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应用根据临床概率校正的d-二聚体诊断肺栓塞(NEJM IF:79)

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Diagnosis of Pulmonary Embolism with d-Dimer Adjusted to Clinical Probability

  • Kearon Clive,de Wit Kerstin,Parpia Sameer et al. Diagnosis of Pulmonary Embolism with d-Dimer Adjusted to Clinical Probability.[J] .N. Engl. J. Med., 2019, 381: 2125-2134.

BACKGROUND 背景

Retrospective analyses suggest that pulmonary embolism is ruled out by a d-dimer level of less than 1000 ng per milliliter in patients with a low clinical pretest probability (C-PTP) and by a d-dimer level of less than 500 ng per milliliter in patients with a moderate C-PTP.

回顾性分析提示,临床验前概率(C-PTP)低的患者如果d-二聚体水平低于1,000 ng/mL,C-PTP中等的患者如果d-二聚体水平低于500 ng/mL,则可排除肺栓塞。

METHODS 方法

We performed a prospective study in which pulmonary embolism was considered to be ruled out without further testing in outpatients with a low C-PTP and a d-dimer level of less than 1000 ng per milliliter or with a moderate C-PTP and a d-dimer level of less than 500 ng per milliliter. All other patients underwent chest imaging (usually computed tomographic pulmonary angiography). If pulmonary embolism was not diagnosed, patients did not receive anticoagulant therapy. All patients were followed for 3 months to detect venous thromboembolism.

我们开展了一项前瞻性研究,本研究认为C-PTP低且d-二聚体水平低于1,000 ng/mL或者C-PTP中等且d-二聚体水平低于500 ng/mL的门诊患者可排除肺栓塞,而不需要进一步检查。所有其他患者均接受了胸部影像学检查(通常为计算机断层肺动脉造影)。如果未诊断为肺栓塞,则患者不接受抗凝治疗。本试验对所有患者进行了3个月随访,旨在检测静脉血栓栓塞。

RESULTS 结果

A total of 2017 patients were enrolled and evaluated, of whom 7.4% had pulmonary embolism on initial diagnostic testing. Of the 1325 patients who had a low C-PTP (1285 patients) or moderate C-PTP (40 patients) and a negative d-dimer test (i.e., <1000 or <500 ng per milliliter, respectively), none had venous thromboembolism during follow-up (95% confidence interval [CI], 0.00 to 0.29%). These included 315 patients who had a low C-PTP and a d-dimer level of 500 to 999 ng per milliliter (95% CI, 0.00 to 1.20%). Of all 1863 patients who did not receive a diagnosis of pulmonary embolism initially and did not receive anticoagulant therapy, 1 patient (0.05%; 95% CI, 0.01 to 0.30) had venous thromboembolism. Our diagnostic strategy resulted in the use of chest imaging in 34.3% of patients, whereas a strategy in which pulmonary embolism is considered to be ruled out with a low C-PTP and a d-dimer level of less than 500 ng per milliliter would result in the use of chest imaging in 51.9% (difference, -17.6 percentage points; 95% CI, -19.2 to -15.9).

共计2,017例患者被纳入研究并接受了评估,其中7.4%在最初诊断性检查中被诊断为肺栓塞。在C-PTP低(1,285例患者)或中等(40例患者)并且d-二聚体检测结果呈阴性(即分别<1,000 ng/mL或<500 ng/mL)的1,325例患者中,无任何患者在随访期间发生静脉血栓栓塞(95%置信区间[CI],0.00~0.29%)。其中包括C-PTP低且d-二聚体水平为500~999 ng/mL的315例患者(95% CI,0.00~1.20%)。在最初未被诊断为肺栓塞且未接受抗凝治疗的全部1,863例患者中,有1例患者(0.05%;95% CI,0.01%~0.30%)发生了静脉血栓栓塞。我们的诊断策略使34.3%的患者接受了胸部影像学检查,而如果肺栓塞排除策略是C-PTP低且d-二聚体水平低于500 ng/mL,则会使51.9%的患者接受胸部影像学检查(差异,-17.6个百分点;95% CI,-19.2~-15.9)。

CONCLUSIONS 结论

A combination of a low C-PTP and a d-dimer level of less than 1000 ng per milliliter identified a group of patients at low risk for pulmonary embolism during follow-up. (Funded by the Canadian Institutes of Health Research and others; PEGeD ClinicalTrials.gov number, NCT02483442.)

通过综合应用C-PTP低且d-二聚体水平低于1,000 ng/mL,我们发现了一个随访期间肺栓塞风险低的患者人群(由加拿大卫生研究院[Canadian Institutes of Health Research]等资助;PEGeD在ClinicalTrials.gov注册号为NCT02483442)。


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