Department of Emergency Medicine, University of Michigan, Ann Arbor, USA.
Acad Emerg Med. 2010 Oct;17(10):1062-71. doi: 10.1111/j.1553-2712.2010.00868.x.
The objective was to evaluate safety of intravenous (IV) tissue plasminogen activator (tPA) delivered without dedicated thrombolytic stroke teams.
This was a retrospective, observational study of patients treated between 1996 and 2005 at four southeastern Michigan hospital emergency departments (EDs) with a prospectively defined comparison to the National Institute of Neurological Disorders and Stroke (NINDS) tPA stroke study cohort. Main outcome measures were mortality, intracerebral hemorrhage (ICH), systemic hemorrhage, neurologic recovery, and guideline violations.
A total of 273 consecutive stroke patients were treated by 95 emergency physicians (EPs) using guidelines and local neurology resources. One-year mortality was 27.8%. Unadjusted Cox model relative risk (RR) of mortality compared to the NINDS tPA treatment and placebo groups was 1.20 (95% confidence interval [CI] = 0.87 to 1.64) and 1.04 (95% CI = 0.76 to 1.41), respectively. The rate of significant ICH by computed tomography (CT) criteria was 6.6% (odds ratio [OR] = 1.03, 95% CI = 0.56 to 1.90 compared to the NINDS tPA treatment group). The proportions of symptomatic ICH by two other prespecified sets of clinical criteria were 4.8 and 7.0%. The rate of any ICH within 36 hours of treatment was 9.9% (RR = 0.94, 95% CI = 0.58 to 1.51 compared to the NINDS tPA group). The occurrence of major systemic hemorrhage (requiring transfusion) was 1.1%. Functional recovery by the modified Rankin Scale score (mRS = 0 to 2) at discharge occurred in 38% of patients with a premorbid disability mRS < 2. Guideline deviations occurred in the ED in 26% of patients and in 25% of patients following admission.
In these EDs there was no evidence of increased risk with respect to mortality, ICH, systemic hemorrhage, or worsened functional outcome when tPA was administered without dedicated thrombolytic stroke teams. Additional effort is needed to improve guideline compliance.
本研究旨在评估无专门溶栓卒中团队条件下静脉（IV）组织型纤溶酶原激活物（tPA）治疗的安全性。
本研究为回顾性观察性研究，纳入 1996 年至 2005 年在密歇根州东南部 4 家医院急诊科接受治疗的患者，前瞻性地与国立神经病学与卒中研究院（NINDS）tPA 卒中研究队列进行比较。主要观察指标为死亡率、颅内出血（ICH）、全身性出血、神经功能恢复和指南违背情况。
共 273 例连续卒中患者接受 95 名急诊医师（EP）根据指南和当地神经病学资源进行治疗。1 年死亡率为 27.8%。未校正 Cox 模型显示，与 NINDS tPA 治疗组和安慰剂组相比，死亡率的相对风险（RR）分别为 1.20（95%置信区间[CI]为 0.87 至 1.64）和 1.04（95%CI 为 0.76 至 1.41）。根据 CT 标准，显著 ICH 发生率为 6.6%（比值比[OR]为 1.03，95%CI 为 0.56 至 1.90，与 NINDS tPA 治疗组相比）。根据另外两组预先指定的临床标准，症状性 ICH 的比例分别为 4.8%和 7.0%。治疗后 36 小时内任何 ICH 的发生率为 9.9%（RR=0.94，95%CI 为 0.58 至 1.51，与 NINDS tPA 组相比）。需要输血的主要全身性出血发生率为 1.1%。发病前残疾程度 mRS＜2 患者出院时按改良 Rankin 量表评分（mRS=0 至 2）恢复功能的比例为 38%。ED 中 26%的患者和住院后 25%的患者出现指南偏离。
在这些急诊科中，当没有专门的溶栓卒中团队时，使用 tPA 治疗并未增加死亡率、ICH、全身性出血或功能结局恶化的风险。需要进一步努力改善指南的依从性。
