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超声造影剂在儿科患者中的应用:是否属于超适应证使用?监管要求与放射科医生的责任。

Ultrasound contrast media in paediatric patients: is it an off-label use? Regulatory requirements and radiologist's liability.

机构信息

Struttura Complessa di Radiologia, Azienda Ospedaliera Pediatrica Santobono-Pausilipon, Via Mario Fiore 6, 80129, Napoli, Italy.

出版信息

Radiol Med. 2012 Feb;117(1):148-59. doi: 10.1007/s11547-011-0718-1. Epub 2011 Sep 2.

DOI:10.1007/s11547-011-0718-1
PMID:21892716
Abstract

The use of ultrasound contrast media is yet to be validated in children. The rare reports in the scientific literature denote their "sporadic" and "experimental" use. Their most likely use is in the setting of off-label prescription of medications. As there are still no guidelines available in Italy for the off-label use of medications, we aim to define the duties, obligations and liability of ultrasound radiologists according to the laws in force.

摘要

超声造影剂在儿童中的应用尚未得到验证。科学文献中罕见的报道表明其“偶发”和“实验性”使用。它们最有可能的用途是在药物标签外使用的情况下。由于意大利目前尚无药物标签外使用的指南,我们旨在根据现行法律确定超声放射科医生的职责、义务和责任。

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Ultrasound contrast media in paediatric patients: is it an off-label use? Regulatory requirements and radiologist's liability.超声造影剂在儿科患者中的应用:是否属于超适应证使用?监管要求与放射科医生的责任。
Radiol Med. 2012 Feb;117(1):148-59. doi: 10.1007/s11547-011-0718-1. Epub 2011 Sep 2.
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本文引用的文献

1
Off-label use of intravascular iodinated organic and MR contrast media.血管内碘有机和磁共振对比剂的超适应证使用。
Radiol Med. 2011 Feb;116(1):1-14. doi: 10.1007/s11547-010-0601-5. Epub 2010 Oct 27.
2
Imaging of the acute scrotum: is there a place for contrast-enhanced ultrasonography?急性阴囊的影像学检查:对比增强超声检查是否有一席之地?
Int Braz J Urol. 2009 Nov-Dec;35(6):692-702; discussion 702-5. doi: 10.1590/s1677-55382009000600008.
3
Imaging of paediatric liver tumours with pathological correlation.小儿肝脏肿瘤的影像学表现及其病理对照
J Ultrasound. 2019 Dec;22(4):503-512. doi: 10.1007/s40477-018-0341-2. Epub 2018 Nov 16.
4
How to perform Contrast-Enhanced Ultrasound (CEUS).如何进行超声造影(CEUS)。
Ultrasound Int Open. 2018 Jan;4(1):E2-E15. doi: 10.1055/s-0043-123931. Epub 2018 Feb 7.
5
Influence of contrast-enhanced ultrasound administration setups on microbubble enhancement: a focus on pediatric applications.超声造影剂给药设置对微泡增强的影响:聚焦儿科应用
Pediatr Radiol. 2018 Jan;48(1):101-108. doi: 10.1007/s00247-017-3976-9. Epub 2017 Sep 11.
6
Use of contrast media in diagnostic imaging: medico-legal considerations.诊断成像中造影剂的使用:法医学考量
Radiol Med. 2015 Sep;120(9):802-9. doi: 10.1007/s11547-015-0549-6. Epub 2015 Jun 17.
7
Contrast enhanced ultrasound (CEUS) in blunt abdominal trauma.腹部钝性创伤中的对比增强超声(CEUS)
Crit Ultrasound J. 2013 Jul 15;5 Suppl 1(Suppl 1):S9. doi: 10.1186/2036-7902-5-S1-S9.
8
US in the assessment of acute scrotum.超声在急性阴囊评估中的应用。 (你原文中的“US”推测应该是“Ultrasound”,所以这样翻译更符合医学语境,如果不是这个意思,请你提供更准确的信息)
Crit Ultrasound J. 2013 Jul 15;5 Suppl 1(Suppl 1):S8. doi: 10.1186/2036-7902-5-S1-S8.
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The role of US examination in the management of acute abdomen.超声检查在急腹症处理中的作用。
Crit Ultrasound J. 2013 Jul 15;5 Suppl 1(Suppl 1):S6. doi: 10.1186/2036-7902-5-S1-S6.
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Radiology. 2008 Mar;246(3):903-9. doi: 10.1148/radiol.2463070652. Epub 2008 Jan 14.