Department of Radiology, University of Alabama at Birmingham, 619 19th St S, JT N322, Birmingham, AL 35233, USA.
Radiology. 2011 Apr;259(1):109-16. doi: 10.1148/radiol.10100906. Epub 2011 Jan 19.
To determine adverse reaction rates in a tertiary care clinical setting after adoption of gadoteridol as the institutional routine magnetic resonance (MR) imaging contrast agent.
With institutional review board approval, informed consent waiver, and HIPAA compliance, a prospective observational study of 28 078 patients who underwent intravenous gadoteridol-enhanced MR imaging from July 2007 to December 2009 was performed. Reactions were recorded by technologists who noted types of reactions, method of injection, and treatment. Reactions were classified as mild, moderate, or severe per American College of Radiology definitions. Comparisons of reaction rates with dose and method of injection were analyzed with the Fisher exact and χ(2) tests.
Overall reaction rate was 0.666% (187 patients), including 177 mild, six moderate, and four severe reactions. Treatment was given in 27 patients (14.4%). The most frequent reaction was nausea (and/or vomiting) in 149 patients (79.7% of patients with any adverse reaction, 0.530% of overall population). Method of injection did not affect reaction rate or severity. There was no difference in type or severity of reactions in comparison of patients receiving half the dose versus patients receiving the standard dose (P = .33-.75).
The observed adverse reaction rate to gadoteridol was lower than previously reported. Specifically, the rate of nausea (0.530%) was less than half the rate (1.4%) in clinical trials of 1251 patients, leading to FDA approval in 1992. Rates of adverse reactions for this macrocyclic contrast agent are comparable to those published for linear gadolinium-based contrast agents.
在采用钆特醇作为机构常规磁共振（MR）成像造影剂后，确定三级护理临床环境中的不良反应发生率。
在机构审查委员会批准、知情同意豁免和 HIPAA 合规的情况下，对 2007 年 7 月至 2009 年 12 月间 28078 例接受静脉内钆特醇增强磁共振成像的患者进行了前瞻性观察性研究。技术员记录不良反应类型、注射方法和治疗方法。根据美国放射学院的定义，将不良反应分为轻度、中度和重度。用 Fisher 确切检验和 χ(2)检验分析反应率与剂量和注射方法的关系。
总体不良反应发生率为 0.666%（187 例），包括 177 例轻度、6 例中度和 4 例重度反应。27 例患者（14.4%）接受了治疗。最常见的不良反应是恶心（和/或呕吐），共 149 例（所有不良反应患者的 79.7%，总人口的 0.530%）。注射方法不影响反应率或严重程度。与接受半剂量的患者相比，接受标准剂量的患者的不良反应类型或严重程度没有差异（P =.33-.75）。
观察到的钆特醇不良反应发生率低于先前的报告。具体而言，恶心（0.530%）的发生率低于 1992 年 FDA 批准时 1251 例临床试验中报告的 1.4%。这种大环造影剂的不良反应发生率与已发表的线性钆基造影剂相似。
