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.

为了评价钆造影剂在血液透析患者中的安全性和药代动力学，进行了体外和临床研究。采用标准方法对Gd-DTPA和Gd-HP-DO3A溶液进行透析。使用了一种经典类型（醋酸纤维素）和两种高性能类型（PMMA和聚丙烯腈）。11例透析患者在常规血液透析（HD）后进行正常剂量对比剂注射。PMMA透析膜8例，醋酸纤维素透析膜3例。分析第1次HD前后、第2次、第3次、第4次HD前后血清钆、BUN、creatinin水平。观察不良反应及水肿情况。体外研究表明，使用透析时间的一级动力学模型，需要11.1小时的透析才能去除97%的注射剂量的造影剂。当透析膜和造影剂比较时，透析膜和所有造影剂之间的差异有统计学意义。在临床研究中，对比剂在第一次透析后析出率为79.1%，在第4次透析后析出率为99.6%。这些结果表明，所有对比剂和两种透析膜都是合适的。没有观察到实验室参数的变化和副作用。因此，目前的研究表明，即使在透析患者中使用普通剂量的造影剂也没有禁忌症。