Onishi Hiromitsu, Murakami Takamichi, Kim Tonsok, Hori Masatoshi, Hirohashi Shinji, Matsuki Mitsuru, Narumi Yoshifumi, Imai Yasuharu, Sakurai Kousuke, Nakamura Hironobu
Department of Radiology, Osaka University Graduate School of Medicine, Osaka, Japan.
J Magn Reson Imaging. 2009 Jan;29(1):106-11. doi: 10.1002/jmri.21608.
To prospectively investigate, by means of a pre-and postexamination questionnaire, the types and frequency of adverse reactions to ferucarbotran (Resovist), a superparamagnetic iron oxide (SPIO) contrast agent.
This study was approved by the ethics committee of each of the institutions involved, and all patients gave written informed consent. One questionnaire asking about baseline symptoms before the injection of ferucarbotran, and one about adverse events over a period of seven days after injection were given to 315 patients who underwent ferucarbotran-enhanced magnetic resonance imaging (MRI) of the liver at several institutions. The data for baseline symptoms were used for reference to exclude false-positive adverse reactions and were also compared with the adverse event data to determine with McNemar's chi-squared test the incidence of each symptom.
Before MR examination, 249 clinical symptoms were reported by 102 of 315 patients (32.4%). After the injection of ferucarbotran, 169 adverse events were observed in 78 patients (24.8%). Eventually, 70 adverse events occurring in 45 patients (14.3%) were judged to be adverse reactions to ferucarbotran, defined as possibly or definitely ferucarbotran-related events. All reactions were of mild intensity.
Ferucarbotran can be considered safe for clinical use in liver MRI.
通过注射前和注射后的调查问卷，前瞻性地调查超顺磁性氧化铁（SPIO）造影剂 ferucarbotran（Resovist）不良反应的类型和发生率。
本研究经各参与机构的伦理委员会批准，所有患者均签署了书面知情同意书。向在多家机构接受 ferucarbotran 增强肝脏磁共振成像（MRI）检查的 315 例患者发放了两份调查问卷，一份询问注射 ferucarbotran 前的基线症状，另一份询问注射后七天内的不良事件。基线症状数据用于排除假阳性不良反应，并与不良事件数据进行比较，以通过 McNemar 卡方检验确定每种症状的发生率。
在 MR 检查前，315 例患者中有 102 例（32.4%）报告了 249 种临床症状。注射 ferucarbotran 后，78 例患者（24.8%）出现了 169 起不良事件。最终，45 例患者（14.3%）出现的 70 起不良事件被判定为对 ferucarbotran 的不良反应，定义为可能或肯定与 ferucarbotran 相关的事件。所有反应均为轻度。
Ferucarbotran 可被认为在肝脏 MRI 临床应用中是安全的。
