钆特酸葡胺注射液在新生儿和2岁以下婴幼儿MRI增强检查中急性不良反应观察

背景 迄今为止，在中国缺乏大量关于新生儿和2岁以下婴幼儿在常规磁共振检查中使用钆对比剂的安全性证据。目的 通过非干预观察方法评估钆特酸葡胺注射液在新生儿和2岁以下婴幼儿常规磁共振检查中的急性不良反应的发生率。方法 7家中心共纳入360例新生儿和2岁以下婴幼儿，对符合入组标准的患者进行安全性评价,统计分析使用SAS 9.4完成。结果 360例患者年龄范围为2天～24个月(平均年龄为8.2个月±7.187)，均接受了一次钆特酸葡胺注射(平均注射量为1.578ml±0.7069)。仅发生1例次不良事件,表现为轻度呕吐，未采取措施患儿自行缓解，与研究药物可能无关，不良事件发生率为0.28%。结论 本研究涉及新生儿和2岁以下婴幼儿使用钆特酸葡胺进行磁共振增强检查是相对安全的，可在临床中推广应用。

Evaluation of gadoterate meglumine immediate adverse adverse events/reactions in newborn and infants younger than two years old

Objective To investigate immediate adverse reactions of gadoterate meglumine during routine clinical utilization in pediatric patients younger than 2 years by non-interventional observation study. Methods A total of?360 neonates and infants were enrolled in?7 centers. Gd-DOTA was injected intravenously at the dosage of 0.2 ml / kg, and then washed with the same amount of saline. One child was administered with Gd-DOTA only once during a single enhance MRI examination, and the interval between two examination was more than 7 days. Safety evaluation was conducted on the patients who met the admission criteria, and statistical analysis was performed using SAS 9.4. Results All included 360 children, ages 2 days to 24 months (a mean age 8.2 months±7.187), received one injection of Gd-DOTA (a mean volume 1.578 ml±0.7069).Only one AE (mild vomiting) that was observed, unlikely related to gadoterate meglumine. Gadoterate meglumine was well tolerated in these children, with low rate?of?adverse events (0.28%) and no SAEs. Conclusion This study confirmed the good safety profile of gadoterate meglumine in routine practice in pediatric patients younger than 2 years and provides more evidence for clinical practice.