本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2314741

摘要内容如下：

背景

在区分缺血性和出血性之前，急性卒中的治疗是具有挑战性的。在未分化的急性卒中患者中，救护车中的极早期血压控制是否能改善预后尚不确定。

方法

我们将症状出现后2小时内在救护车上接受评估的疑似急性卒中（导致运动障碍）和收缩压升高（≥150 mm Hg）的患者随机分为两组，一组接受立即治疗以降低收缩压（目标范围为130至140 mm Hg）（干预组），另一组接受常规血压管理（常规护理组）。主要疗效转归为功能状态，通过随机分组后90天的改良Rankin量表评分（范围:0[无症状]至6[死亡]）进行评估。主要安全性结果是任何严重不良事件。

结果

中国共有2404名患者（平均年龄70岁）接受了随机分组并提供了试验同意书：干预组1205名，常规护理组1199名。症状发作和随机化之间的中位时间为61分钟（四分位间距为41至93），随机化时的平均血压为178/98 mm Hg。2240名患者随后通过影像学检查确诊中风，其中1041名（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158毫米汞柱，而常规护理组为170毫米汞柱。总体而言，两组之间的功能结果没有差异（共同优势比，1.00；95%可信区间[CI]为0.87~1.15），两组严重不良事件的发生率相似。在出血性卒中患者中，院前血压降低与不良功能预后的几率降低相关（常见的比值比为0.75；95%CI，0.60-0.92），但在脑缺血患者中增加（共同比值比，1.30；95%置信区间，1.06至1.60）。

结论

在该试验中，院前降压并未改善未分化急性卒中患者的功能结局，其中46.5%的患者随后被诊断为出血性卒中。（由澳大利亚国家健康和医学研究委员会和其他机构资助）；Interact4 ClinicalTrials.gov编号，NCT03790800；中国试验登记号，CHICTR1900020534。）

英文原文如下：

Abstracts

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 158 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.).

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