移动卒中单元与院内治疗对脑卒中患者的诊断和治疗：一项随机对照试验。

Diagnosis and treatment of patients with stroke in a mobile stroke unit versus in hospital: a randomised controlled trial.

机构信息

Department of Neurology, University Hospital of the Saarland, Homburg, Germany.

出版信息

Lancet Neurol. 2012 May;11(5):397-404. doi: 10.1016/S1474-4422(12)70057-1. Epub 2012 Apr 11.

DOI:10.1016/S1474-4422(12)70057-1

PMID:22497929

Abstract

BACKGROUND

Only 2-5% of patients who have a stroke receive thrombolytic treatment, mainly because of delay in reaching the hospital. We aimed to assess the efficacy of a new approach of diagnosis and treatment starting at the emergency site, rather than after hospital arrival, in reducing delay in stroke therapy.

METHODS

We did a randomised single-centre controlled trial to compare the time from alarm (emergency call) to therapy decision between mobile stroke unit (MSU) and hospital intervention. For inclusion in our study patients needed to be aged 18-80 years and have one or more stroke symptoms that started within the previous 2·5 h. In accordance with our week-wise randomisation plan, patients received either prehospital stroke treatment in a specialised ambulance (equipped with a CT scanner, point-of-care laboratory, and telemedicine connection) or optimised conventional hospital-based stroke treatment (control group) with a 7 day follow-up. Allocation was not masked from patients and investigators. Our primary endpoint was time from alarm to therapy decision, which was analysed with the Mann-Whitney U test. Our secondary endpoints included times from alarm to end of CT and to end of laboratory analysis, number of patients receiving intravenous thrombolysis, time from alarm to intravenous thrombolysis, and neurological outcome. We also assessed safety endpoints. This study is registered with ClinicalTrials.gov, number NCT00153036.

FINDINGS

We stopped the trial after our planned interim analysis at 100 of 200 planned patients (53 in the prehospital stroke treatment group, 47 in the control group), because we had met our prespecified criteria for study termination. Prehospital stroke treatment reduced the median time from alarm to therapy decision substantially: 35 min (IQR 31-39) versus 76 min (63-94), p<0·0001; median difference 41 min (95% CI 36-48 min). We also detected similar gains regarding times from alarm to end of CT, and alarm to end of laboratory analysis, and to intravenous thrombolysis for eligible ischaemic stroke patients, although there was no substantial difference in number of patients who received intravenous thrombolysis or in neurological outcome. Safety endpoints seemed similar across the groups.

INTERPRETATION

For patients with suspected stroke, treatment by the MSU substantially reduced median time from alarm to therapy decision. The MSU strategy offers a potential solution to the medical problem of the arrival of most stroke patients at the hospital too late for treatment.

FUNDING

Ministry of Health of the Saarland, Germany, the Werner-Jackstädt Foundation, the Else-Kröner-Fresenius Foundation, and the Rettungsstiftung Saar.

摘要

背景

仅有 2-5%的中风患者接受溶栓治疗，主要是因为到达医院的时间延迟。我们旨在评估一种新的诊断和治疗方法的疗效，该方法从急救现场开始，而不是在到达医院后开始，以减少中风治疗的延迟。

方法

我们进行了一项随机单中心对照试验，比较移动卒中单元（MSU）和医院干预之间从报警（紧急呼叫）到治疗决策的时间。我们的研究纳入了年龄在 18-80 岁之间且在过去 2.5 小时内出现一种或多种中风症状的患者。根据我们每周的随机化计划，患者接受专门救护车中的院前卒中治疗（配备 CT 扫描仪、即时护理实验室和远程医疗连接）或优化的常规基于医院的卒中治疗（对照组），并进行为期 7 天的随访。患者和研究者都未对分配情况进行盲法。我们的主要终点是从报警到治疗决策的时间，使用 Mann-Whitney U 检验进行分析。我们的次要终点包括从报警到 CT 结束的时间、从报警到实验室分析结束的时间、接受静脉溶栓治疗的患者数量、从报警到静脉溶栓治疗的时间以及神经功能结局。我们还评估了安全性终点。这项研究在 ClinicalTrials.gov 注册，编号为 NCT00153036。

结果

在计划的 200 名患者中的 100 名（预治疗组 53 名，对照组 47 名）进行了我们计划的中期分析后，我们停止了试验，因为我们已经达到了研究终止的预设标准。院前卒中治疗大大缩短了从报警到治疗决策的中位时间：35 分钟（IQR 31-39）与 76 分钟（63-94）相比，p<0.0001；中位差异为 41 分钟（95%CI 36-48 分钟）。我们还发现，对于符合条件的缺血性中风患者，从报警到 CT 结束、从报警到实验室分析结束以及到静脉溶栓治疗的时间也有类似的改善，尽管接受静脉溶栓治疗的患者数量或神经功能结局没有实质性差异。各组的安全性终点似乎相似。