Shang Yongning, Xie Xiaoyan, Luo Yan, Nie Fang, Luo Yukun, Jing Xiang, Liao Jintang, Zheng Rongqin, Wu Rong, Luo Xiaomao, Chen Zhiyi, Xu Youfeng, Zhang Ruifang, Wang Hui, Yuan Jianjun, Zhang Hongxia, Zhu Jiaan, Zhang Wei, Ruan Litao, Yang Min, Li Zhiyan, Luo Hong, Chen Qin, Yan Jiping, Tang Chunlin, Liu Deng, Fang Kejing, Guo Yanli, He Wen
Department of Ultrasound, Southwest Hospital, Army Medical University (Third Military Medical University), Chongqing, 400038, China.
Department of Medical Ultrasonics, Division of Interventional Ultrasound, Institute for the Study of Diagnostic and Interventional Ultrasound, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Eur Radiol. 2023 Feb;33(2):988-995. doi: 10.1007/s00330-022-09108-4. Epub 2022 Oct 7.
We aimed to evaluate the safety of the ultrasound contrast agent sulfur hexafluoride microbubbles in a large group of patients referred for routine contrast-enhanced ultrasound (CEUS).
A retrospective assessment was made of all patients that received sulfur hexafluoride microbubbles intravenously for CEUS at 24 centers between January 2006 and April 2019. Patient demographic details, examination type, and the dose of sulfur hexafluoride microbubbles administered were recorded with specific adverse events (AEs) documentation tools at each center. All AEs were recorded as serious or non-serious. Non-serious AEs were classified by intensity as mild, moderate, or severe according to ACR criteria. The frequencies of AEs across patient subgroups were compared using the chi-square test.
A total of 463,434 examinations were evaluated. Overall, 157 AEs (153 [0.033%] non-serious; 4 [0.001%] serious) were reported after sulfur hexafluoride microbubbles administration, giving an AE frequency of 0.034% (157/463,434). Among the non-serious AEs, 66 (0.014%) were mild, 70 (0.015%) moderate, and 17 (0.004%) severe in intensity. The liver was the most common examination site, presenting an AE frequency of 0.026%. The highest AE frequency (0.092%) was for patients undergoing CEUS for vascular disease. There were no significant gender differences in either the total number or the severity of non-serious AEs (chi-square = 2.497, p = 0.287). The onset of AEs occurred within 30 min of sulfur hexafluoride microbubbles administration in 91% of cases.
The frequency of AEs to sulfur hexafluoride microbubbles is very low and severe reactions are rare, confirming that sulfur hexafluoride microbubbles are appropriate for routine CEUS applications.
• The frequency of AEs to sulfur hexafluoride microbubbles is very low and severe reactions are rare.
我们旨在评估超声造影剂六氟化硫微泡在一大组接受常规超声造影（CEUS）检查的患者中的安全性。
对2006年1月至2019年4月期间在24个中心接受静脉注射六氟化硫微泡进行CEUS检查的所有患者进行回顾性评估。各中心使用特定的不良事件（AE）记录工具记录患者的人口统计学详细信息、检查类型以及六氟化硫微泡的给药剂量。所有AE均记录为严重或非严重。根据美国放射学会（ACR）标准，非严重AE按强度分为轻度、中度或重度。使用卡方检验比较各患者亚组中AE的发生频率。
共评估了463,434次检查。总体而言，在注射六氟化硫微泡后报告了157例AE（153例[0.033%]非严重；4例[0.001%]严重），AE发生率为0.034%（157/463,434）。在非严重AE中，66例（0.014%）为轻度，70例（0.015%）为中度，17例（0.004%）为重度。肝脏是最常见的检查部位，AE发生率为0.026%。接受血管疾病CEUS检查的患者AE发生率最高（0.092%）。非严重AE的总数或严重程度在性别上均无显著差异（卡方 = 2.497，p = 0.287）。91%的AE在注射六氟化硫微泡后30分钟内发生。
六氟化硫微泡的AE发生率非常低，严重反应罕见，证实六氟化硫微泡适用于常规CEUS检查。
• 六氟化硫微泡的AE发生率非常低，严重反应罕见。
