强化救护车转运的降压治疗在超急性期卒中中的应用。
Intensive Ambulance-Delivered Blood-Pressure Reduction in Hyperacute Stroke.
机构信息
From the Department of Neurology, Shanghai East Hospital, School of Medicine, Tongji University (G.L., C.C., F.L., D.H., Y.Z., L.Z., G.M., Y.Y., J.H., Xiahong Xu, X. Xiong, Y.T.), the Institute of Science and Technology for Brain-Inspired Intelligence, Fudan University (C.S.A., L. Song), Shanghai Pudong New District Medical Emergency Center (C.Z.), the Department of Neurology, Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine (F.W.), the Department of Neurology, Shanghai Pudong New District People's Hospital (X.Z.), the Department of Neurology, Gongli Hospital, Pudong New Area (M.J.), and the Department of Neurology, Shanghai University of Medicine and Health Sciences Affiliated Zhoupu Hospital (Xiaoyun Xu), Shanghai, the First Affiliated Hospital of Chengdu Medical College (Y.L., Y.G., J. Yu, S.L., S.H., F.M., Q.T.), the International Clinical Research Center, Chengdu Medical College (Y.L.), the Department of Neurology (J. Yang, S.T., N.Y., B.L., J.G.), the Institute of Neurology (J. Yang), Sichuan Provincial Key Laboratory for Human Disease Gene Study (J. Yang, S.T.), and the Departments of Neurosurgery (R.X.) and Emergency Medicine (M.S.), Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, and the First People's Hospital of Shuangliu District, Chengdu/West China (Airport) Hospital Sichuan University (Y.H.), Chengdu, the George Institute for Global Health China, Beijing (C.S.A., C.C., X.R., M.O., L. Song), Zigong Fourth People's Hospital, Zigong (P.X.), Fushun County People's Hospital, Fushun (L.W.), Kaijiang County People's Hospital, Kaijiang (D.Q.), QianWei County People's Hospital, Leshan (Y.P.), Dazhu People's Hospital, Dazhu (C.L.), the Department of Neurology, Yucheng People's Hospital, Yucheng (J.L.), the Department of Neurology, Sixian People's Hospital, Suzhou (Y.W.), Guanghan People's Hospital, Guanghan (X.W.), and the Department of Neurology, Xuzhou Central Hospital, Xuzhou (G.C.) - all in China; the George Institute for Global Health, Faculty of Medicine, University of New South Wales (C.S.A., C.C., L.B., Q.L., X.C., X.L., X.R., L.L., H.L., M.O., L. Song), the Neurology Department, Royal Prince Alfred Hospital (C.S.A.), Menzies Centre for Health Policy and Economics, University of Sydney (H.L.), Sydney Institute for Women, Children and Their Families, Sydney Local Health District (H.L.), and the School of Health Sciences, Western Sydney University (L. Si) - all in Sydney; the Department of Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan (H.A.); the Stroke Trials Unit, Mental Health and Clinical Neuroscience, University of Nottingham, Nottingham (P.M.B.), Radcliffe Department of Medicine, University of Oxford, Oxford (G.A.F., N.S.), and the University of Leicester, Leicester (T.R.) - all in the United Kingdom; the Department of Neurology, Oslo University Hospital, and the Norwegian Air Ambulance Foundation - both in Oslo (E.C.S.); the University of California, Los Angeles, Los Angeles (J.L.S.); and the Brain Center, University Medical Center Utrecht, Utrecht, the Netherlands (H.B.W.).
出版信息
N Engl J Med. 2024 May 30;390(20):1862-1872. doi: 10.1056/NEJMoa2314741. Epub 2024 May 16.
BACKGROUND
Treatment of acute stroke, before a distinction can be made between ischemic and hemorrhagic types, is challenging. Whether very early blood-pressure control in the ambulance improves outcomes among patients with undifferentiated acute stroke is uncertain.
