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| 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 |
| 李欣1*,夏黎明2,金科3,彭雪华4,丁山5,王强6,易文中7 |
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(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
*通信作者) |
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| 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。 |
| 关键词: 钆特酸葡胺 磁共振成像 新生儿 婴幼儿 安全性 |
| DOI：10.16781/j.0258-879x.2021.12.1434 |
| 投稿时间：2020-03-12 |
| 基金项目: |
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| Acute adverse events/reactions of gadoterate meglumine injection in contrast-enhanced magnetic resonance imaging of newborns and infants under 2 years old |
| LI Xin1*,XIA Li-ming2,JIN Ke3,PENG Xue-hua4,DING Shan5,WANG Qiang6,YI Wen-zhong7 |
(1. Department of Radiology, Tianjin Children's Hospital, Tianjin 300074, China;
2. Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China;
3. Department of Radiology, Hunan Children's Hospital, Changsha 410007, Hunan, China;
4. Department of Radiology, Wuhan Children's Hospital, Wuhan 430015, Hubei, China;
5. Department of Radiology, Jiangxi Provincial Children's Hospital, Nanchang 330006, Jiangxi, China;
6. Department of Radiology, Quanzhou Children's Hospital, Quanzhou 362000, Fujian, China;
7. Department of Radiology, the First People's Hospital of Huaihua, Huaihua 418000, Hunan, China
*Corresponding author) |
| Abstract: |
| 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 contrast-enhanced 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 contrast-enhanced MRI, and it can be popularized in clinic. |
| Key words: gadoterate meglumine magnetic resonance imaging newborns infants safety |
