Schmiedel E
Department of Clinical Development, Bracco-Byk Gulden GmbH, Konstanz, Germany.
Eur J Radiol. 1994 May;18 Suppl 1:S97-103. doi: 10.1016/0720-048x(94)90102-3.
The recently developed monomeric nonionic contrast medium iomeprol was tested in concentrations of 150, 200, 250, 300, 350, and 400 mgI/ml in open multicentre Phase III studies. The clinical testing was performed in a nonselected patient population (n = 4811); a total of 15,850 injections of the contrast medium was used. All the common radiological methods were used in the study, which was performed in over 150 centres. The contrast density was evaluated as good or satisfactory in 99% of the total patient population. Relevant heat and pain sensations occurred rarely; severe heat and pain were reported only 1.25% and 0.3% of the patients, respectively.
最近研发的单体非离子型造影剂碘美普尔,在开放的多中心III期研究中,以150、200、250、300、350和400mgI/ml的浓度进行了测试。临床试验在未经过挑选的患者群体(n = 4811)中进行;总共使用了15850次造影剂注射。该研究在150多个中心进行,使用了所有常见的放射学方法。在全部患者群体中,99%的患者造影剂密度评估为良好或令人满意。相关的热感和痛感很少发生;分别仅有1.25%和0.3%的患者报告有严重的热感和痛感。