1 Department of Radiological Sciences, MS 220, St. Jude Children's Research Hospital, 262 Danny Thomas Pl, Memphis, TN 38105.
AJR Am J Roentgenol. 2014 May;202(5):966-70. doi: 10.2214/AJR.13.12010.
Little information is available regarding the safety of ultrasound contrast agents in children. The purpose of this article was to assess the safety profile of the i.v. administration of ultrasound contrast agents in the pediatric oncology population.
Patients with pediatric solid malignancies who were enrolled on institutional clinical trials conducted between June 2003 and January 2013 and who met our institutional screening criteria for contrast-enhanced ultrasound (CEUS) were eligible. After providing informed consent or assent for CEUS, subjects received i.v. bolus injections of one of two contrast agents for imaging of the primary tumor or a metastatic target lesion. Hemodynamic parameters, including heart rate, cardiac rhythm, and oxygen saturation, were monitored immediately before and for 30 minutes after the administration of the contrast agent. Interviews with the subject or a guardian were conducted by the principal investigator or a radiologist coinvestigator before and after the examination to assess for any adverse effects.
Thirty-four subjects (21 male and 13 female) ranging in age from 8 months to 20.7 years (median, 8.7 years) underwent 134 CEUS. No detrimental change in hemodynamic status occurred in any subject. Three subjects (3/134, 2.2%) reported mild transient side effects on one occasion each, two (2/134, 1.5%) had taste alteration, and one (1/134, 0.8%) reported mild transient tinnitus and lightheadedness. These reactions did not recur in these subjects on subsequent CEUS examinations.
The i.v. administration of ultrasound contrast agents is safe and well tolerated in the pediatric oncology population. Further studies in children are needed to confirm our findings.
关于超声造影剂在儿童中的安全性信息有限。本文旨在评估静脉内给予超声造影剂在儿科肿瘤患者中的安全性概况。
符合机构临床试验入选标准(2003 年 6 月至 2013 年 1 月进行,且符合机构筛选标准用于超声造影(CEUS))且患有儿科实体恶性肿瘤的患者有资格入选。在对 CEUS 提供知情同意或同意后,患者接受两种造影剂之一的静脉推注,用于原发性肿瘤或转移性靶病变的成像。在给予造影剂之前和之后的 30 分钟内,监测包括心率、心律和氧饱和度在内的血液动力学参数。在检查之前和之后,由首席研究员或放射科研究员对受试者或监护人进行访谈,以评估是否存在任何不良影响。
34 名年龄在 8 个月至 20.7 岁(中位数 8.7 岁)的患者进行了 134 次 CEUS。任何患者的血液动力学状态均未发生有害变化。3 名受试者(3/134,2.2%)各报告 1 次轻度短暂的不良反应,2 名(2/134,1.5%)味觉改变,1 名(1/134,0.8%)报告轻度短暂耳鸣和头晕。这些反应在随后的 CEUS 检查中未在这些患者中再次发生。
静脉内给予超声造影剂在儿科肿瘤患者中是安全且耐受良好的。需要在儿童中进一步研究以确认我们的发现。