Chronic Obstructive Pulmonary Disease: Safety and Tolerability of Hyperpolarized 129Xe MR Imaging in Healthy Volunteers and Patients
Chronic Obstructive Pulmonary Disease: Safety and Tolerability of Hyperpolarized 129Xe MR Imaging in Healthy Volunteers and Patients
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DOI：
10.1148/radiol.11102172
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发表时间：
2012-01-01
期刊：
影响因子：
19.7
通讯作者：
McAdams, H. Page
中科院分区：
文献类型：
--
作者：
Driehuys, Bastiaan;Martinez-Jimenez, Santiago;McAdams, H. Page
目的：为了评估吸入多个1升体积的未稀释的超极化氙129（Xe-129），随后长达16秒的屏气和磁共振（MR）imaging.Materials and Methods的安全性和耐受性：这项研究是由机构审查委员会批准，并符合健康保险及责任法案（HIPAA）。获得了书面知情同意书。入组了44例受试者（19例男性，25例女性;平均年龄46.1岁± 18.8岁[标准差]），包括24例健康志愿者、10例慢性阻塞性肺疾病（COPD）患者和10例年龄匹配的对照受试者。所有受试者接受3或4个1-L体积的未稀释超极化的NTA-129，然后进行屏气MR成像。持续监测血氧饱和度、心率和心律以及血压。在每次给药后评估这些参数，沿着呼吸频率和主观症状。在筛选和24小时随访时记录受试者的血清生化和血液学。在这些时间点以及MRI-129 MR成像前2小时内和成像后1小时内获得12导联心电图（ECG）。使用x 2检验评价氙相关症状与受试者组的关系，使用logistic回归评价氙相关症状与受试者年龄的关系。生命体征的变化进行了测试，通过使用重复测量的多变量方差分析test.Results：44名受试者耐受所有氙吸入的显着性，没有受试者退出，没有严重的不良事件发生。未观察到生命体征的显著变化（P > 0.27），随访时无受试者表现出被认为具有临床意义或需要干预的实验室检查或ECG结果变化。大多数受试者（91%）确实出现了短暂的氙相关症状，最常见的是头晕（59%）、感觉异常（34%）、欣快（30%）和感觉减退（30%）。所有症状均在1.6分钟± 0.9分钟内在无临床干预的情况下消退。结论：吸入超极化的利多卡因-129在健康受试者和轻度或中度COPD患者中耐受性良好。受试者确实会出现轻度、短暂的氙相关症状，与其已知的麻醉特性一致。(C)RSNA，2011年
Purpose: To evaluate the safety and tolerability of inhaling multiple 1-L volumes of undiluted hyperpolarized xenon 129 (Xe-129) followed by up to a 16-second breath hold and magnetic resonance (MR) imaging.Materials and Methods: This study was approved by the institutional review board and was HIPAA compliant. Written informed consent was obtained. Forty-four subjects (19 men, 25 women; mean age, 46.1 years +/- 18.8 [standard deviation]) were enrolled, consisting of 24 healthy volunteers, 10 patients with chronic obstructive pulmonary disease (COPD), and 10 age-matched control subjects. All subjects received three or four 1-L volumes of undiluted hyperpolarized Xe-129, followed by breath-hold MR imaging. Oxygen saturation, heart rate and rhythm, and blood pressure were continuously monitored. These parameters, along with respiratory rate and subjective symptoms, were assessed after each dose. Subjects' serum biochemistry and hematology were recorded at screening and at 24-hour follow-up. A 12-lead electrocardiogram (ECG) was obtained at these times and also within 2 hours prior to and 1 hour after Xe-129 MR imaging. Xenon-related symptoms were evaluated for relationship to subject group by using a x 2 test and to subject age by using logistic regression. Changes in vital signs were tested for significance across subject group and time by using a repeated-measures multivariate analysis of variance test.Results: The 44 subjects tolerated all xenon inhalations, no subjects withdrew, and no serious adverse events occurred. No significant changes in vital signs (P > .27) were observed, and no subjects exhibited changes in laboratory test or ECG results at follow-up that were deemed clinically important or required intervention. Most subjects (91%) did experience transient xenon-related symptoms, most commonly dizziness (59%), paresthesia (34%), euphoria (30%), and hypoesthesia (30%). All symptoms resolved without clinical intervention in 1.6 minutes +/- 0.9.Conclusion: Inhalation of hyperpolarized Xe-129 is well tolerated in healthy subjects and in those with mild or moderate COPD. Subjects do experience mild, transient, xenon-related symptoms, consistent with its known anesthetic properties. (C) RSNA, 2011