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欧洲心脏病学会 0/1 小时算法诊断心肌梗死的安全性和有效性:系统评价和荟萃分析。

Safety and efficacy of the European Society of Cardiology 0/1-hour algorithm for diagnosis of myocardial infarction: systematic review and meta-analysis.

机构信息

Department of Medicine, College of Medicine, National Taiwan University, Taipei, Taiwan.

Department of Medicine, College of Medicine, Fu Jen Catholic University, Taipei, Taiwan.

出版信息

Heart. 2020 Jul;106(13):985-991. doi: 10.1136/heartjnl-2019-316343. Epub 2020 Apr 3.

Abstract

OBJECTIVE

The European Society of Cardiology (ESC) 0/1 hour algorithm has been primarily validated in Europe, America and Australasia with less knowledge of its performance outside of these settings. We aim to evaluate the performance of the ESC 0/1 hour algorithm across different contexts.

METHODS

We searched PubMed, Embase, Scopus, Web of Science and the Cochrane Central Register of Controlled Trials for relevant studies published between 1 January 2008 and 31 May 2019. The primary outcome was index myocardial infarction and the secondary outcome was major adverse cardiac event or mortality. A bivariate random-effects meta-analysis was used to derive the pooled estimate of each outcome.

RESULTS

A total of 11 014 patients from 10 cohorts were analysed for the primary outcome. The algorithm based on high-sensitivity cardiac troponin (hs-cTn)T (Roche), hs-cTnI (Abbott) and hs-cTnI (Siemens) had pooled sensitivity of 98.4% (95% CI=95.1% to 99.5%), 98.1% (95% CI=94.6% to 99.3%) and 98.7% (95% CI=97.3% to 99.3%), respectively. The algorithm based on hs-cTnT (Roche) and hs-cTnI (Siemens) had pooled specificity of 91.2% (95% CI=86.0% to 94.6%) and 95.9% (95% CI=94.1% to 97.2%), respectively. Among patients in the rule-out category, the pooled mortality rate at 30 days and at 1 year was 0.1% (95% CI=0.0% to 0.4%) and 0.8% (95% CI=0.5% to 1.2%), respectively. Among patients in the observation zone, the pooled mortality rate was 0.7% (95% CI=0.3% to 1.2%) at 30 days but increased to 8.1% (95% CI=6.1% to 10.4%) at 1 year, comparable to the mortality rate in the rule-in group.

CONCLUSION

The ESC 0/1 hour algorithm has high diagnostic accuracy but may not be sufficiently safe if the 1% miss-rate for myocardial infarction is desired.

PROSPERO REGISTRATION NUMBER

CRD42019142280.

摘要

目的

欧洲心脏病学会(ESC)0/1 小时算法主要在欧洲、美洲和澳大拉西亚进行了验证,对于该算法在这些环境之外的性能了解较少。我们旨在评估 ESC 0/1 小时算法在不同环境下的性能。

方法

我们在 PubMed、Embase、Scopus、Web of Science 和 Cochrane 对照试验中心注册库中检索了 2008 年 1 月 1 日至 2019 年 5 月 31 日期间发表的相关研究。主要结局指标为指数性心肌梗死,次要结局指标为主要不良心脏事件或死亡率。采用双变量随机效应荟萃分析得出每种结局的汇总估计值。

结果

对来自 10 个队列的 11014 例患者进行了主要结局分析。基于高敏心肌肌钙蛋白(hs-cTn)T(罗氏)、hs-cTnI(雅培)和 hs-cTnI(西门子)的算法的汇总敏感性分别为 98.4%(95%CI=95.1%至 99.5%)、98.1%(95%CI=94.6%至 99.3%)和 98.7%(95%CI=97.3%至 99.3%)。基于 hs-cTnT(罗氏)和 hs-cTnI(西门子)的算法的汇总特异性分别为 91.2%(95%CI=86.0%至 94.6%)和 95.9%(95%CI=94.1%至 97.2%)。在排除组患者中,30 天和 1 年的汇总死亡率分别为 0.1%(95%CI=0.0%至 0.4%)和 0.8%(95%CI=0.5%至 1.2%)。在观察区患者中,30 天的死亡率为 0.7%(95%CI=0.3%至 1.2%),但 1 年时增加至 8.1%(95%CI=6.1%至 10.4%),与纳入组的死亡率相当。

结论

ESC 0/1 小时算法具有较高的诊断准确性,但如果需要心肌梗死的 1%漏诊率,则可能不够安全。

PROSPERO 注册号:CRD42019142280。

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