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钆喷酸葡胺给药后的血清铁和血清胆红素。一项针对健康志愿者的药理学研究。

Serum iron and serum bilirubin after administration of Gd-DTPA-dimeglumine. A pharmacologic study in healthy volunteers.

作者信息

Niendorf H P, Seifert W

机构信息

D Radiologie II, Pharma Entwicklung, Schering AG, Berlin/Bergkamen, West Germany.

出版信息

Invest Radiol. 1988 Sep;23 Suppl 1:S275-80. doi: 10.1097/00004424-198809001-00060.

Abstract

Gadolinium (Gd)-DTPA-dimeglumine is an extracellular contrast agent (0.5 mol/L) for magnetic resonance imaging. At a dose of 0.1 mmol/kg body weight occasional slight transient elevations of serum iron and bilirubin were observed. To verify these findings, to determine time course, and to assess probability of drug relationship, a single-blind, randomized cross-over study in 12 healthy male volunteers was conducted. Either 0.25 mmol Gd-DTPA/kg body weight or the corresponding volume control 0.5 ml 0.9% saline/kg body weight were injected intravenously with an interval of one week. No relevant clinical side effects were reported or observed. Differences between the two treatments were found for serum iron, total bilirubin, and indirect bilirubin. An increase of serum iron and total bilirubin is observed at 3 to 4 hours postinjection, with a maximum at 6 to 12 hours. At 24 hours after injection all values were back to baseline range. This is a predictable side effect of no recognizable clinical consequence. The unchanged values of the intraerythrocytic enzymes and of haptoglobin indicate the minor nature of this phenomenon. Current experiences with the clinical application of Gd-DTPA at a dose of 0.1 mmol/kg body weight suggest that serum iron and bilirubin increases with that dose are less frequent and less marked than increases shown in this study at a dose of 0.25 mmol/kg body weight.

摘要

钆(Gd)-二乙三胺五乙酸双葡甲胺是一种用于磁共振成像的细胞外造影剂(0.5摩尔/升)。在剂量为0.1毫摩尔/千克体重时,偶尔观察到血清铁和胆红素出现轻微短暂升高。为了验证这些发现、确定时间进程并评估药物相关性的可能性,对12名健康男性志愿者进行了一项单盲、随机交叉研究。静脉注射0.25毫摩尔钆-二乙三胺五乙酸/千克体重或相应体积对照0.5毫升0.9%生理盐水/千克体重,间隔一周。未报告或观察到相关临床副作用。两种治疗方法在血清铁、总胆红素和间接胆红素方面存在差异。注射后3至4小时观察到血清铁和总胆红素升高,6至12小时达到峰值。注射后24小时所有值均恢复到基线范围。这是一种可预测的副作用,没有可识别的临床后果。红细胞内酶和触珠蛋白的值未改变表明该现象的性质较轻。目前以0.1毫摩尔/千克体重剂量临床应用钆-二乙三胺五乙酸的经验表明,与本研究中0.25毫摩尔/千克体重剂量相比,该剂量下血清铁和胆红素升高的频率较低且程度较轻。

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