Combined use of pretest clinical probability score and latex agglutination D-dimer testing for excluding acute deep vein thrombosis
Combined use of pretest clinical probability score and latex agglutination D-dimer testing for excluding acute deep vein thrombosis
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DOI：
10.1016/j.jvs.2009.06.059
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发表时间：
2009-11-01
影响因子：
4.3
通讯作者：
Kim, Kaya
中科院分区：
文献类型：
--
作者：
Yamaki, Takashi;Nozaki, Motohiro;Kim, Kaya
目标：目前，乳胶凝集D-二聚体试验被广泛用于排除深静脉血栓形成（DVT），但被认为不如基于酶联免疫吸附试验的D-二聚体试验敏感。本研究的目的是确定乳胶凝集D-二聚体测定和预试验临床概率（PTP）评分的不同截止点的组合，而不是单一的1.0 μ g/mL的截止点，是否能够减少疑似DVT患者静脉双功超声（DU）扫描的使用。采用PTP评分和D-二聚体检测对989例疑似DVT患者在静脉DU扫描前进行评估。在计算临床概率得分后，将患者分为低风险（50分）、中等风险（1-2分）和高风险（>= 3分）预测试临床概率组。采用受试者工作特征（ROC）曲线分析确定每种PTP的适当D-二聚体临界点，阳性DU扫描的阴性预测值>98%。研究组包括609例住院患者（68.7%）和277例门诊患者（31.3%）。DVT的患病率为28.9%。有508名患者（57.3%）被归类为低风险，237名（26.8%）为中度风险，141名（14.9%）为高风险PTP。在29例（5.7%）低风险患者、118例（49.8%）中度风险患者和109例（77.3%）高风险PTP评分患者中确定了DVT。ROC曲线分析用于选择D-二聚体的临界点为2.6，1.1，和1.1 μ g/mL的低，中，高风险PTP组，分别。在低危PTP组中，使用不同的D-二聚体临界值，特异性从48.9%增加到78.2%（P <0.0001）。然而，在中度和高风险PTP组中，不同的D-二聚体水平并没有取得实质性的改善。尽管如此，如果使用不同的D-二聚体临界点，静脉DU扫描的总体使用可能减少43.0%（886例中的381例）。在排除DVT的低风险PTP患者中，特定D-二聚体水平与临床概率评分相结合是最有效的。然而，在中度和高风险PTP患者中，推荐的临界点为1.0 μ g/mL可能更可取。这些结果表明，对于不同风险的患者，不同的D-二聚体水平对于使用乳胶凝集D-二聚体测定排除DVT是可行的。（I Vasc Surg 2009;50：1099-105.）
Objective: Currently, the latex agglutination D-dimer assay is widely used for excluding deep vein thrombosis (DVT) but is considered less sensitive than the enzyme-linked immunosorbent assay-based D-dimer test. The purpose of the present study was to determine if a combination of different cutoff points, rather than a single cutoff point of 1.0 mu g/mL, on the latex agglutination D-dimer assay and the pretest clinical probability (PTP) score would be able to reduce the use of venous duplex ultrasound (DU) scanning in patients with suspected DVT.Methods. The PTP score and D-dimer testing were used to evaluate 989 consecutive patients with suspected DVT before venous DU scanning. After calculating the clinical probability scores, patients were divided into low-risk (50 points), moderate-risk (1-2 points), and high-risk (>= 3 points) pretest clinical probability groups. Receiver operating characteristic (ROC) curve analysis was used to determine the appropriate D-dimer cutoff point for each PTP with a negative predictive value of >98% for a positive DU scan.Results: There were 886 patients enrolled. The study group included 609 inpatients (68.7%) and 277 outpatients (31.3%). The prevalence of DVT in this series was 28.9%. There were 508 patients (57.3%) classified as low-risk, 237 (26.8%) as moderate-risk, and 141 (14.9%) as high-risk PTP. DVT was identified in 29 patients (5.7%) with low-risk, 118 (49.8%) with moderate-risk, and 109 (77.3%) with high-risk PTP scores. ROC curve analysis was used to select D-dimer cutoff points of 2.6, 1.1, and 1.1 mu g/mL for the low-, moderate- and high-risk PTP groups, respectively. In the low-risk PTP group, specificity increased from 48.9% to 78.2% (P < .0001) with use of the different D-dimer cutoff value. In the moderate- and high-risk PTP groups, however, the different D-dimer levels did not achieve substantial improvement. Despite this, the overall use of venous DU scanning could have been reduced by 43.0% (381 of 886) if the different D-dimer cutoff points had been used.Conclusions. Combination of a specific D-dimer level with the clinical probability score is most effective in low-risk PTP patients for excluding DVT. In moderate- and high-risk PTP patients, however, the recommended cutoff points of 1.0 mu g/mL may be preferable. These results show that different D-dimer levels for patients differing in risk is feasible for excluding DVT using the latex agglutination D-dimer assay. (I Vasc Surg 2009;50:1099-105.)