Lecourvoisier C, Toulon P
Laboratoire d'hématologie, Hôpital Cochin, 27, rue du Fbg-Saint-Jacques, 75679 Paris cedex 14, France.
Ann Biol Clin (Paris). 2001 Nov-Dec;59(6):693-700.
Diagnosis of pulmonary embolism, a common and potentially fatal disease, is first based on clinical probability assessment, and often requires invasive testing such as pulmonary angiography. However, it often represents a diagnosis challenge. The measurement of D-dimer, a specific fibrin degradation product, was recently introduced in the diagnosis strategy. Even if D-dimer levels are highly sensitive in the diagnosis of pulmonary embolism, they are not specific of an on-going venous thromboembolic process. Its high negative predictive value enables to validly exclude diagnosis of pulmonary embolism, particularly in outpatients, in the case of D-dimer levels below a well-defined cut-off value. Prospective management studies confirmed that D-dimer measurement could be validly used as an initial screening test in patients with clinically suspected pulmonary embolism. Using such a diagnosis strategy, imaging tests would be performed only in the case of high D-dimer levels i.e. above the cut-off level. Even if they constitute the gold standard, conventional Elisa are not useful as a routine emergency test. New rapid and automated assays based on various principles (Elisa-derived or micro-latex agglutination) are now available. All demonstrated both high sensitivity (about 100%) and negative predictive value (over 98%), using a well-defined cut-off level (usually defined to be 500 ng/mL). Finally, with the increasing number of new D-dimer assays currently available, a lack of standardization was pointed out. As the result, both the clinical significance and the cut-off level have to be defined in prospective clinical trials, for each individual assay.
肺栓塞是一种常见且可能致命的疾病,其诊断首先基于临床概率评估,且常常需要诸如肺血管造影等侵入性检查。然而,它往往是一个诊断难题。D - 二聚体(一种特定的纤维蛋白降解产物)的检测最近被引入到诊断策略中。即便D - 二聚体水平在肺栓塞诊断中具有高度敏感性,但它们并非正在发生的静脉血栓栓塞过程所特有的。其高阴性预测值能够有效地排除肺栓塞的诊断,尤其是在门诊患者中,当D - 二聚体水平低于明确界定的临界值时。前瞻性管理研究证实,D - 二聚体检测可有效地用作临床疑似肺栓塞患者的初始筛查试验。采用这样的诊断策略,仅在D - 二聚体水平高即高于临界水平的情况下才会进行影像学检查。即便传统酶联免疫吸附测定(ELISA)构成金标准,但它们作为常规急诊检测并无用处。基于各种原理(源自ELISA或微乳胶凝集)的新型快速自动化检测方法现已可用。所有这些方法在使用明确界定的临界值(通常设定为500 ng/mL)时均显示出高敏感性(约100%)和阴性预测值(超过98%)。最后,随着目前可用的新型D - 二聚体检测方法数量不断增加,有人指出缺乏标准化的问题。因此,对于每种单独的检测方法,其临床意义和临界值都必须在前瞻性临床试验中加以界定。