高敏肌钙蛋白检测 助力心梗早诊早治

2017-09-29 佚名 医师报

近日,在杭州举办的“2017体外诊断新技术高峰论坛”上,复旦大学附属中山医院急诊科副主任姚晨玲教授围绕高敏肌钙蛋白检测(hs-cTn检测)的重要医学价值及其在急诊科和胸痛中心的运用等相关话题进行了深度解读与探讨。

近日,在杭州举办的“2017体外诊断新技术高峰论坛”上,复旦大学附属中山医院急诊科副主任姚晨玲教授围绕高敏肌钙蛋白检测(hs-cTn检测)的重要医学价值及其在急诊科和胸痛中心的运用等相关话题进行了深度解读与探讨。



高敏感方法检测心肌损伤,更早识别危险信号

心肌肌钙蛋白(cTn)是心肌细胞的一种结构蛋白,心肌细胞损伤破坏后cTn会释放到外周血中被检测到。对于诊断心肌损伤,cTn升高不存在假阳性,只要cTn升高就意味着心肌损伤的存在。cTn由三种亚基组成,其中心肌肌钙蛋白T(cTnT)、心肌肌钙蛋白I(cTnI)多用于急性冠状动脉综合征(ACS)的诊断。

目前,国际上还没有hs-cTn检测方法的统一标准,国际临床化学和实验室医学联盟(IFCC)确认的被普遍接受的标准为:最佳不精密度(CV)在第99百分位处应≤10%;在第99百分位以下可检测到至少50%的表观健康人群(LoD)。

“相比传统cTnT检测,高敏感检测在灵敏度、分析精密度方面都有显着提升,其优势就在于可在更早期发现心梗造成的心肌损伤,使得临床可以更加快速准确地诊断并进行干预,从而改善患者预后。”姚晨玲教授指出,“此外,普通cTn检测结果阴性的患者依然有较高的急性心肌梗死(AMI)发生率,而hs-cTnT可以检测出普通cTn无法发现的轻微心梗,不易漏诊有AMI风险的患者、更准确预测患者的预后。”

罗氏诊断新一代Elecsys hs-cTnT检测第99百分位CV值为9%,89%的表观健康人群能被检测到LoD,最低检测浓度仅3 ng/L。研究数据显示,通过使用Elecsys? hs-cTnT检测,平均入院71.5 min即可诊断非ST段抬高型心肌梗死(NSTEMI),较传统cTnT检测缩短约3 h 诊断时间。(Clin Chem. 2010,56:254)

1小时分诊算法:准确筛查  快速诊断

欧洲心脏病学会(ESC)2015年发布的指南中强烈推荐cTn检测使用高敏感方法,且检测结果应该在60 min内得到,此外hs-cTn的0 h /3 h 和0 h /1 h 快速分诊算法被以相同的证据级别推荐(I 类推荐、B级证据)。指南同时推荐0 h /1 h 算法的hs-cTn检测用于鉴别诊断疑似NSTEMI,并指出仅有通过研究验证过0 h /1 h 算法的hs-cTn检测可以进行0 h 和1 h 分诊流程进行快速排除和纳入。

基于罗氏诊断Elecsys? hs-cTnT检测,一项覆盖3大洲、9个国家、入组1,282例急性胸痛患者的TRAPID-AMI前瞻性验证研究显示:将罗氏诊断Elecsys? hs-cTnT作为急性胸痛患者排除或诊断AMI的指标,77.8 %的患者能够在1 h 内被可靠的排除诊断或确诊。

目前,罗氏诊断Elecsys? hs-cTnT 0/1 h 算法排除患者的安全性经过3个多中心临床研究、超过3000例样本人群中得到验证。对于算法排除区域的患者给予更早的出院,被确认是安全的,Elecsys? hs-cTnT检测的阴性预测值高达99.1% ~ 100%,30 d 死亡率仅为0.0% ~ 0.2%。

姚晨玲教授强调:“AMI是严重致命性疾病,需要院前、急诊、心内、实验室等多科室协同配合,尽力缩短每一个环节的时间,进行快速、规范化的诊断和救治。急诊科和胸痛中心承担的是‘守门人’角色,主要任务是快速识别高危患者,转诊至心内科救治,避免漏诊,减少患者的死亡率。”同时,hs-cTn检测及其快速分诊算法帮助临床实现快速、安全地排除低危胸痛。研究证实,hs-cTn检测的应用并不会增加心脏负荷试验、冠状动脉造影等医疗操作的比例,也没有增加患者的总体医疗负担。

2017年5月,中国食品药品监督管理局(CFDA)批准罗氏诊断Elecsys hs-cTnT检测说明书更新,增加了0 h /1 h 分诊流程用途,更快速的分诊算法将帮助中国临床医生更快、更安全地分诊急性胸痛患者,快速诊断心梗。

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    2017-10-05 三生有幸9135

    学习一下谢谢分享

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    2017-10-02 1e207054m17(暂无匿称)

    生物标记物的发展.为临床医生保驾护航

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    2017-09-29 明月清辉

    谢谢分享.学习了

    0

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    2017-09-29 飛歌

    学习了很有用

    0

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    2017-09-29 yjs木玉

    学习了.受益匪浅

    0

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    2017-09-29 1e1a50a1m36(暂无匿称)

    谢谢分享知识学习

    0

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