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急性卒中头部体位的集群随机交叉试验
Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke


Craig S. Anderson ... 心脑血管疾病 • 2017.06.22
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摘要


背景

仰卧位在改善急性卒中后脑血流量和降低吸入性肺炎风险方面的作用促使临床实践中采取不同的头部体位。我们希望确定为了增加大脑灌注,在治疗期间让急性缺血性卒中患者平卧(即背部与地面平行且面部朝上的完全仰卧)是否可以改善患者结局。

 

方法

在9个国家和地区进行的一项实效性、集群随机、交叉试验中,我们分配11,093例急性卒中患者(85%的卒中是缺血性的)采取平卧位或坐位(头部抬高至少30°)接受治疗,根据收治该患者的医院的随机分组情况决定采取哪种体位;入院后立即开始采取指定的体位并且保持24小时。主要结局是使用改良的Rankin量表(评分为0~6分,较高评分表示较大程度的失能,6分表示死亡)评估的90日时的失能程度。

 

结果

卒中症状发生至开始采取指定体位的中位间隔间期是14小时(四分位距,5~35)。平卧位组患者保持体位24小时不变的可能性比坐位组患者低(87%对95%,P<0.001)。在比例风险模型中,在平卧位组患者和坐位组患者之间,根据总体改良的Rankin量表评估的90日的失能结局分布没有显著变化(对于平卧位组改良的Rankin量表评分分布差异未校正比值比,1.01;95%置信区间[CI],0.92~1.10;P=0.84)。90日死亡率在平卧位组是7.3%,坐位组是7.4%(P=0.83)。两组之间包括肺炎在内的严重不良事件差异无显著性。

 

结论

在分配到24小时平卧位的患者和分配到24小时坐位(头部抬高至少30°)的患者之间,急性卒中后的失能结局没有显著差异(澳大利亚国家健康与医学研究委员会[National Health and Medical Research Council of Australia]资助;HeadPoST在ClinicalTrials.gov注册号NCT02162017)。





作者信息

Craig S. Anderson, M.D., Ph.D., Hisatomi Arima, M.D., Ph.D., Pablo Lavados, M.D., M.P.H., Laurent Billot, M.Res., Maree L. Hackett, Ph.D., Verónica V. Olavarría, M.D., Paula Muñoz Venturelli, M.D., Ph.D., Alejandro Brunser, M.D., Bin Peng, M.D., Liying Cui, M.D., Lily Song, M.D., Ph.D., Kris Rogers, M.Biostat., Ph.D., Sandy Middleton, Ph.D., Joyce Y. Lim, M.Nurs., Denise Forshaw, PG.Cert., C. Elizabeth Lightbody, Ph.D., Mark Woodward, Ph.D., Octavio Pontes-Neto, M.D., H. Asita De Silva, D.Phil., Ruey-Tay Lin, M.D., Tsong-Hai Lee, M.D., Ph.D., Jeyaraj D. Pandian, D.M., Gillian E. Mead, M.D., Thompson Robinson, M.D., and Caroline Watkins, Ph.D., for the HeadPoST Investigators and Coordinators*
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.Address reprint requests to Dr. Anderson at the George Institute for Global Health China at Peking University Health Science Center, Ste. 1801, Tower B, Horizon Tower, No. 6 Zhichun Rd., Beijing 100088, China, or at canderson@georgeinstitute.org.cn. *A complete list of sites, trial investigators, and coordinators in the Head Positioning in Acute Stroke Trial (HeadPoST) is provided in the Supplementary Appendix, available at NEJM.org.

 

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