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静脉注射钆塞酸二钠在肝动脉期会降低屏气能力:一项多中心随机安慰剂对照试验

Intravenous Gadoxetate Disodium Administration Reduces Breath-holding Capacity in the Hepatic Arterial Phase: A Multi-Center Randomized Placebo-controlled Trial.

作者信息

McClellan Taylor R, Motosugi Utaroh, Middleton Michael S, Allen Brian C, Jaffe Tracy A, Miller Chad M, Reeder Scott B, Sirlin Claude B, Bashir Mustafa R

机构信息

From the Department of Radiology (T.R.M., B.C.A., T.A.J., C.M.M., M.R.B.) and Center for Advanced Magnetic Resonance Development (M.R.B.), Duke University Medical Center, DUMC 3808, Durham, NC 27710; Departments of Radiology (U.M., S.B.R.), Medical Physics (S.B.R.), Biomedical Engineering (S.B.R.), Medicine (S.B.R.), and Emergency Medicine (S.B.R.), University of Wisconsin, Madison, Wis; and Liver Imaging Group, Department of Radiology, University of California-San Diego, San Diego, Calif (M.S.M., C.B.S.).

出版信息

Radiology. 2017 Feb;282(2):361-368. doi: 10.1148/radiol.2016160482. Epub 2016 Aug 10.

DOI:10.1148/radiol.2016160482
PMID:27509544
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5537625/
Abstract

Purpose To determine, in a multicenter double-blinded placebo-controlled trial, whether maximal hepatic arterial phase breath-holding duration is affected by gadoxetate disodium administration. Materials and Methods Institutional review board approval was obtained for this prospective multi-institutional HIPAA-compliant study; written informed consent was obtained from all subjects. At three sites, a total of 44 volunteers underwent a magnetic resonance (MR) imaging examination in which images were acquired before and dynamically after bolus injection of gadoxetate disodium, normal saline, and gadoterate meglumine, administered in random order in a single session. The technologist and volunteer were blinded to the agent. Arterial phase breath-holding duration was timed after each injection, and volunteers reported subjective symptoms. Heart rate (HR) and oxygen saturation were monitored. Images were independently analyzed for motion artifacts by three radiologists. Arterial phase breath-holding duration and motion artifacts after each agent were compared by using the Mann-Whitney U test and the McNemar test. Factors affecting the above outcomes were assessed by using a univariate, multivariable model. Results Arterial phase breath holds were shorter after gadoxetate disodium (mean, 32 seconds ± 19) than after saline (mean, 40 seconds ± 17; P < .001) or gadoterate meglumine (43 seconds ± 21, P < .001) administration. In 80% (35 of 44) of subjects, arterial phase breath holds were shorter after gadoxetate disodium than after both saline and gadoterate meglumine. Three (7%) of 44 volunteers had severe arterial phase motion artifacts after gadoxetate disodium administration, one (2%; P = .62) had them after gadoterate meglumine administration, and none (P = .25) had them after saline administration. HR and oxygen saturation changes were not significantly associated with contrast agent. Conclusion Maximal hepatic arterial phase breath-holding duration is reduced after gadoxetate disodium administration in healthy volunteers, and reduced breath-holding duration is associated with motion artifacts. RSNA, 2016.

摘要

目的 在一项多中心双盲安慰剂对照试验中,确定钆塞酸二钠给药是否会影响最大肝动脉期屏气持续时间。材料与方法 本前瞻性多机构符合HIPAA规定的研究获得了机构审查委员会的批准;所有受试者均签署了书面知情同意书。在三个研究地点,共有44名志愿者接受了磁共振(MR)成像检查,在单次检查中,以随机顺序分别静脉推注钆塞酸二钠、生理盐水和钆喷酸葡胺,然后在注射前和动态注射后采集图像。技术人员和志愿者对注射药物均不知情。每次注射后记录动脉期屏气持续时间,志愿者报告主观症状。监测心率(HR)和血氧饱和度。由三名放射科医生独立分析图像的运动伪影。使用Mann-Whitney U检验和McNemar检验比较每种药物注射后的动脉期屏气持续时间和运动伪影。采用单变量、多变量模型评估影响上述结果 的因素。结果 钆塞酸二钠注射后的动脉期屏气时间(平均32秒±19)短于生理盐水注射后(平均40秒±17;P <.001)或钆喷酸葡胺注射后(43秒±21,P <.001)。在80%(44例中的35例)的受试者中,钆塞酸二钠注射后的动脉期屏气时间短于生理盐水和钆喷酸葡胺注射后。44名志愿者中有3名(7%)在注射钆塞酸二钠后出现严重的动脉期运动伪影,1名(2%;P = .62)在注射钆喷酸葡胺后出现运动伪影,生理盐水注射后无志愿者出现运动伪影(P = .25)。HR和血氧饱和度变化与造影剂无显著相关性。结论 健康志愿者注射钆塞酸二钠后,最大肝动脉期屏气持续时间缩短,屏气持续时间缩短与运动伪影相关。RSNA,2016年。

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