Michiels J J, Gadisseur A, van der Planken M, Schroyens W, Berneman Z, De Maeseneer M, Hermsen J T, Trienekens P H
Hemostasis and Thrombosis Research, Department of Hematology, University Hospital Antwerp, Edegem.
Acta Chir Belg. 2005 Feb;105(1):16-25.
The requirement for a safe diagnostic strategy should be based on an overall post-test incidence of venous thromboembolism (VTE) of less than 1% during 3 month follow-up. Compression ultrasonography (CUS) has a negative predictive value (NPV) of 97 to 98% indicating a post-CUS incidence of deep vein thrombosis (DVT) of 2 to 3%. A post-CUS DVT incidence of 3% implicates that 90 to 120 DVTs per 1 million inhabitants will be overlooked each year indicating the need to improve the diagnostic work-up of DVT as much as possible. The qualitative D-dimer test (SimpliRed) has a sensitivity of 82 to 89% and a negative predictive value of 94 to 95% indicating a 5 to 6% post-test incidence of DVT, which is not sensitive enough for venous thrombosis exclusion. The post-test DVT incidence could be reduced from 3.2% to 0.6% in one study and from 11% to 2% in another study by the combination of a normal CUS and low clinical score and from 4.5% to 1.6% by the combination of low clinical score and a negative SimpliRed test in one study. The combination of a negative CUS and a negative SimpliRed test reduced the post-test incidence of DVT from 2.6% to < 1% or even < 1% in two management studies without the need of a repeated CUS on the basis of which anticoagulant therapy can safely be withheld. The rapid quantitative turbidimetric D-dimer assay (Tinaquant) has a sensitivity and a negative predictive value (NPV) of 97.7% with a 2.3% post-test incidence of DVT. The combination of a normal Tinaquant D-Dimer test result plus a low to moderate clinical score reduces the post-test incidence of DVT from 2.3 to 0.6% without the need of CUS testing in 29% of patients with suspected DVT. The rapid ELISA VIDAS D-dimer assay has a sensitivity and NPV of 98.6 and 99.5% in two management studies for the exclusion of DVT irrespective of clinical score. The combination of a normal ELISA VIDAS D-Dimer test with clinical score assessment will reduce the post-test DVT incidence of less than 0.5% and the need for CUS testing by 40 to 50%. It is concluded that the sequential use of a rapid quantitative D-dimer test, clinical score and CUS appears to be safe and the most cost-effective diagnostic work-up of DVT.
安全诊断策略的要求应基于3个月随访期间静脉血栓栓塞症（VTE）的总体检测后发病率低于1%。加压超声检查（CUS）的阴性预测值（NPV）为97%至98%，表明CUS检查后深静脉血栓形成（DVT）的发病率为2%至3%。CUS检查后DVT发病率为3%意味着每年每100万居民中将有90至120例DVT被漏诊，这表明需要尽可能改进DVT的诊断检查。定性D-二聚体检测（SimpliRed）的灵敏度为82%至89%，阴性预测值为94%至95%，表明检测后DVT的发病率为5%至6%，对于排除静脉血栓形成来说不够敏感。在一项研究中，通过正常CUS检查和低临床评分的联合使用，检测后DVT发病率可从3.2%降至0.6%；在另一项研究中，通过低临床评分和阴性SimpliRed检测的联合使用，检测后DVT发病率可从11%降至2%。在两项管理研究中，阴性CUS检查和阴性SimpliRed检测的联合使用将检测后DVT发病率从2.6%降至<1%甚至<1%，无需重复进行CUS检查，在此基础上可安全停用抗凝治疗。快速定量比浊法D-二聚体检测（Tinaquant）的灵敏度和阴性预测值（NPV）为97.7%，检测后DVT发病率为2.3%。正常的Tinaquant D-二聚体检测结果加上低至中度临床评分的联合使用，可将检测后DVT发病率从2.3%降至0.6%，在29%疑似DVT患者中无需进行CUS检查。在两项排除DVT的管理研究中，快速ELISA VIDAS D-二聚体检测的灵敏度和NPV分别为98.6%和99.5%，与临床评分无关。正常的ELISA VIDAS D-二聚体检测与临床评分评估的联合使用将检测后DVT发病率降低至<0.5%，并将CUS检查的需求减少40%至50%。结论是，快速定量D-二聚体检测、临床评分和CUS的序贯使用似乎是安全的，并且是DVT最具成本效益的诊断检查方法。
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