Radiology Department, CHU Charles Nicolle, Rouen, France.
Pediatr Radiol. 2011 Nov;41(11):1393-400. doi: 10.1007/s00247-011-2164-6. Epub 2011 Jun 29.
It is debated whether iso-osmolar and low-osmolar contrast media are associated with different incidences of contrast medium-induced nephropathy (CIN) in patients with renal insufficiency.
To compare the incidence of CIN in children undergoing contrast-enhanced multidetector computer tomography (MDCT) with intravenous injection of low-osmolar (iobitridol, Xenetix® 300) or an iso-osmolar (iodixanol, Visipaque® 270) iodinated contrast medium.
One hundred forty-six children with normal renal function were included in this multicenter trial and underwent contrast-enhanced MDCT. The primary endpoint was the relative change in creatinine clearance from 48 h pre- to 72 h postcontrast medium administration using a noninferiority analysis in the intent-to-treat (ITT, n = 128) and per protocol (n = 68) populations. Secondary endpoints were incidence of CIN, global image quality, diagnostic efficacy and clinical safety.
In the ITT population, the noninferiority of iobitridol over iodixanol was demonstrated. CIN incidence was 4.8% (three cases) with iobitridol and 10.6% (seven cases) with iodixanol (not significant). No statistically significant differences were observed for the secondary endpoints.
Comparable satisfactory safety profiles were confirmed for both contrast media, with no significant difference in the incidence of CIN in children with normal renal function.
目前对于肾功能不全患者，等渗与低渗对比剂是否会导致不同的对比剂肾病（CIN）发生率仍存在争议。
比较行静脉注射低渗（碘比醇，Xenetix® 300）或等渗（碘克沙醇，Visipaque® 270）碘对比剂的增强多排 CT（MDCT）的儿童患者中 CIN 的发生率。
本多中心试验纳入了 146 例肾功能正常的儿童，并对其行增强 MDCT 检查。主要终点为意向治疗（ITT，n=128）和符合方案（n=68）人群中，48 h 内至对比剂注射后 72 h 内肌酐清除率的相对变化，采用非劣效性分析。次要终点为 CIN 的发生率、整体图像质量、诊断效能和临床安全性。
在 ITT 人群中，碘比醇与碘克沙醇相比非劣效性得到证实。碘比醇组 CIN 的发生率为 4.8%（3 例），碘克沙醇组为 10.6%（7 例）（无统计学差异）。次要终点未观察到统计学差异。
两种对比剂具有可比较的满意安全性，在肾功能正常的儿童中，CIN 的发生率无显著差异。
