The Safety and Effectiveness of Intravenous Contrast-Enhanced Sonography in Chinese Children—A Single Center and Prospective Study in China

作者：Muyi Mao, Bei Xia, Weiling Chen, Xiaojie Gao, Jun Yang, Shoulin Li, Bin Wang, Huirong Mai, Sixi Liu, Feiqiu Wen, Yungen Gan, Jianming Song, Hong Wei, Weiguo Yang, Yuhui Wu, Shufang Yang, Wei Yu, Hong-kui Yu, Shu-min Fan, Hongwei Tao, Xia Feng, Lin Zhou, Lei Liu · 发表于：Frontiers in Pharmacology · 年份：2019 · DOI：10.3389/fphar.2019.01447 · 被引用次数：36 · 研究领域：Pediatric Urology and Nephrology Studies、Abdominal Trauma and Injuries、Liver Disease and Transplantation

Background and Objective: Intravenous contrast-enhanced ultrasound (CEUS), using the second-generation ultrasound contrast agent SonoVue®, has been widely used in adults. In 2016, it was approved for pediatric applications by the American Food and Drug Administration (FDA). However, it has not been approved by the Chinese Food and Drug Administration (CFDA). The objective of the study was to evaluate the safety and effectiveness of CEUS in children prospectively at a single center in China. Method: A total of 312 cases of Chinese children were enrolled in clinical trials. Contrast agent was given intravenously with two different doses, including 2.4ml/time and 0.03ml/kg. All CEUS was performed for evaluating adverse effect and the diagnostic accuracy compared with the pathology and enhanced CT. Result: (1) All 312 subjects underwent CEUS successfully. The dose of contrast agent for CEUS was 2.4mL between November 2015 and June 2016, which was modified to 0.03ml/kg between July 2016 and April 2019, according to the recommendation of the FDA. (2) With the two different doses of the contrast agent, the heart rate, respiration rate, oxygen saturation and blood pressure of the participants had no statistically significant difference (P>0.05) before and after administration. The blood pressure had been significantly decreased in participants who received combined anesthetic administration. (3) Following 600 intravenous injections of the CEUS, there were 3 cases of transient rash an...