Objective: To explore the feasibility and accuracy of 0-1 h high sensitivity cardiac troponin I (hs-cTnI) concentration and its changes in judging non-ST segment elevation myocardial infarction (NSTEMI), and to investigate the feasibility of a simplified process. Methods: Patients with acute chest pain and suspected NSTEMI who were admitted to the emergency department of Fuwai Hospital, the First Affiliated Hospital of Sun Yat-sen University and Nanjing First Hospital from January 2017 to September 2020 were selected. Hs-cTnI test was carried out for the selected patients at the time of visit (0 h) and 1 h after visit. According to the 0-1 h hs-cTnI diagnostic process and threshold standard recommended by European Society of Cardiology (ESC) guidelines in 2015, the laboratory adjudication was determined. Cardiologists who did not participate in the project design and did not know the results of hs-cTnI test performed the clinical judgment according to the routine diagnosis and treatment process of emergency department. Taking clinical judgment as the gold standard, the diagnostic efficacy of 0-1 h hs-cTnI concentration and its change recommended by the guidelines for judging NSTEMI in Chinese population was analyzed. The guide process was simplified. Under the condition of not considering the time of chest pain, the guideline threshold was used for test and judgement, and the diagnostic efficacy of the simplified process was evaluated. Results: A total of 1 534 patients were enrolled in the study, aged (62±12) years and 952 (62.1%) patients were male. Among them, 402 patients (26.2%) were clinically diagnosed as NSTEMI and 1 132 patients (73.8%) were diagnosed as non-NSTEMI. According to the diagnosis and determination process recommended by the guidelines, NSTEMI was excluded in 672 patients (42.8%), and 464 patients (30.2%) were diagnosed as NSTEMI. The consistency rate with clinical determination reached 92.4% (1 050/1 136), the sensitivity of excluding diagnosis was 99.5% (95%CI: 98.0%-99.9%), the negative predictive value was 99.7% (95%CI: 98.8%-99.9%), and the negative likelihood ratio was 0.008 (95%CI: 0.002-0.335). The diagnostic specificity was 92.6% (95%CI: 90.9%-94.0%), the positive predictive value was 81.9% (95%CI: 78.0%-85.2%), and the positive likelihood ratio was 12.739 (95%CI: 10.356-15.670). According to the simplified process, NSTEMI was excluded in 675 patients (44.0%), and 463 patients (30.2%) were diagnosed as NSTEMI. The consistency rate with clinical judgment was 92.4% (1 051/1 138), the sensitivity of exclusion diagnosis was 99.3% (95%CI: 97.6%-99.8%), the negative predictive value was 99.6% (95%CI: 98.6%-99.9%), and the negative likelihood ratio was 0.012 (95%CI: 0.004-0.389). The diagnostic specificity was 92.6% (95%CI: 90.9%-94.0%), the positive predictive value was 81.9% (95%CI: 78.0%-85.2%), and the positive likelihood ratio was 12.705 (95%CI: 10.328-15.630). There was no significant difference in diagnostic efficacy between the simplified process and the recommended process (all P>0.05). Conclusion: The diagnostic process for judging NSTEMI according to the 0-1 h hs-cTnI concentration and its change criteria recommended by the 2015 ESC guidelines is applicable in the Chinese population and remains highly accurate in judging NSTEMI without considering the duration of chest pain at the time of presentation.
目的： 探索0~1 h高敏肌钙蛋白I（hs-cTnI）浓度及其变化对于判断非ST段抬高型心肌梗死（NSTEMI）的可行性及准确性，并探讨流程简化的可行性。 方法： 选择2017年1月至2020年9月中国医学科学院阜外医院、中山大学附属第一医院、南京市第一医院急诊科就诊的急性胸痛需排除NSTEMI的患者。对入选患者在就诊时（0 h）、就诊后1 h进行hs-cTnI检测，按照2015年欧洲心脏病学会（ESC）指南推荐的0~1 h的hs-cTnI诊断流程及界值标准进行检验判定，由未参与课题设计且不知道hs-cTnI检测结果的心脏科医师按照急诊常规诊疗流程进行临床判定；以临床判定为金标准，分析指南推荐0~1 h的hs-cTnI浓度及其变化对于判断NSTEMI在中国人群中的诊断效能。对该指南流程进行简化，在不考虑胸痛时间的条件下，利用指南界值进行检验判定，并评估简化流程的诊断效能。 结果： 共纳入1 534例患者，年龄（62±12）岁，男952例（62.1%）。其中临床诊断NSTEMI患者402例（26.2%），非NSTEMI患者1 132例（73.8%）。依照指南推荐诊断及判定流程，672例（42.8%）患者排除NSTEMI，464例（30.2%）患者诊断NSTEMI，与临床判定一致率为92.4%（1 050/1 136），排除诊断的灵敏度为99.5%（95%CI：98.0%~99.9%），阴性预测值为99.7%（95%CI：98.8%~99.9%），阴性似然比为0.008（95%CI：0.002~0.335）；纳入诊断的特异度为92.6%（95%CI：90.9%~94.0%），阳性预测值为81.9%（95%CI：78.0%~85.2%），阳性似然比为12.739（95%CI：10.356~15.670）。依据简化流程，675例（44.0%）患者排除NSTEMI，463例（30.2%）患者诊断NSTEMI，与临床判定一致率为92.4%（1 051/1 138），排除诊断的灵敏度为99.3%（95%CI：97.6%~99.8%），阴性预测值为99.6%（95%CI：98.6%~99.9%），阴性似然比为0.012（95%CI：0.004~0.389）；纳入诊断的特异度为92.6%（95%CI：90.9%~94.0%），阳性预测值为81.9%（95%CI：78.0%~85.2%），阳性似然比为12.705（95%CI：10.328~15.630）。简化流程判定结果与指南推荐流程相比，其诊断效能差异均无统计学意义（均P>0.05）。 结论： 2015年ESC指南推荐0~1 h的hs-cTnI浓度及其变化标准判断NSTEMI的诊断流程在中国人群中具有良好的应用价值，且在排除诊断时不考虑就诊时胸痛时间的简化流程仍具有较高的诊断效能。.