CAJ | 학술논문

2009年“高敏感肌钙蛋白”检测试剂投入国内临床应用,2012年国际上又有几种高敏感试剂陆续投入临床应用,且正在进行我国食品药物管理局的报批.高敏肌钙蛋白由于检测敏感性的提高,使得对急性冠脉综合征诊断时间窗提前2～3 h,同时使对心肌损伤的检测范围与前一代试剂相比有了极大的扩展.正是由于涉及范围的扩大给临床带来许多“困惑”.在用的还没“消化”,又有新的即将进来,我们准备好了吗？我们能否像美国那样在食品和药物管理局正式批准前,检验与临床加强学习,加强沟通与交流,形成共识.
2009년“고민감기개단백”검측시제투입국내림상응용,2012년국제상우유궤충고민감시제륙속투입림상응용,차정재진행아국식품약물관리국적보비.고민기개단백유우검측민감성적제고,사득대급성관맥종합정진단시간창제전2～3 h,동시사대심기손상적검측범위여전일대시제상비유료겁대적확전.정시유우섭급범위적확대급림상대래허다“곤혹”.재용적환몰“소화”,우유신적즉장진래,아문준비호료마？아문능부상미국나양재식품화약물관리국정식비준전,검험여림상가강학습,가강구통여교류,형성공식.
The new generation "high-sensitivity cardiac troponin" assays have been used in clinic for nearly 5 years in China.In 2012,several new high-sensitivity assays have been approved to be used in clinic in other countries,and they are under inspection of Chinese Food and Drug Ddministration.Because the new generation assays' sensitivity is improved,acute coronary syndrome could have been diagnosed 2-3 hours earlier,and small cardiac injuries that could not be detected by previous assays are detectable now.But its advantages also bring challenges to doctors.Many doctors can't even use previous assays well.The clinical doctors and laloiatory stuffs need to comunicate and reach a consensus just like American doctors do before American food and drug administration approve it.