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关于移动卒中单元的前瞻性多中心对照试验
Prospective, Multicenter, Controlled Trial of Mobile Stroke Units


James C. Grotta ... 心脑血管疾病 • 2021.09.09
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前瞻性研究证实移动卒中单元改善急性缺血性卒中患者功能性结局

 

吉训明

首都医科大学宣武医院神经外科;北京脑重大疾病研究院

 

急性缺血性脑卒中(acute ischemic stroke,AIS)发病率高、死亡率高而且致残率高。卒中发生后4.5 h内静脉输注重组组织型纤溶酶原激活剂(tissue plasminogen activator,t-PA)溶栓可有效改善患者预后。但院前急救等环节的时间较长,导致在溶栓窗内接受治疗的患者比例较低,因而疗效不佳。

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摘要


背景

移动卒中单元(MSU)是配备工作人员和计算机断层扫描仪的救护车,与急救人员(EMS)标准治疗相比,MSU可更快地使用组织型纤溶酶原激活物(t-PA)进行治疗。MSU可否改变结局,以及在多大程度上改变结局,尚未经过广泛研究。

 

方法

在一项观察性、前瞻性、多中心、每周交替试验中,我们评估了患者在急性卒中症状发生后4.5小时内接受MSU或EMS治疗的结局。主要结局是效用加权改良Rankin量表评分(范围,0~1,评分较高表示根据患者的效用价值系统确定的结局较好[来源于改良Rankin量表评分,该量表评分范围为0~6,评分较高表示残疾较严重])。主要分析涉及符合t-PA治疗标准的患者在90日时的效用加权改良Rankin量表二分评分(≥0.91或<0.91,近似改良Rankin量表评分≤1或>1)。我们还在所有入组患者中进行了分析。

 

结果

本试验入组了1,515例患者,其中1,047例符合t-PA治疗标准;617例接受了MSU治疗,430例接受了EMS治疗。在MSU组和EMS组中,从卒中发病至t-PA给药的中位间隔时间分别为72分钟和108分钟。在符合t-PA治疗标准的患者中,MSU组97.1%的患者接受了t-PA治疗,而EMS组为79.5%。在符合t-PA治疗标准的患者中,MSU组和EMS组90日时的效用加权改良Rankin量表平均评分分别为0.72和0.66(评分≥0.91的校正后比值比,2.43;95%置信区间[CI],1.75~3.36;P<0.001)。在符合t-PA治疗标准的患者中,90日时,MSU组55.0%患者和EMS组44.4%患者的改良Rankin量表评分为0或1。在所有入组患者中,MSU组和EMS组的出院时效用加权改良Rankin量表平均评分分别为0.57和0.51(评分≥0.91的校正后比值比,1.82;95% CI,1.39~2.37;P<0.001)。在次要临床结局方面,总体而言MSU优于EMS。MSU组和EMS组90日时的死亡率分别为8.9%和11.9%。

 

结论

在符合t-PA治疗标准的急性卒中患者中,MSU组90日时的效用加权残疾结局优于EMS组(由以患者为中心的结局研究所[Patient-Centered Outcomes Research Institute]资助,BEST-MSU在ClinicalTrials.gov注册号为NCT02190500)。





作者信息

James C. Grotta, M.D., Jose-Miguel Yamal, Ph.D., Stephanie A. Parker, M.H.A., Suja S. Rajan, Ph.D., Nicole R. Gonzales, M.D., William J. Jones, M.D., Anne W. Alexandrov, Ph.D., Babak B. Navi, M.D., May Nour, M.D., Ph.D., Ilana Spokoyny, M.D., Jason Mackey, M.D., David Persse, M.D., Asha P. Jacob, M.D., Mengxi Wang, Ph.D., Noopur Singh, M.P.H., Andrei V. Alexandrov, M.D., Matthew E. Fink, M.D., Jeffrey L. Saver, M.D., Joey English, M.D., Ph.D., Nobl Barazangi, M.D., Ph.D., Patti L. Bratina, R.N., Michael Gonzalez, M.S., Brandi D. Schimpf, R.N., Kim Ackerson, R.N., Carla Sherman, R.N., Mackenzie Lerario, M.D., Saad Mir, M.D., Jenny Im, R.N., Josh Z. Willey, M.D., David Chiu, M.D., Michael Eisshofer, R.N., Janice Miller, M.D., David Ornelas, R.N., James P. Rhudy, Ph.D., Kevin M. Brown, R.T.R., Bryan M. Villareal, R.N., Marianne Gausche-Hill, M.D., Nichole Bosson, M.D., Greg Gilbert, M.D., Sarah Q. Collins, R.N., Kelly Silnes, M.S., Jay Volpi, M.D., Vivek Misra, M.D., James McCarthy, M.D., Tom Flanagan, M.A., Chethan P.V. Rao, M.D., Joseph S. Kass, M.D., Laura Griffin, D.N.P., Nicole Rangel-Gutierrez, A.C.N.P., Edgar Lechuga, R.N., Jonathan Stephenson, R.N., Kenny Phan, R.T.R., Yvette Sanders, Elizabeth A. Noser, M.D., and Ritvij Bowry, M.D.
From the Mobile Stroke Unit, Memorial Hermann Hospital–Texas Medical Center (J.C.G., J. McCarthy, T.F.), the Departments of Biostatistics and Data Science (J.-M.Y., A.P.J., M.W., N.S., M.G.) and Management, Policy, and Community Heath (S.S.R.), University of Texas School of Public Health, the Departments of Neurology (S.A.P., N.R.G., P.L.B., N.R.-G., E.L., J.S., K.P., Y.S., E.A.N., R.B.) and Emergency Medicine (D.P.), University of Texas McGovern Medical School, the Departments of Emergency Medicine (D.P.) and Neurology (C.P.V.R.), Baylor College of Medicine, the Department of Neurology, Houston Methodist Hospital (D.C., J.V., V.M.), the Department of Neurology, Harris Health–Ben Taub General Hospital (J.S.K.), and HCA Houston Healthcare (L.G.) — all in Houston; the Department of Neurology, University of Colorado, UCHealth Anschutz Medical Campus, Aurora (W.J.J., B.D.S., K.A., M.E., D.O.), and the Department of Neurology, UCHealth Memorial Hospital, Colorado Springs (J. Miller) — both in Colorado; the Department of Neurology, University of Tennessee Health Science Center, Memphis (A.W.A., A.V.A., J.P.R.); the Department of Neurology, Weill Cornell Medicine (B.B.N., M.E.F., C.S., M.L., S.M.), and the Department of Neurology, Columbia University Irving Medical Center (J.Z.W.) — both in New York; the Department of Neurology, Ronald Reagan UCLA Medical Center, Los Angeles (M.N., J.L.S., K.M.B., B.M.V.), the Department of Neurology, Mills Peninsula Medical Center, Burlingame (I.S., J.E., N. Barazangi, J.I.), Los Angeles County Emergency Medical Services, Santa Fe Springs (M.G.-H., N. Bosson), and San Mateo County Emergency Medical Services, South San Francisco (G.G.) — all in California; and the Department of Neurology, Indiana University School of Medicine, Indianapolis (J. Mackey, S.Q.C., K.S.). Address reprint requests to Dr. Grotta at the Mobile Stroke Unit, Memorial Hermann Hospital–Texas Medical Center, 6410 Fannin St., Suite 1423, Houston, TX 77030, or at james.c.grotta@uth.tmc.edu.

 

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