钆特酸葡胺注射液在新生儿和2岁以下婴幼儿磁共振成像增强检查中急性不良事件/反应观察  

Acute adverse events/reactions of gadoterate meglumine injection in contrast-enhanced magnetic resonance imaging of newborns and infants under 2 years old

作　　者：李欣[1] 夏黎明[2] 金科[3] 彭雪华 丁山[5] 王强[6] 易文中[7] LI Xin;XIA Li-ming;JIN Ke;PENG Xue-hua;DING Shan;WANG Qiang;YI Wen-zhong(Department of Radiology,Tianjin Children’s Hospital,Tianjin 300074,China;Department of Radiology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,Hubei,China;Department of Radiology,Hunan Children’s Hospital,Changsha 410007,Hunan,China;Department of Radiology,Wuhan Children’s Hospital,Wuhan 430015,Hubei,China;Department of Radiology,Jiangxi Provincial Children’s Hospital,Nanchang 330006,Jiangxi,China;Department of Radiology,Quanzhou Children’s Hospital,Quanzhou 362000,Fujian,China;Department of Radiology,the First People’s Hospital of Huaihua,Huaihua 418000,Hunan,China)

机构地区：[1]天津市儿童医院放射科,天津300074 [2]华中科技大学同济医学院附属同济医院放射科,武汉430030 [3]湖南省儿童医院放射科,长沙410007 [4]武汉市儿童医院放射科,武汉430015 [5]江西省儿童医院放射科,南昌330006 [6]泉州市儿童医院放射科,泉州362000 [7]怀化市第一人民医院放射科,怀化418000

出　　处：《第二军医大学学报》2021年第12期1434-1437,共4页Academic Journal of Second Military Medical University

摘　　要：目的评估钆特酸葡胺注射液在新生儿和2岁以下婴幼儿常规MRI增强检查中的安全性。方法本研究为前瞻性、多中心、非干预性观察研究。全国7个中心共纳入拟接受钆特酸葡胺对比剂注射后进行MRI增强检查的新生儿及2岁以下婴幼儿360例,通过静脉注射钆特酸葡胺,用量为0.2 mL/kg,注射后用等量生理盐水冲洗。1次MRI增强检查仅给药1次,不重复给药,2次给药间隔7 d以上。分析新生儿和2岁以下婴幼儿注射钆特酸葡胺后急性不良事件/反应的发生率。结果360例患儿年龄为2 d~24个月,平均年龄为(8.20±7.19)个月,中位年龄为6.00个月,均接受1次钆特酸葡胺注射,平均注射剂量为(1.59±0.71)mL。仅1例(0.28%,1/360)患儿发生急性不良事件,表现为轻度呕吐,研究者认为此不良事件与研究药物钆特酸葡胺可能无关,未采取措施,患儿自行缓解;无一例发生与治疗相关的严重急性不良事件/反应以及导致脱落的治疗相关急性不良事件/反应。结论新生儿和2岁以下婴幼儿进行MRI增强检查前接受对比剂钆特酸葡胺注射是相对安全的,可在临床中推广应用。Objective To evaluate the safety of gadoterate meglumine injection in routine contrast-enhanced magnetic resonance imaging(MRI)of newborns and infants under 2 years old.Methods It was a prospective,multicenter and non-intervention observational study.A total of 360 newborns and infants under 2 years old who were to receive contrastenhanced MRI after gadoterate meglumine injection were enrolled from 7 centers in China.Gadoterate meglumine was injected intravenously at the dose of 0.2 mL/kg,and then washed with the same dose of physiological saline.Each child was administered with gadoterate meglumine only once during each contrast-enhance MRI,and the interval between 2 administrations was more than 7 d.The incidence of acute adverse events/reactions was analyzed after gadoterate meglumine injection in newborns and infants under 2 years old.Results The age of the 360 children ranged from 2 d to 24 months,with an average age of(8.20±7.19)months and a median age of 6.00 months.They all received 1 injection of gadoterate meglumine,with an average injection dose of(1.59±0.71)mL.Only 1 child(0.28%,1/360)had an acute adverse event,presenting as mild vomiting,which was considered to be unrelated to gadoterate meglumine.No measures were taken,and the patient was relieved spontaneously.No treatment-related serious acute adverse events/reactions occurred.Conclusion It is safe for newborns and infants under 2 years old to receive contrast agent gadoterate meglumine injection before contrastenhanced MRI,and it can be popularized in clinic.

关 键 词：钆特酸葡胺 磁共振成像 新生儿 婴幼儿 安全性 

分 类 号：R445.2[医药卫生—影像医学与核医学] R72[医药卫生—诊断学]