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北美一个大型中心基于护理人员的院前纤维蛋白溶解疗法的可行性和适用性。

Feasibility and applicability of paramedic-based prehospital fibrinolysis in a large North American center.

作者信息

Welsh Robert C, Travers Andrew, Senaratne Mano, Williams Randall, Armstrong Paul W

机构信息

University of Alberta, Edmonton, Alberta, Canada.

出版信息

Am Heart J. 2006 Dec;152(6):1007-14. doi: 10.1016/j.ahj.2006.06.022.

Abstract

BACKGROUND

Although considered the highest level of evidence and critical-to-test novel therapies, clinical trials are unrepresentative of the "real world" as they lack a true patient denominator, which limits general applicability of results. Accordingly, in conjunction with the Assessment of the Safety and Efficacy of a New Thrombolytic Regimen 3+ trial, we evaluated a comprehensive contemporary cohort of patients with ST segment elevation myocardial infarction (STEMI) to investigate: feasibility, applicability, safety, and efficacy of de novo paramedic-based prehospital fibrinolysis (PHF) program.

METHODS

Prospective observational comparative cohort of all patients with STEMI encountered during the Assessment of the Safety and Efficacy of a New Thrombolytic Regimen 3+ enrollment period. Time-to-treatment, systematic electrocardiographic (ECG) analysis, peak creatine kinase, inhospital clinical events, and mortality were assessed.

RESULTS

During the 22-month study period, 1095 patients with STEMI were admitted to hospital; 46% (119/258) of eligible patients received PHF (< or = 6 hours of symptom onset by ambulance). Paramedics contacted the study physician 3.6 times per week: 33% (119/357) of patients enrolled, and ECG transmission failure is 6%. Time-to-treatment was reduced with PHF versus inhospital (1 hour 43 minutes vs 2 hours 38 minutes; P < .001). Despite higher baseline Thrombolysis in Myocardial Infarction Scores and greater ECG territory at risk (ST), prehospital patients achieved more favorable outcomes: peak creatine kinase (1413 vs 1549 U/L; P = .122), Q wave at discharge (56.3% vs 70.7%; P = .003), and intracranial hemorrhage (0% vs 0.8%; P < 1.0), respectively. Inhospital mortality for PHF versus inhospital patients was 3.4% versus 4.8% (P = .627), with an adjusted odds ratio of 0.60 (confidence interval, 0.19-1.87).

CONCLUSION

Feasibility and applicability of PHF was demonstrated with a substantial reduction in treatment delay and favorable clinical outcomes. Extending the unrealized potential of paramedic-based PHF programs in North America is feasible and desirable.

摘要

背景

尽管临床试验被认为是证据的最高级别且对测试新型疗法至关重要,但由于缺乏真实的患者总数,它们无法代表“现实世界”,这限制了研究结果的普遍适用性。因此,结合一项新溶栓方案3+安全性和有效性评估试验,我们评估了一个当代综合性ST段抬高型心肌梗死(STEMI)患者队列,以研究基于急救医疗人员的院前纤溶治疗(PHF)新方案的可行性、适用性、安全性和有效性。

方法

在新溶栓方案3+入组期间对所有STEMI患者进行前瞻性观察性比较队列研究。评估治疗时间、系统性心电图(ECG)分析、肌酸激酶峰值、院内临床事件和死亡率。

结果

在为期22个月的研究期间,1095例STEMI患者入院;46%(119/258)的符合条件患者接受了PHF(救护车送达症状发作时间≤6小时)。急救医疗人员每周联系研究医生3.6次:33%(119/357)的患者入组,心电图传输失败率为6%。与院内治疗相比,PHF治疗时间缩短(1小时43分钟对2小时38分钟;P<.001)。尽管院前患者心肌梗死溶栓评分基线较高且心电图危险区域(ST段)更大,但他们获得了更有利的结果:肌酸激酶峰值(1413对1549 U/L;P=.122)、出院时Q波(56.3%对70.7%;P=.003)和颅内出血(0%对0.8%;P<1.0)。PHF患者与院内治疗患者的院内死亡率分别为3.4%和4.8%(P=.627),调整后的优势比为0.60(置信区间,0.19 - 1.87)。

结论

PHF的可行性和适用性得到了证明,治疗延迟大幅减少且临床结果良好。在北美扩展基于急救医疗人员的PHF方案未实现的潜力是可行且可取的。

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