集群随机、交叉试验研究急性脑卒中患者的头部定位。
Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke.
机构信息
From the George Institute for Global Health (C.S.A., H.A., L.B., M.L.H., P.M.V., K.R., J.Y.L., M.W.) and Faculty of Medicine (C.S.A., L.B., M.L.H., L.S., K.R., J.Y.L., M.W.), University of New South Wales, the Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners (C.S.A.), the Nursing Research Institute, St. Vincent's Health (S.M.), and Australian Catholic University (S.M., C.W.) - all in Sydney; the George Institute China at Peking University Health Science Center (C.S.A., L.S.) and the Department of Neurology, Peking Union Medical College Hospital (B.P., L.C.) Beijing, and the Department of Neurology, 85 Hospital of People's Liberation Army, Shanghai (L.S.) - all in China; the Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan (H.A.); the Department of Neurology and Psychiatry, Clínica Alemana de Santiago (P.L., V.V.O., P.M.V., A.B.), Facultad de Medicina, Clínica Alemana Universidad del Desarrollo (P.L.), and Departamento de Ciencias Neurológicas, Facultad de Medicina, Universidad de Chile (P.L.) - all in Santiago, Chile; the College of Health and Wellbeing, University of Central Lancashire, Preston (M.L.H., D.F., C.E.L., C.W.), the George Institute for Global Health, University of Oxford (M.W.), the Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh (G.E.M.), and the Department of Cardiovascular Sciences and NIHR Biomedical Research Unit, University of Leicester, Leicester (T.R.) - all in the United Kingdom; the Department of Epidemiology, Johns Hopkins University, Baltimore (M.W.); the Stroke Service-Neurology Division, Department of Neuroscience and Behavior, Ribeirão Preto School of Medicine, University of São Paulo, São Paulo (O.P.-N.); the Clinical Trials Unit, Department of Pharmacology, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka (H.A.D.S.); the Department of Neurology, Christian Medical College, Ludhiana, India (J.D.P.); and the Department of Neurology, Kaohsiung Medical University and Hospital, Kaohsiung (R.-T.L.), and the Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan (T.-H.L.) - both in Taiwan.
出版信息
N Engl J Med. 2017 Jun 22;376(25):2437-2447. doi: 10.1056/NEJMoa1615715.
BACKGROUND
The role of supine positioning after acute stroke in improving cerebral blood flow and the countervailing risk of aspiration pneumonia have led to variation in head positioning in clinical practice. We wanted to determine whether outcomes in patients with acute ischemic stroke could be improved by positioning the patient to be lying flat (i.e., fully supine with the back horizontal and the face upwards) during treatment to increase cerebral perfusion.
METHODS
In a pragmatic, cluster-randomized, crossover trial conducted in nine countries, we assigned 11,093 patients with acute stroke (85% of the strokes were ischemic) to receive care in either a lying-flat position or a sitting-up position with the head elevated to at least 30 degrees, according to the randomization assignment of the hospital to which they were admitted; the designated position was initiated soon after hospital admission and was maintained for 24 hours. The primary outcome was degree of disability at 90 days, as assessed with the use of the modified Rankin scale (scores range from 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death).
RESULTS
The median interval between the onset of stroke symptoms and the initiation of the assigned position was 14 hours (interquartile range, 5 to 35). Patients in the lying-flat group were less likely than patients in the sitting-up group to maintain the position for 24 hours (87% vs. 95%, P<0.001). In a proportional-odds model, there was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the lying-flat group and patients in the sitting-up group (unadjusted odds ratio for a difference in the distribution of scores on the modified Rankin scale in the lying-flat group, 1.01; 95% confidence interval, 0.92 to 1.10; P=0.84). Mortality within 90 days was 7.3% among the patients in the lying-flat group and 7.4% among the patients in the sitting-up group (P=0.83). There were no significant between-group differences in the rates of serious adverse events, including pneumonia.
CONCLUSIONS
Disability outcomes after acute stroke did not differ significantly between patients assigned to a lying-flat position for 24 hours and patients assigned to a sitting-up position with the head elevated to at least 30 degrees for 24 hours. (Funded by the National Health and Medical Research Council of Australia; HeadPoST ClinicalTrials.gov number, NCT02162017 .).
背景
急性中风后采取仰卧位以改善脑血流和预防吸入性肺炎的作用，导致临床实践中头位的变化。我们旨在确定通过将患者定位为仰卧位（即背部水平且面部朝上的完全仰卧位）来增加脑灌注，是否可以改善急性缺血性中风患者的预后。
方法
在 9 个国家进行的一项实用、集群随机、交叉试验中，我们将 11093 名急性中风患者（85%的中风为缺血性中风）分配到仰卧位或坐位，头部抬高至少 30 度，具体取决于患者入院的医院的随机分组；指定的位置在入院后不久开始，并维持 24 小时。主要结局是使用改良 Rankin 量表评估的 90 天残疾程度（评分范围为 0 至 6，得分越高表示残疾程度越严重，得分为 6 表示死亡）。
结果
中风症状发作与开始指定位置之间的中位间隔为 14 小时（四分位距，5 至 35）。仰卧组的患者比坐位组的患者更不可能维持 24 小时的位置（87%对 95%，P<0.001）。在比例优势模型中，仰卧组和坐位组患者的 90 天残疾结局分布在全球改良 Rankin 量表上没有显著变化（仰卧组评分分布差异的调整比值比，1.01；95%置信区间，0.92 至 1.10；P=0.84）。仰卧组的 90 天死亡率为 7.3%，坐位组为 7.4%（P=0.83）。两组之间严重不良事件的发生率（包括肺炎）没有显著差异。
结论
24 小时仰卧位与 24 小时头部抬高至少 30 度的坐位患者的急性中风后残疾结局无显著差异。（由澳大利亚国家卫生与医学研究委员会资助；HeadPoST ClinicalTrials.gov 编号，NCT02162017）。
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