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钆双胺注射液在严重肾功能不全患者以及接受血液透析或持续性非卧床腹膜透析患者中的药代动力学。

Pharmacokinetics of gadodiamide injection in patients with severe renal insufficiency and patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis.

作者信息

Joffe P, Thomsen H S, Meusel M

机构信息

Department of Nephrology, Copenhagen University Hospital at Herlev, Denmark.

出版信息

Acad Radiol. 1998 Jul;5(7):491-502. doi: 10.1016/s1076-6332(98)80191-8.

Abstract

RATIONALE AND OBJECTIVES

The authors performed this study to evaluate the pharmacokinetics, dialysability, and safety of gadodiamide injection in patients with severely reduced renal function not treated with renal replacement therapy and patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis.

MATERIALS AND METHODS

Twenty-seven patients--nine with severely reduced renal function (glomerular filtration rate, 2-10 mL/min), nine undergoing hemodialysis, and nine undergoing continuous ambulatory peritoneal dialysis--were followed up for 5, 8, and 22 days, respectively, after receiving gadodiamide injection (0.1 mmol per kilogram body weight).

RESULTS

Gadodiamide injection caused no changes in renal function. In patients with severely reduced renal function, the elimination half-life of gadodiamide injection was prolonged (34.3 hours +/- 22.9) compared with data in healthy volunteers (1.3 hours +/- 0.25). An average of 65% of the gadodiamide injected was eliminated during a hemodialysis session. After 22 days of continuous ambulatory peritoneal dialysis, 69% of the total amount of gadodiamide was excreted; this reflects the low peritoneal clearance. In all patients, no metabolism or transmetallation of gadodiamide was found. There were no contrast material-related adverse events.

CONCLUSION

Gadodiamide is dialysable and can safely be used in patients with severely impaired renal function or those undergoing hemodialysis or continuous ambulatory peritoneal dialysis. No precautions to increase the elimination are necessary.

摘要

原理与目的

作者开展本研究以评估钆双胺注射液在未接受肾脏替代治疗的严重肾功能减退患者以及接受血液透析或持续性非卧床腹膜透析患者中的药代动力学、透析性及安全性。

材料与方法

27例患者——9例严重肾功能减退(肾小球滤过率为2 - 10 mL/分钟),9例接受血液透析,9例接受持续性非卧床腹膜透析——在接受钆双胺注射液(每千克体重0.1 mmol)后分别随访5天、8天和22天。

结果

钆双胺注射液未引起肾功能改变。在严重肾功能减退患者中,钆双胺注射液的消除半衰期较健康志愿者数据(1.3小时±0.25)延长(34.3小时±22.9)。血液透析一次期间平均消除65%注入的钆双胺。持续性非卧床腹膜透析22天后,钆双胺总量的69%被排出;这反映了腹膜清除率较低。在所有患者中,未发现钆双胺的代谢或金属转移。未发生与造影剂相关的不良事件。

结论

钆双胺可透析,可安全用于严重肾功能受损患者或接受血液透析或持续性非卧床腹膜透析的患者。无需采取增加消除的预防措施。

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