0.9 mg/kg) or placebo. One trial was prematurely terminated due to signs of efficacy of the intervention arm; we did not include this trial because we were not able to obtain data for the portion of the participants with wake-up stroke after requesting this information from the trial authors. We identified six ongoing trials.
AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials for recommendations concerning recanalisation therapies for wake-up stroke. Results from ongoing trials will hopefully establish the efficacy and safety of such therapies.
约五分之一的中风发生在睡眠期间（醒来时中风）。传统上，醒来时中风的患者被认为不符合溶栓治疗条件，因为中风发作时间不明。然而，一些研究表明这些患者可能从再通治疗中获益。
评估静脉溶栓及其他再通治疗与对照相比，对醒来时出现急性缺血性中风患者的影响。
我们检索了Cochrane中风组试验注册库（上次检索时间：2018年1月9日）。此外，我们于2017年12月检索了以下电子数据库：Cochrane图书馆中的Cochrane对照试验中心注册库（CENTRAL；2017年第11期）、MEDLINE、Embase、美国国立卫生研究院正在进行的试验注册库ClinicalTrials.gov、世界卫生组织国际临床试验注册平台（WHO ICTRP）、ISRCTN注册库以及中风试验注册库。我们还筛选了相关试验的参考文献列表，联系了试验研究者，对相关参考文献进行了追踪，并联系了相关设备和器械的制造商。
针对醒来时出现急性缺血性中风患者的静脉溶栓药物或动脉内治疗的随机对照试验。
两名综述作者应用入选标准，提取数据，并使用GRADE方法评估试验质量和偏倚风险。我们获取了已发表和未发表的数据。
我们纳入了一项有9名参与者的试点试验。该试验是一项可行性试验，纳入了中风发作时间不明且灌注计算机断层扫描显示有梗死风险的缺血组织有体征的参与者，他们被随机分配接受阿替普酶（0.9mg/kg）或安慰剂治疗。一项试验因干预组出现疗效迹象而提前终止；我们未纳入该试验，因为在向试验作者索要该信息后，我们仍无法获取醒来时中风患者部分的相关数据。我们确定了六项正在进行的试验。
随机对照试验中没有足够证据为醒来时中风的再通治疗提供推荐。正在进行的试验结果有望确定此类治疗的疗效和安全性。
