Shoaibi Azadeh, Tavris Dale R, McNulty Steven
Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, MD 20993, USA.
Transl Res. 2009 Nov;154(5):250-6. doi: 10.1016/j.trsl.2009.07.004. Epub 2009 Aug 3.
Cardiac troponins are the most sensitive and specific biomarker for myocardial infarction (MI) diagnosis. If there is a gender bias in MI diagnosis, it could be reduced by more consistently applying objective diagnostic criteria to improve women's outcomes. This study set out to assess the accuracy and correlates of the cardiac troponin I (cTnI) assay in the diagnosis of non-ST-segment elevation MI, to determine how the assay accuracy and correlates vary by gender, and to explore the interaction between factors that may influence cTnI accuracy and affect gender differences in diagnosis. The data were obtained from the CHECKMATE study. It included 924 patients with possible myocardial ischemia excluding subjects with ST-segment elevation. The Dade-Behring Stratus CS STAT near-patient instrument (Dade Behring, Inc, Newark, Del) was used to measure cTnI. We assessed baseline troponin accuracy using a standard MI definition. There were 125 subjects with a definite MI diagnosis. Baseline troponin was 44% sensitive and 97% specific in predicting MI, with no significant gender differences. In contrast, other positive cardiac markers, namely rising or falling creatine-kinase MB fraction and positive electrocardiogram, occurred more frequently in men. Sensitivity (SE) of baseline troponin was higher in subjects where baseline troponin was obtained longer than 2 hours after the chest pain onset. The study did not observe a significant difference in the assay SE or specificity by gender. This observation, plus the fact that other positive cardiac markers occurred more frequently in men, suggest the troponin test may help to improve the diagnosis of MI in women.
心肌肌钙蛋白是诊断心肌梗死（MI）最敏感且特异的生物标志物。如果在MI诊断中存在性别偏见，那么通过更一致地应用客观诊断标准来改善女性的诊断结果，这种偏见可能会减少。本研究旨在评估心肌肌钙蛋白I（cTnI）检测在非ST段抬高型MI诊断中的准确性及其相关因素，确定检测准确性及其相关因素如何随性别而变化，并探讨可能影响cTnI准确性及诊断中性别差异的因素之间的相互作用。数据来自CHECKMATE研究。该研究纳入了924例可能存在心肌缺血的患者，排除了ST段抬高的患者。使用Dade-Behring Stratus CS STAT床边检测仪器（Dade Behring公司，纽瓦克，特拉华州）检测cTnI。我们采用标准的MI定义评估基线肌钙蛋白的准确性。有125例患者被明确诊断为MI。基线肌钙蛋白预测MI的敏感性为44%，特异性为97%，无显著性别差异。相比之下，其他阳性心脏标志物，即肌酸激酶同工酶MB分数升高或降低以及心电图阳性，在男性中出现的频率更高。在胸痛发作后2小时以上获取基线肌钙蛋白的受试者中，基线肌钙蛋白的敏感性（SE）更高。该研究未观察到检测的SE或特异性在性别上存在显著差异。这一观察结果，再加上其他阳性心脏标志物在男性中出现频率更高这一事实，表明肌钙蛋白检测可能有助于改善女性MI的诊断。
