Bisset G S, Emery K H, Meza M P, Rollins N K, Don S, Shorr J S
Department of Radiology, Duke University Medical Center, Box 3808, Durham, NC 27710, USA.
Pediatr Radiol. 1996;26(6):409-15. doi: 10.1007/BF01387316.
To evaluate the safety and efficacy of orally administered perflubron for bowel recognition on MR imaging in a pediatric population.
A multicenter trial evaluated 39 pediatric subjects before and after ingestion of perflubron with T1-, proton-density, and T2-weighted sequences through the abdomen and/or pelvis. Post-contrast images were compared with pre-contrast images. Safety was evaluated through assessment of adverse events, clinical laboratory parameters, and vital signs.
With regard to efficacy analysis, improvement in the percent of bowel darkened was observed for 85 % of the subjects on T1-weighted images and for 95 % of the subjects on proton-density and T2-weighted images. For images of the abdominal region, the percent of bowel darkened was improved for 90-92 % of the subjects across pulse sequences. Improvement rates for the images of the pelvic region ranged from 71 % to 100 %. For at least 75 % of the subjects, proton-density and T2-weighted images of the body and tail of the pancreas, left lobe of the liver, mesenteric fat, and pathological tissue were improved relative to predosing images. Twenty-three percent of the subjects experienced some adverse effects, most of which were minor and related to the digestive system. Clinical laboratory and vital sign evaluations revealed no trends associated with the administration of perflubron.
Perflubron is a relatively safe and effective gastrointestinal MR contrast agent in the pediatric population.
评估口服全氟溴烷用于儿科人群磁共振成像肠道显影的安全性和有效性。
一项多中心试验对39名儿科受试者在摄入全氟溴烷前后进行了评估，通过腹部和/或骨盆的T1加权、质子密度加权和T2加权序列成像。将增强后图像与增强前图像进行比较。通过评估不良事件、临床实验室参数和生命体征来评估安全性。
在疗效分析方面，85%的受试者在T1加权图像上肠道变黑百分比有所改善，95%的受试者在质子密度加权和T2加权图像上肠道变黑百分比有所改善。对于腹部区域的图像，90%至92%的受试者在各个脉冲序列上肠道变黑百分比均有改善。盆腔区域图像的改善率在71%至100%之间。对于至少75%的受试者，胰腺体尾部、肝脏左叶、肠系膜脂肪和病理组织的质子密度加权和T2加权图像相对于给药前图像有所改善。23%的受试者出现了一些不良反应，其中大多数较为轻微且与消化系统有关。临床实验室和生命体征评估未发现与全氟溴烷给药相关的趋势。
全氟溴烷在儿科人群中是一种相对安全有效的胃肠道磁共振造影剂。
