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首页> 外文期刊>Acta Radiologica >Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children
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Safety of gadobutrol: results of a non-interventional study of 3710 patients, including 404 children

机译：加巴福酚的安全性：3710名患者的非介入研究结果，包括404名儿童

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Background The safety of gadolinium-based contrast agents is a hot topic in radiology. Purpose To evaluate the safety profile of gadobutrol during routine use. Material and Methods Prospective, non-interventional study in 80 centers in Germany. The primary outcome was the number of adverse drug reactions (ADR) following gadobutrol administration. Results A total of 3710 patients were included in the analysis, including 404 children (10.9%). A total of 6026 magnetic resonance imaging examinations of organs/organ systems and 872 magnetic resonance angiography examinations were performed. A total of 22 (0.59%) patients experienced at least one ADR. Nausea and vomiting were the most frequent ADRs, experienced by nine (0.24%) and three (0.08%) patients, respectively. One serious ADR was recorded (anaphylactoid reaction). No deaths were reported. Conclusion This non-interventional study in 3710 patients confirmed gadobutrol as a safe and reliable contrast agent in adults and children.
机译：背景技术基于钆的造影剂的安全性是放射学中的热门话题。 目的在常规使用过程中评估加巴福洛尔的安全性曲线。 德国80个中心的材料与方法预期，非介入研究。 初级结果是加巴福酚给药后不利药物反应（ADR）的数量。 结果分析中共有3710名患者，包括404名儿童（10.9％）。 共进行总共6026个磁共振成像检查器官/器官系统和872个磁共振血管造影检查。 共22例（0.59％）患者至少经历了至少一个ADR。 恶心和呕吐是最常见的ADR，分别经历了9（0.24％）和三（0.08％）患者。 记录一个严重的ADR（过敏反应）。 没有报告死亡。 结论3710例患者的这种非介入性研究证实了Gadobutrol作为成人和儿童安全可靠的造影剂。

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