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高敏肌钙蛋白 I 检测的连续变化与心肌梗死的早期诊断。

Serial changes in highly sensitive troponin I assay and early diagnosis of myocardial infarction.

机构信息

Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany.

出版信息

JAMA. 2011 Dec 28;306(24):2684-93. doi: 10.1001/jama.2011.1896.

DOI:10.1001/jama.2011.1896
PMID:22203537
Abstract

CONTEXT

Introduction of highly sensitive troponin assays into clinical practice has substantially improved the evaluation of patients with chest pain.

OBJECTIVE

To evaluate the diagnostic performance of a highly sensitive troponin I (hsTnI) assay compared with a contemporary troponin I (cTnI) assay and their serial changes in the diagnosis of acute myocardial infarction (AMI).

DESIGN, SETTING, AND PATIENTS: A total of 1818 patients with suspected acute coronary syndrome were consecutively enrolled at the chest pain units of the University Heart Center Hamburg, the University Medical Center Mainz, and the Federal Armed Forces Hospital Koblenz, all in Germany, from 2007 to 2008. Twelve biomarkers including hsTnI (level of detection, 3.4 pg/mL) and cTnI (level of detection, 10 pg/mL) were measured on admission and after 3 and 6 hours.

MAIN OUTCOME MEASURES

Diagnostic performance for AMI of baseline and serial changes in hsTnI and cTnI results at 3 hours after admission to the emergency department.

RESULTS

Of the 1818 patients, 413 (22.7%) were diagnosed as having AMI. For discrimination of AMI, the area under the receiver operating characteristic (ROC) curve was 0.96 (95% CI, 0.95-0.97) for hsTnI on admission and 0.92 (95% CI, 0.90-0.94) for cTnI on admission. Both were superior to the other evaluated diagnostic biomarkers. The use of hsTnI at admission (with the diagnostic cutoff value at the 99th percentile of 30 pg/mL) had a sensitivity of 82.3% and a negative predictive value (for ruling out AMI) of 94.7%. The use of cTnI (with the diagnostic cutoff value at the 99th percentile of 32 pg/mL) at admission had a sensitivity of 79.4% and a negative predictive value of 94.0%. Using levels obtained at 3 hours after admission, the sensitivity was 98.2% and the negative predictive value was 99.4% for both hsTnI and cTnI assays. Combining the 99th percentile cutoff at admission with the serial change in troponin concentration within 3 hours, the positive predictive value (for ruling in AMI) for hsTnI increased from 75.1% at admission to 95.8% after 3 hours, and for cTnI increased from 80.9% at admission to 96.1% after 3 hours.

CONCLUSIONS

Among patients with suspected acute coronary syndrome, hsTnI or cTnI determination 3 hours after admission may facilitate early rule-out of AMI. A serial change in hsTnI or cTnI levels from admission (using the 99th percentile diagnostic cutoff value) to 3 hours after admission may facilitate an early diagnosis of AMI.

摘要

背景

高敏肌钙蛋白检测在临床实践中的应用极大地改善了胸痛患者的评估。

目的

评估高敏肌钙蛋白 I(hsTnI)检测与当代肌钙蛋白 I(cTnI)检测在急性心肌梗死(AMI)诊断中的诊断性能,并评估其连续变化。

设计、地点和患者:2007 年至 2008 年,德国汉堡大学心脏中心、美因茨大学医学中心和科布伦茨联邦武装部队医院的胸痛病房连续收治了 1818 例疑似急性冠状动脉综合征患者。入院时和入院后 3 小时和 6 小时检测了包括 hsTnI(检测水平 3.4 pg/mL)和 cTnI(检测水平 10 pg/mL)在内的 12 种生物标志物。

主要观察指标

入院时和入院后 3 小时 hsTnI 和 cTnI 连续变化对 AMI 的诊断性能。

结果

1818 例患者中,413 例(22.7%)诊断为 AMI。对于 AMI 的鉴别诊断,入院时 hsTnI 的受试者工作特征(ROC)曲线下面积为 0.96(95%CI,0.95-0.97),入院时 cTnI 的曲线下面积为 0.92(95%CI,0.90-0.94)。两者均优于其他评估的诊断生物标志物。入院时使用 hsTnI(诊断截止值为第 99 百分位 30 pg/mL)的灵敏度为 82.3%,阴性预测值(用于排除 AMI)为 94.7%。入院时使用 cTnI(诊断截止值为第 99 百分位 32 pg/mL)的灵敏度为 79.4%,阴性预测值为 94.0%。使用入院后 3 小时获得的水平,hsTnI 和 cTnI 检测的灵敏度均为 98.2%,阴性预测值均为 99.4%。将入院时第 99 百分位截止值与入院后 3 小时内肌钙蛋白浓度的连续变化相结合,hsTnI 的阳性预测值(用于确诊 AMI)从入院时的 75.1%增加到 3 小时后的 95.8%,cTnI 的阳性预测值从入院时的 80.9%增加到 3 小时后的 96.1%。

结论

在疑似急性冠状动脉综合征患者中,入院后 3 小时测定 hsTnI 或 cTnI 可能有助于早期排除 AMI。入院至 3 小时 hsTnI 或 cTnI 水平的连续变化(使用第 99 百分位诊断截止值)可能有助于早期诊断 AMI。

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