Clinical and experimental studies on the safety of gadolinium contrast agents in renal failure patient.

钆造影剂对肾功能衰竭患者安全性的临床和实验研究。

• 批准号: 09670961
• 负责人: OKADA Susumu
• 金额: $ 1.98万
• 依托单位: Nippon Medical School
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (C)
• 财政年份: 1997
• 资助国家: 日本
• 起止时间: 1997 至 1998
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-09670961/
• 关键词: MRI; contrast medium; gadolinium; renal failure; hemodialysis; ガドリニウム造影剤

In order to evaluate the safety and pharmacokinetics of gadolinium contrast agents in patients with hemodialysis, in vitro and clinical studies were performed. Gd-DTPA and Gd-HP-DO3A solutions were dialysed by standard methods. One classic type (cellulose acetate) and two high-performance types (PMMA and polyacrylonitrile) were used. Eleven dialysis patients underwent normal dose contrast injection followed by usual hemodialysis (HD). PMMA dialysis membranes were used for 8 patients and cellulose acetate membranes for 3 patients. Serum level of gadolinium, BUN and creatinin were analyzed before and after the 1st HD, after the 2nd, 3rd and 4th HD.Side effect and edema were carefully observed. In vitro studies showed that 11.1 hours of dialysis would be necessary to remove 97% of the injected dose of contrast agent by using a first-order kinetic model of dialysis time. When dialysis membranes and contrast agents were compared, statistically significant differences were noted between dialysis membrane and all contrast agents. In the clinical study, 79.1% of the contrast agent was dialyzed after the 1st dialysis and 99.6% after the 4th dialysis. These results showed that all contrast agents and both dialysis membranes were suitable. Neither changes in laboratory parameters nor side effects were observed. The present study suggests, consequently, there are no contraindications when using the ordinary dose of contrast agent even in patients with dialysis.

为了评估血液透析患者的g adolin对比剂的安全性和药代动力学，体外和临床研究。 GD-DTPA和GD-HP-DO3A溶液通过标准方法透析。使用了一种经典类型（乙酸纤维素）和两种高性能类型（PMMA和聚丙烯硝基烯）。 11例透析患者接受了正常的剂量对比注射，然后进行了通常的血液透析（HD）。 PMMA透析膜用于8例患者，乙酸纤维素膜用于3例患者。在第1，第三，第三和第4个HD效应和水肿之后，对gadolinium，bun和肌蛋白的血清水平进行了分析。体外研究表明，通过使用透析时间的一阶动力学模型去除97％注射剂量的对比剂的透析需要11.1小时的透析。当比较透析膜和对比剂时，透析膜和所有对比剂之间会发现统计学上的显着差异。在临床研究中，在第1次透析后，将79.1％的对比剂透析，第四透析后99.6％。这些结果表明，所有对比剂和两个透析膜都是合适的。没有观察到实验室参数的变化和副作用。因此，本研究表明，即使在透析患者中​​，也没有使用造影剂的普通剂量时，也没有禁忌症。