四川地区高敏肌钙蛋白T参考值的建立及其在胸痛患者中诊断急性心肌梗死的价值

Establishment of Reference Value of Hs-cTnT in Sichuan Region and Its Diagnostic Value in Patients with Chest Pain

目的基于四川地区大样本健康人群,根据不同年龄及性别,建立高敏肌钙蛋白T(hs-cTnT)第99百分位参考值,并通过回顾性研究验证建立的参考值在胸痛患者中诊断急性心肌梗死(AMI)的价值。方法随机挑选成都市8个独立社区各个年龄段的志愿者,通过问卷调查记录志愿者基本资料并进行体格、心电图、超声检查等确定健康志愿者。采集血液分析hs-cTnT水平,按性别和年龄建立hs-cTnT第99百分位参考值。同时回顾性纳入2009年7月至2014年7月四川大学华西医院急诊收治的胸痛患者2 249例,比较本次研究建立的参考值(14ng/L)与厂商所提供的参考值诊断急诊胸痛患者发生AMI的灵敏度、特异度、阳性预测值和阴性预测值。结果共纳入1 305例符合标准的健康志愿者,其中男性hs-cTnT水平为4.3(3.2~5.9)ng/L,高于女性3.0(3.0~3.1)ng/L,差异有统计学意义(P<0.01)。男性和女性年龄与hs-cTnT的相关系数分别为0.43和0.29(P<0.01),呈正相关。<45岁、45~<60岁和≥60岁年龄段男性hs-cTnT第99百分位值分别为10.8ng/L、15.4ng/L和19.7ng/L,女性分别为4.6ng/L、8.9ng/L、18.8ng/L。回顾性纳入急诊胸痛患者2 249例采用新确立的第99百分位值与14.0ng/L分别进行验证,60岁以下人群,本研究建立的参考值和14.0ng/L比较其诊断价值无差异,60岁及以上人群,其诊断AMI的灵敏度和阴性预测值差异无统计学意义(P>0.05),特异度和阳性预测值明显提高(男性:0.67vs.0.56,0.83vs.0.79,P<0.05;女性:0.75vs.0.68,0.74vs.0.69,P<0.05)。结论 60岁以下中国四川地区人群hs-cTnT第99百分位参考值为14.0ng/L,60岁及以上人群为20.0ng/L。

Objective To establish the reference value of high sensitive cardiac troponin T （hs-cTnT） and the efficiency of reference value in the diagnosis of chest pain. Methods Volunteers from eight independent communities in Chengdu, Sichuan were selected with detailed records of physical examination, electrocardiogram, ultrasound examination. The level of hs-cTnT for healthy volunteers was tested to determine ninety-ninth percentile references according to sex and ages. 2 249 patients with chest pain in the emergency department of Western China Hospital from July 2009 to July 2014 were enrolled to measure the efficiency of reference value for diagnosing acute myocardial infarction （AMI）. Results There were 1 305 volunteers included finally. Among them, the mean hs-cTnT level of male was 4.3 （3.2-5.9） ng/L, which was significantly higher than that of female 3.0 （3.0-3.1） ng/L （ P〈0.01）. The correlation coefficient between age and hs-cTnT level was 0.43 （male） and 0.29 （female）, and the P-value was less than 0.01. The 99th percentile values of male were 10.8 ng/L, 15.4 ng/L and 19.7 ng/L for 〈45 yr., 45-〈60 yr. and ≥60 yr., respectively. Those values of female were 4.6 ng/L, 8.9 ng/L, 18.8 ng/L, respectively. There was no difference in sensitivity and specificity between the value we figured out and manufactures provided （14.0 ng/L） for those 〈60 yr.. For the patients ≥60 yr., the sensitivity and negative predictive value did not show diversity （ P〉0.05） but the specificity and positive predictive value showed significant difference （male： 0.67 vs. 0.56 and 0.83 vs. 0.79, P〈0.05;female：0.75 vs. 0.68 and 0.74 vs. 0.69, P〈0.05）. Conclusion We recommends that the ninety-ninth percentile reference value of patients 〈60 yr. should be 14.0 ng/L, while 20.0 ng/L for those patients≥60 yr.