OBJECTIVES: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.
DESIGN AND SETTING: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.
RESULTS: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.
CONCLUSION: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.
-
【ELISA D-dimer measurement for the clinical suspicion of pulmonary embolism in the emergency department: one-year observational study of the safety profile and physician's prescription.].
【用于急诊科临床肺栓塞的ELISA D-二聚体测量：为期一年的安全性和医生处方观察性研究。】
复制标题
收藏
DOI：10.1179/acb.2003.58.4.004文章类型：杂志文章
复制DOI
译文
目的：验证快速ELISA D-二聚体的安全性，将其作为急诊科（ED）门诊患者在临床怀疑肺栓塞（PE）的第一步诊断步骤，并回顾性评估医师处方的适用性。
设计与地点：对某城市大学教学医院急诊科住院患者的体征和症状进行观察性研究，该体征和症状证明了快速ELISA D-二聚体测定处方的正确性（维达斯； Biomerieux；法国），是体育一线诊断测试。根据结果的不确定性，根据D-二聚体浓度，肺闪烁显像，螺旋计算机断层扫描（螺旋CT），静脉超声和动脉造影的适当组合，建立或排除急性PE。所有D-二聚体值低于500 ng / ml临界点的患者均在6个月后进行了随访。
结果：对395例患者进行了研究。在179名患者中发现了正常的D-二聚体浓度<500 ng / ml（占队列的45％）。回顾性分析表明，这些患者中没有人具有很高的预检临床可能性。这179名患者在6个月内均未接受抗凝治疗或未发生PE事件（阴性预测值100％； 95％CI为98.0至100％；敏感性为100％； 95％CI为90.3至100％）。 D-二聚体值高于500 ng / ml的216例患者（55％）中，有32例确诊为PE，该病患病率为8.1％。尽管D二聚体值大于500 ng / ml，但仍有86例患者（22％）没有进行其他检查，指出22％的D-二聚体测量值使用不当。
结论：这项观察性研究证实，当检测前临床概率低或检测到PE时，正常的快速ELISA D-二聚体值（<500 ng / ml）作为排除PE诊断的第一步诊断步骤是安全的临床实践。中间的。然而，该疾病的低患病率（8.1％）表明存在潜在的过度使用和不适当的处方。
设计与地点：对某城市大学教学医院急诊科住院患者的体征和症状进行观察性研究，该体征和症状证明了快速ELISA D-二聚体测定处方的正确性（维达斯； Biomerieux；法国），是体育一线诊断测试。根据结果的不确定性，根据D-二聚体浓度，肺闪烁显像，螺旋计算机断层扫描（螺旋CT），静脉超声和动脉造影的适当组合，建立或排除急性PE。所有D-二聚体值低于500 ng / ml临界点的患者均在6个月后进行了随访。
结果：对395例患者进行了研究。在179名患者中发现了正常的D-二聚体浓度<500 ng / ml（占队列的45％）。回顾性分析表明，这些患者中没有人具有很高的预检临床可能性。这179名患者在6个月内均未接受抗凝治疗或未发生PE事件（阴性预测值100％； 95％CI为98.0至100％；敏感性为100％； 95％CI为90.3至100％）。 D-二聚体值高于500 ng / ml的216例患者（55％）中，有32例确诊为PE，该病患病率为8.1％。尽管D二聚体值大于500 ng / ml，但仍有86例患者（22％）没有进行其他检查，指出22％的D-二聚体测量值使用不当。
结论：这项观察性研究证实，当检测前临床概率低或检测到PE时，正常的快速ELISA D-二聚体值（<500 ng / ml）作为排除PE诊断的第一步诊断步骤是安全的临床实践。中间的。然而，该疾病的低患病率（8.1％）表明存在潜在的过度使用和不适当的处方。
