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柏林急性缺血性脑卒中患者移动卒中单元派遣与功能结局的关联。

Association Between Dispatch of Mobile Stroke Units and Functional Outcomes Among Patients With Acute Ischemic Stroke in Berlin.

机构信息

Center for Stroke Research Berlin, Charité-Universitätsmedizin Berlin, Germany.

Klinik für Neurologie, Medical Park Berlin Humboldtmühle, Berlin, Germany.

出版信息

JAMA. 2021 Feb 2;325(5):454-466. doi: 10.1001/jama.2020.26345.

Abstract

IMPORTANCE

Effects of thrombolysis in acute ischemic stroke are time-dependent. Ambulances that can administer thrombolysis (mobile stroke units [MSUs]) before arriving at the hospital have been shown to reduce time to treatment.

OBJECTIVE

To determine whether dispatch of MSUs is associated with better clinical outcomes for patients with acute ischemic stroke.

DESIGN, SETTING, AND PARTICIPANTS: This prospective, nonrandomized, controlled intervention study was conducted in Berlin, Germany, from February 1, 2017, to October 30, 2019. If an emergency call prompted suspicion of stroke, both a conventional ambulance and an MSU, when available, were dispatched. Functional outcomes of patients with final diagnosis of acute cerebral ischemia who were eligible for thrombolysis or thrombectomy were compared based on the initial dispatch (both MSU and conventional ambulance or conventional ambulance only).

EXPOSURE

Simultaneous dispatch of an MSU (computed tomographic scanning with or without angiography, point-of-care laboratory testing, and thrombolysis capabilities on board) and a conventional ambulance (n = 749) vs conventional ambulance alone (n = 794).

MAIN OUTCOMES AND MEASURES

The primary outcome was the distribution of modified Rankin Scale (mRS) scores (a disability score ranging from 0, no neurological deficits, to 6, death) at 3 months. The coprimary outcome was a 3-tier disability scale at 3 months (none to moderate disability; severe disability; death) with tier assignment based on mRS scores if available or place of residence if mRS scores were not available. Common odds ratios (ORs) were used to quantify the association between exposure and outcome; values less than 1.00 indicated a favorable shift in the mRS distribution and lower odds of higher levels of disability.

RESULTS

Of the 1543 patients (mean age, 74 years; 723 women [47%]) included in the adjusted primary analysis, 1337 (87%) had available mRS scores (primary outcome) and 1506 patients (98%) had available the 3-tier disability scale assessment (coprimary outcome). Patients with an MSU dispatched had lower median mRS scores at month 3 (1; interquartile range [IQR], 0-3) than did patients without an MSU dispatched (2; IQR, 0-3; common OR for worse mRS, 0.71; 95% CI, 0.58-0.86; P < .001). Similarly, patients with an MSU dispatched had lower 3-month coprimary disability scores: 586 patients (80.3%) had none to moderate disability; 92 (12.6%) had severe disability; and 52 (7.1%) had died vs patients without an MSU dispatched: 605 (78.0%) had none to moderate disability; 103 (13.3%) had severe disability; and 68 (8.8%) had died (common OR for worse functional outcome, 0.73, 95% CI, 0.54-0.99; P = .04).

CONCLUSIONS AND RELEVANCE

In this prospective, nonrandomized, controlled intervention study of patients with acute ischemic stroke in Berlin, Germany, the dispatch of mobile stroke units, compared with conventional ambulances alone, was significantly associated with lower global disability at 3 months. Clinical trials in other regions are warranted.

摘要

重要性

溶栓治疗急性缺血性脑卒中的效果具有时间依赖性。能够在到达医院之前进行溶栓治疗的救护车(移动卒中单元[MSU])已被证明可以缩短治疗时间。

目的

确定派遣 MSU 是否与急性缺血性脑卒中患者的临床结局改善相关。

设计、设置和参与者:这是一项前瞻性、非随机、对照干预研究,于 2017 年 2 月 1 日至 2019 年 10 月 30 日在德国柏林进行。如果紧急呼叫提示怀疑为中风,将同时派遣常规救护车和 MSU(如果有)。根据初始派遣情况(MSU 和常规救护车或仅常规救护车),比较最终诊断为急性脑缺血且有溶栓或取栓适应证的患者的功能结局。

暴露因素

同时派遣 MSU(配备计算机断层扫描和/或血管造影、床边即时检验和溶栓能力)和常规救护车(n = 749)与仅派遣常规救护车(n = 794)。

主要结局和测量指标

主要结局是 3 个月时改良 Rankin 量表(mRS)评分(残疾评分范围为 0 分,无神经功能缺陷,至 6 分,死亡)的分布情况。主要次要结局是 3 个月时的 3 级残疾量表(无至中度残疾;重度残疾;死亡),如果有 mRS 评分,则根据 mRS 评分进行残疾分级,如果 mRS 评分不可用,则根据居住地进行残疾分级。采用常见比值比(OR)来量化暴露与结局之间的关联;小于 1.00 的值表示 mRS 分布向有利方向转移,发生更高水平残疾的可能性降低。

结果

在调整后的主要分析中,纳入了 1543 例患者(平均年龄 74 岁,723 例女性[47%]),其中 1337 例(87%)有可用的 mRS 评分(主要结局),1506 例(98%)有可用的 3 级残疾量表评估(主要次要结局)。派遣 MSU 的患者 3 个月时的中位数 mRS 评分较低(1;四分位距[IQR],0-3),而未派遣 MSU 的患者为 2(IQR,0-3;mRS 评分较差的常见 OR,0.71;95%CI,0.58-0.86;P < 0.001)。同样,派遣 MSU 的患者 3 个月时的主要次要残疾评分较低:586 例(80.3%)为无至中度残疾;92 例(12.6%)为重度残疾;52 例(7.1%)死亡,而未派遣 MSU 的患者为:605 例(78.0%)为无至中度残疾;103 例(13.3%)为重度残疾;68 例(8.8%)死亡(功能结局较差的常见 OR,0.73,95%CI,0.54-0.99;P = 0.04)。

结论和相关性

在这项对德国柏林急性缺血性脑卒中患者的前瞻性、非随机、对照干预研究中,与单独派遣常规救护车相比,派遣移动卒中单元与 3 个月时的总体残疾程度降低显著相关。需要在其他地区开展临床试验。

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