一项多中心、与研究地点无关的盲法研究，旨在比较使用1.0M钆布醇（加朵维显）的对比增强磁共振血管造影与体动脉内数字减影血管造影的诊断准确性。
A multicenter, site-independent, blinded study to compare the diagnostic accuracy of contrast-enhanced magnetic resonance angiography using 1.0M gadobutrol (Gadovist) to intraarterial digital subtraction angiography in body arteries.
作者信息
Schaefer Fritz K W, Schaefer Philipp J, Altjohann Christian, Bourne Michael, Decobelli Francesco, Goyen Mathias, Griffiths Paul D, Kopka Lars, Kreitner Karl F, Link Johann, Oberholzer Katja, Pering Christiane, Poeckler-Schoeninger Christiane, Ruehm Stefan G, Sachoran Mansur R, Schulte-Altedorneburg Gernot, Springer Oliver S, Steiner Paul, Wall Alexander, Winterer Jan, Tombach Bernd
机构信息
Department of Diagnostic Radiology, University Hospital Schleswig-Holstein Campus Kiel, Arnold-Heller-Strasse 9, 24105 Kiel, Germany.
出版信息
Eur J Radiol. 2007 Feb;61(2):315-23. doi: 10.1016/j.ejrad.2006.09.002. Epub 2006 Oct 30.
PURPOSE
Prospective evaluation of diagnostic accuracy of single field-of-view contrast-enhanced MR Angiography (ceMRA) with 1.0M gadobutrol compared to intraarterial DSA in body arteries.
MATERIALS AND METHODS
In an European multicenter study 179 patients underwent ceMRA and DSA. For each indication five prospectively defined vessel segments were evaluated by local investigators onsite and by three site-independent blinded readers (BR) independently.
RESULTS
The agreement between ceMRA and DSA diagnosis was statistically significant in the onsite (96.6%) and blinded reader (86.6-90.2%) evaluation. Sensitivity, specificity, accuracy, positive (PPV) and negative predictive values (NPV) for detection of relevant stenosis (>50%) were calculated for the right and left internal carotid arteries, and common and external iliac arteries: Sensitivity was 95-98% (onsite) and 76-96% (BR), specificity 94-96% (onsite) and 86-94% (BR), accuracy 96% (onsite) and 87-93% (BR), NPV 98-99% (onsite) and 84-98% (BR), and PPV 79-93% (onsite) and 44-91% (BR), respectively.
CONCLUSION
CeMRA of body arteries using 1.0M gadobutrol provides diagnostic information comparable to intraarterial DSA.
目的
前瞻性评估单视野对比增强磁共振血管造影（ceMRA）使用1.0M钆布醇与动脉内数字减影血管造影（DSA）相比在体动脉中的诊断准确性。
材料与方法
在一项欧洲多中心研究中，179例患者接受了ceMRA和DSA检查。对于每个适应症，由现场的当地研究人员和三名独立于检查部位的盲法阅片者（BR）分别对五个前瞻性定义的血管节段进行评估。
结果
在现场评估（96.6%）和盲法阅片者评估（86.6 - 90.2%）中，ceMRA与DSA诊断之间的一致性具有统计学意义。计算了左右颈内动脉以及髂总动脉和髂外动脉检测相关狭窄（>50%）的敏感性、特异性、准确性、阳性预测值（PPV）和阴性预测值（NPV）：敏感性在现场为95 - 98%，盲法阅片者为76 - 96%；特异性在现场为94 - 96%，盲法阅片者为86 - 94%；准确性在现场为96%，盲法阅片者为87 - 93%；NPV在现场为98 - 99%，盲法阅片者为84 - 98%；PPV在现场为79 - 93%，盲法阅片者为44 - 91%。
结论
使用1.0M钆布醇进行体动脉的ceMRA可提供与动脉内DSA相当的诊断信息。
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