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脑磁共振成像在那他珠单抗治疗的多发性硬化症患者药物警戒中的诊断性能

Diagnostic performance of brain MRI in pharmacovigilance of natalizumab-treated MS patients.

作者信息

Wattjes Mike P, Wijburg Martijn T, Vennegoor Anke, Witte Birgit I, Roosendaal Stefan D, Sanchez Esther, Liu Yaou, Martins Jarnalo Carine O, Richert Nancy D, Uitdehaag Bernard Mj, Barkhof Frederik, Killestein Joep

机构信息

Department of Radiology and Nuclear Medicine, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.

Department of Radiology and Nuclear Medicine, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands/Department of Neurology, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.

出版信息

Mult Scler. 2016 Aug;22(9):1174-83. doi: 10.1177/1352458515615225. Epub 2015 Nov 12.

DOI:10.1177/1352458515615225
PMID:26564995
Abstract

BACKGROUND

In natalizumab-treated multiple sclerosis (MS) patients, magnetic resonance imaging (MRI) is considered as a sensitive tool in detecting both MS disease activity and progressive multifocal leukoencephalopathy (PML).

OBJECTIVE

To investigate the performance of neuroradiologists using brain MRI in detecting new MS lesions and asymptomatic PML lesions and in differentiating between MS and PML lesions in natalizumab-treated MS patients. The secondary aim was to investigate interrater variability.

METHODS

In this retrospective diagnostic study, four blinded neuroradiologists assessed reference and follow-up brain MRI scans of 48 natalizumab-treated MS patients with new asymptomatic PML lesions (n = 21) or new MS lesions (n = 20) or no new lesions (n = 7). Sensitivity and specificity for detection of new lesions in general (MS and PML lesions), MS and PML lesion differentiation, and PML detection were determined. Interrater agreement was calculated.

RESULTS

Overall sensitivity and specificity for the detection of new lesions, regardless of the nature of the lesions, were 77.4% and 89.3%, respectively; for PML-MS lesion differentiation, 74.2% and 84.7%, respectively; and for asymptomatic PML lesion detection, 59.5% and 91.7%, respectively. Interrater agreement for the tested categories was fair to moderate.

CONCLUSION

The diagnostic performance of trained neuroradiologists using brain MRI in pharmacovigilance of natalizumab-treated MS patients is moderately good. Interrater agreement among trained readers is fair to moderate.

摘要

背景

在接受那他珠单抗治疗的多发性硬化症(MS)患者中,磁共振成像(MRI)被认为是检测MS疾病活动和进行性多灶性白质脑病(PML)的敏感工具。

目的

研究神经放射科医生使用脑部MRI检测接受那他珠单抗治疗的MS患者中新发MS病灶和无症状PML病灶以及区分MS和PML病灶的表现。次要目的是研究评估者间的变异性。

方法

在这项回顾性诊断研究中,四位不知情的神经放射科医生评估了48例接受那他珠单抗治疗的MS患者的参考脑MRI扫描和随访脑MRI扫描,这些患者中有新发无症状PML病灶(n = 21)或新发MS病灶(n = 20)或无新病灶(n = 7)。确定了总体检测新病灶(MS和PML病灶)、MS和PML病灶鉴别以及PML检测的敏感性和特异性。计算评估者间的一致性。

结果

无论病灶性质如何,检测新病灶的总体敏感性和特异性分别为77.4%和89.3%;PML-MS病灶鉴别的敏感性和特异性分别为74.2%和84.7%;无症状PML病灶检测的敏感性和特异性分别为59.5%和91.7%。所测试类别的评估者间一致性为中等。

结论

在接受那他珠单抗治疗的MS患者的药物警戒中,训练有素的神经放射科医生使用脑部MRI的诊断表现中等良好。训练有素的阅片者之间的评估者间一致性为中等。

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