Fr Verschuren, Hainaut P, Fr Thys, Elamly A, Dessomme B, Lavenne E, Reynaert M S
Service des Urgences, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Avenue Hippocrate 10, B-1200 Bruxelles, Belgium.
Acta Clin Belg. 2003 Jul-Aug;58(4):233-40. doi: 10.1179/acb.2003.58.4.004.
To validate the safety profile of a rapid ELISA D-dimer as the first diagnostic step in the clinical suspicion of pulmonary embolism (PE) in outpatients admitted to an emergency department (ED), and to retrospectively evaluate the appropriateness of the physician's prescription.
An observational study of all patients admitted to the ED of an urban university teaching hospital with signs and symptoms justifying the prescription of a rapid ELISA D-dimer measurement (Vidas; Biomerieux; France) as the first line diagnostic test for PE. Acute PE was established or excluded according to an appropriate combination of the D-dimer concentration, the lung scintigraphy, the spiral computerized tomography (spiral CT), the venous ultrasonography, and the arteriography in case of uncertain results. All patients with D-dimer values under the cut-off point of 500 ng/ml were followed up after 6 months.
395 patients were studied. A normal D-dimer concentration < 500 ng/ml was found in 179 patients (45% of the cohort). The retrospective analysis showed that none of these patients were found to have a high pre-test clinical probability. None of these 179 patients received anticoagulation nor displayed a PE event during a 6-month period (negative predictive value 100%; 95% CI, 98.0 to 100%; sensitivity 100%; 95% CI, 90.3 to 100%). Among the 216 patients (55%) with D-dimer values above 500 ng/ml, PE was confirmed in 32 cases, for a prevalence of the disease of 8.1%. Eighty-six patients (22%) had no additional testing in spite of positive D dimer values > 500 ng/ml, pointing out a 22% rate of inappropriate use of the D-dimer measurement.
This observational study confirms that a normal rapid ELISA D-dimer value (< 500 ng/ml) used as a first diagnostic step in ruling out the diagnosis of PE is a safe clinical practice when the pre-test clinical probability is low or intermediate. Nevertheless, the low prevalence rate of the disease (8.1%) suggests a potential overused and inappropriate prescription.
验证快速酶联免疫吸附测定法（ELISA）检测D - 二聚体作为急诊科（ED）门诊疑似肺栓塞（PE）患者的首个诊断步骤的安全性，并回顾性评估医生处方的合理性。
对一所城市大学教学医院急诊科收治的所有患者进行观察性研究，这些患者具有的体征和症状表明应将快速ELISA法检测D - 二聚体（Vidas；生物梅里埃公司；法国）作为PE的一线诊断试验。根据D - 二聚体浓度、肺闪烁扫描、螺旋计算机断层扫描（螺旋CT）、静脉超声检查以及结果不确定时的动脉造影的适当组合来确定或排除急性PE。所有D - 二聚体值低于500 ng/ml临界值的患者在6个月后进行随访。
共研究了395例患者。179例患者（占队列的45%）的D - 二聚体浓度正常，<500 ng/ml。回顾性分析显示，这些患者中没有一例具有高的检测前临床概率。在这179例患者中，没有一例在6个月期间接受抗凝治疗，也没有发生PE事件（阴性预测值为100%；95%可信区间，98.0至100%；敏感性为100%；95%可信区间，90.3至100%）。在216例（55%）D - 二聚体值高于500 ng/ml的患者中，32例确诊为PE，疾病患病率为8.1%。86例患者（22%）尽管D - 二聚体值>500 ng/ml呈阳性，但未进行其他检查，表明D - 二聚体检测的不适当使用率为22%。
这项观察性研究证实，当检测前临床概率较低或中等时，将正常快速ELISA法检测D - 二聚体值（<500 ng/ml）作为排除PE诊断的首个诊断步骤是一种安全的临床实践。然而，该疾病的低患病率（8.1%）表明可能存在过度使用和不适当处方的情况。
