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一项在常规临床实践中对比离子型与非离子型造影剂的前瞻性试验:不良反应比较

A prospective trial of ionic vs nonionic contrast agents in routine clinical practice: comparison of adverse effects.

作者信息

Wolf G L, Arenson R L, Cross A P

机构信息

Department of Radiology, University of Pittsburgh, PA.

出版信息

AJR Am J Roentgenol. 1989 May;152(5):939-44. doi: 10.2214/ajr.152.5.939.

Abstract

A multicenter study of adverse effects of ionic and nonionic contrast agents was conducted in three similar time periods. In 1985, before approval of the nonionic contrast agents by the Food and Drug Administration, 6006 consecutive patients received iv ionic agents for urography or CT. After approval of the nonionic agents, 7170 consecutive patients referred for the same examinations were studied. The two groups of patients were significantly different, but the differences were small and did not uniformly favor either group. The incidence of adverse effects in the patients given ionic contrast material was significantly higher than that of the nonionic group (4.17% vs 0.69%, p less than .001). The reactions were also more severe in the ionic group than in the nonionic group (p less than .005). A patient questionnaire disclosed that many patients did not feel well for hours to days after the procedure and also did not immediately resume normal activities of daily living. The nonionic agent was significantly less distressful than the ionic agent. We conclude that nonionic agents cause fewer and less severe adverse effects. Reducing adverse effects can save the patient or the examining site either time or money. However, this study does not show that nonionic agents are more cost-effective than ionic agents.

摘要

在三个相似时间段内开展了一项关于离子型和非离子型造影剂不良反应的多中心研究。1985年,在食品药品管理局批准非离子型造影剂之前,6006例连续患者接受静脉注射离子型造影剂用于尿路造影或CT检查。在非离子型造影剂获批后,对7170例因相同检查前来就诊的连续患者进行了研究。两组患者存在显著差异,但差异较小且并非一致地有利于任何一组。接受离子型造影剂的患者中不良反应发生率显著高于非离子型组(4.17% 对0.69%,p<0.001)。离子型组的反应也比非离子型组更严重(p<0.005)。一份患者调查问卷显示,许多患者在检查后的数小时至数天内感觉不适,并且也没有立即恢复正常的日常生活活动。非离子型造影剂引起的不适明显少于离子型造影剂。我们得出结论,非离子型造影剂引起的不良反应更少且更轻。减少不良反应可为患者或检查机构节省时间或金钱。然而,本研究并未表明非离子型造影剂比离子型造影剂更具成本效益。

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