METHODS
We randomly assigned patients with suspected acute stroke that caused a motor deficit and with elevated systolic blood pressure (≥150 mm Hg), who were assessed in the ambulance within 2 hours after the onset of symptoms, to receive immediate treatment to lower the systolic blood pressure (target range, 130 to 140 mm Hg) (intervention group) or usual blood-pressure management (usual-care group). The primary efficacy outcome was functional status as assessed by the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days after randomization. The primary safety outcome was any serious adverse event.
RESULTS
A total of 2404 patients (mean age, 70 years) in China underwent randomization and provided consent for the trial: 1205 in the intervention group and 1199 in the usual-care group. The median time between symptom onset and randomization was 61 minutes (interquartile range, 41 to 93), and the mean blood pressure at randomization was 178/98 mm Hg. Stroke was subsequently confirmed by imaging in 2240 patients, of whom 1041 (46.5%) had a hemorrhagic stroke. At the time of patients' arrival at the hospital, the mean systolic blood pressure in the intervention group was 159 mm Hg, as compared with 170 mm Hg in the usual-care group. Overall, there was no difference in functional outcome between the two groups (common odds ratio, 1.00; 95% confidence interval [CI], 0.87 to 1.15), and the incidence of serious adverse events was similar in the two groups. Prehospital reduction of blood pressure was associated with a decrease in the odds of a poor functional outcome among patients with hemorrhagic stroke (common odds ratio, 0.75; 95% CI, 0.60 to 0.92) but an increase among patients with cerebral ischemia (common odds ratio, 1.30; 95% CI, 1.06 to 1.60).
CONCLUSIONS
In this trial, prehospital blood-pressure reduction did not improve functional outcomes in a cohort of patients with undifferentiated acute stroke, of whom 46.5% subsequently received a diagnosis of hemorrhagic stroke. (Funded by the National Health and Medical Research Council of Australia and others; INTERACT4 ClinicalTrials.gov number, NCT03790800; Chinese Trial Registry number, ChiCTR1900020534.).
背景
在能够区分缺血性和出血性类型之前，急性中风的治疗极具挑战性。在症状出现后 2 小时内，在救护车上对疑似急性中风且收缩压升高（≥150mmHg）的患者进行早期降压治疗，是否能改善未经区分的急性中风患者的预后尚不确定。
方法
我们将发病后 2 小时内接受评估且伴有运动障碍的疑似急性中风患者，随机分为接受立即降压治疗（目标范围为 130 至 140mmHg）的干预组（n=1205）或接受常规降压治疗的常规治疗组（n=1199）。主要疗效结局是随机分组后 90 天改良 Rankin 量表（范围 0[无症状]至 6[死亡]）的功能状态评分。主要安全性结局是任何严重不良事件。
结果
中国共有 2404 例（平均年龄 70 岁）患者接受随机分组并同意参与试验：干预组 1205 例，常规治疗组 1199 例。症状发作至随机分组的中位时间为 61 分钟（四分位距 41 至 93），随机分组时的平均血压为 178/98mmHg。2404 例患者中，2240 例（46.5%）经影像学检查确诊为中风，其中 1041 例（46.5%）为出血性中风。在患者到达医院时，干预组的平均收缩压为 159mmHg，而常规治疗组为 170mmHg。总的来说，两组的功能结局没有差异（常见比值比，1.00；95%置信区间 [CI]，0.87 至 1.15），且两组的严重不良事件发生率相似。院前降压与出血性中风患者预后不良的几率降低相关（常见比值比，0.75；95%CI，0.60 至 0.92），但与缺血性中风患者预后不良的几率增加相关（常见比值比，1.30；95%CI，1.06 至 1.60）。
结论
在这项试验中，院前降压治疗并未改善未经区分的急性中风患者的功能结局，其中 46.5%的患者随后被诊断为出血性中风。（由澳大利亚国家卫生和医学研究委员会等资助；INTERACT4 临床试验.gov 编号，NCT03790800；中国临床试验注册中心编号，ChiCTR1900020534。）
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