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

为了评价钆对比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。通过标准方法透析Gd-DTPA和Gd-HP-DO 3A溶液。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名透析患者接受了正常剂量的造影剂注射，然后进行了常规血液透析（HD）。8例患者使用PMMA透析膜，3例患者使用醋酸纤维素膜。分别于第1次透析前、第2次透析后、第3次透析后、第4次透析后检测血清钆、尿素氮、肌酐水平，观察不良反应及水肿情况。体外研究表明，通过使用透析时间的一级动力学模型，需要11.1小时的透析才能清除97%的造影剂注射剂量。当比较透析膜和造影剂时，透析膜和所有造影剂之间存在统计学显著差异。在临床研究中，第一次透析后79.1%的造影剂被透析，第四次透析后99.6%的造影剂被透析。这些结果表明，所有造影剂和两种透析膜均适用。未观察到实验室参数变化或副作用。因此，本研究表明，即使对于透析患者，使用普通剂量的造影剂也没有禁忌症。

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.